GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 13397-24-5
Chemical Name Calcium sulfate dihydrate [gypsum (mineral)]
Substance ID H27-A-017/C-017A_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

PHYSICAL HAZARDS
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 (ICSC (2009)).
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 (ICSC (2009)).
11 Self-heating substances and mixtures Not classified
-
-
- - It is not combustible (ICSC (2009)).
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.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - From a reported LD50 value of > 2,000 mg/kg for rats (SIDS (2005)), 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 in a skin irritation test (OECD TG 404, GLP compliance) using rats, no irritation reaction was observed after 4-hour application with 500 mg calcium sulfate dihydrate (CAS: 10101-41-4) (SIDS (2005)). From the above result, it was judged to be "Not classified."
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Not classified
-
-
- - As the information on calcium sulfate dihydrate (CAS RN: 10101-41-4), in a Buehler test (OECD TG 406, GLP compliance) using guinea pigs, it was concluded to be not sensitizing from the sensitization score of 0 for all tested animals (SIDS (2005)).
From the above result, it was judged to be "Not classified."
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." There are no in-vivo and in-vitro data on this substance, but for calcium sulfate (dehydrate) (CAS RN 10101-41-4), an analog substance of this substance, it is reported that an in vivo micronucleus test was negative (SIDS (2005)), and a bacterial reverse mutation test was negative (SIDS (2005)). Moreover, it is reported for calcium sulfate (CAS RN 7778-18-9) that a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were negative in vitro (SIDS (2005)).
6 Carcinogenicity Classification not possible
-
-
- - Due to no classification result by other organizations and lack of data, the classification is not possible. Besides, it is written in DFGOT that intratracheal injection in hamsters or intraperitoneal injection in rats of fibers (gypsum fibres) of calcium sulfate (gypsum) (CAS RN: 7778-18-9) does not induce tumors (DFGOT vol. 8 (1997)).
7 Reproductive toxicity Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
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 on 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, not this substance, but a calcium sulfate dihydrate (CAS RN: 10101-41-4) 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.
Besides, results of comparing effects on the lung by an anhydrate 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 3-fold high value only in fibrous form after a 3-week recovery period were shown (ACGIH (7th, 2006)).
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.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible
-
-
- - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data.
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.

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