Registration Dossier
Registration Dossier
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EC number: 201-184-7 | CAS number: 79-19-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Ames et al.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Thiosemicarbazide
- EC Number:
- 201-184-7
- EC Name:
- Thiosemicarbazide
- Cas Number:
- 79-19-6
- Molecular formula:
- CH5N3S
- IUPAC Name:
- hydrazinecarbothioamide
- Test material form:
- solid: crystalline
Constituent 1
Method
- Target gene:
- Histidine-requiring gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 1,600, 1,200, 800, 400, 200, 100 μg / 0.1 ml / Plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation).
DURATION
- Preincubation period:20 min
- Exposure duration:48 hours, 37ºC
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test substance thiosemicarabzide was not mutagenic in the strains TA100; TA1535 and TA98 of S. typhimurium with and without metabolic activation.
- Executive summary:
A bacterial mutagenicity assay was performed for the test item Thiosemicarbazide in strains TA100, TA1535 and TA98 of S. typhimurium. The test item dilutions were prepared in water: 1,600, 1,200, 800, 400, 200, 100 μg / 0.1 ml / Plate. Plates were incubated at 37ºC for 48-72h and after this period colonies were counted. The test substance resulted to be non mutagenic to the tester strains with and without metabolic activation.
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