1-Dodecene, mixed with 1-decene and 1-octene, dimers, hydrogenated

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to or similar to study guidelines OECD 471: GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

and Method B14 (92/69/EEC Directive)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dec-1-ene, dimers, hydrogenated

EC Number:

500-228-5

EC Name:

Dec-1-ene, dimers, hydrogenated

Cas Number:

68649-11-6

Molecular formula:

C20H42

IUPAC Name:

Hydrogenated dimerization products of 1-decene

Constituent 2

Reference substance name:

1-decene dimer, hydrogenated

IUPAC Name:

1-decene dimer, hydrogenated

Details on test material:

- Name of test material (as cited in study report):MCP992
- Physical state: amber liquid
- Storage condition of test material: room temperature

Method

Target gene:

Not applicable

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 liver microsomal fraction from Arochlor 1254 induced male SD rats

Test concentrations with justification for top dose:

10ul/50ul, 3.1ul/50ul, 0.97/50ul, 0.3ul/50ul, and 0.094ul/50ul

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Vehicle is acetone

Migrated to IUCLID6: 2-aminoanthracene, 2-nitrofluorene, N-methyl-N-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

Serial dilutions were prepared in acetone to deliver 10, 3.1, 0.97, 0.3, and 0.094ul of test material in plates with and without metabolic activation in 50ul aliquots per bacterial plate. Five concentrations of the test material were assayed in triplicate against each tester strain, using the direct plate incorporation method. Measured aliquots of one of the bacterial cultures were dispensed into sets of test tubes followed by 2.0ml of molten, trace histidine supplemented , top agar, 0.1ml of the test material formulation, vehicle or positive control and either 0.5ml S9-mix or phosphate buffer. The contents of each test tube were mixed and equally distributed onto the surface of agar plates. This procedure was repeated, in triplicate, for each bacterial strain and for each concentration of test material both with and without S9-mix.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

No toxicity at 5000 ug/plate

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 bacterial reverse mutation test to assess the genotoxicity of the test material was negative. This finding does not warrant classification of the test material as a mutagen 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:

The test material was studied in the Ames assay using Salmonella typhimurium test strains TA98, TA100, TA102, TA1535, and TA1537 in the absence and presence of a liver S9 fraction for metabolic activation. Two tests were performed using five dose levels. The test material did not induce any significant changes in the number of revertant colonies with or without metabolic activation and was not cytotoxic and any dose level. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies. It is concluded that in this study, the test material is not a mutagenic agent. This finding does not warrant classification of the test material 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.