Registration Dossier
Registration Dossier
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EC number: 442-080-3 | CAS number: -
Genetic toxicity: in vivo
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Some details on test material, test procedure and test results are lacking. Justification for read across approach is explained in the endpoint summary.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
- Principles of method if other than guideline:
- Micronucleus assay was performed in male mouse administered by one intraperitoneal injection per day, for 3 consecutive days.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- 1 injection per day on 3 consecutive days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 1000, 2000 mg/kg
Basis:
nominal conc.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Additional information on results:
- The initial test gave a positive trend from 2.1 micronucleated polychromatic erythrocytes / 1000 to 3.8 in the high dose. Peripheral blood smears were negative as was a repeat bone marrow test using doses of 1000 and 2000 mg/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The initial test gave a positive trend from 2.1 micronucleated polychromatic erythrocytes / 1000 to 3.8 in the high dose. Peripheral blood smears were negative as was a repeat bone marrow test using doses of 1000 and 2000 mg/kg bw/day. - Executive summary:
Micronucleus assay was performed in male mouse administered by one intraperitoneal injection per day, for 3 consecutive days. The initial test gave a positive trend from 2.1 micronucleated polychromatic erythrocytes / 1000 to 3.8 in the high dose. Peripheral blood smears were negative as was a repeat bone marrow test using doses of 1000 and 2000 mg/kg bw/day.
Conclusion
Negative
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