Registration Dossier
Registration Dossier
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EC number: 202-855-7 | CAS number: 100-47-0
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2000
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Benzonitrile
- EC Number:
- 202-855-7
- EC Name:
- Benzonitrile
- Cas Number:
- 100-47-0
- Molecular formula:
- C7H5N
- IUPAC Name:
- benzonitrile
- Reference substance name:
- Toluene
- EC Number:
- 203-625-9
- EC Name:
- Toluene
- Cas Number:
- 108-88-3
- Molecular formula:
- C7H8
- IUPAC Name:
- toluene
- Reference substance name:
- Benzaldehyde
- EC Number:
- 202-860-4
- EC Name:
- Benzaldehyde
- Cas Number:
- 100-52-7
- Molecular formula:
- C7H6O
- IUPAC Name:
- benzaldehyde
- Reference substance name:
- Terephthalonitrile
- EC Number:
- 210-783-2
- EC Name:
- Terephthalonitrile
- Cas Number:
- 623-26-7
- Molecular formula:
- C8H4N2
- IUPAC Name:
- terephthalonitrile
- Reference substance name:
- Benzene-1,3-dicarbonitrile
- EC Number:
- 210-933-7
- EC Name:
- Benzene-1,3-dicarbonitrile
- Cas Number:
- 626-17-5
- Molecular formula:
- C8H4N2
- IUPAC Name:
- isophthalonitrile
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 13 weeks (micronucleus test at the end of a 90 day study)
- Frequency of treatment:
- daily
- Post exposure period:
- no data
Doses / concentrations
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- Remarks:
- Basis: actual ingested
- No. of animals per sex per dose:
- 9-10 males; 7-10 females
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- systemic toxicity at 37.5 mg/kg/d (females) and 75 mg/kg/d (males)
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Benzonitrile did not increase the rate of micronuclei in polychromatic erythrocytes in a micronucleus test conducted at the end of a 90 day study in mice. - Executive summary:
At the end of a sub-chronic oral toxicity study in 7-10 B6C3F1-mice/sex/dose a micronucleus test was conducted. Exposure to benzonitrile did not increase the rate of micronuclei in polychromatic erythrocytes at doses up to 600 mg/kg/d. This micronucleus test conducted at the end of a 90 day study is valid according to OECD 474. Systemic adverse effects were reported at 37.5 mg/kg/d. Benzonitrile is considered to be not mutagenic in vivo.
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