GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 7778-18-9 |
| Chemical Name | Calcium sulfate |
| Substance ID | H27-A-014/C-014A_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2015)). |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2015)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on June 2015)). |
| 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)) |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 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. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | From an LD50 value of > 5,000 mg/kg for rats (SIDS (2009)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that no irritation reaction was observed in a skin irritation test (OECD TG 404, GLP compliance) in which 500 mg of calcium sulfate dihydrate (CAS: 10101-41-4) was applied to rats for 4 hours (SIDS (2005)). From the above result, the substance was judged as "Not classified." |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that effects were not observed after application of this substance to rabbit eyes (SIDS (2009), ACGIH (7th, 2006)), and conjunctivitis was reported in humans exposed to dust of this substance (HSDB (Access on June 2015)). Both were judged as insufficient to be used for the classification due to unknown details. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. No in vivo data on this substance, and as for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were negative (SIDS (2009)). For calcium sulfate dehydrate, an analogous substance of this substance, it is reported that an in vivo micronucleus test was negative (SIDS (2009)), and a bacterial reverse mutation test was negative in vitro (SIDS (2009)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Due to no classification result by other organization and lack of data, the classification is not possible. Besides, it is written that intratracheal injection in hamsters or intraperitoneal injection in rats of fibers (gypsum fibres) of calcium sulfate (gypsum) (CAS: 7778-18-9) does not induce tumors (DFGOT vol. 8 (1997)). |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | It is not a test report on this substance itself (anhydrate), 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 it in up to Category 2 from this data. However, 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. |
| 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). |
| 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 (anhydrate). 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 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 decreases in serum 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. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Not classified |
- |
- | - | From 48-hour LC50 > 1970 mg/L for crustacea (Daphnia magna) and 96-hour LC50 > 1970 mg/L for fish (Pimephales promelas) (both SIDS, 2009), it was classified as "Not classified." |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Reliable chronic toxicity data were not obtained. Due to being not water-insoluble (water solubility = 2.4 g/L, GESTIS, 2015), and "Not classified" for acute toxicity, it was classified as "Not classified." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |