Registration Dossier
Registration Dossier
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EC number: 474-180-8 | 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method B12 of Commission Directive 2000/32/EC
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
Constituent 1
Test animals
- Species:
- other: Mouse, albino Crl:CD-1 TM(ICR)BR
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Arachis oil.
- No. of animals per sex per dose:
- Male: 320 mg/kg; No. of animals: 7; Sacrifice time: 48 hours
Male: 320 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 160 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 80 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Results and discussion
- Additional information on results:
- Doses producing toxicity:
The maximum tolerated dose was 320 mg/kg
A statistically significant decrease in the PCE/NCE ratio
was observed in the 48 hour 320 mg/kg test material dose
group when compared to the concurrent control group. This
accompanied by the presence of clinical signs was taken to
indicate that systemic absorption had occured and exposure
to the target tissue achieved.
Observations:
There was no evidence of a significant increase in the
incidence of micronucleated polychromatic erythrocytes in
animals dosed with the test material when compared to the
concurrent vehicle control groups.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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