Propylidynetrimethanol, ethoxylated

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study in full compliance with OECD Guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, ethoxylated

EC Number:

500-110-3

EC Name:

Propylidynetrimethanol, ethoxylated

Cas Number:

50586-59-9

Molecular formula:

C3H5(CH2O(C2H4O)nH) sum of n: >1 - <6.5 mol EO

IUPAC Name:

Propylidynetrimethanol, ethoxylated

Details on test material:

- Name of test material (as cited in study report): Polyether V 531
- Molecular weight: 356
- Physical state: liquid
- Content: 100 %
- Stability under test conditions: the stability in the vehicle was approved analytically

Method

Target gene:

not applicable

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

S9: isolated from Arochlor 1254 male Sprague Dawley rat liver microsomal fraction

Test concentrations with justification for top dose:

900, 1800, 3600 µg/ml

Vehicle / solvent:

deionized water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see below

Details on test system and experimental conditions:

Positive controls:
without S9 mix: Mitomycin C, 0.1 µg/ml (for 4 hour treatment) and 0.03 µg/ml (for 18 hour treatment)
with S9 mix: Cyclophosphamide, 2 µg/ml
Chromosomes were prepared 18 and 30 hours (for 4 hour treatment) or 18 hours (for 18 hour treatment) after start of treatment with test substances. The treatment interval was 4 hours with and without metabolic activation and 18 hours without metabolic activation. In each experimental group two paralell cultures were set up. Per culture 100 metaphases were scored for structural chromosomal aberrations. Polyploid metaphases were recorded.

Evaluation criteria:

An increased incidence of gaps of both types without concomitant increase of other aberration types was not considered as indication of a clastogenic effect.
A test was considered positive, if there was a relevant and statistically significant increasein the aberration rate.
A test was considered negative, if there was no such increase at any time interval.
A test was also considered negative, if there were statistical significant values, which were, however, within the range of historical negative controls.
In addition, a test was considered equivocal if there was an increase of aberrant metaphases above the range of attached historical negative controls, provided the increase was not significant and the result of the negative control was not closely related to the data of the respective treatment group. A test was also considered equivocal, if its result was implausible.

Statistics:

Statistical significance at the 5% level (p<0.05) was evaluated by means of the chi-square test. Evaluation was performed only for cells carrying aberrations exclusive gaps.

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

- Effects on pH: none
- Effects of osmolality: no effects
- Water solubility: soluble up to at least 360 mg/ml
- Precipitation: none

Applicant's summary and conclusion

Executive summary:

The clastogenic potential of the test substance was evaluated in a chromosome aberration test on Chinese hamster V79 cells in the presence and absence of S9 mix according to OECD TG 473.

None of the cultures treated with the test substance in the absence and in the presence of S9 mix showed biologically relevant or statistically significant increased numbers of aberrant metaphases.

Based on this test, the test substance is considered not to be clastogenic for mammalian cells in vitro.