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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro DNA damage and/or repair study
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD TG 479.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: as detailed in the study report
Principles of method if other than guideline:
Method: other: procedure as quoted in report - outline details only are given (see Reference).
GLP compliance:
not specified
Type of assay:
sister chromatid exchange assay in mammalian cells

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9
Test concentrations with justification for top dose:
0 to 1600 nl/ml

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The in vitro sister chromatid exchange assay in mammalian cells to assess the genotoxicity of unleaded gasoline (API PS-6) was non-mutagenic. This finding does not warrant classification of unleaded gasoline as a genotoxin under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Unleaded gasoline (API PS-6) was examined for its potential to induce sister chromatid exhange in Chinese hamster ovary (CHO) cells, in both the presence and absence of an S9 metabolic activation system. The doses were from 0 to 1600 nl/ml with or without activation. Unleaded gasoline did not induce a statistically significant increase sister chromatid exchange frequency with or without activation. Both the positive and negative controls responded appropriately. Under the conditions of this study, API PS-6 was non-genotoxic. This finding does not warrant classification of unleaded gasoline as a genotoxin under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.