In Vivo Toxicity Testing Flashcards
What are the two factors of hazard identification that tie into risk characteriation?
Dose-Response assessment
Exposure assessment
Identification of a Hazard leads to allows for ____ (4)
- Epidemiology
- Toxicology (in vivo)
- In vitro tests
- Structure-activity analyses
True/False? Academic institutions always follow strict guidelines.
False
True/False? All drugs developed for human use are tested.
True
True/False? Most chemicals in commerse today have been tested as safe.
False, most of them haven’t been tested at all (yikes)
What is the OECD?
Organisation for Economic Co-operation and Development
Guidelines for the testing of chemicals (~100 most relevant methods of testing)
What is the testing scheme for new chemicals? (8 steps)
- Test material identification
- Chemical characterisation
- Literature review
- Structure/activity assessment
- Short term animal studies
- in vitro genetic toxicity
- metabolism/pharmacokinetics
- subchronic toxicity
- specialized results
- Reproductive/teratology
- Chronic toxicity
- Oncogenicity
What do the Screening Information Data Set tests cover? (6 things)
- acute toxicity
- chronic toxicity
- developmental and reproductive toxicity
- mutagenicity
- ecotoxicity
- environmental fate
True/False? Most of the 3000 high production volume chemicals are missing one or more of the SIDS tests?
True, 93%
True/False? Almost half of the 3000 high production volume chemicals are missing all of the SIDS tests?
True, 43%
True/False? Approximately one third of the 3000 high production volume chemicals have all six of the SIDS tests
False, 7%
What are the EPAs problems regarding toxicity data?
Too many chemicals, too little data
What are the three most used animals for testing?
Mice, birds and fish
True/false? The amount of animals killed for research and education is larger than any other category of animals killed
False (opposite is true)
True/False? On the basis of dose per unit of body mass, toxic effects in humans are usually in the same dose range as those for experimental animals.
False, basis of dose per unit of body surface
True/False? Increasing sample size gives better results.
…
Define point of departure
The point at which extrapolation from experimental data begins
How many animals are typically used in a cohort analysis?
140
What is the time span of a subacute test?
8 months
What is the time span of a subchronic test?
12 months
What is the time span of a chronic test?
45 months
What are the 5 objectives of long term toxicity testing?
- Determine therapeutic margins in the species studied
- Determine dose-response relationship of behavioural, functional, and histopathological effects of a drug when administered repeatedly
- Determine the target organs for potential toxicity
- Determine the existence of speices and sex difference
- Determine whether the toxicity is reversible
How do carcinogenic/mutagenetic studies differ in practice from in theory?
It’s expensive
Why are males exposed for 60 days in a developmental/reproductive study as opposed to 14 days in females?
Spermatogenesis takes approximately 2 months
