Registration Dossier
Registration Dossier
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EC number: 401-990-0 | CAS number: 106990-43-6 CHIMASSORB 119; LOWILITE 19
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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle/solvent used: 0.5% of an aqueous solution of sodium carboxymethylcellulose
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- no data
- Post exposure period:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- Male animals: 24 per dose
Female animals: 24 per dose
Examinations
- Tissues and cell types examined:
- no data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No statistically significant increase (p>0.05) in the number of micronucleated polychromatic eritrocytes compared with the negative control animals.
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