Registration Dossier
Registration Dossier
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EC number: 701-328-3 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP study comparable to guideline study with acceptable restrictions for Oxirane, mono[(C12-14-alkyloxy)methyl] derivs / ERC Nr 17, which is structurally similar to Oxirane, mono[(C13-15-alkyloxy)methyl] derivs. Thus the study is used for read-across to avoid duplicate tests.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Laboratory Procedure for Assessing Specific Locus Mutations at the TK Locus in Cultured L5178Y Mouse Lymphoma Cells. D. Clive and J.
Spector. Mutation Research 31 (1975) 17-29.
- A Mutational Assay System Using the Thymidine Kinase Locus in Mouse Lymphoma Cells. D. Clive, W. 6, Flamm, M. R. Machesko and N. J.
Bernheim. Mutation Research 16 (1972) 77-87. - GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Oxirane, mono[(C12-14-alkyloxy)methyl] derivs.
- EC Number:
- 271-846-8
- EC Name:
- Oxirane, mono[(C12-14-alkyloxy)methyl] derivs.
- Cas Number:
- 68609-97-2
- Molecular formula:
- C15H30O2 + C17H34O2 + C19H38O2 + C12H26O + C14H30O + C30H60O4 + C32H64O4
- IUPAC Name:
- Oxirane, 2-((C12-14-alkyloxy)methyl)derivs
- Details on test material:
- - Name of test material (as cited in study report): R0069
- Physical state: Clear Liquid
Constituent 1
Method
- Target gene:
- Thimidine Kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 31.75 µg/mL, 62.5 µg/mL, 125 µg/mL, 250 µg/mL and 500 µg/mL.
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Ethyl methanesulfonate that does not require activation to induce mutations, a promutagen (2-acetylaminofluorene) which depends on highly reactive S-9 for its mutagenic and toxi.c properties, and a promutagen dimethylnitrósamine) that requires noninduce
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Under the experimetal conditions the substance R0069 did not showed any evidence of mutagenicity.
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