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Diss Factsheets
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EC number: 234-448-5 | CAS number: 12004-14-7
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and guideline
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)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 10101-41-4
- EC Number:
- 600-148-1
- Cas Number:
- 10101-41-4
- IUPAC Name:
- 10101-41-4
- Reference substance name:
- calcium sulfate, dihydrate
- IUPAC Name:
- calcium sulfate, dihydrate
- Details on test material:
- - Name of test material (as cited in study report): Calcium sulfate, dihydrate
- Analytical purity: 99.9%
- Lot/batch No.: Sigma Aldrich LOT no. - 109H0166
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Calcium sulfate, dihydrate was dissolved in 1 % CMC (Sodium carboxymethyl Cellulose) and supersonic wave was used to prepare the highest dose concentration.
- Duration of treatment / exposure:
- 1 day
- Frequency of treatment:
- Single treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1250, 2500 and 5000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 6
- Positive control(s):
- - mitomycin C
- Doses / concentrations: 0.5 mg/kg and 1.0 mg/kg
Examinations
- Details of tissue and slide preparation:
- To observe the cell multiplication of bone marrow, 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:
- At least 2000 polychromatic erythrocytes per animal were scored for the incidence of micronuclei
- Statistics:
- ANOVA (using Sigmastat 2.0 statistic programme)
Results and discussion
Any other information on results incl. tables
Table 1: 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 (0.5mg/kg) Positive control (1.0mg/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 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Calcium sulfate dihydrate showed negative results in the micronucleus test in vivo up to the test concentration of 5000 mg/kg b.w - Executive summary:
This study summary was provided for the registration of calcium sulfate.
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.
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