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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP. Guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl [(4-methylphenyl)sulphonyl]carbamate
EC Number:
226-952-9
EC Name:
Ethyl [(4-methylphenyl)sulphonyl]carbamate
Cas Number:
5577-13-9
Molecular formula:
C10H13NO4S
IUPAC Name:
ethyl [(4-methylphenyl)sulfonyl]carbamate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Each strain derived from Salmonella typhimuriun LT2 contains one mutation in the histidine operon, resulting in a requirement for histidine. In adittion, to increase their sensitivity to mutagenic substance, further mutations have been added.

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Test concentrations with justification for top dose:
Range: 125 - 5000 µg/plate
Details on test system and experimental conditions:
The day before treatment, cultures, will be inoculated from froz

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Genotoxicity:
other: No increase in the nobody of revertants.
Cytotoxicity / choice of top concentrations:
other: Any other information on results incl. tables
Vehicle controls validity:
other: each bacterial tester strain treated with the vehicle
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Under the experimental conditions, the test substance Tolfamato did not show any mutagenic activity in this bacterial reverse mutation test on Salmonella typhimurium.

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions, the test substance Tolfamato did not show any mutagenic activity in this bacterial reverse mutation test on Salmonella typhimurium.