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What Is a Case Study?

An in-depth study of one person, group, or event

Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

Benefits and Limitations

Types of case studies, how to write a case study.

A case study is an in-depth study of one person, group, or event. In a case study, nearly every aspect of the subject's life and history is analyzed to seek patterns and causes of behavior. Case studies can be used in various fields, including psychology, medicine, education, anthropology, political science, and social work.

The purpose of a case study is to learn as much as possible about an individual or group so that the information can be generalized to many others. Unfortunately, case studies tend to be highly subjective, and it is sometimes difficult to generalize results to a larger population.

While case studies focus on a single individual or group, they follow a format similar to other types of psychology writing. If you are writing a case study, it is important to follow the rules of APA format .  

A case study can have both strengths and weaknesses. Researchers must consider these pros and cons before deciding if this type of study is appropriate for their needs.

One of the greatest advantages of a case study is that it allows researchers to investigate things that are often difficult to impossible to replicate in a lab. Some other benefits of a case study:

• Allows researchers to collect a great deal of information
• Give researchers the chance to collect information on rare or unusual cases
• Permits researchers to develop hypotheses that can be explored in experimental research

On the negative side, a case study:

• Cannot necessarily be generalized to the larger population
• Cannot demonstrate cause and effect
• May not be scientifically rigorous
• Can lead to bias

Researchers may choose to perform a case study if they are interested in exploring a unique or recently discovered phenomenon. The insights gained from such research can help the researchers develop additional ideas and study questions that might be explored in future studies.

However, it is important to remember that the insights gained from case studies cannot be used to determine cause and effect relationships between variables. However, case studies may be used to develop hypotheses that can then be addressed in experimental research.

Case Study Examples

There have been a number of notable case studies in the history of psychology. Much of  Freud's work and theories were developed through the use of individual case studies. Some great examples of case studies in psychology include:

• Anna O : Anna O. was a pseudonym of a woman named Bertha Pappenheim, a patient of a physician named Josef Breuer. While she was never a patient of Freud's, Freud and Breuer discussed her case extensively. The woman was experiencing symptoms of a condition that was then known as hysteria and found that talking about her problems helped relieve her symptoms. Her case played an important part in the development of talk therapy as an approach to mental health treatment.
• Phineas Gage : Phineas Gage was a railroad employee who experienced a terrible accident in which an explosion sent a metal rod through his skull, damaging important portions of his brain. Gage recovered from his accident but was left with serious changes in both personality and behavior.
• Genie : Genie was a young girl subjected to horrific abuse and isolation. The case study of Genie allowed researchers to study whether language could be taught even after critical periods for language development had been missed. Her case also served as an example of how scientific research may interfere with treatment and lead to further abuse of vulnerable individuals.

Such cases demonstrate how case research can be used to study things that researchers could not replicate in experimental settings. In Genie's case, her horrific abuse had denied her the opportunity to learn language at critical points in her development.

This is clearly not something that researchers could ethically replicate, but conducting a case study on Genie allowed researchers the chance to study phenomena that are otherwise impossible to reproduce.

There are a few different types of case studies that psychologists and other researchers might utilize:

• Collective case studies : These involve studying a group of individuals. Researchers might study a group of people in a certain setting or look at an entire community. For example, psychologists might explore how access to resources in a community has affected the collective mental well-being of those living there.
• Descriptive case studies : These involve starting with a descriptive theory. The subjects are then observed, and the information gathered is compared to the pre-existing theory.
• Explanatory case studies : These   are often used to do causal investigations. In other words, researchers are interested in looking at factors that may have caused certain things to occur.
• Exploratory case studies : These are sometimes used as a prelude to further, more in-depth research. This allows researchers to gather more information before developing their research questions and hypotheses .
• Instrumental case studies : These occur when the individual or group allows researchers to understand more than what is initially obvious to observers.
• Intrinsic case studies : This type of case study is when the researcher has a personal interest in the case. Jean Piaget's observations of his own children are good examples of how an intrinsic cast study can contribute to the development of a psychological theory.

The three main case study types often used are intrinsic, instrumental, and collective. Intrinsic case studies are useful for learning about unique cases. Instrumental case studies help look at an individual to learn more about a broader issue. A collective case study can be useful for looking at several cases simultaneously.

The type of case study that psychology researchers utilize depends on the unique characteristics of the situation as well as the case itself.

There are also different methods that can be used to conduct a case study, including prospective and retrospective case study methods.

Prospective case study methods are those in which an individual or group of people is observed in order to determine outcomes. For example, a group of individuals might be watched over an extended period of time to observe the progression of a particular disease.

Retrospective case study methods involve looking at historical information. For example, researchers might start with an outcome, such as a disease, and then work their way backward to look at information about the individual's life to determine risk factors that may have contributed to the onset of the illness.

Where to Find Data

There are a number of different sources and methods that researchers can use to gather information about an individual or group. Six major sources that have been identified by researchers are:

• Archival records : Census records, survey records, and name lists are examples of archival records.
• Direct observation : This strategy involves observing the subject, often in a natural setting . While an individual observer is sometimes used, it is more common to utilize a group of observers.
• Documents : Letters, newspaper articles, administrative records, etc., are the types of documents often used as sources.
• Interviews : Interviews are one of the most important methods for gathering information in case studies. An interview can involve structured survey questions or more open-ended questions.
• Participant observation : When the researcher serves as a participant in events and observes the actions and outcomes, it is called participant observation.
• Physical artifacts : Tools, objects, instruments, and other artifacts are often observed during a direct observation of the subject.

Section 1: A Case History

This section will have the following structure and content:

Background information : The first section of your paper will present your client's background. Include factors such as age, gender, work, health status, family mental health history, family and social relationships, drug and alcohol history, life difficulties, goals, and coping skills and weaknesses.

Description of the presenting problem : In the next section of your case study, you will describe the problem or symptoms that the client presented with.

Describe any physical, emotional, or sensory symptoms reported by the client. Thoughts, feelings, and perceptions related to the symptoms should also be noted. Any screening or diagnostic assessments that are used should also be described in detail and all scores reported.

Your diagnosis : Provide your diagnosis and give the appropriate Diagnostic and Statistical Manual code. Explain how you reached your diagnosis, how the client's symptoms fit the diagnostic criteria for the disorder(s), or any possible difficulties in reaching a diagnosis.

Section 2: Treatment Plan

This portion of the paper will address the chosen treatment for the condition. This might also include the theoretical basis for the chosen treatment or any other evidence that might exist to support why this approach was chosen.

• Cognitive behavioral approach : Explain how a cognitive behavioral therapist would approach treatment. Offer background information on cognitive behavioral therapy and describe the treatment sessions, client response, and outcome of this type of treatment. Make note of any difficulties or successes encountered by your client during treatment.
• Humanistic approach : Describe a humanistic approach that could be used to treat your client, such as client-centered therapy . Provide information on the type of treatment you chose, the client's reaction to the treatment, and the end result of this approach. Explain why the treatment was successful or unsuccessful.
• Psychoanalytic approach : Describe how a psychoanalytic therapist would view the client's problem. Provide some background on the psychoanalytic approach and cite relevant references. Explain how psychoanalytic therapy would be used to treat the client, how the client would respond to therapy, and the effectiveness of this treatment approach.
• Pharmacological approach : If treatment primarily involves the use of medications, explain which medications were used and why. Provide background on the effectiveness of these medications and how monotherapy may compare with an approach that combines medications with therapy or other treatments.

This section of a case study should also include information about the treatment goals, process, and outcomes.

When you are writing a case study, you should also include a section where you discuss the case study itself, including the strengths and limitiations of the study. You should note how the findings of your case study might support previous research. 

In your discussion section, you should also describe some of the implications of your case study. What ideas or findings might require further exploration? How might researchers go about exploring some of these questions in additional studies?

Here are a few additional pointers to keep in mind when formatting your case study:

• Never refer to the subject of your case study as "the client." Instead, their name or a pseudonym.
• Read examples of case studies to gain an idea about the style and format.
• Remember to use APA format when citing references .

A Word From Verywell

Case studies can be a useful research tool, but they need to be used wisely. In many cases, they are best utilized in situations where conducting an experiment would be difficult or impossible. They are helpful for looking at unique situations and allow researchers to gather a great deal of information about a specific individual or group of people.

If you have been directed to write a case study for a psychology course, be sure to check with your instructor for any specific guidelines that you are required to follow. If you are writing your case study for professional publication, be sure to check with the publisher for their specific guidelines for submitting a case study.

Simply Psychology. Case Study Method .

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach . BMC Med Res Methodol . 2011 Jun 27;11:100. doi:10.1186/1471-2288-11-100

Gagnon, Yves-Chantal.  The Case Study as Research Method: A Practical Handbook . Canada, Chicago Review Press Incorporated DBA Independent Pub Group, 2010.

Yin, Robert K. Case Study Research and Applications: Design and Methods . United States, SAGE Publications, 2017.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

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What the Case Study Method Really Teaches

• Nitin Nohria

Seven meta-skills that stick even if the cases fade from memory.

It’s been 100 years since Harvard Business School began using the case study method. Beyond teaching specific subject matter, the case study method excels in instilling meta-skills in students. This article explains the importance of seven such skills: preparation, discernment, bias recognition, judgement, collaboration, curiosity, and self-confidence.

During my decade as dean of Harvard Business School, I spent hundreds of hours talking with our alumni. To enliven these conversations, I relied on a favorite question: “What was the most important thing you learned from your time in our MBA program?”

Alumni responses varied but tended to follow a pattern. Almost no one referred to a specific business concept they learned. Many mentioned close friendships or the classmate who became a business or life partner. Most often, though, alumni highlighted a personal quality or skill like “increased self-confidence” or “the ability to advocate for a point of view” or “knowing how to work closely with others to solve problems.” And when I asked how they developed these capabilities, they inevitably mentioned the magic of the case method.

Harvard Business School pioneered the use of case studies to teach management in 1921. As we commemorate 100 years of case teaching, much has been  written  about the effectiveness of this method. I agree with many of these observations. Cases expose students to real business dilemmas and decisions. Cases teach students to size up business problems quickly while considering the broader organizational, industry, and societal context. Students recall concepts better when they are set in a case, much as people remember words better when used in context. Cases teach students how to apply theory in practice and how to induce theory from practice. The case method cultivates the capacity for critical analysis, judgment, decision-making, and action.

There is a word that aptly captures the broader set of capabilities our alumni reported they learned from the case method. That word is meta-skills, and these meta-skills are a benefit of case study instruction that those who’ve never been exposed to the method may undervalue.

Educators define meta-skills as a group of long-lasting abilities that allow someone to learn new things more quickly. When parents encourage a child to learn to play a musical instrument, for instance, beyond the hope of instilling musical skills (which some children will master and others may not), they may also appreciate the benefit the child derives from deliberate, consistent practice. This meta-skill is valuable for learning many other things beyond music.

In the same vein, let me suggest seven vital meta-skills students gain from the case method:

1. Preparation

There is no place for students to hide in the moments before the famed “cold call”— when the teacher can ask any student at random to open the case discussion. Decades after they graduate, students will vividly remember cold calls when they, or someone else, froze with fear, or when they rose to nail the case even in the face of a fierce grilling by the professor.

The case method creates high-powered incentives for students to prepare. Students typically spend several hours reading, highlighting, and debating cases before class, sometimes alone and sometimes in groups. The number of cases to be prepared can be overwhelming by design.

Learning to be prepared — to read materials in advance, prioritize, identify the key issues, and have an initial point of view — is a meta-skill that helps people succeed in a broad range of professions and work situations. We have all seen how the prepared person, who knows what they are talking about, can gain the trust and confidence of others in a business meeting. The habits of preparing for a case discussion can transform a student into that person.

2. Discernment

Many cases are long. A typical case may include history, industry background, a cast of characters, dialogue, financial statements, source documents, or other exhibits. Some material may be digressive or inessential. Cases often have holes — critical pieces of information that are missing.

The case method forces students to identify and focus on what’s essential, ignore the noise, skim when possible, and concentrate on what matters, meta-skills required for every busy executive confronted with the paradox of simultaneous information overload and information paucity. As one alumnus pithily put it, “The case method helped me learn how to separate the wheat from the chaff.”

3. Bias Recognition

Students often have an initial reaction to a case stemming from their background or earlier work and life experiences. For instance, people who have worked in finance may be biased to view cases through a financial lens. However, effective general managers must understand and empathize with various stakeholders, and if someone has a natural tendency to favor one viewpoint over another, discussing dozens of cases will help reveal that bias. Armed with this self-understanding, students can correct that bias or learn to listen more carefully to classmates whose different viewpoints may help them see beyond their own biases.

Recognizing and correcting personal bias can be an invaluable meta-skill in business settings when leaders inevitably have to work with people from different functions, backgrounds, and perspectives.

4. Judgment

Cases put students into the role of the case protagonist and force them to make and defend a decision. The format leaves room for nuanced discussion, but not for waffling: Teachers push students to choose an option, knowing full well that there is rarely one correct answer.

Indeed, most cases are meant to stimulate a discussion rather than highlight effective or ineffective management practice. Across the cases they study, students get feedback from their classmates and their teachers about when their decisions are more or less compelling. It enables them to develop the judgment of making decisions under uncertainty, communicating that decision to others, and gaining their buy-in — all essential leadership skills. Leaders earn respect for their judgment. It is something students in the case method get lots of practice honing.

5. Collaboration

It is better to make business decisions after extended give-and-take, debate, and deliberation. As in any team sport, people get better at working collaboratively with practice. Discussing cases in small study groups, and then in the classroom, helps students practice the meta-skill of collaborating with others. Our alumni often say they came away from the case method with better skills to participate in meetings and lead them.

Orchestrating a good collaborative discussion in which everyone contributes, every viewpoint is carefully considered, yet a thoughtful decision is made in the end is the arc of any good case discussion. Although teachers play the primary role in this collaborative process during their time at the school, it is an art that students of the case method internalize and get better at when they get to lead discussions.

6. Curiosity

Cases expose students to lots of different situations and roles. Across cases, they get to assume the role of entrepreneur, investor, functional leader, or CEO, in a range of different industries and sectors. Each case offers an opportunity for students to see what resonates with them, what excites them, what bores them, which role they could imagine inhabiting in their careers.

Cases stimulate curiosity about the range of opportunities in the world and the many ways that students can make a difference as leaders. This curiosity serves them well throughout their lives. It makes them more agile, more adaptive, and more open to doing a wider range of things in their careers.

7. Self-Confidence

Students must inhabit roles during a case study that far outstrip their prior experience or capability, often as leaders of teams or entire organizations in unfamiliar settings. “What would you do if you were the case protagonist?” is the most common question in a case discussion. Even though they are imaginary and temporary, these “stretch” assignments increase students’ self-confidence that they can rise to the challenge.

In our program, students can study 500 cases over two years, and the range of roles they are asked to assume increases the range of situations they believe they can tackle. Speaking up in front of 90 classmates feels risky at first, but students become more comfortable taking that risk over time. Knowing that they can hold their own in a highly curated group of competitive peers enhances student confidence. Often, alumni describe how discussing cases made them feel prepared for much bigger roles or challenges than they’d imagined they could handle before their MBA studies. Self-confidence is difficult to teach or coach, but the case study method seems to instill it in people.

There may well be other ways of learning these meta-skills, such as the repeated experience gained through practice or guidance from a gifted coach. However, under the direction of a masterful teacher, the case method can engage students and help them develop powerful meta-skills like no other form of teaching. This quickly became apparent when case teaching was introduced in 1921 — and it’s even truer today.

For educators and students, recognizing the value of these meta-skills can offer perspective on the broader goals of their work together. Returning to the example of piano lessons, it may be natural for a music teacher or their students to judge success by a simple measure: Does the student learn to play the instrument well? But when everyone involved recognizes the broader meta-skills that instrumental instruction can instill — and that even those who bumble their way through Bach may still derive lifelong benefits from their instruction — it may lead to a deeper appreciation of this work.

For recruiters and employers, recognizing the long-lasting set of benefits that accrue from studying via the case method can be a valuable perspective in assessing candidates and plotting their potential career trajectories.

And while we must certainly use the case method’s centennial to imagine yet more powerful ways of educating students in the future, let us be sure to assess these innovations for the meta-skills they might instill, as much as the subject matter mastery they might enable.

• Nitin Nohria is a professor and former dean at Harvard Business School and the chairman of Thrive Capital, a venture capital firm based in New York.

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Top 40 Most Popular Case Studies of 2021

Two cases about Hertz claimed top spots in 2021's Top 40 Most Popular Case Studies

Two cases on the uses of debt and equity at Hertz claimed top spots in the CRDT’s (Case Research and Development Team) 2021 top 40 review of cases.

Hertz (A) took the top spot. The case details the financial structure of the rental car company through the end of 2019. Hertz (B), which ranked third in CRDT’s list, describes the company’s struggles during the early part of the COVID pandemic and its eventual need to enter Chapter 11 bankruptcy. 

The success of the Hertz cases was unprecedented for the top 40 list. Usually, cases take a number of years to gain popularity, but the Hertz cases claimed top spots in their first year of release. Hertz (A) also became the first ‘cooked’ case to top the annual review, as all of the other winners had been web-based ‘raw’ cases.

Besides introducing students to the complicated financing required to maintain an enormous fleet of cars, the Hertz cases also expanded the diversity of case protagonists. Kathyrn Marinello was the CEO of Hertz during this period and the CFO, Jamere Jackson is black.

Sandwiched between the two Hertz cases, Coffee 2016, a perennial best seller, finished second. “Glory, Glory, Man United!” a case about an English football team’s IPO made a surprise move to number four.  Cases on search fund boards, the future of malls,  Norway’s Sovereign Wealth fund, Prodigy Finance, the Mayo Clinic, and Cadbury rounded out the top ten.

Other year-end data for 2021 showed:

• Online “raw” case usage remained steady as compared to 2020 with over 35K users from 170 countries and all 50 U.S. states interacting with 196 cases.
• Fifty four percent of raw case users came from outside the U.S..
• The Yale School of Management (SOM) case study directory pages received over 160K page views from 177 countries with approximately a third originating in India followed by the U.S. and the Philippines.
• Twenty-six of the cases in the list are raw cases.
• A third of the cases feature a woman protagonist.
• Orders for Yale SOM case studies increased by almost 50% compared to 2020.
• The top 40 cases were supervised by 19 different Yale SOM faculty members, several supervising multiple cases.

CRDT compiled the Top 40 list by combining data from its case store, Google Analytics, and other measures of interest and adoption.

All of this year’s Top 40 cases are available for purchase from the Yale Management Media store .

And the Top 40 cases studies of 2021 are:

1.   Hertz Global Holdings (A): Uses of Debt and Equity

2.   Coffee 2016

3.   Hertz Global Holdings (B): Uses of Debt and Equity 2020

4.   Glory, Glory Man United!

5.   Search Fund Company Boards: How CEOs Can Build Boards to Help Them Thrive

6.   The Future of Malls: Was Decline Inevitable?

7.   Strategy for Norway's Pension Fund Global

8.   Prodigy Finance

9.   Design at Mayo

10. Cadbury

11. City Hospital Emergency Room

13. Volkswagen

14. Marina Bay Sands

15. Shake Shack IPO

16. Mastercard

17. Netflix

18. Ant Financial

19. AXA: Creating the New CR Metrics

20. IBM Corporate Service Corps

21. Business Leadership in South Africa's 1994 Reforms

22. Alternative Meat Industry

23. Children's Premier

24. Khalil Tawil and Umi (A)

25. Palm Oil 2016

26. Teach For All: Designing a Global Network

27. What's Next? Search Fund Entrepreneurs Reflect on Life After Exit

28. Searching for a Search Fund Structure: A Student Takes a Tour of Various Options

30. Project Sammaan

31. Commonfund ESG

32. Polaroid

33. Connecticut Green Bank 2018: After the Raid

34. FieldFresh Foods

35. The Alibaba Group

36. 360 State Street: Real Options

37. Herman Miller

38. AgBiome

39. Nathan Cummings Foundation

40. Toyota 2010

A Framework to Guide Selection of Chemical Alternatives (2014)

Chapter: 12 case studies.

Case Studies

To illustrate how the committee’s framework can be applied, two case studies are presented in this chapter. The case studies represent different users in contrasting decision contexts with diverse priorities. Case Study 1 was written from the perspective of a fictitious manufacturing company with limited expertise. Case Study 2 is intended to demonstrate how new types of data can be used by a company with sufficient scientific resources.

CASE STUDY 1: CHEMICAL SUBSTITUTION OF A RESTRICTED SUBSTANCE (decaBDE)

In Case Study 1, we present a scenario where the use of a substance, the flame retardant decabromodiphenyl ether (decaBDE), is restricted through regulation, and an alternative must be selected from available chemical and material options that have a range of trade-offs. This case study was written from the perspective of a fictitious company—KayDisplay, a small U.S. manufacturer of specialty displays for retail kiosks. In this scenario, the company wants to expand its market by selling products in the European Union (EU), but its current products contain a substance (decaBDE) that is restricted in the EU and is being phased out in the United States (EPA 2012g). This case study illustrates how a chemical alternatives assessment was conducted by a single company as part of an internal feasibility study to determine whether there are alternatives to using materials with decaBDE in order to be able to sell their products in the EU.

While considering this case study, it is important to note that:

• KayDisplay is a fictitious corporate entity, and has been envisioned as a small company headquartered in Washington State, with limited in-house expertise in chemistry, material sciences, and toxicology.
• The chemical alternatives assessment reflects the internal effort of a single company, and not the more extensive assessments that might be expected of regulators facilitating a multistakeholder review of a substance prior to regulatory action.
• Conducting a meaningful chemical alternatives assessment and implementing an informed substitution at a smaller company, like KayDisplay, can only be successful when published information is available. In this particular case, KayDisplay has access to recent multistakeholder and regulator-created alternatives assessments from which to draw.
• The use of tools or modules in this case study should not be interpreted as committee endorsement. Instead, these tools should be viewed as plausible options for an entity to use in this situation.
• The committee’s framework will be applied through Step 7 (comparative chemical hazard assessment) and context-dependent steps (Step 8 and beyond) will be described narratively.
• Alternatives to decaBDE have been studied extensively, so this scenario offers a relatively data-rich case through which to demonstrate the committee’s framework.

Steps 1- 4 of the Committee’s Framework

Step 1: Identify Chemical of Concern

The substance of interest for this assessment is the brominated flame retardant decabromodiphenyl ether (decaBDE). EU legislation restricts the use of certain hazardous substances in electrical and electronic equipment (EC 2003), including decaBDE, and KayDisplay’s kiosk displays would be regulated under Restriction of Hazardous Substances (RoHS, Directive 2002/95/EC), if the company were to place these products on the market in the EU.

Step 2: Scoping and Problem Formulation

Electronic hardware put on the market in the EU cannot contain decaBDE or other polybrominated biphenyl ethers (PBDEs) at levels in

excess of 1000 ppm in any homogenous material found in the product. As designed, the KayDisplay enclosure is made of a low- gloss blend of polyphenylene ether and high-impact polystyrene (PPE/HIPS), with 15%wt decaBDE added to meet UL V-0 flammability rating requirements.

Step 2a: Scoping

Identify Stakeholders and Determine Their Role

The IC2 includes a “Stakeholder Involvement Module,” which KayDisplay will use to consider potential stakeholders. As a small firm, KayDisplay is unable to directly contact regulators, governments, or nongovernment organizations, but will consult with key executives and technical experts within the company, relevant suppliers, and customers. Initial input from stakeholders includes:

• Company representatives: Senior leadership and executives support eliminating decaBDE to expand the company’s market to the EU. They support selecting alternatives that are not expected to be restricted in the future as long as they are technically and economically feasible. They do not need to be involved in technical or context-dependent assessments, but must approve the final decision.
• Technical experts : The primary person responsible for conducting this assessment is the mechanical designer of the enclosure because she is responsible for selecting the material for the parts. Other internal stakeholders will be consulted, including the product managers, procurement engineers, manufacturing engineers, regulatory compliance experts, and product marketing. These inputs will be noted when relevant.
• Supply chain: The direct supplier of the plastic enclosure will be consulted to identify potential alternatives and to provide input on performance and economic issues. The supplier does not want to lose KayDisplay as a customer, but the supplier is sensitive to cost and therefore not willing to acquire new capital equipment to support a change.
• Customers: KayDisplay’s products are sold to companies that assemble kiosks for retail sales (business to business). Key customers in the U.S. were consulted, along with potential EU customers. U.S. customers were most interested in maintaining fire safety and avoiding cost increases. Potential EU customers expect safe, RoHS-compliant products containing no decaBDE, and would prefer that the product qualify for an ecolabel. One ecolabel of interest to KayDisplay’s potential customers is the Total Cost of Ownership (TCO), a European sustainability certification for information technology products, including displays. Products must meet several requirements to be TCO certified, including a requirement that plastic parts weighing more than 25 grams must not contain flame retardants or plasticizers with organically bound bromine or chlorine (TCO Development AB 2012).

Goals, Principles, Decision Rules and Constraints

As a small company in a competitive market, KayDisplay is under significant cost pressure, so it must minimize cost increases. However, the company understands that the current solution is highly cost-optimized, so it may not be possible to bring in a new material or design at cost parity. If there must be a material or process cost increase to meet the new requirement, the company will favor alternatives that offer a performance or aesthetic improvement, which could potentially be used to market the product at a higher price point to compensate. KayDisplay would prefer to use the same design for both the U.S. and EU markets to minimize costs and to increase inventory flexibility.

Based on EU customers’ heightened interest in health and environmental issues, as well as executive support for reducing the risk of future regulations, the product team will attempt to include options that could meet the criteria to earn TCO Display 6.0 certification. However, if cost targets cannot be met within the ecolabel requirements, RoHS-compliant halogenated alternatives may also be considered.

KayDisplay has not conducted a formal alternatives assessment before and has no established principles or policies to guide the assessment. Through an internet search, it was able to locate several sets of principles from which to choose. The product team found a set that aligned with company values and included reducing hazard, minimizing exposure, using the best available information, requiring disclosure and transparency, resolving trade-offs, and taking action. The company will use a “missing data neutral” approach and not assume missing data would receive either the worst or best possible score for an end point or criterion.

As a small company, KayDisplay relies on guidance from outside experts to complete some of

FIGURE 12-1 Chemical structure of decabromodiphenyl ether (decaBDE), CAS number 1163-19-5.

the analyses in the chemical alternatives assessment because it does not have experts on certain tools or methods on staff.

Step 2b: Problem Formulation

Gather Information on Chemical of Interest

Since KayDisplay does not have a chemist or toxicologist on staff, the company is dependent upon published information to gather information about the substance of interest. Fortunately, decaBDE has been studied extensively. The team was able to gather the following information about decaBDE:

Identifying the Chemical. DecaBDE has been identified and described in previous publications. According to Lassen et al. (2006):

• “DecaBDE is a polybrominated diphenyl ether (PBDEs), a group of aromatic brominated compounds in which one to ten hydrogens in the diphenyl oxide structure are replaced by bromine.”
• “Decabromodiphenyl ether, or Deca-BDE, as indicated by the name, has ten bromine atoms attached to the diphenyl oxide structure and a bromine content of 82%-83%. It is used as a flame retardant” ( Figure 12-1 ).
• “The CAS No (chemical identification number) of decabromodiphenyl ether is 1163-19-5. The substance is also known as decabromodiphenyl oxide (DBDO) or bis(pentabromophenyl) ether.”
• “Three different PBDEs have been commonly commercially available. They are referred to as penta-, octa-, and decabromodiphenyl ether, but each product is, in fact, a mixture of brominated diphenyl ethers.”
• The commercial product decaBDE may contain up to 3% of other PBDEs, mostly nonabromodiphenyl ether.

Function and Application and Performance Requirements. DecaBDE is an additive flame retardant:

• Flammability rating: In the U.S., V-0 grade plastics are required for display enclosures. Although the EU has less stringent requirements, the same products will be sold in both markets, so the flammability rating for the alternative materials must be V-0 at 1/16 inch thickness (Lassen et al. 2006).
• Mechanical properties: The alternative must meet or exceed current mechanical properties and performance as listed in the datasheet for the PPE/HIPS resin ( Table 12-1 ).
• Manufacturing: The plastic enclosure parts are injection-molded. Significantly changing the material or using another resin might require new molds. The injection molding supplier would charge KayDisplay for any significant process changes, as well as the non-recurring engineering (NRE) expense of the new molds. Information about the costs associated with mold and process changes are important and would be used for economic analysis. Table 12-2 presents characteristics of the current injection mold process.

TABLE 12-1 Mechanical Properties for the PPE/HIPS Resin Used in KayDisplay’s Kiosks.

TABLE 12-2 Physical Properties for the Injection Mold Process Used by KayDisplay’s Current Supplier

Human Health and Environmental Effects, Exposure Pathways, and Life Cycle Segments.

• Hazards. The human health impacts, environmental impacts, and exposure pathways associated with PBDEs are well established. PBDEs are persistent, they bioaccumulate, and are of high concern to human health because they adversely affect the endocrine (e.g., thyroid) system and neurological development (de Wit 2002). Studies have demonstrated that decaBDE breaks down into more toxic PBDEs through photodegradation, microbial degradation, and metabolism (Rossi and Heine 2007). DecaBDE is an additive flame retardant (not reacted into the polymer molecule), so it can leave the material under certain conditions and enter the environment. People are exposed to PBDEs through inhalation, ingestion and dermal absorption of dust particles in the air where electronic products are installed and used (Johnson-Restrepo and Kannan 2009). Occupational exposure occurs through the same routes, but at higher concentrations at locations producing PBDEs or formulations containing PBDEs, plastic component manufacturing facilities (such as injection molders), and electronics waste recycling and disposal facilities.
• Regulations. Although this assessment is focused on decaBDE as the substance of interest, no other PBDEs can be considered as possible replacements because they are also restricted by the RoHS Directive.

Determining Assessment Methods

For this Case Study, Steps 1 through 7 will be completed in their entirety to demonstrate the framework. Actions planned for Steps 8 through 12 will only be described narratively.

• Step 3 (identify potential alternatives) will be completed through consultation with the current supplier of the plastic injection molded parts and online and offline literature searches.
• Step 5 (assess physicochemical properties) will be completed through literature searches, relying heavily on the EPA’s 2014 DfE report entitled, An Alternatives Assessment for the Flame Retardant Decabromodiphenyl Ether (DecaBDE) and in accordance with guidance provided in Chapter 5 .
• Step 6 (assess human health hazards, assess ecotoxicity, and conduct comparative exposure assessment) will be completed through literature searches, relying heavily on the DfE’s DecaBDE alternatives assessment, as well as guidance presented in Chapters 6 - 8 .
• Step 7 (identify safer alternatives) will be completed using the GreenScreen ® for Safer Chemicals tool, with a preference for choosing alternatives that are Benchmark 2 or better. GreenScreen ® assessments may be supplemented with additional investigations, if needed. Data gaps will be handled in accordance with the GreenScreen ® guidelines.

Step 8 and beyond will not be executed as part of this case study, but to complete the exercise of

fully planning the assessment, the following steps and tools will be selected:

• Step 8 (Life Cycle Thinking) would be completed as described in the “Life Cycle Module” of the IC2. Published life cycle assessments would be used to understand the contribution of the housings to the overall environmental impacts of display products. Findings from Step 8 could trigger additional life cycle investigations (Step 9.1) and/or exposure assessments (Sub-step 6 of Step 6.3).
• Step 9.2 (performance assessment) would be completed by screening materials based on properties on their respective datasheets, by prototyping enclosure parts in the alternative materials, and subjecting the prototype parts to standard inspection and qualification tests. Flammability ratings may be verified. The “Performance Module” of the IC2 may be consulted for additional considerations.
• Step 9.3 (economic assessment) would be completed to assess the internal costs and benefits of different options, including changes in material cost, manufacturing costs and NRE charges, costs of compliance for RoHS (such as analytical testing to prove compliance), costs of certification for the TCO ecolabel, and potential market benefits from improved environmental features (such as having ecolabel certification), performance, and aesthetics. Net present value may be used to evaluate the merits of the proposal to enter the EU market, which is the driving force for eliminating decaBDE. The payback period will be calculated. Externalized costs will not be considered. The “Cost and Availability Module” of the IC2 may be consulted for additional considerations.
• Step 10 (identify acceptable alternatives) would be completed by comparing results of Step 9 to the requirements established in Step 2, and by ensuring that the alternatives had lower overall impact to the environment based on any findings in Step 8 and/or 9.1 (Life Cycle Thinking and additional life cycle assessment). Assessment methods, assumptions, data, results, and conclusions would also be documented.
• Step 11 (comparing) would be accomplished using a comparison summary matrix and weighted ranking of the performance, economic, and environmental criteria for each alternative. The best solution would be selected based on the results of Step 11.
• Step 12 (implementation) would be completed by integrating the implementation plan for the alternative solution into the overall plan for KayDisplay’s entry into the EU market. The list of stakeholders would be reviewed to determine if others needed to be consulted. The alternative would be piloted and then ramped up to volume production, addressing issues as they are identified. Finally, a milestone date would be set to review the implementation and to consider new potential alternatives prior to designing the next model.

Steps 3 and 4: Identify Potential Alternatives and Initial Screening

An extensive list of potential alternatives can be found in the literature, so the KayDisplay mechanical designer grouped the alternatives to narrow the assessment ( Table 12-3 ).

Based on preliminary screening, KayDisplay will primarily consider PPE/HIPS with halogenated and non-halogenated flame retardants and a material change to PC/ABS with non-halogenated flame retardants.

After consulting with the injection molder and conducting online and offline literature searches, the KayDisplay mechanical designer identifies the following options:

• PPE/HIPS with a halogenated flame retardant,
• PPE/HIPS with a non-halogenated flame retardant, and
• PC/ABS with a non-halogenated flame retardant.

To identify potential halogenated and non-halogenated flame retardant alternatives, KayDisplay again refers to the DfE’s DecaBDE Alternatives Assessment (AA) . KayDisplay is able to share the extended list of alternatives in the report with the injection molding supplier. After conferring with the supplier about available resins and comparing the properties in the resins’ technical datasheets to those in Table 12-4 .

Therefore, the chemical alternatives to be evaluated in the assessment are:

• Decabromodiphenyl ethane [DBDPE],
• Antimony trioxide [ATO],
• Resorcinol bis-diphenylphosphate [RDP], and
• Triphenyl phosphate [TPP].

TABLE 12-3 Potential Alternatives

a The option of continuing to use decaBDE at levels below 1000ppm will not be considered because decaBDE is not effective as a flame retardant at that low level.

TABLE 12-4 Remaining Alternatives

a DecaBDE also requires the use of Antimony Trioxide (ATO).

TABLE 12-5 Physicochemical Properties of DecaBDE and Potential Alternatives

Physical State of Chemical (ambient conditions)

Physical state indicates if a chemical substance is a solid, liquid, or gas under ambient conditions, and is determined from the melting and boiling points. Chemicals with a melting point more than 25°C are considered solid. Those with a melting point less than 25°C and a boiling point more than 25°C are considered liquid, and those with a boiling point less than 25°C are considered a gas.

Relevance to exposure: Physical state influences the potential for dermal and inhalation exposure. For solids, there is potential for the inhalation and ingestion of dust particles and dermal contact. For liquids, there is potential for direct dermal contact but not for direct inhalation of the liquid (except in operations that produce aerosols). In the case of these alternatives, all are solid at room temperature except for RDP, but once RDP is blended into a polymer, it has the same exposure potential as a solid, so the assessment will consider the inhalation and ingestion of dust particles and dermal contact in the solid form for all alternatives.

Vapor Pressure

Relevance to exposure: Vapor pressure indicates the potential for a chemical to volatilize into the atmosphere. If a chemical has a vapor pressure leading to volatilization at room temperature or typical environmental conditions, then the chemical may evaporate and present the potential for inhalation of the gas or vapor. For a Design for the Environment (DfE) chemical alternatives assessment, inhalation exposure is assumed to occur if the vapor pressure is greater than 1 × 10 -8 mm Hg. A default value of <10 -8 was assigned for chemicals without data that are anticipated to be non-volatile this is based on EPA HPV assessment guidance (EPA 2011b).

Log K ow (LogP), Water Solubility (mg/L), and dE (eV)

Relevance to bioavailability: Log K ow can be used to evaluate absorption and distribution in biological organisms, potential acute aquatic toxicity by narcosis, and potential general population exposure via ingestion. Generally, chemicals with a Log K ow < 5 are orally bioavailable to mammals; chemicals with logKow < 4 are water soluble and available to aquatic species. LogKow is linearly related to bioaccumulation factor (BAF) up to Log K ow ~ 5, where lower water solubility levels off and bioavailability becomes asymptotic.

Relevance to aquatic toxicity: LogP “usually correlates well with acute aquatic toxicity. For non-ionic organic chemicals that are toxic through narcosis, acute and chronic toxicity increases exponentially with increases in logP up to a value of about 5-7” (Voutchkova et al. 2011). Chemicals with logP <2 have higher probability of having low acute and chronic aquatic toxicity (Voutchkova et al. 2011).

Relevance to environmental transport: Chemicals with a high Log K ow also tend to bind strongly to soil and sediment.

Log K ow cannot be measured for inorganic substances, polymers, and other materials that are not soluble in either water or octanol. This is indicated in the table with “No data.”

Water solubility indicates the potential of a chemical to dissolve in water and form an aqueous solution. Water soluble chemicals present a higher potential for human exposure through the ingestion of contaminated drinking water (including well water). In general, absorption after oral ingestion of a chemical with water solubility less than 10 -3 mg/L is not expected. Water soluble chemicals are more likely to be transported into groundwater, absorbed through the gastrointestinal tract or lungs, partition to aquatic compartments, and undergo atmospheric removal by rain washout. A substance with water solubility at or below 10 -3 mg/L is considered insoluble.

HOMO-LUMO gap (∆E, eV): The energy separation between the highest occupied and lowest unoccupied molecular orbitals (HOMO–LUMO gap, ∆E) is related to broad chemical reactivity (Fukui et al. 1952). A molecule with a small ∆E is considered

more chemically reactive for covalent bonding than one with a larger ∆E. Chemicals with ∆E > 6.5 eV (as calculated by DFT) are much less likely to be acutely or chronically toxic to aquatic species (Kostal et al. in press; Voutchkova-Kostal et al. 2012). Conclusions:

Aquatic toxicity: DecaBDE and TPP have logP > 2 and ∆E < 6.5 eV, which puts them in the high risk category for high acute and/or chronic aquatic toxicity. DBDPE also has ∆E < 6.5 eV but its high logP value (14) suggests it is not very bioavailable to aquatic species, so is likely to be of low/moderate aquatic toxicity.

Bioaccumulation: DecaBDE and DBDPE is likely to have high tendency to bioaccumulate; TPP will likely have a lower bioaccumulation tendency due to its lower logP and higher water solubility; The likelihood of bioaccumulation for RDP will depend strongly on its dissociation to monomer units in the environment.

Environmental transport: Of the alternatives assessed, DBDPE is likely to bind most strongly to soil and sediment (highest logKow).

NOTE: Most data and text in Table 12-5 are from the DfE DecaBDE AA. However, information in this section is simulated, and presented as if it had been obtained by environmental scientists and chemists at KayDisplay’s resin formulator. All italicized text is taken from EPA 2014i.

Step 5: Assess Physicochemical Properties

The physicochemical properties of decaBDE, DBDPE, ATO, RDP, and TPP are compiled in DfE’s DecaBDE AA and presented in Table 12-5 . KayDisplay does not have chemists or toxicologists on staff, so they will rely on the EPA’s DfE DecaBDE report data and conclusions.

Step 6.1: Assess Human Health (Chemical Hazards)

The human health effects of decaBDE, DBDPE, ATO, RDP, and TPP have been compiled in DfE’s DecaBDE AA. Similar to Step 5, KayDisplay will rely on the determinations published in DfE’s DecaBDE AA because the company does not have chemists or toxicologists on staff to complete comparable work (see Table 12-6 ).

It should be noted that this tabular format is only one way of presenting summary data. There are other approaches, such as ToxPi, which are illustrated in the second case study and in Appendix C .

Step 6.2: Assess Ecotoxicity Hazards

The ecotoxicity effects of decaBDE, DBDPE, ATO, RDP, and TPP have been compiled in DfE’s DecaBDE AA. As in Step 5, KayDisplay will rely on the determinations in the EPA DfE report because the company does not have chemists or toxicologists on staff (see Table 12-7 ).

Although several of the alternatives under consideration (e.g., ATO, RDP) will be found primarily in sediment and soil, the DfE DecaBDE AA only evaluates aquatic toxicity because ecotoxicity data for terrestrial species was limited or completely absent for the chemicals assessed. Therefore, potential for impacts of the alternatives on high trophic level and terrestrial wildlife is unclear and could not be fully assessed.

Step 6.3: Conduct Comparative Exposure Assessment

Human and environmental exposures to decaBDE are described in Section 5.1.5 of DfE’s DecaBDE AA and the EPA report, An Exposure Assessment of Polybrominated Diphenyl Ethers (EPA 2010b). Because the manufacturing process for the enclosure part, the product-use pattern, and end-of-life hardware disposal are expected to be the same for decaBDE and its alternatives, the exposure scenarios and routes will be considered the same for alternatives as for decaBDE, which is consistent with DfE practice (Lavoie et al. 2010).

• Human exposure (occupational) from EPA 2014: “According to the U.S. EPA’s 2010 exposure assessment of polybrominated diphenyl ethers (PBDEs), individuals in occupations that would lead to higher exposures to specific congeners have higher concentrations of PBDE congeners in their blood than the general public (EPA 2010b). Workers involved in the manufacturing or recycling and disposal of products containing PBDE flame retardants have greater exposure to the chemical compared to the general population (Sjodin et al. 1999; Thomsen et al. 2001; Thuresson et al. 2006).”
• Human exposure (consumer/user) from EPA 2014: “Consumer exposure to decaBDE is possible given that it can be released from common home products and become a component in house dust (Stapleton et al. 2004; Takigamie et al. 2008). It is also possible that workers exposed to decaBDE may inadvertently carry particles containing the chemical home with them. This may lead to exposure to family members through household dust or direct contact, as has been proven with other hazardous chemicals such as pesticides and lead (Thompson et al. 2003; Minnesota Department of Health 2010). DecaBDE has been found in dust within automobiles (Lagalante et al. 2009) and automobile air (Mandalakis et al. 2008). The primary route of consumer exposure to decaBDE is through the ingestion of dust or, for infants, ingestion of breast milk, followed by food and water ingestion and dermal absorption (Lorber 2008; Petito Boyce et al. 2009; EPA 2010a). Inhalation may also be a relevant route of exposure (EPA 2010b). Children have higher levels of exposure to decaBDE than do adults (Petito Boyce et al. 2009), likely due to higher hand- to- mouth behavior.” Information about exposure of decaBDE and alternatives is shown on Table 12-8 on toxicokinetics.
• Environmental exposures from EPA 2014i: “Environmental releases of decaBDE can occur during each stage of a product’s life cycle, including chemical manufacturing, product manufacturing, product storage and use, and end-of-life handling (EPA 2009)”. This is expected to be true for alternatives, as well. Tables 12-9 , 12-10 , and 12-11 list persistence, transport, and bioaccumulation levels for decaBDE and alternatives.

TABLE 12-6 Human Health Effects Data from Dfe’s DecBDE Alternatives Assessment

NOTE: VL = Very Low hazard L = Low hazard M = Moderate hazard H = High hazard VH = Very High hazard Endpoints (VL, L, M, H, and VH) were assigned based on empirical data. Endpoints in italics ( VL, L, M, H, and VH ) were assigned using values from predictive models and/or professional judgment. § Based on analogy to experimental data for a structurally similar compound. * Ongoing studies may result in a change in this endpoint. a This compound is included in the ongoing EPA Work Plan evaluation for Antimony Trioxide. SOURCE: Adapted from EPA 2014i.

TABLE 12-7 Ecotoxicity Data from DfE’s Alternatives Assessment

NOTE: VL = Very Low hazard L = Low hazard M = Moderate hazard H = High hazard VH = Very High hazard Endpoints (VL, L, M, H, and VH) were assigned based on empirical data. Endpoints in italics ( VL, L, M, H, and VH ) were assigned using values from predictive models and/or professional judgment. ‡ The highest hazard designation of any of the oligomers with MW <1,000. R Recalcitrant: Substance is comprised of metallic species that will not degrade, but may change oxidation state or undergo complexation processes under environmental conditions. ** Aquatic toxicity: EPA/DfE criteria are based in large part upon water column exposures which may not be adequate for poorly soluble substances such as many flame retardants that may partition to sediment and particulates. a This compound is included in the ongoing EPA Work Plan evaluation for Antimony Trioxide. SOURCE: Adapted from EPA 2014i.

TABLE 12-8 Toxicokinetic Data

Step 7: Identify Safer Alternatives

The combined hazard table for decaBDE, DBDPE, ATO, RDP, and TPP from the DfE’s DecaBDE AA report is shown in Table 12-12 .

“Confidence in the categorization of endpoint hazard levels,” in Section 4.2: Data Sources and Assessment Methodology of the DfE DecaBDe AA, deals with how data were collected, prioritized and reviewed for use in the development of hazard profiles. According to the report, “High-quality experimental studies lead to a thorough understanding of behavior and effects of the chemical in the environment and in living organisms. Analog approaches and SAR-based estimation methods [were] also useful tools and are discussed throughout this section” (EPA 2014i).

KayDisplay recognizes that there are varying levels of confidence (per Chapter 6 ) in the different end point categorizations (vH, H, M, L, vL), and the company understands that measured data are not necessarily higher confidence than models. However the company has insufficient expertise to differentiate the confidence levels, and therefore will assume approximately equal confidence levels for the categorizations of end points for the purpose of this assessment.

• Relative hazards: In reviewing the hazard summary table for the alternatives, KayDisplay finds that DBDPE/ATO shows improvements over decaBDE in repeated dose toxicity and irritation, but not in the original areas of concern (persistence, bioaccumulation, and neurodevelopmental toxicity), nor in transformation products. RDP/ATO shows improvements over decaBDE/ATO in the original areas of concern, but does not offer clear improvements in every impact area, and appears to have higher aquatic toxicity.
• Trade-off resolution: In order to help resolve this trade-off and make a decision, KayDisplay had originally considered applying a scoring scheme. However, the company found that constructing a robust scoring scheme, or chemical ranking and scoring (CRS) system, is difficult and can lead to incorrect conclusions (Davis et al. 1994; Swanson and Socha 1997). For example, if a scoring system assigned each chemical very high (vH) four points, each high (H) three points, each medium (M) two points, each low (L) one point, and each very low (vL) zero points, the results would indicate that a substance with all Ms (score 28) would appear worse than a PBT like decaBDE (score 23) if each end point were

TABLE 12-9 Persistence for DecaBDE and Alternatives

TABLE 12-10 Transport for DecaBDE and Alternatives

equally weighted. A weighted scoring scheme could be an improvement, but as noted above, constructing a robust weighted scoring scheme is difficult and would be beyond the capabilities of KayDisplay.

Instead of creating its own system, KayDisplay referred to the “Hazard Assessment Module” of the IC2, which recommends using GreenScreen ® for Safer Chemicals as a way of integrating information across human health and environmental topics (Clean Production Action 2014).

The GreenScreen ® benchmark scoring system uses structured decision logic to assign a single integer score to each chemical being assessed. This scheme incorporates national and international precedents to weigh and prioritize combinations of hazard end points.

The GreenScreen ® defines four hazard levels for substances:

• Benchmark 1 — “Avoid - Chemical of High Concern”

TABLE 12-11 Bioaccumulation for DecaBDE and Alternatives

• Benchmark 2 — “Use but Search for Safer Substitutes”
• Benchmark 3 — “Use but Still Opportunity for Improvement”
• Benchmark 4 — “Prefer - Safer Chemical”

“Each benchmark includes a set of criteria that a chemical, along with its known and predicted transformation products, must pass” (Rossi and Heine 2007). For example, if a chemical met any of the following criteria, it would be classified as “Benchmark 1:

• a. PBT = High P + High B + [very High T (Ecotoxicity or Group II Human) or High T (Group I or II* Human)]
• b. vPvB = very High P + very High B
• c. vPT = very High P + [very High T (Ecotoxicity or Group II Human) or High T (Group I or II* Human)]
• d. vBT = very High B + [very High T (Ecotoxicity or Group II Human) or High T (Group I or II* Human)]
• e. High T (Group I Human)” (Clean Production Action 2011)

The criteria for each benchmark become progressively more demanding, with Benchmark 4 representing the most preferred (least hazardous) chemicals.

GreenScreen ® attempts to use all available data, including analogs, models, and expert judgment, to assess end points. It has a hierarchy of data adequacy to establish whether the hazard data were of sufficient quality to meet the requirements of the assessment process. End points with insufficient information to assess the hazard are assigned a data gap (DG). There are also minimum datasets which, if not met, will either lower the score or result in the chemical receiving a rating of “U,” denoting that there is insufficient data to enable evaluation. This is consistent with KayDisplay’s choice in Step 2 to be labeled, “missing data neutral.”

As noted above, KayDisplay does not have chemists or toxicologists on staff, and therefore cannot complete GreenScreen ® in-house. However, GreenScreen ® is aligned with the DfE hazard criteria, and the Clean Production Action has published draft benchmark scores for many of the substances in the DfE DecaBDE AA (see Table 12-11 ).

Based on the GreenScreen ® scores, RDP (Benchmark 2) with TPP (Benchmark 2) appears safer than DecaBDE (Benchmark 1) or DBDPE (Benchmark 1) with ATO (Benchmark 1). However, KayDisplay headquarters are located in Washington State, where water issues are of the highest priority, so the company will further investigate the potential aquatic toxicity of RDP/TPP.

KayDisplay was able to contact the chemical supplier of RDP, and the team learned that commercial formulations of RDP, which contain TPP contamination (<5%), have been subjected to acute ecotoxicity testing, and that the commercial mixture shows no toxicity at the maximum water solubility level, using what is called the Water Accommodated Fraction (WAF) methodology in accordance with OECD guidance. Although RDP/TPP will most likely sequester in sediments, tests using aquatic organisms as surrogates indicate that concerns with water issues are minimal and, for this application it appears to be acceptable.

Based on these analyses, KayDisplay concludes that alternatives based on RDP/TPP meet the requirement of being safer than those based on the original DecaBDE/ATO, so RDP/TPP alternatives will be evaluated further. Alternatives based on DBDPE/ATO (Benchmark 1) will not be evaluated further because DBDPE/ATO is only minimally safer than the original DecaBDE/ATO and does not meet the goal of being Benchmark 2 or better.

Once alternatives based on DBDPE/ATO have been eliminated, the remaining alternatives are:

• PPE/HIPS with RDP/TPP
• PC/ABS with RDP/TPP

Both alternatives meet the ecolabel requirement. However, the PPE/HIPS option with RDP/TPP offers a lower cost, but may not meet flammability and performance targets. In contrast, the PC/ABS option with RDP/TPP costs more, but is likely to meet flammability requirements and offer performance and aesthetic benefits. It is clear that additional assessments must be completed to select and implement a single alternative.

As noted earlier, Steps 8- 13 will not be completed as part of this case study.

TABLE 12-12 Combined Hazard Table from DfE Alternatives Analysis

NOTE: VL = Very Low hazard L = Low hazard M = Moderate hazard H = High hazard VH = Very High hazard Endpoints (VL, L, M, H, and VH) were assigned based on empirical data. Endpoints in italics ( VL, L, M, H, and VH ) were assigned using values from predictive models and/or professional judgment. § Based on analogy to experimental data for a structurally similar compound. * This alternative may contain impurities. These impurities have hazard designations that differ from the flame retardant alternative, Brominated poly(phenylether), as follows, based on experimental data: HIGH for human health, HIGH for aquatic toxicity, VERY HIGH for bioaccumulation, and VERY HIGH for persistence. This chemical is subject to testing in an EPA consent order for this endpoint. * Ongoing studies may result in a change in this endpoint. ‡ The highest hazard designation of any of the oligomers with MW <1,000.

R Recalcitrant: Substance is comprised of metallic species that will not degrade, but may change oxidation state or undergo complexation processes under environmental conditions.

** Aquatic toxicity: EPA/DfE criteria are based in large part upon water column exposures which may not be adequate for poorly soluble substances such as many flame retardants that may partition to sediment and particulates.

1 This compound is included in the ongoing EPA Work Plan evaluation for Antimony Trioxide.

SOURCE: EPA 2014i.

TABLE 12-13 Clean Production Action Draft Benchmark Scores

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CASE STUDY 2: CHEMICAL SUBSTITUTION OF A HAZARDOUS BIOLOGICALLY ACTIVE COMPOUND (GLITAZONE)

In this case study, an alternatives assessment will be performed on three chemicals that were originally developed as pharmaceutical agents. The rationale for choosing this example was driven in part by the committee’s statement of task requiring examples demonstrating “how high throughput and high content data streams could inform assessment of potentially safer substitutes early in the chemical development process” (see Chapter 1 ). This case study was specifically intended to illustrate how in silico and in vitro high throughput screening (HTS) data, animal toxicity data, and human health outcome data can be used to assess potential hazards associated with a chemical substitution.

When considering this case study, it is important to note the following:

• This case study represents a hypothetical situation where there is a need to find a substitution for a biologically active ingredient that has been identified to cause severe liver injury. This was the result of accidental ingestion by humans during or after the use of the product containing this active ingredient.
• Although based on a real-life historical problem, the presentation of data has been adapted to illustrate the use of the committee’s framework. The approach shown is for illustration purposes only and is not intended as a commentary on any drug development or regulatory process.
• Many of the comparisons made here are based on data and knowledge that were not available at the time of regulatory approval for these drugs. The human health observations associated withthese chemicals drove much of the scientific investigation that led to the development of some of the key in vitro assays and their implications for safety that are discussed in this case study.
• This case study is not intended to imply that all chemical alternatives should be held to the same level of stringency (e.g., as commonly used in the development of pharmaceuticals).
• Publicly available data have been used throughout this case study. For example, the mammalian safety assessments for all three chemicals are taken from the original Summary Basis of Approval documents that are publicly available from the FDA through the Freedom of Information Act. These studies were conducted according to Good Laboratory Practice (GLP) guidelines and formed the basis for regulatory approval.

Steps 1- 4 of the Framework

Concerns for human health have been identified with the primary biologically active ingredient, ( RS )-5-(4-[(6-hydroxy-2,5,7,8-tetramethylchroman-2-yl)methoxy]benzyl)thiazolidine-2,4-dione, in a product that is widely used across the world. This ingredient ( Figure 12-2 ) is commonly referred to by its abbreviated trade name, Glitazone-T, and is the chemical of concern in this scenario. Numerous reports of severe liver injury, sometimes fatal, in people exposed to products containing Glitazone-T have come to light, so there is a desire to reduce human exposure, eliminate Glitazone-T from the product, or find an alternative chemical substitute for this active ingredient.

Glitazone-T is the primary biologically-active ingredient in the products in which it is used. The exact mechanism of action of Glitazone-T has not been clearly established, although its stimulatory effect on the peroxisomal proliferator activated receptor gamma (PPARγ) is well known and thought to play a key role in its biological effectiveness. In vitro experiments with Glitazone-T showed that the activity of PPARγ increased by 50% at a concentration of 0.72 µM when tested in transfected HepG2 cells. In 3T3-L1 adipocytes, it was shown to reduce the uptake of 2-deoxyglucose by 50% at a concentration of 2 µM. 51

Regulatory authorities have identified Glitazone-T as having potential adverse effects on human health. Products containing this active ingredient have been linked to numerous cases of severe liver injury, and in some cases, these effects result in fatalities (Watkins and Whitcomb 1998). The bioavailability of Glitazone-T is approximately 58%. Product effectiveness requires relatively high concentrations in the final formulation. As a

_____________

51 Data available from FDA Summary Basis of Approval by FOIA request.

FIGURE 12-2 Chemical structure of Glitazone-T, CAS # 97322-87-7.

consequence, it is estimated that the maximum adult human daily exposure to the active ingredient is approximately 400 mg through the normal use of products containing Glitazone-T. Any proposed alternative must satisfy government bodies and product consumers that it has a substantially improved safety profile for human health.

Other considerations in Step 2 include identification of the following:

• Stakeholders : Relevant internal stakeholder groups include safety experts, chemists, and pharmacologists. External stakeholders include relevant advocacy groups and regulatory agencies. These groups may have differing views on the relative importance of the various aspects of an alternatives assessment, such as the relative weight given to functional performance vs. environmental or human health concerns for any proposed alternative.
• Guiding assumptions and values implicit in the assessment : Avoid persistent, bioaccumulative, and toxic (PBT) chemicals. Whenever possible, the GreenScreen ® for Safer Chemicals® classification system will be used to assign health and ecological hazard ratings.
• Function and performance requirements for the substance of concern and alternatives: Complete removal of Glitazone-T would eliminate any functional use of those products where this active ingredient is included, rendering the product nonviable from an economic perspective. Any alternative must be able to replace the biological activity of Glitazone-T, including activation of PPARγ, which is thought to be critical to the beneficial effects observed from using this class of product.
• Hazards of concern and potential exposure tradeoffs that should be evaluated in the assessment : Alternatives to Glitazone-T must have a lower potential for causing human hepatotoxicity. Ecotoxicity must also be considered, since release of Glitazone-T and its alternatives to wastewater can occur. Because of the beneficial aspects of the product, human health considerations are considered a primary motivation.
• Assessment Steps to be completed : Steps 1-8 and 10 should be completed. Because product use is anticipated to be similar, a comparative Exposure Assessment (Step 6.3) and Life Cycle Thinking (Step 8) should be adequate and the optional Step 9 not needed.
• Identify safer alternatives: In Step 7, assessments of in vivo data will be completed using the GreenScreen ® tool. GreenScreen ® assessments may be supplemented with additional data sources, such in vitro and in silico investigations, if needed. Remaining data gaps will be handled in accordance with the GreenScreen ® guidelines. End points with insufficient information to assess the hazard are assigned a data gap (DG). For illustration purposes, the uncertainty of each in vivo finding will also be considered. 52 Factors used to evaluate parameter uncertainty will include robustness of the data (e.g., multiple studies, multiple species, adequacy of the reporting of the results), and model uncertainty (e.g., relevance of an assay end point to a human health end point of concern). A neutral approach to uncertainty and missing data will be used in this example (see Chapter 9 for more details).
• Life Cycle Thinking (Step 8) will qualitatively determine if there are differences in material or energy flow or synthetic history exist between

52 Strategies for handling uncertainty in other endpoints could also be developed.

FIGURE 12-3 Chemical structures of R-ThZD and P-ThZD.

the original chemical (Glitazone-T) and the potential alternatives.

Step 3: Identify Potential Alternatives

Numerous structural analogs to Glitazone-T are available, but for the most part these were deemed to have either lower potency against the PPARγ receptor or had physicochemical properties, such as solubility or bioavailability, that would reduce their effectiveness as a replacement for Glitazone-T. However, two viable alternatives have been identified: 5-(4-{2-[Methyl(2-pyridinyl)amino]ethoxy}benzyl)-1,3-thiazolidine-2,4-dione, commonly referred to as R-ThZD and 5-{4-[2-(5-Ethyl-2-pyridinyl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione, also known as P-ThZD. Structures for these alternatives are shown in Figure 12-3 .

In in vitro experiments, R-ThZD and P-ThZD were shown to increase the activity of PPARγ by 50% at concentrations of 0.082 µM and 0.81 µM, respectively, when tested in transfected HepG2 cells. In in vitro 3T3-L1 adipocytes R-ThZD and P-ThZD were shown to reduce the uptake of 2-deoxyglucose by 50% at concentrations of 50 nM and 3 µM, respectively.

General assessment of physicochemical properties indicates that both alternatives have similar physical characteristics in terms of their melting point, boiling point, and vapor pressure (see Table 12-14 ). However, computational assessments of the aqueous solubility of both R-ThZD and P-ThZD suggest that these chemicals are significantly more water soluble than Glitazone-T.

Assessment of Ecological Impact Based on Physicochemical Properties

Comparison of the physicochemical properties of Glitazone-T with the other two Glitazone alternatives show the same thiazolidinone ring structure, but Glitazone-T has a phenolic functional group as well as a prospectively liable, if masked, carbonyl group (Weltman et al 2011). The pKa (base) value is also orders of magnitude different between these chemicals. Hence the environmental fate and impact of Glitazone-T, its metabolites, or degradation products are uncertain.

Assessment of the ecological impact of a chemical and its degradation or metabolic products is best based on direct data. For P-ThZD, it has been experimentally determined that it and its major metabolites do not significantly bioaccumulate, persist in the aquatic environment, show toxicity to aquatic organisms, or become absorbed by sewage solids (Drug Bank, 2013a). An evaluation of R-ThZD can be carried out by comparison of physicochemical properties of P-ThZD and R-ThZD. Both P-ThZD and R-ThZD have similar chemical structures, functional groups, molecular weights, and logPs, as well as calculated pK a s and polar surface areas (psa). It is reasonable to assume that environmental binding, persistence, degradation, and transformation of R-ThZD is well modeled by P-ThZD (Drug Bank, 2013b). In terms of chemical structure, the only difference is in the substitution of pyridine rings, which would have a minor effect on the reactivity.

Assessment of Human Health Impacts Based on Physicochemical Properties

In comparing the physicochemical properties of R-ThZD and P-ThZD to Glitazone-T, it can be hypothesized that the lower Log P values for R-ThZD and P-ThZD and higher predicted aqueous solubility (see Table 12-12 ) will increase their relative bioavailability when compared to Glitazone-T. Given that the in vitro potency of R-ThzD is superior to

TABLE 12-14 : Physicochemical Properties for Glitazone-T, P-ThZD, and R-ThZD

a Values for cLogP in this table were determined using the Biobyte software package.

SOURCE: ChemSpider 2014a, b,c.

that for Glitazone-T against the PPARγ receptor, and the in vitro potency of P-ThzD is comparable to that for Glitazone-T, then higher bioavailability of these alternatives will lead to a decrease in their relative concentrations in the end products. A direct result will be a reduction in the level of human exposure to these biological active ingredients, assuming that similar product usage patterns are equivalent.

Step 6.1: Assess Chemical Hazards for Human Health

This section examines the various data streams available for hazard assessment by looking at in silico, in vitro, and in vivo data.

Computational Assessment of Safety

In silico predictions for a variety of different properties were obtained for Glitazone-T, P-ThZD, and R-ThZD using some available quantitative structure activity relationship (QSAR) models. Model outputs include predictions of cytotoxicity to cells; inhibition of the human Ether-a-go-go Related Gene (hERG) ion channel that is associated with prolonged cardiac QT interval; volume of distribution; free fraction in human plasma; and other end points ( Table 12-15 ). The rationale for choosing these predicted properties is explained in more detail in Chapter 8 .

• Cytotoxicity: Compounds that cause cytotoxicity at lower in vitro concentrations will generally have a higher probability of causing toxicity in vivo at lower plasma concentrations (Greene et al. 2010a). The in silico predictions suggest that P-ThZD and R-ThZD will have a higher LC 50 values for cytotoxicity in cells compared to Glitazone-T. Thus, cytotoxicity associated with these chemicals likely occurs at higher in vivo (plasma) concentrations.
• hERG inhibition: hERG channel inhibition has been shown to cause QT interval prolongation in humans. This alteration of the cardiac electrical cycle has been implicated in the onset of ventricular tachyarrhythmias like torsades de pointes, which can result in sudden death. In silico predictions suggest that there is no increased risk of hERG Inhibition with either R-ThZD or P-ThZD when compared to GitazoneT.
• Volume of distribution, free fraction, and passive permeability: Volume of distribution (Vd ss ) has

TABLE 12-15 Various Predicted Properties for Glitazone-T, P-ThZD, and R-ThZD

Note: Data for this table were generated by a committee member using unpublished Pfizer data.

been shown to correlate with the lowest observable adverse effect level (LOAEL) in preclinical studies, where higher Vd ss values lead to lower LOAEL concentrations (Sutherland et al. 2012). The Vd ss for all three compounds is predicted to be low, suggesting that there would be no substantial increased safety concern from either R-ThZD or P-ThZD when compared with Glitazone-T. Passive permeability is linked to bioavailability, where highly permeable compounds have high bioavailability. Moderate passive permeability was predicted for Glitazone-T, whereas R-ThZD and P-ThZD are expected to be higher, indicating that R-ThZD and P-ThZD would have better bioavailability. In addition, since the pharmacological action of a compound is generally driven by the unbound fraction in vivo, then a higher free fraction indicates that lower total drug doses would be needed to elicit the desired effect of the compound. The free fraction for both R-ThZD and P-ThZD is predicted to be ~9-fold and ~3-fold higher than Glitazone-T, suggesting that the overall exposure required to achieve the intended effect would be lower. 53

• Thiazolidinedione structural alert: The thiazolidinedione substructure has been identified as a structural alert associated with hepatotoxicity resulting in liver failure and/or cholestatic hepatitis (Greene et al. 2010b). Cyp3A4 enzyme induction has also been observed with compounds containing this structural group. The mechanism of toxicity is thought to be via CYP mediated oxidation of the activated methylene to give a reactive quinoid intermediate (see Figure 12-4 ), which can be trapped with glutathione (GSH) in a reactive metabolite assay. All three compounds contain this structural alert, so it cannot be determined if the two alternatives, R-ThZD and P-ThZD, would have an improved safety profile when compared to the hepatotoxic Glitazone-T compound.
• Mitochondrial dysfunction and BSEP inhibition: Many eukaryotic cells derive the majority of their energy needs from the mitochondrial

53 This observation could also affect wastewater concentrations of these compounds.

FIGURE 12-4 Formation of a reactive quinoid intermediate.

production of adenosine triphosphate (ATP). Interfering with mitochondrial production of ATP will deplete cellular energy stores, and may result in cellular stress and cell death. Glitazone-T is predicted to have a high likelihood of having an adverse impact on mitochondrial function, whereas R-ThZD and P-ThZD are predicted to have only a moderate likelihood of having an effect on mitochondrial function. Therefore, it might be expected that both R-ThZD and P-ThZD would have a lower likelihood of having adverse safety effects. As a co-factor to mitochondrial dysfunction, inhibition of the Bile Salt Extraction Pump (BSEP), an energy-dependent transporter, has been linked to causing cholestasis and hepatic injury. All three compounds are predicted to have similar inhibitory effects on BSEP. This information doesn’t allow for differentiating between these chemicals on the basis of this potential mechanism of liver injury.

Based on the in silico analysis, R-ThZD and P-ThZD offer a slightly more favorable hazard profile than Glitazone-T due to a lower predicted potential for causing cytotoxicity, better predicted bioavailability, and lower plasma protein binding.

Using In Vitro Data to Assess Safety Hazards

• In vitro absorption, distribution, metabolism, and excretion (ADME) assessments: When comparing in vitro ADME data for all three compounds, R-ThZD was shown to have moderate metabolic stability in human liver microsomes and hepatocytes, whereas Glitazone-T had poor detection sensitivity in the experimental conditions. R-ThZD also had good passive permeability compared to Glitazone-T. No data were available for P-ThZD, but based on its close structural similarity and similar physicochemical properties to R-ThZD, along with similar in silico predictions for passive permeability, Vd ss and protein binding, it might be expected that these two compounds would show similar profiles in the in vitro systems. Despite some observed differences in their interactions with specific biological pathways or proteins, metabolic stability and permeability have been shown to be strongly correlated with physicochemical characteristics, such as lipophilicity and pKa.

When comparing these compounds for their effects on endoplasmic reticulum stress, which has been linked to a number diseases, R-ThZD showed an measurable increase in the nuclear translocation of XBP1, part of the endoplasmic reticulum stress pathway, at much lower concentrations than Glitazone-T and P-ThZD, which may indicate a slightly higher concern for adverse effects with R-ThZD.

TABLE 12-16 In Vitro Safety Data.

NOTE: Data for this table were generated by a committee member using unpublished Pfizer data.

Finally, R-ThZD and P-ThZD had fewer off-target effects when compared to Glitazone-T in a panel of biochemical binding assays. Greater target promiscuity has been linked to a higher likelihood of observing toxicity at lower exposures (see Chapter 8 for more details).

• ToxCast data: Glitazone-T and P-ThZD have been profiled in numerous in vitro assays as part of the ToxCast initiative. Figure 12-5 shows the in vitro profile in the Apredica high content assays, where data for P-ThZD Glitazone-T are presented. This figure illustrates that Glitazone-T has increased effects on p53 and mitochondrial membrane potential when compared to P-ThZD, which suggests that P-ThZD may have a better safety profile.

Similarly, when comparing the profiles for these two compounds in the Attagene nuclear hormone receptor panels in Figure 12-6 , it can be seen that aside from the intended biological activity of these molecules, Glitazone-T is having an effect on more of these receptors than P-ThZD. Based on these observations, it may be expected that P-ThZD would have a better safety profile than Glitazone-T.

This trend is also observed when comparing the in vitro profiles of the two chemicals in the BioSeek platform ( Figure 12-7 ), where it can be observed that Glitazone-T has a much stronger response across almost all of the measured end points when compared to the profile for P-ThZD. Similar data were not available for R-ThZD, but based on the close structural similarity and similar physicochemical properties to R-ThZD, along with similar in silico predictions for passive permeability, Vd ss and protein binding, it might be expected that these two compounds would show similar profiles in the in vitro systems, although differences could be present based on the observation that these two chemicals have different activities for XBP1 and BSEP.

Glitazone-T is more cytotoxic in THLE cells when compared to P-ThZD and R-ThZD, which probably reflects its greater impact on mitochondrial function. Similarly, there is a general lack of off-target activity for P-ThZD and R-ThZD when compared to Glitazone-T. Although P-ThZD is a more potent inhibitor of the BSEP transporter than either R-ThZD or Glitazone-T, this finding by itself may not translate into a direct biological effect in vivo. R-ThZD has a greater impact on inducing ER stress based on the XBP1 reporter assay, and so may be expected to show in vivo toxicity at lower plasma concentrations than P-ThZD. From the ToxCast profiles, P-ThZD has a “cleaner” profile across the three assay platforms when compared to Glitazone-T. Therefore, it might be expected to have a better in vivo safety profile aside from those effects related to the primary mechanism of action of these compounds. ToxCast data were not available for R-ThZD, and so comparisons between these two alternatives cannot be made. Based on the in vitro assessments of Glitazone-T, P-ThZD, and R-ThZD, it can be inferred that both P-ThZD and R-ThZD

would have fewer effects on a biological system compared to Glitazone-T, making them potentially viable safer alternatives.

Mammalian Toxicity Assessment

Comparisons between Glitazone-T, R-ThZD, and P-ThZD were made based on the available data using the GreenScreen ® classification system. 54

Acute mammalian toxicity : Glitazone-T has an acute oral LD 50 of greater than 2000 mg/kg in multiple species, and so it receives a hazard designation of Low. P-ThZD, however, has an acute oral LD 50 = 181mg/kg in mice, which is considered to be Very High. Similarly, R-ThZD has a mouse LD 50 = 300 mg/kg, so its acute mammalian toxicity is categorized as High.

Carcinogenicity: In mice, Glitazone-T showed an increased hemangiosarcoma incidence in females at 400 mg/kg and in males and females at 800 mg/kg. In mice, Glitazone-T showed an increased hepatocellular carcinoma incidence in females at 800 mg/kg (Herman et al. 2002). P-ThZD showed benign and/or malignant transitional cell neoplasms in rats at 4 mg/kg/day and an increased incidence of urinary bladder tumors at 63 mg/kg. R-ThZD showed a significant increase in benign adipose tissue tumors (lipomas) in rats at doses greater than or equal to 0.3 mg per kg (mg/kg/day) for 104 weeks. On the basis of this evidence, all three chemicals are categorized as Moderate.

Mutagenicity/genotoxicity : Glitazone-T was not mutagenic in bacteria at concentrations up to 10,000 µg/plate, with or without metabolic activation. In a Chinese hamster fibroblast assay, both aneuploid cells and giant cell forms were noted after exposure to 2.9 µg/ml without metabolic activation for 48 hours. With activation, the number of cells with endoreduplicated chromosome was increased with Glitazone-T at 58 and 64 µg/ml. Pronounced cytotoxicity and increased structural chromosome aberrations frequency were observed following 6 hours of exposure to Glitazone-T at 178 µg/ml without activation and at 163 µg/ml with activation. Results of the in vitro mouse lymphoma mutation assay at cytotoxicity-limited concentrations up to 30 µg/ml were mixed because minimal, but significant increases in mutation frequency were noted in two out of five trials without metabolic action and in two out of six trials with activation. The unscheduled DNA synthesis was observed in hepatocytes isolated 2 or 24 hours post-dose from rats given single oral doses of Glitazone-T at 1,000, 1,500, or 2,000 mg/kg. Thus, it is concluded that the Glitazone-T genotoxic potential should be categorized as Moderate.

P-ThZD showed no mutagenic or genotoxic potential in bacterial mutagenicity studies, in vitro mammalian tests, and in vivo micronucleus studies. Thus, it can be concluded that P-ThZD genotoxic potential should be categorized as Low.

The overall genotoxicity potential of R-ThZD appears to be equivocal since the tests of chromosomal aberration, unscheduled DNA, and in vivo mouse micronucleus were all negative, while the incidence of forward mutations at the thymidine kinase locus of mouse lymphoma LS 178Y cells was increased by R-ThZD in triplicate assays in the presence of S-9 mix. Thus, it can be concluded that R-ThZD genotoxic potential should be categorized as Moderate.

Reproductive & developmental toxicity : Pregnancy duration was slightly shorter in rats given Glitazone-T at 1000 mg/kg when compared with untreated controls. Growth rate of rat pups was reduced in both sexes following high dose (2000 mg/kg/day) Glitazone-T. This effect was particularly pronounced between postnatal days 29 to 57. Aside from these findings, Glitazone-T had little or no effect on fertility, teratology, and peri- and post-natal development in rodents and rabbits. Based on this information, the reproductive hazard categorization is Low and the developmental hazard categorization is Very Low.

In studies with P-ThZD (Takeda Canada 2012), rats exhibited delayed parturition, embryotoxicity, delayed development, and reduced fetal weights at oral doses > 40 mg/kg/day. In rabbits, embryotoxicity was observed at an oral dose of 160 mg/kg. Based on this information, both the reproductive and the developmental hazard categorizations are Moderate.

R-ThZD treatment of rabbits and rats was studied by GSK (GSK 2012). Treatment of rats during early pregnancy did not result in notable implantation or embryo impacts. However, treatment of both rats and rabbits during mid-late pregnancy was associated with growth retardation and fetal death. Teratogenicity was not observed. Placental pathology was observed with R-ThZD treatment of rats (>3 mg/kg/day) but not in rabbits (100 mg/kg/day). When rats were treated during pregnancy and lactation with R-ThZD, reductions in

54 Alternative (e.g., GHS) classification schemes could be used.

FIGURE 12-5 Apredica assay profiles for Glitazone-T (Trogliatazone) and P-ThZD (Pioglitazone). NOTE: Data in figure are from EPA ToxCast Initiative; figure generated using Spotfire.

FIGURE 12-6 Attagene Nuclear Hormone Receptor panel assay profiles for Glitazone-T (Trogliatazone) and P-ThZD (Pioglitazone). NOTE: Data in figure are from EPA ToxCast Initiative; figure generated using Spotfire.

FIGURE 12-7 BioSeek panel assay profiles for Glitazone-T (Trogliatazone) and P-ThZD (Pioglitazone). NOTE: Data in figure are from EPA ToxCast Initiative; figure generated using Spotfire. Conclusions from the In Vitro Safety Data.

litter size and neonatal viability were observed. Postnatal growth retardation that was reversible after puberty was also seen. The no-effect dose for effects on the placenta, embryo, and offspring was 0.2 mg/kg/day in rats and 15 mg/kg/day in rabbits. Fertility was decreased at a dose of 40 mg/kg per day, and estrous cyclicity was altered at 2 mg/kg per day, but these effects were not noted at doses less than 0.2 mg/kg per day. These effects were attributed to altered plasma levels of progesterone and estradiol. Based on this information, the reproductive and developmental hazard categorizations are High.

Neurotoxicity: In rats given amorphous Glitazone-T at 6, 25, 100, or 400 mg/kg by gavage for 13 weeks, there were no deaths or drug-related clinical signs. Based on this information, the neurotoxicity hazard categorization is considered Low. No functional or behavioral toxicity was observed in offspring of rats given oral doses up to 80 mg/kg of P-ThZD. Based on this information the neurotoxicity hazard categorization is considered Moderate.

In a 13-week dietary range-finding study, mice were given R-ThZD at doses of 0, 0.4, 2, 10, or 20 mg/kg/day by dietary admixture. There was no mortality. No remarkable clinical signs were noted except firm, but palpable, swellings in the scapular areas noted in 14/16 animals in the high-dose group and 6/l6 animals dosed at 10 mg/kg/day. Based on this information, the neurotoxicity hazard categorization is considered Moderate.

Repeated dose toxicity : In 13-week studies with Glitazone-T, dose-related increases in absolute and relative liver weight of 21%-75% in male rats at 400 mg/kg and 14%-48% in female rats at 50 mg/kg were observed. Heart weight and its body weight ratios in female rats increased 28%-53% at 200 and 400 mg/kg at week 13, respectively. No effects in dogs or monkeys given up to 400 mg/kg/day for 28 days. Based on this information, the repeat dose hazard categorization is Moderate.

Anemia with reduced erythrocytes, hematocrit and hemoglobin concentration, and splenic extramedullary hematopoiesis were present in rats after 13 weeks of oral administration of P-ThZD at doses of 100 or 300 mg/kg. The toxicological no effect dose might be near 30 mg/kg. Based on this information, the repeat dose hazard categorization is Moderate.

In a 13-week study, there was a dose-related increase in scapular adipose tissue weight in female

mice at 2 mg/kg/day. Because this brown adipose tissue is not found in people, this response is not considered relevant. In males, there was a slight increase of 10% in kidney weight at 2 mg/kg/day and above. An increase of up to 16% in heart weight at 10 and 20 mg/kg/day was noted. This end point was chosen as the point of departure because heart effects were noted in longer-term studies in multiple species. Based on this information, the repeat dose hazard categorization is Moderate.

Respiratory and skin sensitization: No information is available to assess the respiratory and skin sensitization hazards associated with Glitazone-T, P-ThZD, or R-ThZD. Therefore, the respiratory and skin sensitization hazard categorization is Unknown.

Eye and Skin irritation/corrosivity : No information is available to assess the eye and skin irritation and the corrosive hazards associated with Glitazone-T, P-ThZD, or R-ThZD. Therefore the eye and skin irritation and corrosivity hazard categorization is Unknown.

Mammalian toxicity summary : Table 12-17 summarizes the mammalian toxicity assessment based on the GreenScreen ® classification system.

Step 6.2: Assess Ecotoxicity (Chemical Hazards)

This section compares the environmental toxicity of three compounds: P-ThZD, R-ThZD, and Glitazone-T. There is sufficient experimental data for P-ThZD to characterize the aquatic toxicity by comparing the measured toxic end points to the thresholds described in several chemical alternatives assessments. There is, however, a lack of directly measured empirical data to characterize the aquatic toxicity of R-ThZD or Glitazone-T. The toxicity of the latter two chemicals, compared to P-ThZD, was estimated based on the chemical properties and reactivity of these chemicals. There is, however, uncertainty in any conclusions when comparing a chemical with an experimentally well-defined toxicity (P-ThZD) relative to the other two alternatives, which have no direct measurements of aquatic toxicity. The latter is a significant data gap in making any comparison.

There is no terrestrial toxicity data for any of these three compounds. However, the mammalian toxicity data generated to estimate human toxicity (see Mammalian Toxicity Summary) can be used to compare the toxicity of these three compounds to small mammals.

TABLE 12-17 Summary of Mammalian Toxicity Assessment

Note: Toxicity data has been benchmarked using the GreenScreen® system. The uncertainty associated with each toxicological finding is depicted by colors (green = minimal uncertainty, yellow= moderate uncertainty, orange = highly uncertain, gray = data gap)

Aquatic Toxicity

Weltman et al. (2011) provide an assessment of the environmental fate and effects of P-ThZD conducted as a higher-tier assessment triggered by exceeding screening criteria under a preliminary evaluation based on “Guideline on the Environmental Risk Assessment of Medicinal Products from Human Use”(EMA 2006). The data generated included various physical-chemical parameters (e.g., biodegradation, K ow , aerobic transformation in sediments, K oc ) and toxicity to sewage microorganisms. The aquatic toxicity was characterized based on toxicological testing with a freshwater algae (species not provided), a freshwater invertebrate ( Daphnia magna ), and an early life stage fish (species not provided).

The algal test was a 72-hour exposure that measured the algal response as average specific growth rate and yield (as cell number) over a range of concentrations. The testing provided a no observed effect concentration (NOEC) and percentage effect (relative to controls) of EC 10 , EC 20 , and EC 50 . The EC 10 was the lowest effect level measured. The invertebrate test was a 21-day test that measured the parental mortality and reproduction (as neonates per female) over a range of concentrations. The testing provided a NOEC for reproduction, an overall NOEC (reproduction and mortality), and a percentage mortality (relative to controls and measured as immobile adults) of EC 20 , EC 40 , and EC 50 . The EC 20 was the lowest effect measured.

The fish early life stage test derived a NOEC in a 21-day test (range of concentrations) based on larval survival (post-hatch) and growth of larvae over the course of the test.

Several of the existing chemical assessment alternatives reviewed in this report ( Chapter 7 ) use the type of ecological toxicity test data measured in this study of P-ThZD to characterize the acute and chronic toxicity of a chemical based on a range of thresholds. Table 12-18 summarizes the thresholds and categories provided by the four chemical alternatives assessments that provide quantitative characterizations of toxicity.

Characterization of Aquatic Toxicity

The various categories in Table 12-18 were applied to the toxicity data from Weltman et al. (2011) to characterize the aquatic toxicity of P-ThZD. The toxicity data for algae included the following:

• Algal toxicity (growth rate) had a measured EC 10 at 0.702 mg/L, but there was no further response at higher concentrations. The authors report the EC 50 at some concentration above 0.851 mg/L. Therefore the characterization of the EC 50 for growth rate as very high toxicity is a conservative (i.e., environmentally protective) characterization. The actual EC 50 may be higher.
• Algal toxicity (yield) had a measured EC 10 at 0.189 mg/L and a measured EC 20 at 340 mg/L, but there was no further response at higher concentrations. The authors report the EC 50 at some concentration above 0.851 mg/L. Therefore, the characterization of the EC 50 for yield as very high toxicity is a conservative (i.e., environmentally protective) characterization. The actual EC 50 may be higher.
• Weltman et al. (2011) estimate the overall NOEC for algae at 0.189 mg/L, which was the EC 10 for the yield end point. They did not estimate a LOEC. However, we used the EC 20 for yield (the first measured response above the NOEC), 0.340 mg/L as the LOEC.

The toxicity data for invertebrates were chronic end points (21- day test) and included the following:

• Invertebrate mortality (measured as invertebrate mobility) had a chronic LOEC of 0.0387 mg/l based on a LC 20 for adult mobility.
• A NOEC of 0.296 mg/l and a LOEC of 0.530 for reproduction measured as the number of offspring produced per adult D. magna .
• An estimated overall NOEC of 0.7530 (Weltman et al. 2011).

The fish early life stage toxicity tests indicated no response in survival of fry over the course of the test (32 days). The estimated NOEC and LOEC for body weight were 0.0584 mg/L and 0.1296 mg/L, respectively.

Table 12-19 provides this comparison. The aquatic toxicity for P-ThZD is generally characterized as high toxicity, with the exception of the characterization of NOEL under the P20ASys.

In terms of structure, the difference in the compounds is only in the substitution of pyridine rings, which would have a minor effect on the reactivity. This analysis indicates that the toxicity of the two compounds is likely to be similar.

TABLE 12-18 Aquatic Toxicological End Points and Assigned Category from Chemical Alternatives Assessments

Measurement of plasma protein binding in human serum showed that Glitazone-T was greater than 99.9% bound to protein, whereas P-ThZD and R-ThZD were 99.2% and 99.7% bound, respectively. Therefore, the free concentration available for the intended pharmacological action will be approximately seven times greater in the case of P-ThZD and two times greater for R-ThZD. These differences in free concentrations and absorption result in lower concentrations being required of both P-ThZD and R-ThZD to achieve the same biological effect compared to Glitazone-T, assuming equivalent potency against the PPARγ receptor across all three chemicals.

In vitro experiments have shown a 50% increase in PPARγ activity following exposure of transfected HepG2 cells with 0.72 µM Glitazone-T. In 3T3-L1, adipocytes Glitazone-T was shown to reduce the uptake of 2-deoxyglucose by 50% at a concentration of 2 µM. The bioavailability (the amount entering the bloodstream) of Glitazone-T is approximately 58%; for product effectiveness, it is necessary to have relatively high concentrations. As a result, it is estimated that the maximum adult human daily exposure to the active ingredient is in the region of 400 mg through the normal use of products containing Glitazone-T.

During in vitro experiments, R-ThZD and P-ThZD were shown to increase the activity of PPARγ by 50% at concentrations of 0.082 µM and 0.81 µM, respectively, when tested in transfected HepG2 cells. In 3T3-L1, adipocytes R-ThZD and P-ThZD were shown to reduce the uptake of 2-deoxyglucose by 50% at concentrations of 50 nM and 3 µM, respectively. The bioavailability of P-ThZD and R-ThZD is 81% and 60%, respectively, and the free concentrations in plasma are seven times greater for P-ThZD and two times greater for R-ThZD when

TABLE 12-19 Summary of Toxicity Data for P-ThZD

compared to Glitazone-T. Based on these data, it is anticipated that concentrations of the biological ingredient in products will be substantially reduced; the anticipated maximum daily exposure to the active ingredient will be in the region of 45 mg in the case of P-ThZD and 4 mg in the case of R-ThZD.

Step 7: Are Alternatives Considered Safer?

Based on the available data, there are numerous ways to visualize and compare the profiles of the chemicals. No one way is considered as the preferred method. In all cases, one effect has not been deliberately ranked over another. Table 12-18 shows one approach incorporating the data into a single rank ordering of alternatives.

Another way to visualize and rank order these compounds would be to use the ToxPi, software, as explained in Appendix C and Reif et al. 2013. This software allows the categories of data to be grouped and weighted, if desired, to give a graphic comparison of chemicals. In addition to the graphic comparison, ToxPi software can be used to calculate an overall score for each chemical, using all the domains of data. In addition, the impact of giving more weight to some evidence categories on the overall ranking of compounds can easily be explored.

For the purpose of illustrating the effect that relative weightings can have on an overall assessment and ranking, data were grouped into seven logical categories or slices as outlined in Table 12-21 . For the purpose of the illustration, the individual data points were rescaled to fall between 0 and 1, where “1” represents the most favorable value of the three for the data point in question and the rest are converted to a fraction of this data point. It should

be noted that for some properties, lower numbers are considered more favorable than higher ones. For this reason, the calculations were adjusted to compensate for this directionality. Finally, no absolute thresholds were defined for an assay or property values because this was beyond the scope of the committee.

In Figure 12-8 , the different slices of the pie charts represent the different components of the physicochemical properties, in vitro data, and in vivo and in silico predictions. In this example of data integration, the in vivo safety and exposure assessments carry the highest weighting, as illustrated by the lengths of the arcs for each slice. Preclinical ADME and in vitro data were the next highest weightings, with off-target activity, in silico predictions and physicochemical properties given the lowest weightings.

The relative ranking of each chemical can be seen in the three data points that the arrows point to. The higher ToxPi score represents a more favorable compound. In this example, P-ThZD had the best score, with R-ThZD in second place, and Glitazone-T the least favorable. As shown by the relative size of each slice, Glitazone-T was ranked last because of lower (unfavorable) scores in exposure, in vitro safety, off-target activities, and physicochemical properties.

In Figure 12-9 , greater emphasis was placed on the in vivo (e.g., animal) safety assessments, increasing this to contribute 50% of the overall score for each compound. This was done to illustrate the effect of putting greater weight on the safety of a product over the functional use of the alternatives. In this case, Glitazone-T was the most favorable option, with P-ThZD second and R-ThZD the least favored.

In these analyses, the committee recognizes that there are varying levels of confidence in the different end point categorizations. In the illustration with mammalian toxicity data, uncertainty was considered and handled using a Missing-Data-Neutral approach (see Chapter 9 for more details). In this approach, the presence of uncertainty and missing data are noted, but would not exclude, or otherwise demote, the alternative at this point in the selection process.

Step 8: Life Cycle Thinking

In Step 8 (Life Cycle Thinking), it is first important to map the product system. For an agent like Glitazone-T, the key elements of the product system include: (a) transportation and storage of raw materials; (b) initial production of the active ingredient; (c) secondary processing resulting in the production of the product formulation; (d) product storage and distribution; (e) auxiliary operations, including disposal of production waste products; (f) therapeutic usage; and (g) post-consumer disposal and environmental fate of the drug and its metabolites (Mata et al. 2012). Life Cycle Thinking did not identify a significant difference in these areas, when the life cycle of the original chemical was compared to that of the alternative. Thus, additional screening life cycle analyses or more quantitative analyses were not required.

Step 10: Identify Acceptable Alternatives

In Figure 12-10 , ToxPi was used to integrate different types of information (as discussed in Chapter 9 ). Specifically, ToxPi is used to combine the data from the human exposure assessments with the functional efficacy of each compound at the PPAR receptor, to incorporate a measure of functional performance into the weighting and ranking process. In addition, the relative contribution from the exposure and performance slices were increased to give exposure and performance the greatest emphasis, followed by in vivo safety, in vitro safety, preclinical ADME with in silico predictions, and physicochemical properties, off-target activities having the lowest weight. This illustrates the impact that weighting of functional performance as the highest criteria for selection can have at the integration step and how it may influence the outcome of an alternatives assessment. In this case, R-ThZD was the most favorable option, with P-ThZD in second place, and Glitazone-T least favored.

From these examples, it becomes clear that each of the three chemicals can be ranked as the most favorable, depending on the relative emphasis placed on the data points available. Depending on the entity performing the alternatives assessment, subtle differences in a chemical’s attributes and rankings may lead to selection (or deselection) of an alternative. In this case, each of the alternatives has one or more human health or ecological hazards that may be desirable to avoid. Therefore, some framework users may initiate additional research and development efforts (Step 13).

The real-life outcome was that Glitazone-T

(Troglitazone) was withdrawn from the market in 2000, less than three years after regulatory approval, as a result of cases of severe liver injury in patients taking the drug. R-ThZD (Rosiglitazone) was approved in 1999 and reached peak sales of $2.5 billion in 2007, but was finally withdrawn in 2012, after reports linked the drug to cardiac toxicity. P-ThZD (pioglitazone) was approved by the FDA in 1999 and achieved sales worth $2.4 billion in 2008. It is still prescribed today, but has been withdrawn in some markets because of concerns with its association to bladder cancer after extended periods of treatment. Additional research and development efforts have led to the development of novel pharmaceutical treatment options for type 2 diabetes mellitus.

TABLE 12-20 Incorporation of Data into a Single Rank Ordering of Alternatives. Note: A relative level of preference is assigned where “1” is the most preferable and “3” is the least preferable.

TABLE 12-21 Components of ToxPi Slices in Case Study Illustration

NOTE: AUC = area under receiver operating characteristic curve; PPB = parts per billion; C max = maximum concentration; VD ss = volume of distribution at steady-state; T max = time of maximum plasma concentration; BSEP = bile salt export pump; hERG = human Ether-à-go-go-Related Gene; MDR = multi-drug resistant; THLE = T-antigen-immortalized human liver epithelial; COX2 = cyclooxygenase-2; 5-HT = serotonin transporter; PPAR = peroxisome proliferator-activated receptor; PDE3 = phosphodiesterase 3; Na = sodium; Ca = calcium; CB1 = cannabinoid receptor 1; GABAA = γ-Aminobutyric acid a; NE = norepinephrine; 5HT2b = 5-Hydroxytryptamine receptor 2B; LC 50 = lethal concentration 50; XBP1 = X-box binding protein 1; LogP = partition coefficient; LogD = distribution coefficient; PSA = prostate-specific antigen

FIGURE 12-8 ToxPi visualization of data by data type and resultant rank ordering of chemicals.

FIGURE 12-9: ToxPi visualization of data with in vivo safety heavily weighted.

FIGURE 12-10 ToxPi visualization of data with functional efficacy heavily weighted.

Historically, regulations governing chemical use have often focused on widely used chemicals and acute human health effects of exposure to them, as well as their potential to cause cancer and other adverse health effects. As scientific knowledge has expanded there has been an increased awareness of the mechanisms through which chemicals may exert harmful effects on human health, as well as their effects on other species and ecosystems. Identification of high-priority chemicals and other chemicals of concern has prompted a growing number of state and local governments, as well as major companies, to take steps beyond existing hazardous chemical federal legislation. Interest in approaches and policies that ensure that any new substances substituted for chemicals of concern are assessed as carefully and thoroughly as possible has also burgeoned. The overarching goal of these approaches is to avoid regrettable substitutions, which occur when a toxic chemical is replaced by another chemical that later proved unsuitable because of persistence, bioaccumulation, toxicity, or other concerns.

Chemical alternative assessments are tools designed to facilitate consideration of these factors to assist stakeholders in identifying chemicals that may have the greatest likelihood of harm to human and ecological health, and to provide guidance on how the industry may develop and adopt safer alternatives. A Framework to Guide Selection of Chemical Alternatives develops and demonstrates a decision framework for evaluating potentially safer substitute chemicals as primarily determined by human health and ecological risks. This new framework is informed by previous efforts by regulatory agencies, academic institutions, and others to develop alternative assessment frameworks that could be operationalized. In addition to hazard assessments, the framework incorporates steps for life-cycle thinking - which considers possible impacts of a chemical at all stages including production, use, and disposal - as well as steps for performance and economic assessments. The report also highlights how modern information sources such as computational modeling can supplement traditional toxicology data in the assessment process.

This new framework allows the evaluation of the full range of benefits and shortcomings of substitutes, and examination of tradeoffs between these risks and factors such as product functionality, product efficacy, process safety, and resource use. Through case studies, this report demonstrates how different users in contrasting decision contexts with diverse priorities can apply the framework. This report will be an essential resource to the chemical industry, environmentalists, ecologists, and state and local governments.

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Chapter-wise Business Studies Case Studies Class 12 Solved Pdf 2023-24

• CBSE Board , Class 12th
• Team Vidya Setu
• Last modified on Aug 28, 2023

Business studies case studies class 12 are available for students to practice on this page. The Central Board of secondary education has changed the paper pattern and now asks more case studies than direct questions. Business studies class 12 case studies with solutions are provided to students such that they can easily assess their performance with the solutions provided. The business studies class 12 case studies pdf download is available for students.

Business Studies is a main subject of the Commerce Stream in class 12th that helps students to understand how businesses are crucial for the economy. As the present students are the future of the nation. So, if any student wants to establish their own business then the basic learnings will serve them practically that is beyond academics. NCERT Books for Class 12 Business Studies are designed on the CBSE Class 12 Business Studies Syllabus.

Students can also go through the CBSE Class 12 Business Studies Sample Paper and business studies previous year question papers to practice more and score well in the 12th Boards. VidyaSetu is one of the leading Online portals that is known for providing Free Online Video Lectures by subject experts. Every Online Class is based on a particular chapter of Business Studies in a way to develop a deep understanding so that students can themselves solve business studies case studies in class 12 . Business case study examples are provided in such a way that students can get an idea of every topic’s case studies. Business case studies with solutions are provided on this page below. Students can also find the Business Studies class 12 question bank pdf and business studies book at VidyaSetu.

Also Check: Accounts Project Class 11

Important chapters of Business Studies

Part A: Principles and Functions of Management

• Nature and Significance of Management
• Principles of Management
• Business Environment
• Controlling

Part B: Business Finance and Marketing

• Financial Management
• Financial Markets
• Marketing Management

Chapter-wise Business Studies Class 12 Case Studies With Solutions-

Business studies case studies class 12 has become the most important question as it is tricky and at the same time needs an absolute understanding of the topic. Earlier CBSE used to ask direct questions regarding the meaning, advantages, or disadvantages but now they ask business case studies. This is the case as the central board of secondary education felt that there should be more understanding in business studies so that students could apply it practically in the near future. Business case studies examples are given below with solutions of business studies case studies class 12.

Watch Youtube Video Lectures that will help you solve business studies case studies class 12 For all chapters

Youtube Lecture- 25- Multiple Choice Question: Principles of Management

Youtube Lecture- 26- Long Answer Question: Principles of Management

Youtube Lecture- 39- Short Answer Question

Youtube Lecture- 40- Long Answer Question

Youtube Lecture- 72- Business Environment, MCQs

Youtube Lecture- 73- Short Answer Question

Youtube Lecture- 74- Long Answer Questions

Tips to Solve Case Study Questions in Business Studies

Let’s attempt to understand and solve the case study questions for business studies in class 12. As was already established, two books cover the full syllabus. Students should carefully read the NCERT book because it has been written in clear, basic English. Despite being just theory, the exam is quite difficult.

• Read the passage in depth.
• Try to comprehend the situation and focus on the questions asked.
• Generally, the passage given in Business Studies is lengthy, but the solutions are brief and simple.
• Can follow a reversal pattern, i.e. read the questions before and then search for the answers. You will save time.
• Answer briefly and precisely.
• Focus on solidifying key Business Studies fundamentals for acing any case study. If your concepts are clear, you can answer them quickly.
• While answering the case study, pick the keywords or any keyline based on which you withdraw your conclusion. You need to highlight the reason for your answer.

If these simple concepts are kept in mind, students can do well on case study-based problems in class 12 Business Studies.

Benefits Of Solving Business Studies Class 12 Case Studies With Solutions

• It helps students in understanding what kind of questions can come in the business studies examination and also test their knowledge and preparation.
• Students will get aware of answers and the board exam paper pattern.
• Candidates can analyze their preparation for the coming exam by solving the previous year’s question papers.
• Candidates will also understand how to manage to complete the exam on time.
• Solving business studies case studies class 12 will help in Building Confidence in students.
• Solving the case studies can help you to score more than 90% marks in CBSE class 12th business studies exam

Conclusion-

The business studies case studies class 12 mainly focuses on providing business case studies with solutions pdf to make it student-friendly and useful for both Class 12th Exams and other Competitive Examinations. Business studies class 12 case studies pdf download covers chapter-wise case studies with solutions. The students can download business case studies with solutions pdf from the page above at absolutely free of cost.

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CBSE Case Study Class 12

While preparing for the board exams, students are being judged on different levels of skills, such as writing, reading, etc. CBSE Case Study Class 12 questions are one of them that helps in assessing critical thinking.

The Central Board of Secondary Education will be asking the case study questions in the Class 12 board examination. Therefore, here on this page, we have provided the CBSE Case Study Class 12 for Maths, Physics, Chemistry, Biology and other subjects. Our subject matter experts have prepared Case Study questions so that Apart from the basic standard questions, students can have a variety of problems to solve. 

Just like MCQs, and other written types questions CBSE Case Study Class 12 questions will impact the overall performance of a student. Therefore for the convenience of the students we have provided the download links here, so that they can easily access the Class 12 Case Study.

Download Subject Wise CBSE Case Study Class 12 Question and Answers PDF 

There are three different streams in class 12th: Science, Arts & Commerce. And all these streams have a variety of subjects therefore, here our subject experts have crafted the Subject Wise Case Study For Class 12. Download Subject Wise CBSE Case Study Class 12 Question and Answers PDF from the below given links.

CBSE Case Study Questions Class 12 for Maths

To learn how to answer CBSE Case Study Class 12 maths questions, it would be a good choice to refer to the separate set of questions in PDF. CBSE Case Study Questions for Class 12 Maths can be quite useful and helpful in understanding how the board will prepare the case based questions for maths. 

The Maths Case studies are distributed into different chapters as per the prescribed syllabus of maths. Each and every chapter contains several number of case studies problems which enable the learners to gain in-depth knowledge in the subject.

The maths case study questions of class 12 are usually based on the formula. If any student wants to get a good score in maths case studies then they have to be well versed with a set of formulas as per the chapters and topics. Case Study Class 12 Maths can be downloaded here on this website for free of cost.

Case Study Questions Class 12 Chapter 1 Relations And Functions

Case Study Questions Class 12 Chapter  3 Matrices

Case Study Questions Class 12 Chapter  4 Determinants

Case Study Questions Class 12 Chapter  5 Continuity And Differentiability

Case Study Questions Class 12 Chapter  6 Application Of Derivatives

Case Study Questions Class 12 Chapter  8 Application Of Integrals

Case Study Questions Class 12 Chapter  9 Differential Equations

Case Study Questions Class 12 Chapter  10 Vector Algebra

Case Study Questions Class 12 Chapter  11 Three Dimensional Geometry

Case Study Questions Class 12 Chapter  12 Linear Programming

Case Study Questions Class 12 Chapter  13 Probability

CBSE Case Study Questions Class 12 for Physics

CBSE Class 12 Physics Case Study for different chapters can be interesting to solve. Class 12th physics case studies generally contain descriptive paragraphs and 4 to 5 different questions are given based on the paragraph. Students are required to read the paragraph thoroughly and understand them as well as observe the given data and information to answer the Class 12 Case Study Questions for Physics. 

In order to solve those questions students are required to have a better understanding of the basic level of physics concepts too, so make sure to use Class 12 Revision Notes of Physics. 

Case Study Questions Class 12 Chapter 1 Electric Charges and Fields

Case Study Questions Class 12 Chapter 2 Electrostatic Potential And Capacitance

Case Study Questions Class 12 Chapter 3 Current Electricity

Case Study Questions Class 12 Chapter 4 Moving Charges And Magnetism

Case Study Questions Class 12 Chapter 5 Magnetism And Matter

Case Study Questions Class 12 Chapter 6 Electromagnetic Induction

Case Study Questions Class 12 Chapter 7 Alternating Current

Case Study Questions Class 12 Chapter 8 Electromagnetic Waves

Case Study Questions Class 12 Chapter 9 Ray Optics & Optical Instruments

Case Study Questions Class 12 Chapter 10 Wave Optics

Case Study Questions Class 12 Chapter 11 Dual Nature Radiation & Matter

Case Study Questions Class 12 Chapter 12 Atoms

Case Study Questions Class 12 Chapter 13 Nuclei

Case Study Questions Class 12 Chapter 14 Semiconductor Electronics - Materials, Devices & Simple Circuits

CBSE Case Study Questions Class 12 for Chemistry

Students opted for Science stream will have to study CBSE Case Study Class 12 Chemistry. The given PDF of CBSE Class 12 Case Study Questions for Chemistry will enable the students to practice tons of questions on a regular basis. It will help them to revise the chemistry questions and its syllabus frequently. The Case study questions allow students to think more creative and find the answers in the quickest way possible. Links to download the PDF file of Class 12 Chemistry Case Study are given here.

Case Study Questions Class 12 Chapter 1 The Solid State

Case Study Questions Class 12 Chapter  2 Solutions

Case Study Questions Class 12 Chapter  3 Electrochemistry

Case Study Questions Class 12 Chapter  4 Chemical Kinetics

Case Study Questions Class 12 Chapter  5 Surface Chemistry  

Case Study Questions Class 12 Chapter  7 The p-Block Elements

Case Study Questions Class 12 Chapter  8 The d- and f-Block Elements

Case Study Questions Class 12 Chapter  9 Coordination Compounds

Case Study Questions Class 12 Chapter  10 Haloalkanes And Haloarenes

Case Study Questions Class 12 Chapter 11 Alcohols, Phenols And Ethers

Case Study Questions Class 12 Chapter  12 Aldehydes. Ketones & Carboxylic Acids

Case Study Questions Class 12 Chapter  13 Amines

Case Study Questions Class 12 Chapter 14 Biomolecules

CBSE Case Study Questions Class 12 for Biology

There are lots of chapters in class 12 Biology from which Class 12 Case Study Questions can be framed. Going through such types of questions help the students to assess their understanding level in the topics discussed in NCERT Class 12 Biology Books. By practicing the Class 12 Case Study Questions for Biology students will be very confident to ace the board exam. Also the Biology case study will be very useful for the NEET exam preparation.

Doing a regular practice of Class 12 Biology Case Study questions is a great way to score higher marks in the board exams as it will help students to develop a grip on the concepts. 

Case Study Questions Class 12 Chapter 2 Sexual Reproduction in Flowering Plants

Case Study Questions Class 12 Chapter 3 Human Reproduction

Case Study Questions Class 12 Chapter 4 Reproductive Health

Case Study Questions Class 12 Chapter 5 Principles of Inheritance & Variation

Case Study Questions Class 12 Chapter 6 Molecular Basic of Inheritance

Case Study Questions Class 12 Chapter 8 Human Health And Diseases

Case Study Questions Class 12 Chapter 10 Microbes in Human Welfare

Case Study Questions Class 12 Chapter 11 Biotechnology - Principles & Processes

Case Study Questions Class 12 Chapter 12 Biotechnology And Its Applications

Case Study Questions Class 12 Chapter 13 Organisms And Populations

Case Study Questions Class 12 Chapter 15 Biodiversity And Conversation

Case study types of questions are generally descriptive that helps to gather more information easily so, it is kinda easy to answer. However, our subject matter experts have given the solutions of all the CBSE Case Study Class 12 Biology questions.

Passage Based Class 12 Case Study Questions in PDF

CBSE Class 12 Case studies are known as Passage Based Questions. These types of problems usually contain a short/long paragraph with 4 to 5 questions. 

Students can easily solve Passage Based Class 12 Case Study Questions by reading those passages. By reading the passage students will get the exact idea of what should be the answers. Because the passage already contains some vital information or data. However a better understanding of the basic concepts that can be learned from the NCERT Class 12 Textbooks will aid in solving the Case based questions or passage based questions.

How to Download CBSE Case Study of Class 12?

Follow the below given simple steps to know how to download CBSE Case Study of Class 12:-

• Open Selfstudys website in your browser
• Go to the navigation menu that look like this
• Now, click on CBSE and then Case Study respectively
• A new page will open, where you have to click on “Class 12”
• Now, you are ready to select the subject for which you want to download the case study questions.

How to Solve Case Study Based Questions of Class 12?

There are very simple methods that a student should keep in mind while solving CBSE Case Study Class 12 for any subject:

• Read each line of paragraph carefully and pay attention to the given data/numbers. Often questions are framed according to the highlighted data of the passage.
• Since case study questions are often framed in Multiple choice questions, students should have the knowledge of elimination methods in MCQs.
• Having a good understanding of the topics that are discussed in CBSE Class 12 Books are ideal to Solve Case Study Based Questions of Class 12.

Features Of Class 12 Case Study Questions And Answers PDF

The three most noticeable features of Class 12 Case Study Questions And Answers Pdf are -

• It Is Free To Use:  Keeping in mind the need of students and to help them in doing Self Study, our team has made all the PDF of CBSE Case Study Class 12 free of cost.
• Answers Are Given:  Not only the PDFs are free provided but answers are given for all the questions of CBSE Case Study Class 12. 
• PDF Can Be Downloaded Or Viewed Online:  Many students don’t like to download the PDFs on their device due to the shortage of storage. Therefore, CBSE Class 12 Case Study questions are made available here in online format, so that students can view them online. However, through the Selfstudys app, a learner can download the PDFs too.

Benefits of Using CBSE Class 12 Case Study Questions and Answers

The CBSE Class 12 Case Study Questions and Answers can help a student in several ways:

• In Exam Preparation:  Those who go through the CBSE Case Study Class 12 will find support during the exam preparation as case based questions are also asked in the CBSE Class 12 Board examination. 
• Help in brushing up the previous learnings:  No matter how brilliant you are, you have to revise the studied topics time and again to keep them refreshed. And in this task, the CBSE Class 12 Case Study Questions and Answers can help a lot.
• To develop the critical thinking:  Able to analyse information and make an objective judgement is a skill that is known as critical thinking. A student of class 12 can use CBSE Case Study Class 12 with answers to develop critical thinking so that they can make better decisions in their life and in the board examination.

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• Knowledge Base

Methodology

• What Is a Case Study? | Definition, Examples & Methods

What Is a Case Study? | Definition, Examples & Methods

Published on May 8, 2019 by Shona McCombes . Revised on June 22, 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating and understanding different aspects of a research problem .

Table of contents

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyze the case, other interesting articles.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

• Provide new or unexpected insights into the subject
• Challenge or complicate existing assumptions and theories
• Propose practical courses of action to resolve a problem
• Open up new directions for future research

TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.

Unlike quantitative or experimental research , a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.

However, you can also choose a more common or representative case to exemplify a particular category, experience or phenomenon.

Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

• Exemplify a theory by showing how it explains the case under investigation
• Expand on a theory by uncovering new concepts and ideas that need to be incorporated
• Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews , observations , and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.

Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.

The aim is to gain as thorough an understanding as possible of the case and its context.

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In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis , with separate sections or chapters for the methods , results and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyze its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Degrees of freedom
• Null hypothesis
• Discourse analysis
• Control groups
• Mixed methods research
• Non-probability sampling
• Quantitative research
• Ecological validity

Research bias

• Rosenthal effect
• Implicit bias
• Cognitive bias
• Selection bias
• Negativity bias
• Status quo bias

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McCombes, S. (2023, June 22). What Is a Case Study? | Definition, Examples & Methods. Scribbr. Retrieved September 6, 2023, from https://www.scribbr.com/methodology/case-study/

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Blog Graphic Design

15+ Professional Case Study Examples [Design Tips + Templates]

By Alice Corner , Jan 12, 2023

Let me ask you a question: Have you ever bought something — within the last 10 years or so — without reading its reviews or without a recommendation or prior experience of using it?

If the answer is no — or at least, rarely — you get my point.

For businesses selling consumer goods, having raving reviews is a good way to get more customers. The same thing applies to B2B and/or SaaS businesses — but for this type of business, besides regular, short reviews, having a detailed case study can help tremendously.

Case studies are an incredibly effective form of marketing that you can use to help promote your product and plan your marketing strategy effectively. You can also use it as a form of customer analysis or as a sales tool to inspire potential customers.

So what does a case study look like and how can you create one? In this article, I’m going to list over 15 marketing case study examples, case study tips, and case study templates to help you create a case study that converts.

Click to jump ahead:

• What is a Case Study?
• Marketing Case Study Examples

Sales Case Study Examples

Simple case study examples, business case study examples.

• Case Study FAQs

What is a case study?

A case study is a research method to gain a better understanding of a subject or process. Case studies involve in-depth research into a given subject, in order to understand its functionality and successes.

In the context of a business, however, case studies take customer success stories and explore how they use your product to help them achieve their business goals.

As well as being valuable marketing tools, case studies are a good way to evaluate your product as it allows you to objectively examine how others are using it.

It’s also a good way to interview your customers about why they work with you.

Related: What is a Case Study? [+6 Types of Case Studies]

What is a marketing case study?

A marketing case study is a type of marketing where you use your existing customers as an example of what your product or services can achieve. You can also create case studies of internal, successful marketing projects.

Here’s an example of a marketing case study template:

Return to Table of Contents

Marketing case study examples

Marketing case studies are incredibly useful for showing your marketing successes. Every successful marketing campaign relies on influencing a consumer’s behavior, and a great case study can be a great way to spotlight your biggest wins.

In the marketing case study examples below, a variety of designs and techniques to create impactful and effective case studies.

Show off impressive results with a bold marketing case study

Case studies are meant to show off your successes, so make sure you feature your positive results prominently. Using bold and bright colors as well as contrasting shapes, large bold fonts, and simple icons is a great way to highlight your wins.

In well-written case study examples like the one below, the big wins are highlighted on the second page with a bright orange color and are highlighted in circles.

Making the important data stand out is especially important when attracting a prospective customer with marketing case studies.

Use a simple but clear layout in your case study

Using a simple layout in your case study can be incredibly effective, like in the example of a case study below.

Keeping a clean white background, and using slim lines to help separate the sections is an easy way to format your case study.

Making the information clear helps draw attention to the important results, and it helps improve the  accessibility of the design .

Business case study examples like this would sit nicely within a larger report, with a consistent layout throughout.

Use visuals and icons to create an engaging and branded business case study

Nobody wants to read pages and pages of text — and that’s why Venngage wants to help you communicate your ideas visually.

Using icons, graphics, photos, or patterns helps create a much more engaging design. 

With this Blue Cap case study icons, colors, and impactful pattern designs have been used to create an engaging design that catches your eye.

Use a monochromatic color palette to create a professional and clean case study

Let your research shine by using a monochromatic and minimalistic color palette.

By sticking to one color, and leaving lots of blank space you can ensure your design doesn’t distract a potential customer from your case study content.

In this case study on Polygon Media, the design is simple and professional, and the layout allows the prospective customer to follow the flow of information.

The gradient effect on the left-hand column helps break up the white background and adds an interesting visual effect.

Did you know you can generate an accessible color palette with Venngage? Try our free accessible color palette generator today and create a case study that delivers and looks pleasant to the eye:

Add long term goals in your case study

When creating a case study it’s a great idea to look at both the short term and the long term goals of the company to gain the best understanding possible of the insights they provide.

Short-term goals will be what the company or person hopes to achieve in the next few months, and long-term goals are what the company hopes to achieve in the next few years.

Check out this modern pattern design example of a case study below:

In this case study example, the short and long-term goals are clearly distinguished by light blue boxes and placed side by side so that they are easy to compare.

Use a strong introductory paragraph to outline the overall strategy and goals before outlining the specific short-term and long-term goals to help with clarity.

This strategy can also be handy when creating a consulting case study.

Use data to make concrete points about your sales and successes

When conducting any sort of research stats, facts, and figures are like gold dust (aka, really valuable).

Being able to quantify your findings is important to help understand the information fully. Saying sales increased 10% is much more effective than saying sales increased.

In sales case study examples, like this one, the key data and findings can be presented with icons. This contributes to the potential customer’s better understanding of the report.

They can clearly comprehend the information and it shows that the case study has been well researched.

Use emotive, persuasive, or action based language in your marketing case study

Create a compelling case study by using emotive, persuasive and action-based language when customizing your case study template.

In this well-written case study example, we can see that phrases such as “Results that Speak Volumes” and “Drive Sales” have been used.

Using persuasive language like you would in a blog post. It helps inspire potential customers to take action now.

Keep your potential customers in mind when creating a customer case study for marketing

82% of marketers use case studies in their marketing  because it’s such an effective tool to help quickly gain customers’ trust and to showcase the potential of your product.

Why are case studies such an important tool in content marketing?

By writing a case study you’re telling potential customers that they can trust you because you’re showing them that other people do.

Not only that, but if you have a SaaS product, business case studies are a great way to show how other people are effectively using your product in their company.

In this case study, Network is demonstrating how their product has been used by Vortex Co. with great success; instantly showing other potential customers that their tool works and is worth using.

Related: 10+ Case Study Infographic Templates That Convert

Case studies are particularly effective as a sales technique.

A sales case study is like an extended customer testimonial, not only sharing opinions of your product – but showcasing the results you helped your customer achieve.

Make impactful statistics pop in your sales case study

Writing a case study doesn’t mean using text as the only medium for sharing results.

You should use icons to highlight areas of your research that are particularly interesting or relevant, like in this example of a case study:

Icons are a great way to help summarize information quickly and can act as visual cues to help draw the customer’s attention to certain areas of the page.

In some of the business case study examples above, icons are used to represent the impressive areas of growth and are presented in a way that grabs your attention.

Use high contrast shapes and colors to draw attention to key information in your sales case study

Help the key information stand out within your case study by using high contrast shapes and colors.

Use a complementary or contrasting color, or use a shape such as a rectangle or a circle for maximum impact.

This design has used dark blue rectangles to help separate the information and make it easier to read.

Coupled with icons and strong statistics, this information stands out on the page and is easily digestible and retainable for a potential customer.

Less is often more, and this is especially true when it comes to creating designs. Whilst you want to create a professional-looking, well-written and design case study – there’s no need to overcomplicate things.

These simple case study examples show that smart clean designs and informative content can be an effective way to showcase your successes.

Use colors and fonts to create a professional-looking case study

Business case studies shouldn’t be boring. In fact, they should be beautifully and professionally designed.

This means the normal rules of design apply. Use fonts, colors, and icons to create an interesting and visually appealing case study.

In this case study example, we can see how multiple fonts have been used to help differentiate between the headers and content, as well as complementary colors and eye-catching icons.

Whether you’re a B2B or B2C company, business case studies can be a powerful resource to help with your sales, marketing, and even internal departmental awareness.

Business and business management case studies should encompass strategic insights alongside anecdotal and qualitative findings, like in the business case study examples below.

Conduct a B2B case study by researching the company holistically

When it comes to writing a case study, make sure you approach the company holistically and analyze everything from their social media to their sales.

Think about every avenue your product or service has been of use to your case study company, and ask them about the impact this has had on their wider company goals.

In business case study examples like the one above, we can see that the company has been thought about holistically simply by the use of icons.

By combining social media icons with icons that show in-person communication we know that this is a well-researched and thorough case study.

This case study report example could also be used within an annual or end-of-year report.

Highlight the key takeaway from your marketing case study

To create a compelling case study, identify the key takeaways from your research. Use catchy language to sum up this information in a sentence, and present this sentence at the top of your page.

This is “at a glance” information and it allows people to gain a top-level understanding of the content immediately. 

You can use a large, bold, contrasting font to help this information stand out from the page and provide interest.

Learn  how to choose fonts  effectively with our Venngage guide and once you’ve done that.

Upload your fonts and  brand colors  to Venngage using the  My Brand Kit  tool and see them automatically applied to your designs.

The heading is the ideal place to put the most impactful information, as this is the first thing that people will read.

In this example, the stat of “Increase[d] lead quality by 90%” is used as the header. It makes customers want to read more to find out how exactly lead quality was increased by such a massive amount.

If you’re conducting an in-person interview, you could highlight a direct quote or insight provided by your interview subject.

Pick out a catchy sentence or phrase, or the key piece of information your interview subject provided and use that as a way to draw a potential customer in.

Use charts to visualize data in your business case studies

Charts are an excellent way to visualize data and to bring statistics and information to life. Charts make information easier to understand and to illustrate trends or patterns.

Making charts is even easier with Venngage.

In this consulting case study example, we can see that a chart has been used to demonstrate the difference in lead value within the Lead Elves case study.

Adding a chart here helps break up the information and add visual value to the case study. 

Using charts in your case study can also be useful if you’re creating a project management case study.

You could use a Gantt chart or a project timeline to show how you have managed the project successfully.

Use direct quotes to build trust in your marketing case study

To add an extra layer of authenticity you can include a direct quote from your customer within your case study.

According to research from Nielsen , 92% of people will trust a recommendation from a peer and 70% trust recommendations even if they’re from somebody they don’t know.

So if you have a customer or client who can’t stop singing your praises, make sure you get a direct quote from them and include it in your case study.

You can either lift part of the conversation or interview, or you can specifically request a quote. Make sure to ask for permission before using the quote.

This design uses a bright contrasting speech bubble to show that it includes a direct quote, and helps the quote stand out from the rest of the text.

This will help draw the customer’s attention directly to the quote, in turn influencing them to use your product or service.

Case Study Examples Summary

Once you have created your case study, it’s best practice to update your examples on a regular basis to include up-to-date statistics, data, and information.

You should update your business case study examples often if you are sharing them on your website.

It’s also important that your case study sits within your brand guidelines – find out how Venngage’s My Brand Kit tool can help you create consistently branded case study templates.

Case studies are important marketing tools – but they shouldn’t be the only tool in your toolbox. Content marketing is also a valuable way to earn consumer trust.

Case Study FAQ

Why should you write a case study.

Case studies are an effective marketing technique to engage potential customers and help build trust.

By producing case studies featuring your current clients or customers, you are showcasing how your tool or product can be used. You’re also showing that other people endorse your product.

In addition to being a good way to gather positive testimonials from existing customers , business case studies are good educational resources and can be shared amongst your company or team, and used as a reference for future projects.

How should you write a case study?

To create a great case study, you should think strategically. The first step, before starting your case study research, is to think about what you aim to learn or what you aim to prove.

You might be aiming to learn how a company makes sales or develops a new product. If this is the case, base your questions around this.

You can learn more about writing a case study  from our extensive guide.

Some good questions you could ask would be:

• Why do you use our tool or service?
• How often do you use our tool or service?
• What does the process of using our product look like to you?
• If our product didn’t exist, what would you be doing instead?
• What is the number one benefit you’ve found from using our tool?

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• Mathematics
• Class 12 Maths Case...

Class 12 Maths Case Study Questions

Table of Contents

Class 12 Maths question paper will have 1-2 Case Study Questions. These questions will carry 5 MCQs and students will attempt any four of them. As all of these are only MCQs, it is easy to score good marks with a little practice. Class 12 Maths Case Study Questions are available on the myCBSEguide App and Student Dashboard .

Why Case Studies in CBSE Syllabus?

CBSE has introduced case study questions in the CBSE curriculum recently. The purpose was to make students ready to face real-life challenges with the knowledge acquired in their classrooms. It means, there was a need to connect theories with practicals. Whatsoever the students are learning, they must know how to apply it in their day-to-day life. That’s why CBSE is emphasizing case studies and competency-based education .

Case Study Questions in Maths

Let’s have a look over the class 12 Mathematics sample question paper issued by CBSE, New Delhi. Question numbers 17 and 18 are case study questions.

Focus on concepts

If you go through each MCQ there, you will find that the theme/case study is common but the questions are based on different concepts related to the theme. It means, that if you have done ample practice on the various concepts, you can solve all these MCQs in minutes.

Easy Questions with a Practical Approach

The difficulty level of the questions is average or say easy in some cases. On the other hand, you get four options to choose from. So, you get two levels of support to get full marks with very little effort.

Practice Questions Regularly

Most of the time we feel that it’s easy and neglect it. But in the end, we have to pay for this negligence. This may happen here too. Although it’s easy to score good marks on the case study questions if you don’t practice such questions, you may lose your marks. So, we suggest students should practice at least 30-40 such questions before writing the board exam.

12 Maths Case-Based Questions

We are giving you some examples of case study questions here. We have arranged hundreds of such questions chapter-wise on the myCBSEguide App. It is the complete guide for CBSE students. You can download the myCBSEguide App and get more case study questions there.

Case Study Question – 1

• A is a diagonal matrix
• A is a scalar matrix
• A is a zero matrix
• A is a square matrix
• If A and B are two matrices such that AB = B and BA = A, then B 2 is equal to

Case Study Question – 2

• 4(x 3  – 24x 2   + 144x)
• 4(x 3 – 34x 2   + 244x)
• x 3  – 24x 2   + 144x
• 4x 3  – 24x 2   + 144x
• Local maxima at x = c 1
• Local minima at x = c 1
• Neither maxima nor minima at x = c 1
• None of these

Case Study Questions Matrices -1

Answer Key:

Case Study Questions Matrices – 2

Read the case study carefully and answer any four out of the following questions: Once a mathematics teacher drew a triangle ABC on the blackboard. Now he asked Jose,” If I increase AB by 11 cm and decrease the side BC by 11 cm, then what type of triangle it would be?” Jose said, “It will become an equilateral triangle.”

Again teacher asked Suraj,” If I multiply the side AB by 4 then what will be the relation of this with side AC?” Suraj said it will be 10 cm more than the three times AC.

Find the sides of the triangle using the matrix method and  answer the following questions:

• (a) 3  ×  3

Case Study Questions Determinants – 01

DETERMINANTS:  A determinant is a square array of numbers (written within a pair of vertical lines) that represents a certain sum of products. We can solve a system of equations using determinants, but it becomes very tedious for large systems. We will only do 2 × 2 and 3 × 3 systems using determinants. Using the properties of determinants solve the problem given below and answer the questions that follow:

Three shopkeepers Ram Lal, Shyam Lal, and Ghansham are using polythene bags, handmade bags (prepared by prisoners), and newspaper envelopes as carrying bags. It is found that the shopkeepers Ram Lal, Shyam Lal, and Ghansham are using (20,30,40), (30,40,20), and (40,20,30) polythene bags, handmade bags, and newspapers envelopes respectively. The shopkeeper’s Ram Lal, Shyam Lal, and Ghansham spent ₹250, ₹270, and ₹200 on these carry bags respectively.

• (b) Shyam Lal
• (a) Ram Lal

Case Study Questions Determinants – 02

Case study questions application of derivatives.

• R(x) = -x 2  + 200x + 150000
• R(x) = x 2  – 200x – 140000
• R(x) = 200x 2  + x + 150000
• R(x) = -x 2  + 100 x + 100000
• R'(x) > 0
• R'(x) < 0
• R”(x) = 0
• (a) -x 2  + 200x + 150000
• (a) R'(x) = 0
• (c) 257, -63

Case Study Questions Vector Algebra

• tan−1⁡(5/12)
• tan−1⁡(12/3)
• (b) 130 m/s
• (a)  tan−1⁡(5/12)
• (b) 170 m/s

More Case Study Questions

These are only some samples. If you wish to get more case study questions for CBSE class 12 maths, install the myCBSEguide App. It has class 12 Maths chapter-wise case studies with solutions.

12 Maths Exam pattern

Question Paper Design of CBSE class 12 maths is as below. It clearly shows that 20% weightage will be given to HOTS questions. Whereas 55% of questions will be easy to solve.

• No. chapter-wise weightage. Care to be taken to cover all the chapters
• Suitable internal variations may be made for generating various templates keeping the overall weightage to different forms of questions and typology of questions the same.

Choice(s): There will be no overall choice in the question paper. However, 33% of internal choices will be given in all the sections

12 Maths Prescribed Books

• Mathematics Part I – Textbook for Class XII, NCERT Publication
• Mathematics Part II – Textbook for Class XII, NCERT Publication
• Mathematics Exemplar Problem for Class XII, Published by NCERT
• Mathematics Lab Manual class XII, published by NCERT

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• CBSE Class 10 Maths Sample Paper 2020-21
• Case Study Class 10 Maths Questions
• Competency Based Learning in CBSE Schools
• Class 11 Physical Education Case Study Questions
• Class 11 Sociology Case Study Questions
• Class 12 Applied Mathematics Case Study Questions
• Class 11 Applied Mathematics Case Study Questions

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Case Study 12

Business Studies Class 12 Case Studies With Solutions

Here we have to provide Case Study Of Business Studies Class 12 CBSE PDF Download from BST Class 12 case studies with answers books prepared by the subject experts.

Case Study Of Business Studies Class 12 CBSE PDF

Business studies class 12 case studies with solutions, answers.

Part A & B: Principles and Functions of Management & Business Finance and Marketing

• Business Studies Class 12 Chapter 1 Case Studies
• Business Studies Class 12 Chapter 2 Case Studies
• Business Studies Class 12 Chapter 3 Case Studies
• Business Studies Class 12 Chapter 4 Case Studies
• Business Studies Class 12 Chapter 5 Case Studies
• Business Studies Class 12 Chapter 6 Case Studies
• Business Studies Class 12 Chapter 7 Case Studies
• Business Studies Class 12 Chapter 8 Case Studies
• Business Studies Class 12 Chapter 9 Case Studies
• Business Studies Class 12 Chapter 10 Case Studies
• Business Studies Class 12 Chapter 11 Case Studies
• Business Studies Class 12 Chapter 12 Case Studies

Case Studies in Business Studies Business Studies Case Studies Business Studies Commerce

CBSE Expert

CBSE Class 12 Physics Case Study Questions PDF Download

Case Study questions for the Class 12 Physics board exams are available here. You can read the Class 12 Physics Case Study Questions broken down by chapter. Subject matter specialists and seasoned teachers created these quizzes. You can verify the right response to each question by referring to the answer key, which is also provided. To achieve success on your final exams, practice the following questions.

CBSE (Central Board of Secondary Education) is a renowned educational board in India that designs the curriculum for Class 12 Physics with the goal of promoting a scientific temperament and nurturing critical thinking among students. As part of their Physics examination, CBSE includes case study questions to assess students’ ability to apply theoretical knowledge to real-world scenarios effectively.

Chapter-wise Solved Case Study Questions for Class 12 Physics

Before the exams, students in class 12 should review crucial Physics Case Study issues. They will gain a better understanding of the kinds of Case Study questions that may be asked in Physics exams for Grade 12. These questions were created by our highly qualified standard 12 Physics staff based on the questions that appeared most frequently in last year’s exams. The solutions have been written in a way that will make them simple to grasp and will aid students in grade 12 in understanding the topics.

Best Books for Class 12 Physics Exams

Strictly in accordance with the new term-by-term curriculum for the class 12 board exams to be held in the academic year 2023–2024, which will include multiple choice questions based on new board typologies including stand-alone MCQs and case-based MCQs with an assertion–reason. Included are inquiries from the official CBSE Question Bank that was released in April 2024. What changes have been made to the book: strictly in accordance with the term-by-term syllabus for the board exams that will be held during the 2024 academic year? Chapter- and topic-based Questions with multiple choices that are based on the unique evaluation method used for the Class 12th Physics Final Board Exams.

Key Benefits of Solving CBSE Class 12 Physics Case Study Questions

• Application of Concepts: Case study questions demand the application of theoretical knowledge in practical scenarios, preparing students for real-world challenges and professional pursuits.
• Critical Thinking: By evaluating and analyzing case studies, students develop critical thinking abilities, enabling them to approach complex problems with a logical mindset.
• In-Depth Understanding: Addressing case study questions necessitates a thorough understanding of physics concepts, leading to a more profound comprehension of the subject matter.
• Holistic Evaluation: CBSE adopts case study questions as they provide a holistic evaluation of a student’s aptitude and proficiency in physics, moving beyond rote memorization.
• Preparation for Competitive Exams: Since competitive exams often include similar application-based questions, practicing case study questions equips students for various entrance tests.

How to Approach CBSE Class 12 Physics Case Study Questions

• Read and Analyze Thoroughly: Carefully read the case study to grasp its context and identify the underlying physics principles involved.
• Identify Relevant Concepts: Highlight the physics theories and concepts applicable to the given scenario.
• Create a Systematic Solution: Formulate a step-by-step solution using the identified concepts, explaining each step with clarity.
• Include Diagrams and Charts: If relevant, incorporate diagrams, charts, or graphs to visually represent the situation, aiding better comprehension.
• Double-Check Answers: Always review your answers for accuracy, ensuring that they align with the principles of physics.

Tips for Excelling in CBSE Class 12 Physics

• Conceptual Clarity: Focus on building a strong foundation of physics concepts, as this will enable you to apply them effectively to case study questions.
• Practice Regularly: Dedicate time to solving case study questions regularly, enhancing your proficiency in handling real-world scenarios.
• Seek Guidance: Don’t hesitate to seek guidance from teachers, peers, or online resources to gain additional insights into challenging concepts.
• Time Management: During exams, practice efficient time management to ensure you allocate enough time to each case study question without rushing.
• Stay Positive: Approach case study questions with a positive mindset, embracing them as opportunities to showcase your skills and knowledge.

CBSE Class 12 Physics case study questions play a pivotal role in promoting practical understanding and critical thinking among students. By embracing these questions as opportunities for growth, students can excel in their physics examinations and beyond.

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Case Study Questions for Class 12 Physical Education

Table of Contents

[PDF] Download Case Study Questions for Class 12 Physical Education

Physical Education plays a significant role in imparting knowledge about body motion and methods to enhance flexibility, subsequently benefiting an individual’s mental and physical capabilities.

Here you will find case study based questions for class 12 physical education.

Chapter List

Chapter 1 Planning in Sports Case Study Chapter 2 Sports and Nutrition Case Study Chapter 3 Yoga and Lifestyle Case Study Chapter 4 Physical Education and Sports for CWSN – Children with Special Needs: Divyangs Case Study Chapter 5 Children and Women in Sports Case Study Chapter 6 Test and Measurement in Sports Case Study Chapter 7 Physiology and Injuries in Sports Case Study Chapter 8 Biomechanics and Sports Case Study Chapter 9 Psychology and Sports Case Study Chapter 10 Training in Sports Case Study

Important Points About Case-Based Questions in Physical Education Class 12:

• Case-based questions hold a weightage of around 15 to 20% in the 2022-23 examination cycle.
• These questions revolve around everyday life scenarios and require thorough reading of the provided passage.
• They cover various units prescribed by CBSE for Physical Education, demanding complete knowledge of the syllabus.
• When approached with the right mindset, case-based questions can be the highest scoring part of the examination.
• CBSE plans to increase the weightage of such questions in the future.

Key Instructions for Preparing for Case-Based Questions:

• It is crucial for students to read the passage in-depth before attempting the questions.
• Students must prepare well for these questions as they demand complete knowledge of the various concepts in the syllabus.
• These questions are centered around everyday life, making them relevant to students’ understanding of the subject matter.
• CBSE intends to further increase the weightage of such questions in the upcoming years.
• Proper preparation for case-based questions can significantly impact a student’s performance in the Physical Education board exam.

Case Study Question Format for Physical Education

In the CBSE board examinations for class 12, the questions pertaining to Physical Education have historically come in two distinct types: objective and subjective.

However, the latest circular issued by CBSE for the 2022-23 academic session has introduced a significant change. CBSE has explicitly indicated that competency-based questions, including case studies, will be distinct from subjective questions. It’s now highly likely that CBSE will exclusively present objective questions in the CBSE class 12 Physical Education case study section.

Types of CBSE Class 12 Physical Education Case Study Questions:

• Historically, CBSE class 12 Physical Education exams have featured two types of questions: objective and subjective.
• Objective questions typically involve selecting the correct answer from multiple options.
• Subjective questions require students to provide detailed, written responses.
• However, recent changes suggest that CBSE may now focus primarily on objective questions in the case study section.

Benefits of Studying Physical Education:

• Physical Education education provides insights into body motion and techniques to enhance flexibility.
• Improved flexibility contributes to enhanced mental and physical abilities.
• This subject empowers individuals to lead healthier lives through informed choices.
• It fosters an understanding of the importance of physical well-being.

Preparation Tips for Class 12 Physical Education Case Study Questions

To excel in class 12 Physical Education board exams, it’s essential for students to prepare thoroughly for case-based questions. Here are some straightforward tips to tackle them effectively:

• Carefully read the given text.
• Understand the situation and pay attention to the question.
• Analyze before crafting your response.
• Practice extensively.
• Keep your answers concise and on-topic.

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The War in Ukraine and the Future of European Integration (10/12/23)

The Center for the Study of Europe at Boston University presents: The War in Ukraine and the Future of European Integration: The Case for an Accession and Revision Treaty – A Lunch Talk by Federico Fabbrini .

Thursday, October 12, 2023 12:30 to 1:45 PM Pardee School of Global Studies | 121 Bay State Road Lunch provided. Register using form below. [ Add to calendar ]

Federico Fabbrini is Full Professor of European Law at the School of Law & Government of Dublin City University (DCU), where he is the Director of the Law Research Centre. He is also the founding director of the DCU Brexit Institute, where he is the Principal Investigator of both the EU-funded Jean Monnet Network BRIDGE , the EU-funded Jean Monnet Centre of Excellence REBUILD  and the EU-funded Jean Monnet Module Post-Brexit Law . He is also involved as a WP-PI in the Horizon Europe project REGROUP .

Moderated by Vivien Schmidt, Jean Monnet Professor of European Integration, Professor of International Relations, and Professor of Political Science, Boston University.

The War in Ukraine and the Future of European Integration: The Case for an Accession and Revision Treaty

A European Studies lunch talk by Federico Fabbrini • Thursday, October 12, 2023 • 12:30 to 1:45 PM • Pardee School of Global Studies, 121 Bay State Road (Riverside Room)

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Tesla Model 3

Tesla model 3 highland officially unveiled with new design and unexpected features.

Just hours after photos leaked of the upcoming Tesla Model 3 refresh , codenamed “Project Highland,” Tesla has officially unveiled its highly-anticipated facelift in Europe.

The Model 3 has been due for a refresh, remaining mostly-unchanged since its original release in 2017. Most car models get a mid-cycle refresh after about 3 years, and big exterior changes after about 7 years – but Tesla has always done things a little differently, with smaller continual improvements rather than sticking with traditional model cycles.

But now we’ve seen a real, honest-to-goodness refresh of the Tesla Model 3, and it’s quite a big one.

Exterior changes – front end, headlights, badging

The refresh includes a “facelifted” front-end design, interior changes like more screen space (including a new rear display), and increased range. Tesla says that the refresh replaces more than half of the parts in the vehicle, though we’re not exactly sure how it measures that metric.

The most striking change is obviously the new design, which keeps most of the same look of the current Model 3, but changes the front end to look sleeker, removing the somewhat bulbous bump in the front end of the current Model 3.

We saw this front end in a leaked photo back in April , and it looks like it was the real thing all along. Now we have actual photos from Tesla, so you can see the changes in their full glory.

These photos show the new “Ultra Red” color, replacing the current red multi-coat. This color is available in the US on other models, so we imagine it will make its way here, but we’ll have to wait to hear from Tesla about this one.

The headlights have also gotten narrower and more aggressive-looking, in keeping with the general changes to make the front end look sleeker.

And the rear end now has “TESLA” badging, instead of the previous Tesla “T” logo in the middle.

More efficiency = more range

Tesla says that the refreshed Model 3 will have longer range, rated at 344 miles WLTP for the SR RWD version, and 421 miles WLTP for the LR, both with 18″ aero wheels. These numbers are an 11-12% improvement from WLTP ratings for the current Model 3.

But note that those are WLTP numbers, so they’re bigger than the US EPA numbers will be when they come out. If we expect a similar 11-12% improvement, then you’ll see roughly a ~300 mile EPA range on the SR and ~370 miles on the LR. Tesla has also been accused of overstating vehicle range so these numbers should be taken in context.

This increased range largely comes from improvements in aerodynamics, with a lower and less bulbous front end, channeling air around the vehicle more effectively. This has resulted in a Cd of .219, Tesla’s lowest yet (down from .225 on the current Model 3), which improves range by 5-8% on its own.

Another improvement is new wheel cover inserts which strike a compromise between consumers’ desires for larger-looking wheels and more range. Aerodynamic wheel inserts can increase range by a lot , but many think the wheels look better without the caps on (personally, I disagree, but whatever floats your boat).

A huge amount of unexpected interior improvements

There is a significant slate of interior changes as well, which we can’t even list all of here:

• A new rear 8-inch touchscreen, giving rear seat passengers climate controls and entertainment
• Deleted stalks on the steering column, much as in the Model S and X, with the gear selector now on the touchscreen and turn signal buttons on the left side of the steering wheel
• Ventilated front seats, which can be controlled from outside the vehicle through Tesla’s phone app, heating or cooling them up before you get in the car
• Cushier rear seats (now perforated, but not ventilated like the front seats)
• The sound system has been upped to 17 speakers (from 14)
• Improved bluetooth microphone performance
• Improved wi-fi and bluetooth for better connectivity to routers and phone keys
• A quieter interior than on the original Model 3, due to several changes to aerodynamics and materials
• Customizable interior ambient lighting
• Larger rear trunk, up to 594 liters from 561

According to daily Model 3 drivers who’ve gotten the opportunity to spend a little time in the car , these improvements are expansive and almost all positive. We can’t wait until the car comes stateside and we get an opportunity to drive one (or maybe we’ll get a chance while we’re at IAA in Munich this week (edit: we did, here are Fred’s impressions )).

Changes are now live on Tesla’s European sites , where the refreshed Model 3 is now available for order.

Deliveries begin in October (right after Tesla’s shameless FSD transfer scheme expires) in left-hand drive markets in Europe and the Middle East. Tesla has not yet announced when deliveries begin for North America (or for RHD markets like the UK). We don’t have pricing for North America yet, either, but in Norway for example, the SR version is the same base price as before, and the LR version is 10,000 NOK (~$941 USD) more expensive. So far, no performance Highland version has been announced.

Electrek’s Take

We’ve expected this refresh for quite a while now, but now that we see it, it’s a lot more extensive than we had imagined it would be.

The front end changes have been well documented, but the significant overhaul of the interior is quite a lot more than expected.

I personally love most of the changes, but am not a fan of the new steering wheel. While I haven’t tried this specific one, the “yoke” wheel on the Model S was not that pleasant to use. I’m sure it would be fine after getting used to it, but turn signal stalks are just so convenient and familiar, and I don’t like the change to buttons.

Top comment by Noel Von Froggenstein

Nice looking but deleting more physical controls especially turn indicator stalks seem crazy. How do you indicate half way around a roundabout? No parking sensors either. Front is a big improvement, gone is the duck face.

Same for using the screen for gear selection, which just feels kludgy – though that command isn’t used nearly as often as the turn signals, so it’s not as offensive to me personally.

And, lest you think I am merely a luddite, recall that in our original Model 3 review , I raved about almost everything about this car, including the changes that many considered odd. It was and is an exceptional vehicle, and the Highland changes do not change that on balance.

We’ll have to wait and see if changing 50% of the parts in the car results in a few glitches here and there with early models, but Tesla has gotten a lot better at manufacturing since the early days, so hopefully it won’t be too bad. Even my early Model 3 (VIN ~2500) has been mostly free of problems (except for the stinky feet air conditioning issue – it remains to be seen if Tesla has finally solved this with Highland, but we sure hope they have).

What do you think of the new Project Highland Model 3 Refresh? Let us know in the comments below. (edit: and, now that we’ve seen it in person at IAA, have a look at this short video below)

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Jameson has been driving electric vehicles since 2009, and has been writing about them and about clean energy for electrek.co since 2016.

You can contact him at [email protected]

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