8/21 - Regulatory vs Clinical Toxicology

NOAEL

What term in regulatory toxicology refers to the level of a substance at which there are no adverse effects?

MRL

What term in regulatory toxicology refers to the level below which a substance must be to still be safe, if it cannot be completely eradicated?

ADI

What term in regulatory toxicology refers to the level at which a substance can be consumed on a daily basis without causing adverse effects, if it cannot be completely eradicated?

In vitro

What type of testing includes carcinogenicity, genotoxicity, and mutagenicity tests?

In vivo

What type of tests include acute, subacute, and chronic toxicity tests?

Mutagenicity

What type of in vitro tests include the Ames and MLA tests and are done to test whether an existing organism will undergo gene mutations due to a substance?

Genotoxicity

What type of in vitro tests include the micronucleus and chromosomal aberration tests and are done to test whether the chromosomes of an organism will be affected by a substance?

Ames

What mutagenicity test is done on S. typhimurium and E. coli to test whether there is selection of revertants? It uses strains developed not to grow without histidine, which are then exposed to a substance to determine whether they will reverse mutate and grow without histidine.

MLA

Which mutagenicity test is done on rodent or human cells to look for selection of gene mutations after exposure to a chemical?

Micronucleus

What genotoxicity test/assay is done on rodent or human cells to determine whether nuclear aberrations or changes in the structure or number of chromosomes occur after exposure to a chemical? It can be done in vitro or in vivo and takes biotransformation into account (Howell-Jolly body formation). Mechanisms include chromosomal breaks and disruption of the mitotic apparatus.

Metabolism

In the Ames test, liver microsomes, kidney microsomes, or liver cells are added to determine if toxicity is mediated by what? Microsomes test whether there is CYP450 biotransformation, and whole liver cells test whether there is conjugated reaction-mediated biotransformation.

Fluctuation

Which method of the Ames test is based on the principle that multiplying bacteria results in a change in pH, using color changes to identify the change? Liver/kidney microsomes and liver cells can be used. This allows testing of more compounds at variable concentrations at the same time than the normal method of the Ames test.

COMET

What assay is used to test for genotoxicity and is a sensitive and reliable technique used to detect DNA damage at the level of individual cells? It measures DNA strand breaks and observes how far fragmented DNA migrates in an electric field, creating this namesake shape. It is also called a single-cell gel electrophoresis (SCGE). Fragmented DNA will migrate faster than intact DNA.

Acute

What in vivo toxicity tests use single dose toxicity, are the traditional first classification and dose-range finding test, determine lethality and LD50, serve as the start of the cumulative dose-effect response, and use rats, mice, hamsters, and chickens?

Subacute

What in vivo toxicity tests are a defined protocol, use 7-10 repetitive doses to different dosage groups, use clinical observation and postmortem pathology, and use substance characterization?

Chronic

Which in vivo toxicity tests use a 90-day rodent toxicity assay, to define NOAEL and LOEL? Daily exposure will indicate all possible adverse effects and at least 3 different doses are given to male and female rodents. It is over an extended period, with daily clinical, urine, and blood sampling.

Hamsters

Which animals are used to test male reproductive toxicity, as they have no blood-testis barrier?

Oocytes

What cells are used to test female reproductive toxicity by analyzing cumulus expansion and maturation?

Transgenerational

Which toxicity type is when offpsring show clinical signs after exposure of the mother? Zearalenone, DES, and glyphosate all do this.