Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: chromosomal damage
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Food and Drug Administration (FDA) Good Laboratory Practice Regulations for Nonclinical Studies (GLP Guidelines)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals and environmental conditions:
The NTP also routinely conducts peripheral blood micronucleus tests on mice that are treated in the 13-week toxicity studies as part of the bioassay program

Administration / exposure

Duration of treatment / exposure:
treatments are administered at 24 hr.
No. of animals per sex per dose:
there are normally 5 male animals per treatment group

Examinations

Statistics:
in the micronucleus test, animals are treated with a chemical and then the frequency of micronucleated cells is determined at some specified time after treatment. If a treated group of animals shows significantly higher frequencies of micronucleated cells than do the untreated control animals, then the chemical is considered to be capable of inducing structural and/or numerical chromosomal damage.

Results and discussion

Additional information on results:
After a 24-hour exposure to the camphor, no dose-group of either sex showed a ~ignificant increase in micronucle iscompared to the control.

Applicant's summary and conclusion