Registration Dossier
Registration Dossier
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EC number: 500-116-6 | CAS number: 52609-19-5 1 - 2.5 moles ethoxylated
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: mammalian cell gene mutation assay
Test material
- Reference substance name:
- Alcohols, C16-18, ethoxylated
- EC Number:
- 500-212-8
- EC Name:
- Alcohols, C16-18, ethoxylated
- Cas Number:
- 68439-49-6
- IUPAC Name:
- 68439-49-6
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- dose finding test: 0, 1 - 100 µg/mL (solubility limit)
main test: 0, 1.8, 6, 18, 60, 100 µg/mL - Vehicle / solvent:
- H0 medium with 1% ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H0 medium with 1% ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulfonate (300 µg/mL), 3-methylcholanthrene (10 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Evaluation criteria:
- According to Guideline.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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