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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-135-0 | CAS number: 10043-01-3
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions. Well-presented study, with relevant measurement of chemical concentrations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Method remark:
500 mg of test material with about 0.1 mL of sterile distilled water for humidity was applied to the abraded and intact sites on the shaved
backs (2.5 x 2.5 cm) of rabbits. It was held in place for 4 hours with three fold gauze patches, which was applied in place with elasticity bandage
then was fixed with non-irritating tape (3M paper-tape) to prevent leakage. After 4 hours, three gauze patches were removed and the
exposed areas were washed using warm water without altering the existing response or the integrity of the epidermis.
The skin of animals was examined in accordance with an OECD scoring method for signs of erythema and oedema and the responses scored at 1, 24, 48 and 72 hours after the patches removal. Mortality, clinical signs and body weight were also observed. - GLP compliance:
- yes
- Remarks:
- (Test No. BO2112)
Test material
- Reference substance name:
- calcium sulfate,dihydrate
- IUPAC Name:
- calcium sulfate,dihydrate
- Reference substance name:
- 10101-41-4
- EC Number:
- 600-148-1
- Cas Number:
- 10101-41-4
- IUPAC Name:
- 10101-41-4
- Details on test material:
- Name of test material: Calcium sulfate, dihydrate
- Molecular formula (if other than submission substance): CaSO4•2H2O
- Molecular weight (if other than submission substance): 172.171
- Smiles notation (if other than submission substance): O.O.[O-]S(=O)(=O)[O-].[Ca+2]
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Density -2.32 g/cm3)
- Solubility in water - 2.05 g/L at 20 °C
- Synonyms: Alabaster
Annaline
C.I. Pigment white 25
Gypsum
Gypsum stone
Land and plaster
Light spar
Magnesia white
Mineral white
Native calcium sulfate
Precipitated calcium sulfate
Sainite
Satin spar
Sulfuric acid, calcium(2+) salt, dihydrate
Terra alba
- Calcium sulfate, dihydrate consists of colorless, monoclinic and hygroscopic crystals
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test condition : Test organism
- Age: 3 to 4 months old
- Number of animals: 3 animals
- Sex: Males weighting 2.1 kg ~ 2.4 kg
Total dose: 500 mg/site/rabbit of calcium sulfate, dihydrate
Vehicle: Not used
Route of administration: With an occluded patch
Exposure time period: 4 hours
Scoring method used: OECD method (Grading of skin reaction)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- none
- Controls:
- yes
- Amount / concentration applied:
- Concentration: 500 mg
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours.
- Number of animals:
- 3
- Details on study design:
- 500 mg of test material with about 0.1 mL of sterile distilled water for humidity was applied to the abraded and intact sites on the shaved
backs (2.5 x 2.5 cm) of rabbits. It was held in place for 4 hours with three fold gauze patches, which was applied in place with elasticity bandage
then was fixed with non-irritating tape (3M paper-tape) to prevent leakage.
After 4 hours, three gauze patches were removed and the exposed areas were washed using warm water without altering the existing response or the integrity of the epidermis.
The skin of animals was examined in accordance with an OECD scoring method for signs of erythema and oedema and the responses scored at 1, 24, 48 and 72 hours after the patches removal. Mortality, clinical signs and body weight were also observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 (hrs)
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No erythema
- Remarks on result:
- other: No erythema
- Irritation parameter:
- other: Oedema
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72, (hrs)
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No oedema
- Remarks on result:
- other: No oedema
- Irritant / corrosive response data:
- - Not irritating: no erythema, no eschar and no oedema was observed at the skin on the backs of three rabbits.
- There were no clinical signs in relation to spread with calcium sulfate, dihydrate. - Other effects:
- Weight loss was observed in 24 hours after the administration.
Body weight was almost recovered in 72 hours.
Any other information on results incl. tables
The skin on the backs of three rabbits appeared unaffected.
- Not irritating: no erythema, no eschar and no oedema was observed at the skin on the backs of three rabbits.
- There were no clinical signs in relation to spread with calcium sulfate, dihydrate.
Weight loss was observed in 24 hours after the administration.
Body weight was almost recovered in 72 hours.
Evaluation of skin irritation
Right site: Calcium sulfate, dihydrate
Change Erythema & Eschar
Applicated area Intact Abraded
Phase (hrs) 1 24 48 72 1 24 48 72
Animal ID 0 0 0 0 0 0 0 0
M01 0 0 0 0 0 0 0 0
M02 0 0 0 0 0 0 0 0
M03 0 0 0 0 0 0 0 0
Total 0 0 0 0 0 0 0 0
Mean 0 0 0 0 0 0 0 0
Total of mean 0
Erythema and Eschar formation
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beef redness) to eschar formation preventing grading of erythema
Right site: Calcium sulfate, dihydrate
Change Oedema
Applicated area Intact Abraded
Phase (hrs) 1 24 48 72 1 24 48 72
Animal ID 0 0 0 0 0 0 0 0
M01 0 0 0 0 0 0 0 0
M02 0 0 0 0 0 0 0 0
M03 0 0 0 0 0 0 0 0
Total 0 0 0 0 0 0 0 0
Mean 0 0 0 0 0 0 0 0
Total of mean 0
- Oedema formation
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well defined by definite raising)
3 - Moderate oedema (raised approximately 1 mm)
4 - Severe oedema (raised more than 1 mm and extending beyond area of exposure)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Calcium sulfate, dihydrate did not make skin irritation at the test concentration
- Not irritating: no erythema, no eschar and no oedema was observed at the skin on the backs of three rabbits.
- There were no clinical signs in relation to spread with calcium sulfate, dihydrate.
Weight loss was observed in 24 hours after the administration.
Body weight was almost recovered in 72 hours
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)