Registration Dossier
Registration Dossier
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EC number: 251-607-4 | CAS number: 33629-47-9
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- EC Number:
- 251-607-4
- EC Name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- Cas Number:
- 33629-47-9
- Molecular formula:
- C14H21N3O4
- IUPAC Name:
- N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
Constituent 1
impurity 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- 24h
- Frequency of treatment:
- 2
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
Applicant's summary and conclusion
- Conclusions:
- Under our experimental conditions, the test substance Butraline technique does not induce damage to the chromoses or the mitotic apparatus of mice bone marrow cells after twho oral administrations, at a 24-hour interval, at the dose levels of 200, 400 or 800 mg/kg/day.
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