Item | Information |
---|---|
CAS RN | 10034-76-1 |
Chemical Name | Calcium sulfate hemihydrate [calcined gypsum, bassanite, or calcination] |
Substance ID | m-nite-10034-76-1_v1 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not an aerosol product. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Flammable solids | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2015)). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It is estimated that it does not react vigorously with water from water solubility data measured. Water solubility: 2.4 g/L (20 degrees C) (GESTIS (Access on June 2015)) | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound that does not contain halogen but contains oxygen, but the classification is not possible due to no data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | It is an inorganic compound. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | From a reported LD50 value of > 2,000 mg/kg for calcium sulfate dihydrate (converted to a hemihydrate equivalent: > 1,686 mg/kg) for rats (SIDS (2005)) and a reported LD50 value of > 5,000 mg/kg for calcium sulfate anhydrate (converted to a hemihydrate equivalent: >5,331 mg/kg) for rats (SIDS (2009)), the substance was classified as "Not classified." | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Vapours) | Not classified (Not applicable) |
- |
- | - | "Solids" according to GHS definition. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a skin irritation test (OECD TG 404, GLP compliance) in which 500 mg calcium sulfate dihydrate was applied to rats for 4 hours, no irritation reaction was observed (SIDS (2005)). From the above result, it was judged to be "Not classified." | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Skin sensitization | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, in a Buehler test (OECD TG 406, GLP compliance) on calcium sulfate dihydrate, it was concluded to be not sensitizing from the sensitization score of 0 for all tested animals (SIDS (2005)). |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." No in vivo and in-vitro data on this substance, but the following was reported for analogous substances: as for in vitro, calcium sulfate (CAS RN 7778-18-9) showed negative in a bacterial reverse mutation test and a chromosomal aberration test with cultured mammalian cells (SIDS (2005)); and as for calcium sulfate dihydrate (CAS RN 10101-41-4), an in vivo micronucleus test was negative (SIDS (2005)), and a bacterial reverse mutation test was negative (SIDS (2005)). As above, the judgement was conducted based on the information on analogous substances. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | Due to no classification result by other organizations and lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Classification not possible |
- |
- | - | It is not a test report on this substance itself (hemihydrate), but calcium sulfate dihydrate was administered by gavage to rats in a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD TG 422), in which effects on fertility in parent animals and development of the offspring were not observed even after administration up to the limit dose (1,000 mg/kg/day) (SIDS (2009)). It is not possible to classify up to Category 2 from this data. Because this data are screening test results, and no other available data were obtained, the substance was classified as "Classification not possible" due to lack of data. |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Category 3 (Respiratory tract irritation) |
Warning |
H335 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
From the information that this substance is irritating to the respiratory tract in humans (ACGIH (7th, 2006)), it was classified in Category 3 (respiratory tract irritation). | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | As for humans, there is no report on clear health effects by this substance itself (hemihydrate). There are following reports: effects were observed in chest X-ray findings in plaster mold makers in the Stoneware plant in Germany (DFGOT vol. 2 (1991)); dyspnea and lung shadows in X-ray examination were found in a cross-sectional study of Canadian gypsum miners and millers; and effects were observed in lung parenchyma and function in a cross-sectional study of British gypsum mine employees (ACGIH (7th, 2006)). However, there is no exposure information in the epidemiological data, and effects of exposure to quartz cannot be excluded. As for experimental animals, sufficient information on this substance was not obtained. Besides, results of comparing effects on the lung by this substance with the different appearance (powdery, fibrous) were reported. In a 3-week inhalation exposure test using rats, a 2-fold increase in glutathione levels in bronchoalveolar lavage (BAL) in both forms immediately after an administration period and a 3-fold high value only in fibrous form after a 3-week recovery period were shown (ACGIH (7th, 2006)). Besides, not this substance, but a dihydrate was administered by gavage to rats in a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD TG 422), in which decreases in total protein, albumin, BUN, AST, ALT, and creatinine were observed in males at 300 mg/kg/day or higher (converted to a 90-day equivalent: not less than 117 mg/kg/day) (SIDS (2009)). These changes were above the range of Category 2. As above, there is no report on clear health effects of this substance in humans and no sufficient toxicity test data in experimental animals. Therefore, the classification is not possible due to lack of data. |
FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Classification not possible |
- |
- | - | No data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | No data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. | FY2015 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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