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EC number: 237-399-8 | CAS number: 13770-92-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Calcium disulphamate
- EC Number:
- 237-399-8
- EC Name:
- Calcium disulphamate
- Cas Number:
- 13770-92-8
- Molecular formula:
- Ca.2H3NO3S
- IUPAC Name:
- calcium disulfamate
Constituent 1
- Specific details on test material used for the study:
- Content: 90.9 g/100 g
Identiy: Confirmed
Homogeneity: The test substance was homogenous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor and the sponsor holds this responsibility.
pH: ca. 7 (undiluted test substance, moistened with deionized water; determined in th elab prior to start of the GLP study). Ca. 6 (20% aqueous preparation, determined in the lab prior to start of the GLP study).
Physical state/color: Solid/white
Storage conditions: Room temperature
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 20% (w/v) suspension in deionized water
- Duration of treatment / exposure:
- 4 h
- Details on study design:
- The objective of this in vitro test is to assess the potential of the test substance to cause serious eye damage. According to OECD Guideline 437 (adopted July 2013), also substances that do not require classification for eye irritation or serious eye damage can be identified. However, due to insufficient predictivity the latter derivation is not recommended by the test facility.
The test method consists of a topical exposure of the test substance to the epithelial surface of isolated corneas from the eyes of cattle freshly slaughtered. Corneal opacity is quantitatively measured as the amount of light transmitted through the cornea. Permeability is quantitatively measured as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro Irritancy Score (IVIS) of the test substance which is used for the prediction of serious eye damage.
Isolated bovine cornea: The test system is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle
(age of the animals: minimum 12 months, maximum 60 months).
Supplier: Schlachthof Mannheim, Schlachthofstr. 21, 68165 Mannheim, Germany
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of 3 corneas
- Value:
- 0.1
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not corrosive to eyes
- Executive summary:
The objective was to assess the eye irritating potential of Calcium disulphamate. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test.
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation in deionized water to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance preparation for an exposure period of 4 hours.
In addition to the test substance, a negative control (NC; deionized water) and a positive control (PC; 20% imidazole in deionized water) were applied to three corneas each. Corneal opacity was quantitatively measured as the amount of light transmitted through the cornea. Permeability was quantitatively measured as the amount of sodium fluorescein dye
that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance. The mean IVIS for the test substance, the negative and the positive control was 0.1, 14.1, and 160.3, respectively. The substance was therefore not identified as corrosive or severe irritant.
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.
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