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Diss Factsheets
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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
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Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- repeated dose toxicity: other route
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable with restrictions.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Method:Twenty hamsters received intratracheal administration of man-made calcium sulfate fiber (D = 1.0 microns, L = 17.8 microns) for 5 weeks, after which they were observed for 2 years for tumor development.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium sulfate
- EC Number:
- 231-900-3
- EC Name:
- Calcium sulfate
- Cas Number:
- 7778-18-9
- IUPAC Name:
- calcium sulfate
- Details on test material:
- - Name of test material: Calcium sulfate
- CAS number :7778-18-9
- EC Number: 231-900-3
- Molecular formula (if other than submission substance): CaSO4
- Molecular weight (if other than submission substance): 136.14 g/mol
- Smiles notation (if other than submission substance): [Ca+2].[O-]S([O-])(=O)=O
-InChl (if other than submission substance):=1/Ca.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Appearance: white solid
- Density -2.96 g/cm3)
- Melting point-1460 °C
- Solubility in water - 2.1 g/L (20 °C
- Synonyms: Plaster of Paris, Drierite,, Gypsum
Constituent 1
Test animals
- Species:
- hamster, Syrian
- Strain:
- other: hamster, Syrian
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: Syrian hamster
Sex: Female
Number of animals: 20 females/group
Age/Weight at study initiation: Age not indicated; 80 g
ADMINISTRATION / EXPOSURE
Route of administration: intratracheal intubation
Exposure period: 5 weeks
Frequency of treatment: once weekly
Post-exposure observation period: 2 years after the first administration.
Doses: total dose10 mg/animal (0.20 ml fiber suspension and 0.3 ml air per dose).
Control group: yes, untreated
Particle size: mean D 1.0 µm, L 17.8 µm (respirable)
CLINICAL OBSERVATIONS AND FREQUENCY
- Mortality/clinical signs: frequency not indicated
- Body weight: frequency not indicated
PATHOLOGICAL EXAMINATIONS
- Macroscopic examinations: all moribund animals and surviving animals at termination of the study were subjected to routine autopsies.
- Microscopic examinations: all organs were fixed and subjected to histopathological examinations using hematoxylin eosin stain and other special stains.
Administration / exposure
- Route of administration:
- other: Intratracheally
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 weeks
- Frequency of treatment:
- Frequency of treatment:2 mg/animal each week for 5 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Dose:10 mg/animal total
- No. of animals per sex per dose:
- twenty female animals
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- ADMINISTRATION / EXPOSURE
Route of administration: intratracheal intubation
Exposure period: 5 weeks
Frequency of treatment: once weekly
Post-exposure observation period: 2 years after the first administration.
Doses: total dose10 mg/animal (0.20 ml fiber suspension and 0.3 ml air per dose).
Control group: yes, untreated
Particle size: mean D 1.0 µm, L 17.8 µm (respirable)
CLINICAL OBSERVATIONS AND FREQUENCY
- Mortality/clinical signs: frequency not indicated
- Body weight: frequency not indicated
PATHOLOGICAL EXAMINATIONS
- Macroscopic examinations: all moribund animals and surviving animals at termination of the study were subjected to routine autopsies.
- Microscopic examinations: all organs were fixed and subjected to histopathological examinations using hematoxylin eosin stain and other special stains.
Examinations
- Observations and examinations performed and frequency:
- Twenty hamsters received intratracheal administration of man-made calcium sulfate fiber (D = 1.0 microns, L = 17.8 microns) for 5 weeks, after which they were observed for 2 years for tumor development.
Three out of twenty animals were found to have tumors. Chronic alveolitis was also seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls. Changes appeared too mild to foster a pneumoconiosis such as asbestos. - Sacrifice and pathology:
- PATHOLOGICAL EXAMINATIONS
- Macroscopic examinations: all moribund animals and surviving animals at termination of the study were subjected to routine autopsies.
- Microscopic examinations: all organs were fixed and subjected to histopathological examinations using hematoxylin eosin stain and other special stains.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No acute deaths were noted after the administrations of fibers.
- Mortality:
- no mortality observed
- Description (incidence):
- No acute deaths were noted after the administrations of fibers.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- comparable between the groups.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- comparable between the groups.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- comparable between the groups.
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- comparable between the groups.
- Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Three out of twenty animals were found to have tumors. Chronic alveolitis was also seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls.
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Three out of twenty animals were found to have tumors. Chronic alveolitis was also seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Three out of twenty animals were found to have tumors. Chronic alveolitis was also seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Three out of twenty animals were found to have tumors. Chronic alveolitis was also seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- comparable between the groups.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Three out of twenty animals were found to have tumors.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Chronic alveolitis was seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Chronic alveolitis was seen with macrophage and neutrophile aggregation and endemateous thickening of the alveolar walls
- Details on results:
- - Mortality and time to death: No acute deaths were noted after the administrations of fibers. Mortality was comparable between the groups.
- Body weight gain: comparable between the groups.
PATHOLOGICAL EXAMINATIONS
The number of tumor bearing hamsters in the calcium sulfate group was 3. Tumors were located in the rib (2; unspecified cell types), heart (1; anaplastic carcinoma) and kidney (1; dark cell carcinoma). In addition, chronic alveolitis with macrophage aggregation, and edematous thickening of alveolar walls with alveolitis was noted.
LOAEL:10 mg/kg bw
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The number of tumor bearing hamsters in the calcium sulfate group was 3. Tumors were located in the rib (2; unspecified cell types), heart (1; anaplastic carcinoma) and kidney (1; dark cell carcinoma). In addition, chronic alveolitis with macrophage aggregation, and edematous thickening of alveolar walls with alveolitis was noted. LOAEL:10 mg/kg bw.
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