NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	10124-43-3
Chemical Name	Cobalt(II) sulfate
Substance ID	m-nite-10124-43-3_v2
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 associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified	- -	-	-	Not combustible (ICSC (J) (2001))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified	- -	-	-	Not combustible (ICSC (J) (2001))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (ICSC (J) (2001))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Information is available that water solubility is 38.3 g/100 g H2O (25 degC) (Lide (88th, 2008)) though it contains metals (Co).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified	- -	-	-	Not oxidizing (IUCLID (2000))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on LD50 values of 510 mg/kg and 424 mg/kg for rats (ATSDR (2004)), the substance was classified into Category 4. [For health hazards, refer also to cobalt (II) chloride (CAS: 7646-79-9)].	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	There is a report that bronchial asthma was reported in workers exposed to various forms of cobalt (CICADs 69 (2006)). Additionally, cobalt compounds are classified into R42/43 in EU classification (EU-Annex I (2009)) and are classified into Category 1 for respiratory tract sensitizer in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2009)). Therefore, the substance was classified into Category 1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	There is a report that 10/25 healthy volunteers were sensitized to cobalt sulfate in a maximization test (DFGOT vol. 23 (2007)). Additionally, in Japan Society For Occupational Health (JSOH), cobalt is classified into Category 1 for skin sensitizer, but the following statement is found: "the substance and its compounds are included in the list of sensitizers, but all of them were recognized as sensitizers." (Recommendations for allowable concentrations (2008)). Therefore, the substance was classified into Category 1. As relevant information, the substance is classified into R42/43 in EU classification (EU-Annex I (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Although the available data on this substance and its hydrates was only (1) and (2), it can be considered that water-soluble divalent cobalt compounds have common characteristics based on (3) and (4). Therefore, as for the potential toxicity of this substance, the classification result of cobalt (II) dichloride, on which the data that can be used for classification was richest, was applied, and it was classified in Category 2. [Evidence Data] (1) For this substance, both positive and negative results in vitro were obtained in a bacterial reverse mutation test. As for in vivo, however, there was no data available (AICIS IMAP (2014)). (2) For cobalt sulfate heptahydrate (CAS RN 10124-43-3), negative results in vivo were obtained in a chromosome aberration test using the bone marrow cells of rats (single oral gavage dose, up to 320 mg/kg) (AICIS IMAP (2014)). (3) This substance is a soluble cobalt compound and the data of cobalt (II) dichloride (CAS RN 7646-79-9), which is divalent soluble cobalt, can be used. This is because both substances are considered to cause adverse effects directly by released divalent cobalt ion after being taken into the body and the read across principles of the OECD are applicable (AICIS IMAP (2014), ECHA RAC & SEAC Final Opinion (Background Doc.) (2020)). (4) Cobalt (II) dichloride, on which the mutagenicity data is richest, was classified in Category 2 for this hazard class (GHS classification result in FY2015). [Reference Data, etc.] (5) In the EU, this substance was classified as Muta. 2 (REACH registration dossier (Accessed Oct. 2021)). Besides, this substance was identified as SVHC based on the classification for carcinogenicity and reproductive toxicity (EU REACH SVHC Support Document (2010)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	Since cobalt and cobalt compounds are classified into "Group 2B" in IARC (IARC 52 (1991)) and are classified into Category 2B in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)), the substance was classified into Category 2. It was concluded that there was clear evidence of carcinogenic activity in rat and mouse 2-year inhalation tests, based on increased incidences of alveolar/bronchiolar neoplasms in both species (NTP TR471 (1998)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] As for data in experimental animals, information on reproductive effects of this substance itself is limited, and toxicity effects related to dosing of this substance are thought to be caused by cobalt ion after absorption in the body. Therefore, information on other water-soluble cobalt compounds was also used for this hazard class. As for effects in humans, it is reported that teratogenicity of cobalt chloride is not observed as written in (5). From (1), (3), (4), water-soluble cobalt compounds cause testicular toxicity and adverse effects on sperms in males and decrease the ability to impregnate females (fertilizing capacity). It is reported that fetotoxicity and teratogenicity occurred at doses where maternal animals did not show marked toxicity in rats and mice (2). From the above, for water-soluble cobalt compounds including this substance, in an oral route, adverse effects on the male genetic organs and decreased fertilizing capacity are reported, and it is reported that teratogenicity was shown at doses without maternal toxicity. Therefore, it was classified in Category 1B for this hazard class. [Evidence Data] (1) In a test in which mice were exposed to cobalt sulfate heptahydrate (CAS: 10026-24-1) by inhalation for 13 weeks, decreased sperm motility at or above 3 mg/m3 and decreased weight of the testis and epididymis, an increased ratio of abnormal sperms at 30 mg/m3 were observed (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013), NICNAS IMAP (Accessed Oct. 2018)). (2) As the result of dosing this substance to pregnant rats by gavage through a gestation period, at the doses (25, 50 mg/kg/day) lower than 100 mg/kg/day where maternal animals showed slight effects (increases in relative weight of the liver, adrenal gland, and spleen), in addition to low values of fetal body weight, delayed development and increased malformations (malformations mainly in the cranium, spine, pelvis, renal tubule, ovary, and testis) in the skeletal system and viscera were observed. When pregnant mice were dosed with this substance at 50 mg/kg/day by gavage during the organogenesis period (gestation days 6-15), delayed development of the skeletal system and an increased incidence of malformations (mainly in the eyelid, kidney, cranium, and spine) were also observed in fetuses (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013)). (3) As the result of dosing male mice with cobalt (II) chloride (CAS: 7646-79-9) by drinking water for 12 weeks followed by mating with untreated females, decreases in the numbers of embryo resorptions and live fetuses at or above 200 ppm (25 mg/kg/day), decreases in the numbers of pregnant females and implantation sites at or above 400 ppm (47 mg/kg/day) were observed. Decreases in weight of the testis, epididymis and so on, a decreased number of sperms in the testis and epididymis, and decreased spermatogenesis were observed in males, and a decreased number of pregnant females is thought to be caused by decreased male fertility (Environmental Risk Assessment for Chemical Substances Vol. 11 (Ministry of the Environment, 2013), NICNAS IMAP (Accessed Oct. 2018), Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009)). (4) As the result of dosing male mice with cobalt (II) chloride by drinking water at 72 mgCo/kg/day for 10 weeks followed by mating with untreated females, a decreased number of pregnant animals, a decreased number of live fetuses per litter, and an increased number of preimplantation losses per litter were observed in a dosed group. The results mentioned above are thought to be effects of decreased male fertility from decreased sperm concentrations. In a recovery group in which dosing males by drinking water was followed by mating and 6-week cessation of dosing, motility and movement speed of sperms became normal while concentrations did not (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009)). [Reference Data, etc.] (5) It is reported that teratogenicity is not observed in humans and that clinical changes were not observed in newborns from women who took cobalt chloride as an anti-anemia drug at delivery (Initial Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009)). (6) It is classified in Repr. 1B in EU CLP.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available. As relevant information, there is the following information for cobalt (II) chloride: In a rat oral test (by gavage), depression of spontaneous activity, muscle tone and respiration were observed at 4.25 mg/kg (ATSDR (2004)). Undesirable effects in humans include retrosternal chest pain, tinnitus, nausea and vomiting, nerve deafness, thyroid hyperplasia with tracheal compression, myxedema and fatigue (HSDB (2004)). Ingestion of a solution of the substance depressed the production of erythrocytes in children and produced cyanosis, coma and death (HSDB (2004)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (heart, respiratory system)	Danger	H372	P260 P264 P270 P314 P501	In the early to mid-1960s, breweries in the United States and Europe added the substance to beer as a foam stabilizer. Several tests reported lethal cardiomyopathy in people who consumed large quantities of beer because of cobalt sulfate ingestion (CICADs 69 (2006)). Based on this information, the substance was classified into Category 1 (heart). In 13-week inhalation tests in rats and mice (0, 0.3, 13, 10 and 30 mg/m3), both rats and mice developed squamous metaplasia of the larynx (>=0.3 mg/m3), chronic inflammation of the larynx, nose and lung (0.3 - 1 mg/m3), and more severe effects at higher exposures (>30 mg/m3) (CICADs 69 (2006)). Since these effects were observed at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (respiratory system).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Category 2	- -	H401	P273 P501	Classified into Category 2 from its 96h-LC50 = 3.6 mg/L for fish (Fathead minnow) (CICAD 69, 2006).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified into Not classified since its bioconcentration potential is low (BCF <=37 (Cyprinus carpio, 6 weeks)), (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1998).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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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