Registration Dossier
Registration Dossier
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EC number: 500-707-9 | CAS number: 162353-70-0
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:
- 2 010
- 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
- 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
Constituent 1
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
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