ABT Reproductive and Developmental Toxicology 2

Question 1

ICH S5(R3) guidelines govern which aspect of pharmaceutical development?

Accepted Answer

Detection of reproductive and developmental toxicity for human pharmaceuticals

Answer

ICH S5(R3) provides internationally harmonized guidelines for reproductive and developmental toxicology studies (fertility, embryo-fetal development, pre-/postnatal development) for drug registration.

Question 2

A 'developmental NOAEL' is used in risk assessment to protect against which type of toxic effect?

Accepted Answer

Adverse effects on the developing organism (structural, functional, or growth-related)

Answer

The developmental NOAEL is the highest dose causing no adverse developmental effects (structural malformations, growth restriction, functional deficits) and is used to set human safety limits.

Question 3

Alcohol is a well-established human teratogen. The most severe outcome of prenatal alcohol exposure is:

Accepted Answer

Fetal alcohol syndrome (FAS) — growth restriction, CNS abnormalities, and facial dysmorphology

Answer

Fetal alcohol syndrome (FAS) is the most severe outcome of prenatal alcohol exposure and is characterized by growth restriction, central nervous system damage, and a characteristic facial phenotype.

Question 4

Which test in the developmental toxicity battery specifically evaluates learning and memory deficits caused by in utero chemical exposure?

Accepted Answer

Developmental neurotoxicity (DNT) study

Answer

The developmental neurotoxicity (DNT) study, guided by OECD 426 and EPA DNT guidelines, assesses functional CNS endpoints including motor activity, learning, memory, and sensory function in offspring.

Question 5

Which male reproductive toxicant causes depletion of spermatogonia by alkylating DNA in the seminiferous epithelium?

Accepted Answer

Dibromochloropropane (DBCP)

Answer

DBCP (dibromochloropropane) is a nematocide that caused permanent infertility in male workers by alkylating and destroying spermatogonial stem cells in the seminiferous epithelium.

ABT - American Board of Toxicology Practice Test

ABT - American Board of Toxicology Practice Test

ABT Reproductive and Developmental Toxicology 2