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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-218-8 | CAS number: 5329-14-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed, non-GLP study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Test concentration was not accurately determined.
- GLP compliance:
- no
- Remarks:
- pre-GLP research project
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ammonium sulphamidate
- EC Number:
- 231-871-7
- EC Name:
- Ammonium sulphamidate
- Cas Number:
- 7773-06-0
- Molecular formula:
- H3NO3S.H3N
- IUPAC Name:
- ammonium sulfamate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- 90 to 99% pure
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, TA1535, TA1537, TA1538
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- not applicable
- Test concentrations with justification for top dose:
- A small crystal of a substance (approximately 1 to 5 µl of asubstance in solution)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: diethyl sulfate
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, TA1535, TA1537, TA1538
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under conditions of this in vitro test, ammonium sulfamte was not demonstrated to be mutagenic.
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.
