Toxicity testing guidelines MCQs With Answer

Toxicity testing guidelines MCQs With Answer

This blog provides a focused collection of multiple-choice questions on toxicity testing guidelines tailored for M.Pharm students. Emphasizing internationally accepted frameworks such as OECD, ICH, GLP, and GHS, the quiz items probe core concepts including acute, subchronic and chronic toxicity protocols, genotoxicity and carcinogenicity batteries, reproductive and developmental toxicity, safety pharmacology, alternative in vitro methods and ethical 3Rs principles. Each question is followed by the correct answer to reinforce learning and exam readiness. Use these MCQs to deepen your understanding of guideline-driven study design, dose selection (NOAEL/LOAEL/MTD), interpretation of results and regulatory expectations vital for drug safety assessment and dossier preparation.

Q1. What is the primary purpose of internationally accepted toxicity testing guidelines (e.g., OECD, ICH)?

• To establish marketing strategies for pharmaceuticals
• To provide harmonized frameworks for designing nonclinical safety studies and risk assessment
• To dictate clinical trial endpoints for efficacy
• To standardize manufacturing batch release tests

Correct Answer: To provide harmonized frameworks for designing nonclinical safety studies and risk assessment

Q2. Which organization originally developed the widely adopted Principles of Good Laboratory Practice (GLP)?

• International Council for Harmonisation (ICH)
• Organisation for Economic Co-operation and Development (OECD)
• World Health Organization (WHO)
• European Medicines Agency (EMA)

Correct Answer: Organisation for Economic Co-operation and Development (OECD)

Q3. Which ICH guideline series specifically addresses carcinogenicity testing of pharmaceuticals?

• ICH S1
• ICH S2
• ICH M3
• ICH Q1

Correct Answer: ICH S1

Q4. The OECD Test Guideline number that describes the up-and-down procedure for acute oral toxicity is:

• OECD TG 420
• OECD TG 423
• OECD TG 425
• OECD TG 409

Correct Answer: OECD TG 425

Q5. In acute toxicity testing, a “limit test” is recommended when:

• The substance is highly toxic and expected to have an LD50 below 50 mg/kg
• The test article is suspected to be non-toxic or of low toxicity at the limit dose, allowing reduced animal use
• Chronic exposure effects are the primary concern
• Dermal penetration needs to be assessed quantitatively

Correct Answer: The test article is suspected to be non-toxic or of low toxicity at the limit dose, allowing reduced animal use

Q6. NOAEL in toxicity studies stands for which of the following?

• No Observed Adverse Effect Level
• Normal Observed Activity and Effect Limit
• New Observed Acute Effect Limit
• Not Observed as an Adverse Effect Level

Correct Answer: No Observed Adverse Effect Level

Q7. The term MTD in nonclinical toxicology refers to:

• Minimum Threshold Dose—the lowest dose producing any effect
• Maximum Tolerated Dose—the highest dose that does not cause unacceptable toxicity
• Median Toxic Dose—the dose causing toxicity in half the population
• Modified Toxicity Determination used only in vitro

Correct Answer: Maximum Tolerated Dose—the highest dose that does not cause unacceptable toxicity

Q8. According to typical regulatory guidance, the duration of a subchronic toxicity study in rodents is:

• 14 days
• 28 days
• 90 days
• 2 years

Correct Answer: 90 days

Q9. A standard genotoxicity testing battery generally includes which combination of tests?

• Ames bacterial reverse mutation test, in vitro mammalian cell assay, in vivo micronucleus test
• Two chronic rodent carcinogenicity studies and a teratology study
• Single-dose acute oral toxicity and dermal irritation tests
• Only the Ames test is sufficient for all regulatory purposes

Correct Answer: Ames bacterial reverse mutation test, in vitro mammalian cell assay, in vivo micronucleus test

Q10. Which ICH guideline provides recommendations on reproductive and developmental toxicity testing for pharmaceuticals?

• ICH S2
• ICH S5
• ICH M4
• ICH Q3

Correct Answer: ICH S5

Q11. ICH M3(R2) is primarily concerned with:

• Quality control of active pharmaceutical ingredients
• Nonclinical safety studies and timing to support human clinical trials
• Guidance on pharmacovigilance reporting after marketing
• Labeling requirements for investigational products

Correct Answer: Nonclinical safety studies and timing to support human clinical trials

Q12. OECD Test Guideline 429 corresponds to which skin sensitization method?

• Dermal Draize irritation test
• Local Lymph Node Assay (LLNA)
• Human repeat insult patch test (HRIPT)
• Skin prick allergy test

Correct Answer: Local Lymph Node Assay (LLNA)

Q13. The OECD Test Guideline 437 refers to which in vitro eye irritation method?

• BCOP (Bovine Corneal Opacity and Permeability)
• Isolated Chicken Eye (ICE)
• Reconstructed Human Epidermis (RHE) skin irritation
• In vivo Draize eye test

Correct Answer: BCOP (Bovine Corneal Opacity and Permeability)

Q14. GHS, a system often referenced in toxicity guideline context, stands for:

• Global Health Standards
• Globally Harmonized System of Classification and Labelling of Chemicals
• General Hazard Specifications
• Guideline for Human Safety

Correct Answer: Globally Harmonized System of Classification and Labelling of Chemicals

Q15. The ethical principles known as the 3Rs in toxicity testing are:

• Reduce, Recycle, Reuse
• Replacement, Reduction, Refinement
• Review, Report, Remediate
• Randomize, Replicate, Rank

Correct Answer: Replacement, Reduction, Refinement

Q16. A commonly accepted “limit dose” for acute oral toxicity studies under many OECD procedures is:

• 50 mg/kg
• 200 mg/kg
• 2000 mg/kg
• 10000 mg/kg

Correct Answer: 2000 mg/kg

Q17. The core battery of safety pharmacology studies typically evaluates which physiological systems?

• Gastrointestinal, hepatic, renal
• Cardiovascular, respiratory, central nervous system
• Endocrine, metabolic, dermatologic
• Ophthalmic, auditory, olfactory

Correct Answer: Cardiovascular, respiratory, central nervous system

Q18. Regulatory carcinogenicity bioassays in rodents are typically conducted for what approximate duration?

• 3 months
• 6 months
• 1 year
• 2 years

Correct Answer: 2 years

Q19. Good Laboratory Practice (GLP) principles apply primarily to which type of studies?

• Clinical trials involving human volunteers
• Non-clinical safety studies and regulatory toxicity testing
• Routine quality control testing of finished products only
• Post-marketing pharmacovigilance case reports

Correct Answer: Non-clinical safety studies and regulatory toxicity testing

Q20. Under typical GLP expectations, critical study records and raw data should be archived for a minimum period of:

• 1 year
• 3 years
• 5 years
• 20 years

Correct Answer: 5 years

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