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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Test Method, Annex Ⅴ (B.12) of Dir. 84/449/EEC
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 72hours
Male: 1000mg/kg; No. of animals: 5; Sacrifice time: 24hours
Male: 1000mg/kg; No. of animals: 5; Sacrifice time: 48hours
Male: 1000mg/kg; No. of animals: 5; Sacrifice time: 72hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 72hours
Female: 1000 mg/kg; No. of animals: 6; Sacrifice times: 24hours
Female: 1000 mg/kg; No. of animals: 7; Sacrifice times: 48hours
Female: 1000mg/kg; No. of animals: 5; Sacrifice times: 72hours

Results and discussion

Additional information on results:
Doses producing toxicity:
In a preliminary experiment 100% of the animals died at 5000mg/kg, while 83% died at 2000mg/kg and 17% at 1500mg/kg.

At the 1000mg/kg dose level one animal (17%) showed pilo-erection and at 500mg/kg no effects were found. In the final experiment at 1000mg/kg no animals died.

Ratio polychromatic/normochromatic: a 1000mg/kg b.w.: not significantly different from the negative controls.

Observations:
The mean number of micronuclei per group and the mean ratio of polychromatic to normochromatic erythro's were calculated. The test groups
showed no increase in the frequency of micronuclei. In negative control animals, the incidence of micronuclei was found to be in the range of
historical data. In positive control animals, a decrease in the ratio polychr.lnorm. erythro's and a statistically significant increase in the number of
micronuclei.

It is concluded that this test is valid and that the substance can be considered as not mutagenic under the experimental conditions of the
micronucleus test.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative