Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to Direcitve 84/449/EEC, B.12 and compliant with B.12.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive 84/449/EEC, B.12 (Mikrokerntest)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
hamster, Chinese
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5% aqueous carboxymethylcellulose
No. of animals per sex per dose:
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 16 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 16 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Additional information on results:
Observations: No cytotoxic effect (PCE/NCE)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative