Mixed LOF

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report similar or equivalent to OECD TG 479 performed on an analogue substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)

GLP compliance:

yes

Type of assay:

sister chromatid exchange assay in mammalian cells

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), light catalytic cracked

EC Number:

265-056-2

EC Name:

Naphtha (petroleum), light catalytic cracked

Cas Number:

64741-55-5

IUPAC Name:

Naphtha (petroleum), light catalytic cracked

Constituent 2

Reference substance name:

Light catalytic cracked naphtha

IUPAC Name:

Light catalytic cracked naphtha

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:

50 to 300 nl/ml without activation and 30 to 200 nl/ml with activation

Vehicle / solvent:

acetone

Controls

Negative solvent / vehicle controls:

yes

Remarks:

acetone

Positive controls:

yes

Positive control substance:

triethylenemelamine

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

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 light catalytically cracked naphtha (API 81-03) was negative with and without activation. This finding does not warrant the classification of light catalytically cracked naphtha as a genotoxin under the new 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:

Light catalytically cracked naphtha (API 81-03) was examined for its potential to induce sister chromatid exchange in Chinese hamster ovary (CHO) cells, in both the presence and absence of an S9 metabolic activation system. The doses were from 50 to 300 nl/ml without activation and 30 to 200 nl/ml with activation. Light catalytically cracked naphtha did not induce a statistically significant increase sister chromatid exchange frequency in the presence or absence of activation. Both the positive and negative controls responded appropriately. Under the conditions of this study, API 81-03 was non-mutagenic with and without activation. This finding does not warrant the classification of light catalytically cracked naphtha as a genotoxin under the new 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.