Ethylidynetrimethanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study and GLP

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1994

Reference 2

Reference Type:

publication

Title:

Newsletter

Author:

JETOC (Japan Chemical Industry Ecology-Toxicology & Information Center)

Year:

1985

Bibliographic source:

JETOC Newsletter 4, 14-20

Reference 3

Reference Type:

publication

Title:

Newsletter

Author:

JETOC (Japan Chemical Industry Ecology-Toxicology & Information Center)

Year:

1995

Bibliographic source:

JETOC Information Sheet 18, 8-11

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse 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

Details on test material:

purity: 99.9 %

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, E coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

S-9-mix from rat liver induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

0, 312.5, 625, 1250, 2500, 5000 µg/plate

Vehicle / solvent:

distilled water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: AF-2, sodium azide, 9-aminoacridine, 2-Aminoanthracene

Details on test system and experimental conditions:

IUCLID4 Type: Ames test, according to the respective guideline

Evaluation criteria:

positive when assay plates with the test substance show a significant increase in revertantcolony count as compared with that on negative control plates and when this effect is reasonably reproducible or dosedependent

Statistics:

yes, but method not mentioned

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, E coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: no toxicity was observed up to a concentration of 5000 µg/plate with or without metabolic activation.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Trimethylolpropane was not mutagenic for bacteria either with or without exogenous metabolic activation up to 5000 µg/plate

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Trimethylolpropane was tested using the Ames test according to OECD TG 471 and GLP and showed no mutagenicactivity either with or without exogenous metabolic activation up to 5000 µg/plate, but cytotoxicity was not reached (MHLW 1994).