Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from similar mixture/product
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Amended Final Report on the Safety Assessment of Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Germ Oil, Rice Bran Acid, Oryza Sativa (Rice) Bran Wax, Hydrogenated Rice Bran Wax, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sat
- Year:
- 2 006
- Bibliographic source:
- International Journal of Toxicology - CIR database
- Report date:
- 2006
Materials and methods
- Principles of method if other than guideline:
- Data are extracted from the 2006 review of the International Journal of Toxicology about the assessment of rice derivates. Since the study reported is dated back to 1987 (Polasa, K., and C. Rukmini. 1987. Mutagenicity tests of cashewnut shell liquid, rice-bran oil and other vegetable oils using the Salmonella typhimurium/microsome system. Food Chem. Toxicol. 25:763–766) we assume that it was performed according to OECD 471
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Rice Bran Oil
- IUPAC Name:
- Rice Bran Oil
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Metabolic activation:
- with and without
- Vehicle / solvent:
- DMSO (20 ml of DMSO with 200 ml of Rice Bran Oil)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- not performed
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- not performed
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- not performed
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: no mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- No substantial increase in the number of revertant colonies was observed in any of the 2 tester strain.
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