Registration Dossier
Registration Dossier
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EC number: 612-366-4 | CAS number: 6172-80-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- bone marrow cells of the Sprague Dawley rat
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- deionized water
- Details on exposure:
- The test substance was administered twice at an interval of 24 hours orally by gavage to the test animals at doses of 200, 600 and 2000 mg per kg body weight.
- Duration of treatment / exposure:
- The test substance was administered twice at an interval of 24 hours orally by gavage to the test animals at doses of 200, 600 and 2000 mg per kg body weight.
- Frequency of treatment:
- The test substance was administered twice at an interval of 24 hours
- Post exposure period:
- 18 h after last administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 600 and 2000 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 5 male / 5 female
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
Examinations
- Tissues and cell types examined:
- bone marrow
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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