Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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

Remarks on result:

other: strain/cell type: Chinese hamster V79 cells

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

A study was performed to investigate the potential of Trimethoylpropan (TMP) rein to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamsters according to OECD TG 476 and GLP in concentrations up to 1400 µg/ml in the presence and in the absence of S9 -mic. cytotoxicity was determined in priliminary experiments. Under the conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore , Trimethylolpropan (TMP) rein is considered to be non-mutagenic in this HPRT assay (Harlan CCR 2010)