Registration Dossier
Registration Dossier
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EC number: 204-327-1 | CAS number: 119-47-1
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
- EC Number:
- 204-327-1
- EC Name:
- 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
- Cas Number:
- 119-47-1
- Molecular formula:
- C23H32O2
- IUPAC Name:
- 2-tert-butyl-6-[(3-tert-butyl-2-hydroxy-5-methylphenyl)methyl]-4-methylphenol
- Details on test material:
- DBMC, purity: 97-98%
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:
- S9 mix, S9 from phenobarbital/beta-naphthoflavone induced male Wistar rat livers
- Test concentrations with justification for top dose:
- pre-tests (2nd, 3rd): -S9 short-term treatment: 0.001 to 3.0 µg/ml, -S9: long-term treatment: 0.16 to 30.0 µg/ml, +S9 short-term treatment: 0.5 to 30 µg/ml; concentrations used for mutation rate analysis: -S9 short-term treatment: 0.094 to 1.5 µg/ml, -S9 long-term treatment: 1.0 to 8.0 µg/ml, +S9 short-term treatment: 12.5 to 22.5 µg/ml
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9: ethylmethanesulphonate, +S9: 7,12-dimethylbenzanthracene
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: Chinese hamster lung fibroblasts (V79)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments.
The author stated that the test substance did not induce gene mutations at the HPRT locus in V79 cells under the experimental conditions used.
Applicant's summary and conclusion
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