Distillates (Fischer-Tropsch), heavy, C18-50-branched, cyclic and linear

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The experimental phase of the study was performed between 22 February 2006 and 31 March 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

Annex V of 2000/32/EC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-220-0

EC Name:

-

Cas Number:

848301-69-9

IUPAC Name:

1-(2-methylpentyl)-3-(6-methylundecyl)cyclopentane; 1-(3,7-dimethyldecyl)-3-(2-methylbutyl)cyclohexane; 1-(3-methyldecyl)-3-(2-methylpentyl)cyclohexane; 4,8,11-trimethylpentadecane; 6,9-dimethylhexadecane; 6-methylheptadecane

Method

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium: TA1535, TA1537, TA98 and TA100. E. coli: WPuvrA-

Metabolic activation:

with and without

Metabolic activation system:

Naphthoflavone/phenobarbitone induced, rat-liver S9.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 0, 15, 50, 150, 500, 1500 and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 0, 15, 50, 150, 500, 1500 and 5000 µg/plate

Vehicle / solvent:

Solvent: tetrahydrofuran

Controls

Untreated negative controls:

yes

Remarks:

2-Aminoanthracene (2-AA); Benzo(a)pyrene (BP)

Negative solvent / vehicle controls:

yes

Remarks:

Tetrahydrafuran

Positive controls:

yes

Positive control substance:

other: N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG); 9-Aminoacridine (9AA); 4-Nitroquinoline-1-oxide (4NQO)

Details on test system and experimental conditions:

Concentration of the test substance resulting in precipitation: 1500 µg/plate

Results and discussion

Test results

Test results 1

Species / strain:

other: Salmonella typhimurium strains TA100 and Escherichia coli strains WP2uvrA-

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

other: Salmonella typhimurium strains TA100 and Escherichia coli strains WP2uvrA-

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

other: Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strains WP2uvrA-

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

other: Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strains WP2uvrA-

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
Solvent control plates gave counts of revertant colonies within the normal range. All positive control chemicals gave increases in revertants, either with or without the metabolising system as appropriate, within expected ranges. No statistically significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance, either with or without metabolic activation. The substance was found to be non-mutagenic under the conditions of this test.

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation Not classified with regards to potential germ cell mutagenicity according to Regulation (EC) No) 1272/2008
negative without metabolic activation Not classified with regards to potential germ cell mutagenicity according to Regulation (EC) No) 1272/2008

non-mutagenic (with and without S9)

Executive summary:

The substance 'Distillates (Fischer-Tropsch), heavy, C18-50, branched, cyclic and linear' has been tested in a bacterial mutagenicity study according to OECD 471 and under GLP using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2uvrA. The test material was dissolved in tetrahydrofuran at concentrations up to 5000 µg/plate. Appropriate solvent and positive controls were included and gave expected results. No toxicity to bacterial cells was observed. No significant increase in the number of revertants was observed at any concentration with and without metabolic activation in any of the strains tested. The results were confirmed in a repeat experiment; both experiments used the direct plate incorporation method.

The test material was considered to be non-mutagenic under the conditions of the tests both with and without S9.