Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: CBA/Ca Ola Hsd miceSource: TOXI-COOP ZRT.Hygienic level during the study: Good conventionalNumber of animals: 28 animals/main test (4 animals/treatment group)Sex: Female, nulliparous, non-pregnantAge of animals: Young adult mice; 11-12 weeks old (at start of the main test)Body weight range at starting: 18.1-23.4 g The weight variation in animals involved in the study did not exceed ± 20 % of the mean weight.Acclimatization time: 7 daysAnimal health: Only healthy animals were usedHousing during acclimatization period: Grouped caging in small groupsHousing during the test: Grouped caging (4 animals/cage)Cage type: Type II. Polypropylene / polycarbonateLight: 12 hours daily, from 6.00 a.m. to 6.00 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 – 70 %Housing/Enrichment: Mice were group-housed to allow social interaction, and with deep wood sawdust bedding, to allow digging and other normal rodent activities.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Based on the preliminary test results the test item was examined in the main test at 50 %, 25 %, 10 % and 5 % (w/v) concentrations as formulations in the selected vehicle of N,N-Dimethylformamide (DMF).
- No. of animals per dose:
- 4 animals/group
- Details on study design:
- Each mouse was topically treated with 25 μL of the appropriate formulations of the test item, the positive control substance or the vehicles (see Table 3) using a pipette, on the dorsal surface of each ear. After the treatments animals were returned to their cages. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control group animals were treated with 25% (w/v) HCA solution (dissolved in AOO) concurrent to the test item groups. No mortality, cutaneous reactions or signs of toxicity were observed in the positive control group.Significant lymphoproliferative response (SI ≥ 3) was noted for HCA (SI = 6.9). The results of the positive control item demonstrated appropriate performance of the test in accordance with the relevant guidelines and confirmed validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- sulfamide 50 % in DMF
- Parameter:
- SI
- Value:
- 0.4
- Test group / Remarks:
- sulfamide 25 % in DMF
- Parameter:
- SI
- Value:
- 0.2
- Test group / Remarks:
- sulfamide 10 % in DMF
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- sulfamide 5 % in DMF
- Cellular proliferation data / Observations:
- Based on results of the preliminary irritation/toxicity test where no significant systemic toxicity and/or irritation were observed SULFAMIDE (CAS No. 7803-58-9) was tested in the LLNA at concentrations of 50 %, 25 %, 10 % and 5 % (w/v) as formulations in DMF. Since the test was valid and no sign of systemic toxicity or significant irritation was observed at the applied concentrations, the proliferation values obtained are considered to reflect the real potential of the test item to cause/not cause lymphoproliferation in the Local Lymph Node Assay. According to evaluation criteria of the relevant guidelines, the lack of a significantly (SI ≥ 3) increased lymphoproliferation up to the maximum attainable concentration of 50 % (w/v, based on solubility) and the lack of a significant dose-response relationship are considered evidence that SULFAMIDE (CAS No. 7803-58-9) is not a skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of the present Local Lymph Node Assay, SULFAMIDE (CAS No. 7803-58-9) tested at the maximum attainable concentration of 50 % (based on solubility) and at concentrations of 25 %, 10 % and 5 % (w/v) as formulations in an appropriate vehicle (DMF) was shown to have no skin sensitization potential.
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.