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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
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:
Final Report on the Safety Assessment of Tocopherol, TocopherylAcetate, TocopherylLinoleate, TocopherylLinoleate/Oleate, TocopherylNicotinate, TocopherylSuccinate, DioleylTocopherylMethylsilanol, Potassium Ascorbyl Tocopheryl Phosphate, Tocophersolan
Author:
Monice Zondlo Fiume
Year:
2002
Bibliographic source:
International Journal of Toxicology, 21 (Suppl. 3): 51-116, 2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Test concentrations with justification for top dose:
0.033 - 10 mg/plate

Results and discussion

Test results
Key result
Species / strain:
other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
The test compound did not induce any relevant increase of the number of revertant colonies/plate in any of the six tester strains.
Thus it can be concluded that dl- a tocopherol is not mutagenic in the Ames test under the described experimental conditions.