Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
N-cyclohexylbenzothiazole-2-sulphenamide was tested in Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 98.8 %

Method

Target gene:
ames assay
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, E. coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
6.25 - 5000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acylamide (TA 98; TA 100);  sodium azide (TA 1535); 9-aminoacridine (TA 1537). with S9: 2-aminoanthracene (all strains)

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, E. coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: 100 µg/plate (TA1537 without S9); 500 µg/plate (TA 1537 with S9); 1500 µg/plate (TA 100 with S9)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

No cytotoxicity was observed in TA 100 without S9 as well as in TA 98 and TA 1535, respectively.

Cytotoxicity: 100 µg/plate (TA1537 without S9); 500 µg/plate (TA 1537 with S9); 1500 µg/plate (TA 100 with S9). Precipitation of the test substance was noted at concentrations of 200 µg/plate and higher.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Executive summary:

The test substance CBS was evaluated in a GLP- and guideline study (OECD TG 471) bacterial gene mutation test. Here, the tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA were used. Treatment by the pre-incubation method was done for doses up to 5000 µg/plate. Toxicity effects varied in a strain-specific manner; at high doses from 200 µg/plate upward precipitations were observed. The test substance CBS was negative in presence and absence of metabolic activation (MHWJ 1997).