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Toxicological information

Genetic toxicity: in vitro

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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:
guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1994
Reference Type:
publication
Title:
Newsletter
Author:
JETOC (Japan Chemical Industry Ecology-Toxicology & Information Center)
Year:
1985
Bibliographic source:
JETOC Newsletter 4, 14-20
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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
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).