Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A reliable publication, summarising derivative pharmaco-toxicological action, was used. However the substance of interest was not revisited in order to verify the contents; for this reason reliability score 2 was used.

Data source

Reference
Reference Type:
secondary source
Title:
2-benzimidazolethiol
Year:
2012
Bibliographic source:
Japan Existing Chemical Data Base (JECDB)

Materials and methods

Test guidelineopen allclose all
Qualifier:
no guideline available
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzimidazole-2-thiol
EC Number:
209-502-6
EC Name:
Benzimidazole-2-thiol
Cas Number:
583-39-1
Molecular formula:
C7H6N2S
IUPAC Name:
1H-benzimidazole-2-thiol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
5000 μg/plate (TA100);
Doses : 0, 312.5, 625, 1250, 2500, 5000 μg/plate.
Vehicle / solvent:
0.5% CMC
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-aminoanthracene; AF-2

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and 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
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and 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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Bacterial test

Purity : 98.5%

Test species/strains : S.typhimurium TA100, TA1535, TA98, TA1537

E. coli WP2 uvrA

Test methods : Guidelines for Screening Mutagenicity Testing of Chemicals (Japan)

 Procedures : Plate incorporation method

 Solvent : DMSO

 Positive controls : -S9 Mix, AF-2 (TA100, WP2, TA98) sodium azide (TA1535) and 9-aminoacridine (TA1537)

+S9 Mix, 2-aminoanthracene (all strains)

 Doses : 0, 312.5, 625, 1250, 2500, 5000 μg/plate

 S-9 : Rat liver, induced with phenobarbital and 5,6-benzoflavone

 Plates/test : 3

 Number of replicates : 2

GLP : Yes

 Test results:

Minimum concentration of the test substance for which toxicity was observed:

Toxicity was observed at a concentration of 5000 μg/plate (TA100) with or without metabolic activation.

 Genetic effects:

S. typhimurium TA100, TA1535, TA 98, TA1537

+ ? -

without metabolic activation: [ ] [ ] [*]

with metabolic activation: [ ] [ ] [*]

E. coli WP2 uvrA

without metabolic activation: [ ] [ ] [*]

with metabolic activation: [ ] [ ] [*]

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Ames tests suggest that the substance colud not be any mutagenic effects.