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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- - Calcium sulfate, dihydrate was dissolved in 1 % CMC (Sodium carboxymethyl Cellulose) and supersonic wave was used to prepare the
highest dose concentration.
- To observe the cell multiplication of bone mallow, a specimen was fixed with methanol. And 4 % Giemsa solution was used for dyeing to
observe the ratio of polychromatic erythrocytes. To observe the micronucleus in the polychromatic erythrocytes, 40 μg/ml acridine was
dropped for dyeing. - GLP compliance:
- yes
- Remarks:
- Tested by KOSHA, Korea.,(No. ICRC/2002/006)
- Type of assay:
- other: Mammalian erythrocyte micronucleus test
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
- Test material form:
- solid: compact
- 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:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Test condition :
- Age at study initiation: 8 weeks
- No. of animals per dose: 6
- Vehicle: 1 % CMC (Sodium Carboxymethyl Cellulose)
- Duration of test: 1 day
- Frequency of treatment: single treatment
- Sampling times and number of samples: 24 hours after administration
- Control groups and treatment: Negative control (1 % CMC (Sodium Carboxymethyl Cellulose)), Positive control (0.5 and 1.0 mg/kg of
Mitomycin C)
- Clinical observations performed: None
- Organs examined at necropsy: not examined
- Criteria for evaluating results: at least 2,000 polychromatic erythrocytes per animals were scored for the incidence of micronuclei.
- Criteria for selection of maximum tolerated dose (M.T.D): preliminary test had conducted with with 1,250, 2,500 and 5,000 mg/kg b.w. to
determine appropriate starting dose level.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - -Vehicle: 1 % CMC (Sodium Carboxymethyl Cellulose)
-Calcium sulfate, dihydrate was dissolved in 1 % CMC (Sodium carboxymethyl Cellulose) and supersonic wave was used to prepare the
highest dose concentration.
- To observe the cell multiplication of bone mallow, a specimen was fixed with methanol. And 4 % Giemsa solution was used for dyeing to
observe the ratio of polychromatic erythrocytes. To observe the micronucleus in the polychromatic erythrocytes, 40 μg/ml acridine was
dropped for dyeing. - Details on exposure:
- Route of administration :
Test substance: oral feed
Positive control: i.p
Dose : 1,250, 2,500 and 5,000 mg/kg b.w
Exposure period : 24 hours
Statistical methods : ANOVA (Using Sigmastat 2.0 statistic programme)
Exposure period : 24 hours - Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- - Frequency of treatment: single treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1,250, 2,500 and 5,000 mg/kg b.w
Basis:
nominal in diet
- No. of animals per sex per dose:
- No. of animals per dose: 6/male
- Control animals:
- yes
- Positive control(s):
- GLP : Yes
Route of administration : Test substance: oral feed
Positive control: i.p
Dose : 1,250, 2,500 and 5,000 mg/kg b.w
Examinations
- Tissues and cell types examined:
- - Clinical observations performed: None
- Organs examined at necropsy: not examined
- Criteria for evaluating results: at least 2,000 polychromatic erythrocytes per animals were scored for the incidence of micronuclei.
- Criteria for selection of maximum tolerated dose (M.T.D): preliminary test had conducted with with 1,250, 2,500 and 5,000 mg/kg b.w. to
determine appropriate starting dose level. - Details of tissue and slide preparation:
- - Calcium sulfate, dihydrate was dissolved in 1 % CMC (Sodium carboxymethyl Cellulose) and supersonic wave was used to prepare the
highest dose concentration.
- To observe the cell multiplication of bone mallow, a specimen was fixed with methanol. And 4 % Giemsa solution was used for dyeing to
observe the ratio of polychromatic erythrocytes. To observe the micronucleus in the polychromatic erythrocytes, 40 μg/ml acridine was
dropped for dyeing. - Evaluation criteria:
- - Criteria for evaluating results: at least 2,000 polychromatic erythrocytes per animals were scored for the incidence of micronuclei.
- Criteria for selection of maximum tolerated dose (M.T.D): preliminary test had conducted with with 1,250, 2,500 and 5,000 mg/kg b.w. to
determine appropriate starting dose level. - Statistics:
- Statistical methods : ANOVA (Using Sigmastat 2.0 statistic programme)
- Statistical results: only positive control group showed statistically increased frequency of micronucleated cells.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- - Statistical results: only positive control group showed statistically increased frequency of micronucleated cells.
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Results : All things being considered, calcium sulfate, dihydrate showed negative result in micronucleus test in vivo up
to the test concentration of 5,000 mg/kg b.w.
Genotoxic effects : Negative
- Statistical results: only positive control group showed statistically increased frequency of micronucleated cells.
Conclusion : Calcium sulfate, dihydrate showed negative result in the micronucleus test in vivo up to the test concentration of 5,000 mg/kg.
Any other information on results incl. tables
Results : All things being considered, calcium sulfate, dihydrate showed negative
result in micronucleus test in vivo up to the test concentration of 5,000 mg/kg b.w.
Effect on mitotic index or PCE/NCE ratio by dose level
Dose (mg/kg) |
Group mean (PCE/(PCE+NCE)) (%) |
Group mean frequency of MNPCE (per 1,000) |
Vehicle 1,250 2,500 5,000 Positive control (0.5 mg/kg) Positive control (1.0 mg/kg) |
60.49 ± 7.77 56.58 ± 9.07 54.61 ± 6.13 54.48 ± 9.02 46.58 ± 10.76
46.96 ± 7.08 |
6.5 7.0 7.7 8.0 19.2 44.8 |
Genotoxic effects : Negative
- Statistical results: only positive control group showed statistically increased frequency of micronucleated cells.
Conclusion : Calcium sulfate, dihydrate showed negative result in the micronucleus testin vivoup to the test concentration of 5,000 mg/kg.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Calcium sulfate, dihydrate showed negative result in the micronucleus test in vivo up to the test concentration of 5,000 mg/kg.
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