MULTIPLE CHOICE

1. Regulatory toxicology aims at guarding the public from dangerous chemical exposures, and depends primarily on which form of study:

• a. observational human studies.
• b. controlled laboratory animal studies.
• c. controlled human studies.
• d. environmental studies.

2. Risk from a public health perspective, is best described as the following:

• a. undesirable endpoint is reached.
• b. a possibility of a bad outcome.
• c. likelihood of an unwanted outcome combined with uncertainty of when it will occur.
• d. a bad outcome is assured and its mechanism is well understood.

3. Which of the following statements is true regarding Risk Analysis:

• a. it is a field of study that has been around for the last century.
• b. it was developed by the pharmaceutical companies in response to concerns over new medications.
• c. it is a relatively new field of study, spurred by new technologically-based risks.
• d. it was largely a private sector venture.

4. Which of the following are tools used in risk analysis?

• a. toxicology
• b. epidemiology
• c. clinical trials
• d. all of the above.

5. Which of the following are common endpoints:

• a. death
• b. No Observable Effect Level
• c. No Observable Adverse Effect Level
• d. Lowest Observable Adverse Effect Level
• e. All of the above.

6. The LD50 is best described as which of the following:

• a. the dose at which 50% of all test animals die
• b. the dose at which 50% of the animals demonstrate a response to the chemical
• c. the dose at which all of the test animals die
• d. the dose at which at least one of the test animals dies

7.. The effective dose is best described as which of the following:

• a. the dose at which 50% of all test animals die
• b. the dose at which some of the animals demonstrate a response to the chemical
• c. the dose at which all of the animals demonstrate a response to the chemical
• d. the dose at which 50% of all test animals demonstrate a response to the chemical

8. Extrapolation is best described as which of the following:

• a. using known information to reach a conclusion.
• b. using known information to infer something about the unknown.
• c. using speculative information to infer something about the known.
• d. a "best guess" approach.

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TRUE AND FALSE 

1. Environmental risk is a well-understood entity.

T ______ F ______

2. Cross-sectional studies look at the exposure and disease at the same time.

T ______ F ______

3. Bias is a problem primarily of Clinical Trials.

T ______ F ______

4. Subchronic studies are shorter than Acute studies.

T ______ F ______

5. The lethal dose refers to the dose at which 50% of test animals die.

T ______ F ______

6. The Maximum Tolerated Dose (MTD) is the level of chemical exposure where 10% of the animals die.

T ______ F ______

7. Case Control Studies start with the exposure and follow for the disease.

T ______ F ______

8. Case Control Studies are good for rare diseases.

T ______ F ______

9. Clinical Trials look at dose-response in animals.

T ______ F ______

10.Dose refers to the amount of a substance in the environment.

T ______ F ______

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ESSAY QUESTIONS

1. Describe the four steps involved in the process of Risk Analysis.

2. Discuss the limitations inherent in risk analysis.