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Registration Dossier
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EC number: 947-329-4 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Chromosome Aberration and Sister Chromatid Exchange Tests in Chinese Hamster Ovary Cells In Vitro. V: Results with 46 Chemicals
- Author:
- Loveday et al.
- Year:
- 1 990
- Bibliographic source:
- Environmental and Molecular Mutagenesis 16:272-303 (1990)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- Not all results displayed.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Sodium etasulfate
- EC Number:
- 204-812-8
- EC Name:
- Sodium etasulfate
- Cas Number:
- 126-92-1
- Molecular formula:
- C8H18O4S.Na
- IUPAC Name:
- sodium 2-ethylhexyl sulfate
Constituent 1
Method
- Target gene:
- n.a.
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
- Test concentrations with justification for top dose:
- 501, 1500, 5010 µg/mL
- Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin, 5 µg/mL (-S9); cyclophosphamide, 50µg/mL (+S9)
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test item was not considered to be clastogenic. - Executive summary:
No enhanced aberration rate in the presence or absence of metabolic activation was observed in this chromosomal aberration assay. Therefore, the test substance was not considered to be clastogenic.
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