Hydrocarbons, C11-14, n-alkanes, isoalkanes, <2% aromatics

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro DNA damage and/or repair study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983/01/13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to or similar to guideline study OECD 479.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

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)

Deviations:

no

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C10-C12, isoalkanes, <2% aromatics

EC Number:

923-037-2

Molecular formula:

(CH2)6-8C4H10

IUPAC Name:

Hydrocarbons, C10-C12, isoalkanes, <2% aromatics

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Tests with and without Metabolic Activation: (media control), 0, 0.5, 1.7, 5.0, 17.0, 50.0 ug/plate
Negative Controls: DMSO, Cyclohexane
Positive controls: EMS - Ethylmehanesulfonate (620 ug/mL) without activation; cyclophosphamide (1.4 ug/mL) with activation

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: EMS - Ethylmehanesulfonate (620 ug/mL) without activation; cyclophosphamide (1.4 ug/mL) with activation

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

not cytotoxic up to 50 uL/mL (maximum dose tested)

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: negative

The test to assess the genotoxicity of the test material was negative. This finding does not warrant the classification of this test material as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

No treatments in either the absence or in the presence of S-9 resulted in a statistically significant increase in revertant numbers. This study was therefore considered to have provided no indication of any test material mutagenic activity. This finding does not warrant the classification of this test material as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.