Registration Dossier
Registration Dossier
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EC number: 439-070-6 | CAS number: 125005-87-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Report of a GLP-compliant study of a close chemical analogue, performed in accordance with the applicable OECD and EU guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - 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:
- -
- EC Number:
- 476-190-8
- EC Name:
- -
- Cas Number:
- 96949-22-3
- Molecular formula:
- Not applicable
- IUPAC Name:
- Biozan
- Details on test material:
- Biozan (EC 476-190-8): water content 10.23%.
Constituent 1
Method
- Target gene:
- Thymidine kinase
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix derived from livers of phenobarbital/beta-naphthoflavone induced male Sprague-Dawley rats.
- Test concentrations with justification for top dose:
- 0, 50, 100, 200, 400, 600 microgrammes/ml (water content of test material excluded)
- Vehicle / solvent:
- R0 medium
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- R0 medium
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: and cyclophosphamide
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
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, Biozan was not mutagenic to L5178Y cells.
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