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EC number: 232-262-9 | CAS number: 7803-58-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
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:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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 forward mutation assay
Test material
- Reference substance name:
- Sulphuric diamide
- EC Number:
- 232-262-9
- EC Name:
- Sulphuric diamide
- Cas Number:
- 7803-58-9
- Molecular formula:
- H4N2O2S
- IUPAC Name:
- Sulphuric diamide
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Supplier: Changzou Foreign Trade Corp.Batch No.: 0073A15 (A01141026)Physical state: solid, crystalline substanceColour: whiteOdour: pungentStorage in a dry place, protected from light
Method
- Target gene:
- Salmonella typhimurium: GCEscherichia coli: AT
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- Based on the results of the preliminary Range Finding Test the following concentrations of the test item were prepared and used in the Initial and Confirmatory Mutation Tests:5000, 1600, 500, 160, 50 and 16 μg/plate.
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO), Ultrapure water (UPW)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO, UPW
- Positive controls:
- yes
- Remarks:
- Salmonella typhimurium TA98 without metabolic activation
- Positive control substance:
- other: 4-Nitro-1,2-phenylenediamine, NPD
- Remarks:
- 4 μg/plate
- Positive controls:
- yes
- Remarks:
- Salmonella typhimurium TA100 and TA1535 without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- 2 μg/plate
- Positive controls:
- yes
- Remarks:
- Salmonella typhimurium TA1537 without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 50 μg/plate
- Positive controls:
- yes
- Remarks:
- Escherichia coli WP2 uvrA without metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- 2 μL/plate
- Positive controls:
- yes
- Remarks:
- Salmonella typhimurium TA98; TA100; TA1535; TA1537 and Escherichia coli WP2 uvrA with metabolic activation [10 % (v/v) rat liver]
- Remarks:
- 2 μg/plate for S. typhimurium strains; 50 μg/plate for E. coli WP2 uvrA
- Details on test system and experimental conditions:
- The study included a Preliminary Solubility Test, a Preliminary Range Finding Test (Informatory Toxicity Test) an Initial Mutation Test (Plate Incorporation Test) and a Confirmatory Mutation Test (Pre-Incubation Test). In the preliminary Range Finding Test as well as in the Initial Mutation Test the plate incorporation method was used.Based on the results of the preliminary tests, a concentrated stock solution was prepared from the test item with Dimethyl sulfoxide (DMSO), which was diluted by serial dilutions to obtain the six dosing solutions investigated in the main tests. The maximum test concentration was in all examined strains 5000 μg test item/plate (±S9 Mix).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. In conclusion, the test item SULFAMIDE (CAS No. 7803-58-9) has no mutagenic activity on the applied bacterium tester strains under the test conditions used in this study.
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