Safety Testing Flashcards
3 general tests
acute toxicity, sub chronic toxicity, chronic toxicity
2 species most commonly used
rats and dogs
_____ are species which will be exposed to the compound
target species
What is FALSE regarding the tested compound?
A) a control vehicle should be used
B) Should be pure or as it is commercially produced
C) Compounds don’t need to be tested
D) vehicle should be inert and not alter properties of tested compound
C - they do need to be safety tested!
3 doses used for sub chronic and chronic toxicity tests?
High - produces clinical signs
Mid-Dose - produces mild toxicosis
Low - largest dose that doesn’t produce toxicosis
How often should you observe effects?
daily
Which is FALSE regarding acute toxicity tests?
A) Only primates are used
B) Is an acute LD50 experiement
C) is a single or multiple exposure in 24 hour period
D) observation period is 1-14d
A - usually rodents (more than 1 species) used
Which is FALSE regarding sub chronic toxicity tests?
A) period of exposure is >1d–>90d
B) rats and cats are most commonly used
C) species are used at 3 different dosage levels plus a control group
D) hematologic and biochemical analyses are made at intervals
B - rats and dogs are most commonly used
What is the time line of a chronic toxicity test?
at least 90 days, usually up to 18 months in mice and 24 months in rats, dogs or primates
How many successive generations of rats are used for reproduction and fertility tests?
2-3
What is the dosing protocol for a reproduction/fertility test?
adult males and females dosed 60d before mating
females treated during gestation and lactation
offspring treated from weaning until lactation
What is a teratogen
a substance that produces non-lethal structural or functional abnormalities in the fetus
_____ is a substance that causes death of the embryo or fetus
embryo toxic or fetotoxic
species we test teratogenicity on?
rabbits, rats or mice
What is the induction of chromosomal changes?
mutagenesis
