Registration Dossier
Registration Dossier
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EC number: 235-795-5 | CAS number: 12738-64-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Remarks:
- Collection of experimental studies evaluated by ECHA/RAC
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- The study was reviewed by ECHA/RAC in the evaluation of in vivo genetic toxicity of sodium benzoate.
Data source
Reference
- Reference Type:
- other: RAC oppinion
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- other: Bone marrow chromosome aberration test
Test material
- Reference substance name:
- Sodium benzoate
- EC Number:
- 208-534-8
- EC Name:
- Sodium benzoate
- Cas Number:
- 532-32-1
- Molecular formula:
- C7H6O2.Na
- IUPAC Name:
- sodium benzoate
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Bone marrow chromosome aberration tests were performed in rats, whereas Host mediated assay was performed in ICR Mice.
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Gavage; two groups were exposed, a and b
- Duration of treatment / exposure:
- a) 6-48 h
b) 6 h - Frequency of treatment:
- a) single
dose
b) 5 d
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A bone marrow chromosome aberration test was performed in Sprague Dawley rats exposed to 0. 50. 500 and 5000 mg/kg bw/day of Sodium benzoate by oral gavage for either one singe dose (group a) or for 5 days (group b). Sampling of bone marrow was performed after 6-48 h in group a and 6 h in group b. No signs of mutagenicity was detected.
- Executive summary:
A bone marrow chromosome aberration test was performed in Sprague Dawley rats exposed to 0. 50. 500 and 5000 mg/kg bw/day of Sodium benzoate by oral gavage for either one singe dose (group a) of for 5 days (group b). Sampling of bone marrow was performed aafter 6-48 h in group a and 6 h in group b. No signs of mutagenicity was detected.
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