1-Tetradecene, polymer with 1-dodecene, distn. residues, hydrogenated, C36-84 fraction

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:

1996-11-20 to 1997-01-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it is compliant with GLP guidance and internationally accepted study guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

EC Number:

500-183-1

EC Name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

Cas Number:

68037-01-4

IUPAC Name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

Details on test material:

- Substance type: Poly alpha olefins (1-decene homopolymer hydrogenated)
- Physical state: Colourless liquid
- Analytical purity: Not reported
- Composition of test material, percentage of components: Not reported
- Lot/batch No.: WG080993
- Stability under test conditions: Not reported
- Storage condition of test material: Ambient temperature in the dark
-Other: A homogenous emulsion was produced with surfactants Sorbitan Stearate and Polysornate 60 in order to be suitable for testing.

Method

Target gene:

histidine operon and the trpE locus

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: histidine deficient

Metabolic activation:

with and without

Metabolic activation system:

S-9

Test concentrations with justification for top dose:

156.25, 312.5, 625, 1250, 2500, or 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: A homogenous emulsion was produced with surfactants Sorbitan Stearate and Polysornate 60 in order to be suitable for testing.
- Justification for choice of solvent/vehicle: The test compounds oily nature made it impossible to prepare a solution or suspension suitable for testing.

Controls

Untreated negative controls:

yes

Remarks:

untreated

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene; 2-nitrofluorene; methyl methane sulphonate; N-ethyl-N-nitro-N-nitrosoguanidine; 9-aminoacridine

Remarks:

Positive controls were selected based on test strain and presence or absence of S-9

Details on test system and experimental conditions:

METHOD OF APPLICATION: Preincubation


DURATION
- Preincubation period: 20 minutes
- Exposure duration: 2 days


SELECTION AGENT (mutation assays): None


NUMBER OF REPLICATIONS: Two independent studies with three replicates each


DETERMINATION OF CYTOTOXICITY
- Method: Not reported

Evaluation criteria:

A 1.5 to 2-fold increase (depending on the strain) in colony counts with a minimum of 20 colonies necessary, a dose-related response (which may not occur in the high-dose group due to toxicity), and/or reproducible results in the two independent tests.

Statistics:

None reported

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: None reported
- Effects of osmolality: None reported
- Evaporation from medium: None reported
- Water solubility: None reported
- Precipitation: Precipitation occurred with the highest concentration (5000 micrograms per plate)


RANGE-FINDING/SCREENING STUDIES: Toxicity tests were performed on TA 100 with doses ranging from 0.1 to 5000 micrograms per plate with no toxicity observed.


C

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative

Dec-1-ene, homopolymer, hydrogenated was not mutagenic.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA1535, TA1537, TA98, and TA100 of S. typhimurium and Escherichia coli strain WP2uvrA were exposed to a homogeneous emulsion of dec-1 -ene, homopolymr, hydrogenated in surfactants, Sorbitan stearate and Polysorbate 60 at concentrations of 156.25, 312.5, 625, 1250, 2500, or 5000 μg/plate in the presence and absence of mammalian metabolic activation using the pre-incubation method.

Dec-1 -ene, homopolymer, hydrogenated was tested up to limit concentrations (5000 μg/plate or 5 mL/plate). The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it is compliant with GLP guidance and internationally accepted study guidelines.

This study will influence the DNEL.