Registration Dossier
Registration Dossier
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EC number: 200-864-0 | CAS number: 75-35-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Volatile compound not tested in desiccator. Study not sufficiently detailed. No information regarding test substance purity.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 1,1-dichloroethylene
- EC Number:
- 200-864-0
- EC Name:
- 1,1-dichloroethylene
- Cas Number:
- 75-35-4
- Molecular formula:
- C2H2Cl2
- IUPAC Name:
- 1,1-dichloroethene
- Details on test material:
- - Name of test material (as cited in study report): Vinylidene chloride
- Compound prepared, purified, and analyzed by previously reported techniques (Elmore, Wong, Laumbach, and Streips)
Constituent 1
Method
- Target gene:
- Hisitidine-revertant
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- No data
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Incubation period: 48 h (37 °C) - Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- The test substance was found to be negative in the in vitro genotoxicity Ames assay in the absence of metabolic activation.
- Executive summary:
The genotoxicity of VDC was determined in a reverse mutation assay conducted in vitro with Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 without metabolic activation. The test substance did not induce any significant increase in the number of revertants in strain TA100.
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