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: The 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

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1988

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
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
deionised water
No. of animals per sex per dose:
Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 24 hoursMale: 6250 mg/kg; No. of animals: 5; Sacrifice time: 48 hoursMale: 6250 mg/kg; No. of animals: 5; Sacrifice time: 72 hoursFemale: 6250 mg/kg; No. of animals: 5; Sacrifice times: 24 hoursFemale: 6250 mg/kg; No. of animals: 5; Sacrifice times: 48 hoursFemale: 6250 mg/kg; No. of animals: 5; Sacrifice times: 72 hours

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negativeThe substance was tested for genetic toxicity in vivo following EU Method B12. Under the experimental conditions the substance did not show any in-vivo mutagenic properties.
Executive summary:

The substance was tested for genetic toxicity in vivo following EU Method B12. Under the experimental conditions the substance did not show any in-vivo mutagenic properties.