NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	7757-82-6
Chemical Name	Disodium sulfate
Substance ID	R01-A-017
Classification year (FY)	FY2019
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)
Model SDS by MHLW (External link)
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2005)).
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2005)).
11	Self-heating substances and mixtures	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2005)).
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	It contains a metal (Na), but because it is estimated to be stable in water from water solubility information of 170 g/L (20 deg C) (GESTIS (Access on August 2019)), it was classified as "Not classified."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	It is an inorganic compound containing oxygen (but not halogen), but the classification is not possible due to no data.
15	Organic peroxides	*	- -	-	-	Inorganic compound. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: >10,000 mg/kg (SIDS (2006))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test according to OECD TG 404 with rabbits, it was concluded as not irritating (SIDS (2006), REACH registration dossier (Access on September 2019)). (2) This substance is not irritating to the skin and slightly irritating to the eyes. Sensitising effects are highly unlikely (SIDS (2006)). [Reference Data, etc.] (3) It was reported that irritation was induced in only one out of 61 volunteers, however, the validity of this report was not assessed (SIDS (2006)). (4) A 10% solution of this substance produced mild irritation in one out of 19 volunteers (SIDS (2006)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2B. [Evidence Data] (1) In an eye irritation test according to OECD TG 405 with rabbits, it was concluded to be slightly irritating, and all the effects were reversible within 7 days (SIDS (2006), REACH registration dossier (Access on September 2019)). (2) This substance is not irritating to the skin and slightly irritating to the eyes. Sensitising effects are highly unlikely (SIDS (2006)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a skin sensitization test (maximization method) according to OECD TG 406 with guinea pigs, no skin reaction was observed, and it was concluded to be negative (REACH registration dossier (Accessed on September 2019)). (2) This substance is not irritating to the skin and slightly irritating to the eyes. Sensitising effects are highly unlikely (SIDS (2006)). [Reference Data, etc.] (3) It was reported that irritation was induced in only one in a human repeated insult skin sensitisation test on 61 volunteers. However, the validity of this report was not assessed (SIDS (2006), REACH registration dossier (Accessed on September (2019))).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There is no in vivo data for this substance, however, based on the weight of evidence (WoE), according to (1), it was classified as "Not classified." [Evidence Data] (1) As for in vitro, there are reports of negative results in a bacterial reverse mutation test and a mammalian cell chromosomal aberration test (SIDS (2006), Risk Assessment Report (Food additives)_Potassium sulfate (Food Safety Commission, 2013)). It is concluded, as a comprehensive decision, in the evaluation in Risk Assessment Report (Food additives) (Food Safety Commission, 2013) that the food additive "potassium sulfate (CAS RN 7778-80-5)" has no genotoxicity of any particular concern for living organisms since negative results were obtained in all tests using salts of sulfuric acid.
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Since only a little information on developmental effects as in (1) and (2) was obtained, and there are no data on sexual function and fertility, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) In a developmental toxicity test in which female mice were administered at a very high dose of 2,800 mg/kg/day by gavage on gestational day 8 through 12, no abnormality was observed in maternal animals, and no teratogenicity, etc. were observed. Besides, increased body weight in pups on postnatal Day 1 was observed, but no difference was observed on postnatal Day 3 (SIDS (2006)). (2) In a developmental toxicity test in which female mice were dosed on a gestational day 8 or 9 by a single subcutaneous injection (60 mg/kg), increases in maternal weight gain and delayed ossifications in fetuses were observed (SIDS (2006)).
8	Specific target organ toxicity - Single exposure	Category 1 (gastrointestinal tract)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1 (gastrointestinal tract). [Evidence Data] (1) This substance was once used as a laxative in humans for medical purposes in oral doses of about 300 mg/kg up to 20 g maximum, but it has been gradually abandoned due to severe diarrhea and abdominal cramping (SIDS (2006)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" for the inhalation and oral routes. [Evidence Data] (1) In a cross-sectional study among 119 male workers exposed to the dust of this substance for 2 months to 31 years, mean urinary excretion of inorganic sulfates exceeding 2.2 g/L in all workers was detected, and 30% of the workers excreted more than 3 g/day of inorganic sulfates. The only symptom indicated by the workers was nasal irritation and runny noses (SIDS (2006)). (2) In a 4-week feeding study with male rats, no toxic effects were observed at up to the highest dose of ca. 2,000 mg/kg/day (SIDS (2006)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour EC50 = 1,584.583 mg/L for algae (Pseudokirchneriella subcapitata) (AQUIRE, 2019, Simmons, 2012), 48-hour EC50 = 3,150.21 mg/L for crustacea (Ceriodaphnia dubia) (AQUIRE, 2019, Soucek, 2007), and 96-hour LC50 = 7,960 mg/L for fish (Pimephales promelas) (AQUIRE, 2019, Mount, 1997).
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour NOEC = 1,060 mg SO4/L (a converted value equivalent to NaSO4: 1,265 mg/L) for algae (Pseudokirchneriella subcapitata), 7-day NOEC = 610 mg SO4/L (a converted value equivalent to NaSO4: 728 mg/L) for crustacea (Ceriodaphnia dubia), and 31-day NOEC = 205 mg SO4/L for fish (Oncorhynchus mykiss) (a converted value equivalent to NaSO4: 245 mg/L) (all, AQUIRE, 2019, Elphick, 2011), although environmental dynamics of the inorganic compound is unknown.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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