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Toxicological information

Genetic toxicity: in vitro

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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:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Method

Target gene:
Histidine-requiring gene
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Species / strain:
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:
- Vehicle(s)/solvent(s) used: water
Details on test system and 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:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
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.