(ethylenedioxy)dimethanol

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

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(ethylenedioxy)dimethanol

EC Number:

222-720-6

EC Name:

(ethylenedioxy)dimethanol

Cas Number:

3586-55-8

Molecular formula:

No exact molecular formula can be given for a complex reaction mixture (UVCB substance).

IUPAC Name:

[2-(hydroxymethoxy)ethoxy]methanol

Method

Target gene:

HPRT

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Details on mammalian cell type (if applicable):

permanent V79 cell line UI/109 from the Chinese hamster.
Forward mutation assay using the HPRT gene; cells deficient in HPRT (due to mutation) are selected by medium containing 6-thioguanine.

Metabolic activation:

with and without

Test concentrations with justification for top dose:

Without MA: 2, 5, 10, 15, 20, 25 µg/ml (3 h exposure); 2, 5, 10, 15, 20, 25 µg/ml (6 h exposure); 1, 2, 5, 7.5, 10, 12.5, 15 µg/ml (repetition 6 h exposure).
With MA: 1, 2, 5, 10, 20, 40 µg/ml (3 h exposure); 0.25, 0.5, 1, 2, 5, 10, 20, 40 µg/ml (6 h exposure)

Vehicle / solvent:

nutrient medium (DMEM)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9,10-dimethylbenzanthracene

ethylmethanesulphonate

Details on test system and experimental conditions:

Positive control:
1 µl/ml ethylmethane sulfonate without metabolic activation (MA)
10 µg/ml dimethylbenz(a)anthracene with MA

Evaluation criteria:

as described in OECD guideline 476

Results and discussion

Test results

Key result

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Weak mutagenic activity with and without metabolic activation at concentrations near the cytotoxic range.

Executive summary:

Study performed according to the OECD guideline 476. V79 cells were exposed without metabolic activation (MA) to: 2, 5, 10, 15, 20, 25 µg/ml (3 h exposure); 2, 5, 10, 15, 20, 25 µg/ml (6 h exposure); 1, 2, 5, 7.5, 10, 12.5, 15 µg/ml (repetition 6 h exposure). With MA the following concentrations were used: 1, 2, 5, 10, 20, 40 µg/ml (3 h exposure); 0.25, 0.5, 1, 2, 5, 10, 20, 40 µg/ml (6 h exposure) The test substance induced an increased number of mutant cells with and without metabolic activation. The test substance was considered to be mutagenic under the condition of this study. Although study results might be discussed critically due to the fact that mutagenic effects occurred at concentrations near cytotoxic concentrations. Results are presumably also due to the hydrolysis product formaldehyde. Weak mutagenic activity with and without metabolic activation at concentrations near the cytotoxic range.