Registration Dossier
Registration Dossier
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EC number: 201-063-9 | CAS number: 77-85-0
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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Reference Type:
- publication
- Title:
- Newsletter
- Author:
- JETOC (Japan Chemical Industry Ecology-Toxicology & Information Center)
- Year:
- 1 985
- Bibliographic source:
- JETOC Newsletter 4, 14-20
- Reference Type:
- publication
- Title:
- Newsletter
- Author:
- JETOC (Japan Chemical Industry Ecology-Toxicology & Information Center)
- Year:
- 1 995
- 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
- 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 %
Constituent 1
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).
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