Registration Dossier
Registration Dossier
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EC number: 234-522-7 | CAS number: 12007-92-0
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US-EPA-FIFRA section 158.340 Guideline 84-2
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- H3BO3
- IUPAC Name:
- Boric acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water.
- Details on exposure:
- Mice given two doses (in 10 mL distilled water) by gavage.
- Duration of treatment / exposure:
- 2 days.
- Frequency of treatment:
- Animals dosed once per day.
- Post exposure period:
- No data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 225 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 450 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 900 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 800 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 3 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
Examinations
- Tissues and cell types examined:
- No data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Clinical signs included rough fur and haunched position.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test substance was not genotoxic.
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