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:
supporting study
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.

Data source

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

Materials and methods

GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
no data
Frequency of treatment:
two intraperitoneal injections, 24 hours apart.
Post exposure period:
24 or 48 hours after dosing.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
250
Basis:
nominal conc.
mg/kg bw/day
Remarks:
Doses / Concentrations:
500
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1000
Basis:
nominal conc.
No. of animals per sex per dose:
5 male and 5 female

Results and discussion

Test resultsopen allclose all
Sex:
male
Genotoxicity:
positive
Remarks:
within the historical control range
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Sex:
female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

At 48 hour sampling time, statistically significant increases in micronucleated polychromatic erythrociteswere observed in males (but not females) given 250 and 500 (but not 1000) mg/kg bw/day.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
In the EMEA literature was reported to be a negative result.