Registration Dossier
Registration Dossier
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EC number: 201-084-3 | CAS number: 78-11-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay in mammalian cells
Test material
- Reference substance name:
- Pentaerithrityl tetranitrate
- EC Number:
- 201-084-3
- EC Name:
- Pentaerithrityl tetranitrate
- Cas Number:
- 78-11-5
- Molecular formula:
- C5H8N4O12
- IUPAC Name:
- 3-(nitrooxy)-2,2-bis[(nitrooxy)methyl]propyl nitrate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced
- Test concentrations with justification for top dose:
- dose range of 0, 160-2,500 pg/ml
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:negative
- Executive summary:
Effects observed in treated and untreated animals showed no relevant differences. In some cases presence of tumors in untreated animals was higher than in animals fed with this substance. Thus, the presence of tumors cannot be attributed to pentaerythritol tetranitrate.
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