Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

86290-81-5

Cas Number:

86290-81-5

IUPAC Name:

86290-81-5

Constituent 2

Reference substance name:

Unleaded gasoline

IUPAC Name:

Unleaded gasoline

Constituent 3

Reference substance name:

API PS-6

IUPAC Name:

API PS-6

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.