Registration Dossier
Registration Dossier
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EC number: 944-459-3 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- : lack of details on test substance
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 68890-70-0 (purity 30%)
- IUPAC Name:
- 68890-70-0 (purity 30%)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to guideline.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- water
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.13%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, plain diet
- Positive control(s):
- Yes.
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- SAMPLING TIMES:
after 90 days - Evaluation criteria:
- According to guideline.
- Statistics:
- No.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- negative
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