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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- 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:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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:
- Name of test substance: Calcium disulphamate
Test substance No.: 16/0399-1
Batch identification: GM0056-WRS-0220
CAS No.: 13770-92-8
Content: 90.9 g/100 g (for details see Study code: 16L00478)
Identity: Confirmed (for details see Study code: 16L00478)
Homogeneity: The test substance was homogeneous 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.
ADDITIONAL TEST SUBSTANCE INFORMATION
pH value: Ca. 7 (undiluted test substance, moistened with deionized water; determined in the lab prior to start of the GLP study)
Physical state / color: Solid / white
Storage conditions: Room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Details on test system:
- Three-dimensional human epidermis model
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and commercially available as kits (EpiDerm™ 200) containing 24 tissues on shipping agarose.
Tissue model: EPI-200
Tissue Lot Number: 23393
Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 95.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Individual and mean OD570values, individual and mean viability values, standard deviations andcoefficient of variation
Test substance identification |
|
tissue 1 |
tissue 2 |
tissue 3 |
mean SD CV [%] |
||
NC |
mean OD570 |
1.758 |
2.019 |
1.930 |
1.902 |
||
viability [% of NC] |
92.4 |
106.1 |
101.5 |
100.0 |
7.0 |
7.0 |
|
16/0399-1 |
mean OD570 |
1.945 |
1.767 |
1.727 |
1.813 |
||
viability [% of NC] |
102.3 |
92.9 |
90.8 |
95.3 |
6.1 |
6.4 |
|
PC |
mean OD570 |
0.052 |
0.047 |
0.054 |
0.051 |
||
viability [% of NC] |
2.7 |
2.5 |
2.8 |
2.7 |
0.2 |
7.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The objective was to assess the skin irritation and corrosion potential of Calcium disulphamate. By using the currently available methods a single in vitro assay is not sufficient to cover the full range of skin irritating/corrosion potential. Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
However, in the current case for Calcium disulphamate the results derived with SIT alone were sufficient for a final assessment. Therefore, further testing in SCT was waived. The potential of the test substance to cause dermal irritation was assessed by a single topical application of ca. 25 μL bulk volume (about 8 mg) of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™). The irritation test was performed with three EpiDerm™ tissues which were incubated with the test substance for 1 hour followed by a 42-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The following results were obtained in the EpiDerm™ skin irritation test:
The test substance is not able to directly reduce MTT.
The final mean viability of the tissues treated with the test substance determined after an exposure period of 1 hour with an about 42-hour post-incubation was 95.3%.
Based on the results observed it was concluded that Calcium disulphamate does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
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