Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-952-9 | CAS number: 5577-13-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: other: DNA or chromosome damage
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: Mamalian cytogenic assay.
Test material
- 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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40-2000 mg/kg body weight
Basis:
- No. of animals per sex per dose:
- Three dose groups, one comprising of 1 male and 1 female, and the other two comprising of 3 males and 3 females received a single dose of Tolfamato. One of the groups comprised of 3 males and 3 females were dosed with the highest concentration that was used for the main study. The observation period after dosing was one to three days. During this period mortality and physical condition were recorded at least once a day.
Results and discussion
Any other information on results incl. tables
Tolfamato is not clastogenic or aneugenic in the bone marrow micronucleus test when sampled at 24 and 48 hours post dosing of male mice up to a dose of 1500 mg/kg (the maximum tolerated dose in accordance with current regulatory guidelines) under the experimental conditions described.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No genotoxic activity
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
