NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	10034-96-5
Chemical Name	Manganese sulphate monohydrate
Substance ID	R01-B-055
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
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)	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	*	- -	-	-	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 (2018)).
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. 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 (2018)).
11	Self-heating substances and mixtures	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2018)).
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	It contains a metalloid (Mn), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 76.2 g/100 mL (20 deg C) (ICSC (2018)).
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). However, 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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. The category was changed from the previous classification by the use of new information sources. [Evidence Data] (1) LD50 (anhydrate) for rats: 782 mg/kg (a converted value equivalent to this substance: 875.2 mg/kg) (ATSDR (2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 12 (1999))
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), it was classified as "Not classified." The category was changed due to new data obtained. [Evidence Data] (1) In two skin irritation tests with rabbits according to OECD TG 404, no skin reaction was observed, and the mean scores at 24/48/72 hours were all 0 (REACH registration dossier (Access on September 2019)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. The category was changed due to new data obtained. [Evidence Data] (1) In an eye irritation test with rabbits according to OECD TG 405 (only one animal, humanely killed after 7 days), since irreversible symptoms were observed, it was judged to be corrosive (REACH registration dossier (Access on September 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) As for in vivo, there are reports of positive results in a micronucleus test and a chromosomal aberration test with mouse bone marrow (CICAD 12 (1999), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) As for in vitro, there are reports of a negative result in a bacterial reverse mutation test and a positive result in a mammalian cell chromosomal aberration test (NTP TR428 (1993), NTP DB (Access on July 2019)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There are no classification results by domestic and international organizations. There are no available reports on humans. Though there is a report in (1), based on the WHO opinion in (2), it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In carcinogenicity tests in which this substance was administered to rats and mice by feeding for 2 years, as for rats, no increased incidence of tumors was observed in both sexes, and it was judged that there was no evidence of carcinogenicity. On the other hand, as for mice, thyroid gland follicular cell adenoma was observed in males, and follicular cell hyperplasia was observed in females. Therefore, it was concluded that there was equivocal evidence of carcinogenicity (NTP TR428 (1993)). (2) The WHO expressed an opinion that firm conclusions on the carcinogenic potential of manganese could not be made based on the equivocal evidence for rodents and the paucity of evidence from other species (CICAD 12 (1999)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Though there are no data on this substance, based on (1)-(4), it was classified in Category 1B. The classification result was changed due to classification as a manganese compound. [Evidence Data] (1) Japan Society For Occupational Health (JSOH) classified manganese and manganese compounds as reproductive toxicants Group 2 (corresponding to Category 1B) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2014)). (2) As a result of cross-over mating in which male and female mice were exposed to manganese chloride tetrahydrate (CAS RN 13446-34-9) by drinking water for 12 weeks and were mated with unexposed females and males, respectively, at the dose where decreased drinking water consumption was observed in parental animals, lower fertility rate in males, and decreases in implantation rate and the number of surviving fetuses in females, were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012), ATSDR (2012)) (3) In a test in which manganese chloride (CAS RN 7773-01-5) was administered to pregnant rats by drinking water throughout gestation, an increase in post-implantation embryonic loss in maternal animals, and developmental retardation of the skeleton and internal organs, and an increased incidence of external malformations such as clubfoot in pups, were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012), ATSDR (2012)). (4) As a result of a test in which manganese chloride tetrahydrate (CAS RN 13446-34-9) was administered to rats by drinking water from 15-20 days before gestation up to 1 month after delivery, and the brains of 40-day-old pups were examined, increased manganese concentrations in the cerebral cortex, changes in 7-10% of the neurocytes in all brain parts, a dose-related increase in the number of glia cells, and noticeable gliosis in the nucleus accumbens were observed (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)). [Reference Data, etc.] (5) Manganese sulfate (II) (CAS RN 7785-87-7), the anhydrate of this substance, was classified in Category 1B in GHS classification of Japan (FY 2017).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] There is no report of single exposure to this substance in humans and experimental animals. Therefore, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) As for manganese sulfate (II) (CAS RN 7785-87-7), the anhydrate of this substance, there is no information of the effects on a single exposure to itself, and there is no useful information of other soluble manganese compounds. Therefore, it was classified as "Classification not possible" in the GHS classification in Japan (FY 2017).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1)-(3), it may cause effects on the central nervous system and respiratory organs as exposure to manganese compounds in humans. Based on (4)-(6), as a result of experimental animal studies with manganese sulfate (as the anhydrate or dihydrate), effects on the central nervous system and respiratory organs were observed within the range of Category 1. Therefore, it was classified in Category 1 (central nervous system, respiratory organs). The classification result was changed from the previous classification by adding information of manganese compounds and reviewing. [Evidence Data] (1) The potential risk on the industry handling manganese sulfate is chronic manganism, and its main target organs are the central nervous system and lungs. In factories manufacturing manganese dioxide (CAS RN 1313-13-9) and manganese salts, slight disorders of lung functions such as bronchitis were observed in workers exposed to an average airborne concentration of 1.13 mg/m3 of manganese for years. In addition, by exposure to high concentrations of manganese, central nervous system disorders (headache, memory disorder, vertigo, weakness and fatigue, then, gait and speech disorders, muscle dystonia, tremors, and finally, convulsive paralyzed extremities) were observed (GESTIS (Access on August 2019)). (2) In a case of ingesting well water containing high concentrations of manganese, and in epidemiological studies of residents living in the area of high concentrations of manganese, the symptoms like manganese toxicity such as a masklike face, muscle rigidity, tremors and psychiatric disorders were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (3) In factories manufacturing manganese oxides and manganese salts, effects on neurobehavioral function were reported due to exposure to the dust of manganese dioxide, manganese tetroxide and manganese salts (sulfates, carbonates, nitrates) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (4) In a test in which rats were exposed to manganese sulfate anhydrate (CAS RN 7785-87-7) by inhalation (6 hours/day, 5 days/week) for 90 days, transient inflammation was observed in the olfactory epithelium in the nasal cavity at 0.5 mg/m3 (converted guidance value: 0.001 mg/L, within the range of Category 1) (ATSDR (2012)). (5) In a test in which rats were exposed to manganese sulfate dihydrate by inhalation (6 hours/day, 5 days/week) for 90 days, increased locomotor activity was observed at 1.5 mg/m3 (converted guidance value: 0.001 mg/L, within the range of Category 1) (ATSDR (2012)). (6) In a test in which monkeys were exposed to manganese sulfate anhydrate by inhalation (6 hours/day, 5 days/week) for 90 days, bronchiolitis and alveolar duct inflammation were observed at 1.5 mg/m3 (converted guidance value: 0.001 mg/L, within the range of Category 1) (ATSDR (2012)).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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