NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	7778-18-9
Chemical Name	Calcium sulfate
Substance ID	m-nite-7778-18-9_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

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)

PHYSICAL HAZARDS

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	-	- -	-	-	-	-	-

HEALTH HAZARDS

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 an LD50 value of > 5,000 mg/kg for rats (SIDS (2009)), it 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 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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	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	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	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 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)).	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 (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.	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 (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.	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))

ENVIRONMENTAL HAZARDS

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)	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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	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."	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))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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