Safety Testing

Question 1

T/F new drugs for human and veterinary use, pesticides, feed additives, and industrial chemicals have to be assessed for their safety and toxicity before marketing

Answer 1

True

Question 2

general tests

Answer 2

acute toxicity

subchronic toxicity

chronic toxicity

Question 3

special tests

Answer 3

reproduction and fertility

teratogenicity

mutagenicity

carcinogenicity

skin, eye or muscle irritation

hemolysis

Question 4

which specied are most commonly used

Answer 4

rats

dogs

Question 5

the tested compound

Answer 5

should be pure or as it is commercially produced

vehicle should be inert and not alter th properties of the tested compound

control vehicle should be used

Question 6

for subchronic and chronic toxcity what dose levels are used

Answer 6

high dose that produces clinical signs

mid dose that produces mild toxicosis

low dose which is the largest dose that does not produce toxicosis

Question 7

acute toxicity

Answer 7

acute LD50/LC50 experiment

single or multiple exposure in 24hr period

observe for 1-14 days

Question 8

aubchronic toxicity

Answer 8

exposure >1 - 90 days

usually 3 different dosage levels plus control

hematologic and biochemical analyses are made at intervals

PM at end of experiment

Question 9

chronic toxicity

Answer 9

similar to subchronic but period if >90days

Question 10

terotogen

Answer 10

any substance that produces non lethal structual or functional abnormalities in the fetus

Question 11

mutagenesis

Answer 11

induction of chromosomal changes

Question 12

how is mutagenicity tested

Answer 12

dominant lethal test

cytologic tests

host-mediated microbial assay