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EC number: 231-900-3 | CAS number: 7778-18-9
- 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)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 10101-41-4
- 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
- Substance type: White powder
- Physical state: Solid
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK, Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 199 - 350g
- Fasting period before study:
- Housing: Housed in groups of five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes
- Diet: Harlan 2014 rodent diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30 -70 %:
- Air changes: 15 changes per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: Volume of ~ 30L (dimensions: 28 cm diameter x 50 cm high)
- Method of holding animals in test chamber: Each rat was held in a tapered, polycarbonate restraining tube fitted with a single tier of the exposure chamber and sealed by means of a rubber 'O' ring
- Source and rate of air: Compressed air was supplied by means of an oil free compressor
- Method of conditioning air: Passed through a water trap and respiratory quality filters
- System of generating particulates/aerosols: SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden Germany)
- Method of particle size determination: Determined three times during the exposure period using a Marple Personal Cascade Impactor )Westech IS Ltd, Beds, UK)
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric method
- Samples taken from breathing zone: yes
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- Mean achieved 3.26 mg/L (calcium sulfate dihydrate), equivalent to >2.61 mg/L calcium sulfate anhydrous
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 3.26 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Equivalent to > 2.61 mg/L calcium sulfate anhydrous
- Mortality:
- No deaths occurred
- Clinical signs:
- other: Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. Animals recovered quickly to appear normal from Day 2 post-exposure
- Body weight:
- One male animal exhibited a reduced bodyweight gain during Week 1 but recovered to show normal development during Week 2. Normal bodyweight development was noted for all other animals during the course of the study.
- Gross pathology:
- With the exception of one instance of dark patches on the lungs, no macroscopic abnormalities were detected at necropsy
Any other information on results incl. tables
Table 1: Temperature and relative humidity in exposure temperature:
Time (minutes) |
Chamber temperature (°C) during exposure |
Chamber relative humidity (%) during exposure |
0 |
21 |
58 |
30 |
21 |
57 |
60 |
21 |
56 |
90 |
21 |
52 |
120 |
21 |
56 |
150 |
21 |
55 |
180 |
21 |
57 |
210 |
21 |
56 |
240 |
21 |
57 |
Table 2: Air flow and oxygen concentration in exposure chamber
Time (minutes) |
Air flow (L/min) during exposure |
Chamber relative humidity (%) during exposure |
-3 |
50 |
- |
0 |
50 |
20.8 |
30 |
50 |
- |
60 |
50 |
- |
90 |
50 |
- |
120 |
50 |
20.8 |
150 |
50 |
- |
180 |
50 |
- |
210 |
50 |
- |
240 |
50 |
20.8 |
Table 3: Exposure chamber atmosphere concentrations
Duration of exposure (minutes) |
Net weight of sample (mg) |
Volume of air sampled (L) |
Chamber flow rate (L/min) |
Atmosphere concentration (mg/L) |
5 |
5.45 |
2 |
50 |
2.73 |
16 |
6.02 |
2 |
50 |
3.01 |
30 |
7.33 |
2 |
50 |
3.67 |
46 |
5.04 |
2 |
50 |
2.52 |
60 |
5.77 |
2 |
50 |
2.89 |
75 |
6.56 |
2 |
50 |
3.28 |
88 |
6.26 |
2 |
50 |
3.13 |
105 |
7.37 |
2 |
50 |
3.69 |
120 |
6.00 |
2 |
50 |
3.00 |
135 |
5.13 |
2 |
50 |
2.57 |
150 |
6.00 |
2 |
50 |
3.00 |
166 |
7.18 |
2 |
50 |
3.59 |
180 |
7.21 |
2 |
50 |
3.61 |
195 |
7.65 |
2 |
50 |
3.83 |
210 |
7.73 |
2 |
50 |
3.87 |
225 |
7.74 |
2 |
50 |
3.87 |
237 |
6.16 |
2 |
50 |
3.08 |
Mean achieved atmosphere concentration (mg/L) = 3.26
Standard deviation = 0.46
Nominal concentration:
Test material use (g) |
150 |
Air flow (L/min) |
50 |
Total generation time (mins) |
243 |
Nominal concentration (mg/L) |
21.3 |
Table 4: Cascade impactor data
Impactor stage number |
Cut point (µm) |
Amount collected (mg) per sample |
Mean amount collected (mg) |
||
1 |
2 |
3 |
|||
3 |
9.0 |
0.02 |
0.14 |
0.08 |
0.08 |
4 |
6.3 |
0.24 |
0.61 |
0.29 |
0.38 |
5 |
4.0 |
0.48 |
0.92 |
0.55 |
0.65 |
6 |
1.7 |
0.28 |
0.51 |
0.32 |
0.37 |
7 |
0.81 |
0.20 |
0.28 |
0.27 |
0.25 |
8 |
0.30 |
0.03 |
0.09 |
0.11 |
0.08 |
Back up filter |
<0.30 |
0.03 |
0.10 |
0.03 |
0.05 |
Total mean amount of test material collected |
1.86 |
Table 5: Calculation
Cut point (µm) |
Log10 Cut point |
Mean cumulative amount less than cut point |
||
(mg) |
% |
Probit |
||
9.0 |
0.954 |
1.78 |
95.7 |
6.72 |
6.3 |
0.799 |
1.40 |
75.3 |
5.68 |
4.0 |
0.602 |
0.75 |
40.3 |
4.76 |
1.7 |
0.230 |
0.38 |
20.4 |
4.17 |
0.81 |
-0.092 |
0.13 |
6.99 |
3.52 |
0.30 |
-0.523 |
0.05 |
2.69 |
3.07 |
Results:
Mean mass median aerodynamic diameter (MMAD) = 2.92 µM
Geometric standard deviation (GSD) = 2.49
Predicted amount less than 4 µm = 63.6%
It is recognised that the mean achieved atmosphere concentration is lower than would generally be acceptable for this type of study. During characterisation, changes were made to the generation system to increase the inhalable portion of the test material, however, these changes also reduced the achievable test atmosphere concentration. However, as these changes reduced the particle size significantly it made it such that even at reduced test atmosphere concentrations the animals would be exposed to higher concentrations of particles <4 μm than if they were to be exposed to the standard target concentration of 5mg/L. It was, therefore, preferable to expose the animals to a lower concentration of test material, as this resulted in the animals being exposed to the highest possible concentration of particles <4μm.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute inhalation median lethal concentration (4 hr LC50) of Calcium sulfate dihydrate, in the HsdHanTM : WIST strain rat, was greater than 3.26 mg/L, the equivalent LC50 value for the anhydrous form of this material is considered to be >2.61mg/L. On the basis of this result, Calcium sulfate dihydrate does not meet the criteria for classification in the EU in accordance with both Council Directive 67/548/EEC as amended and Regulation (EC) No 1272/2008 and will not require labelling for inhalation toxicity.
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.
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