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Toxicological information

Genetic toxicity: in vivo

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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:
2012
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

1
Chemical structure
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

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.