Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
study GLP compliant performed on a similar substanceThe study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier on analogue substance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Distilled water
No. of animals per sex per dose:
6 Males at 2000 mg/kg sacrifice time: 24h
6 Males at 2000 mg/kg sacrifice time: 48h
6 Males at 2000 mg/kg sacrifice time: 72h
6 Feales at 2000 mg/kg sacrifice time: 24h
6 Feales at 2000 mg/kg sacrifice time: 48h
6 Feales at 2000 mg/kg sacrifice time: 72h

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative