Docosyl methacrylate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The potential for Docosan-1-ol (Behenyl alcohol) to induce gene mutations, in vitro, at the HGPRT locus was evaluated in Chinese hamster V79 cells, with and without metabolic activation.

GLP compliance:

not specified

Type of assay:

in vitro mammalian cell transformation assay

Test material

Test material information

Constituent 1

Reference substance name:

Docosan-1-ol

EC Number:

211-546-6

EC Name:

Docosan-1-ol

Cas Number:

661-19-8

Molecular formula:

C22H46O

IUPAC Name:

docosan-1-ol

Method

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

Liver microsomal fractions from 8- to 12-week-old male Wistar rats

Test concentrations with justification for top dose:

2.0, 7.5, 15.0, and 20.0 μg/mL
The selection of doses was based on the results of a previously conducted rangefinding experiment.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
The final concentration of ethanol in the culture medium did not exceed 1% v/v.

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 4 hours

SELECTION: Mutant frequency was determined by seeding known numbers of cells in medium containing thioguanine (11 μg/mL to detect mutant cells, and in medium without thioguanine to determine the total number of surviving cells.

STAIN: Methylene blue (10%) was used for staining in 0.01% KOH solution.

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: Stained colonies with more than 50 cells were counted with a preparation microscope.

Evaluation criteria:

For the test substance to be considered positive, a significant dose-related increase in the mutant frequency or a reproducible and significant positive response for at least one of the test points was required. The test substance also was considered to be mutagenic if there was a reproducible concentration-related increase in the mutation frequency.

Results and discussion

Test results

Key result

Species / strain:

Chinese hamster lung fibroblasts (V79)

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