Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynetrimethanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see “remarks”

Remarks:

GLP-Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol

EC Number:

201-074-9

EC Name:

Propylidynetrimethanol

Cas Number:

77-99-6

Molecular formula:

C6H14O3

IUPAC Name:

2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Method

Target gene:

HPRT locus

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital-naphthoflavone induced rat liver S9 (male wistar rats, 8-12 weeks old)

Test concentrations with justification for top dose:

experiment I:
with and without S9-mix: 43.8, 87.5, 175, 350 700, 1400 µg/ml
incubation time: 4 hours
experiment II:
with S9-mix, incubation time: 4 hours:
43.8, 87.5, 175, 350 700, 1400 µg/ml

without S9-mix, incubation time:24 hours:
43.8, 87.5, 175, 350 700, 1400 µg/ml

Vehicle / solvent:

test item was dissolved in deionised water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: in the presence of S9-mix: 7.12 dimethylbenz(a)anthracene (DMBA); without S9-mIx: ethylmethane sulfonate (EMS)

Details on test system and experimental conditions:

according to the respective guideline

Evaluation criteria:

a test item is classified as mutagenic if it reproducibly induces a muation frequency that is three times above the sponontaneous mutatieon frequecy at least at one of the concentrations in theexperiment

Statistics:

linear regression (latest squares)

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: preliminary toxicity tests

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

negative