NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7758-98-7
Chemical Name	Copper(II) sulfate (anhydrous)
Substance ID	m-nite-7758-98-7_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 associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2001)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2001)).	FY2017	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 (ICSC (J) (2001)).	FY2017	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 the measurement result of water solubility of 20.3 g/100 mL (20 deg C) (ICSC (J) (2001)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, but the classification is not possible due to no data.	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on an LD50 value of 300 mg/kg for rats (EHC 200 (1998)), this substance was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	There are reports on the strong irritation and corrosivity in humans (HSDB (Access, June 2017)) and reports that it is markedly irritating to the skin and causes redness and pain (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). From these results, this substance was classified in Category 1. Besides, this substance is classified as "Skin Irrit. 2" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In humans, it is indicated to be a strong irritant causing conjunctivitis, edema of the eyelids, ulceration, corneal opacity, etc. (HSDB (Access on June 2017)) and causing redness and pain (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). Since there are reports of corrosivity in skin irritation (HSDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)), this substance was classified in Category 1. Besides, in the EU CLP classification, this substance is classified as "Eye Irrit. 2" (ECHA CL Inventory (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	In humans, there are many reports suggesting that skin sensitization occurred when a 0.5-5.0% aqueous solution or petrolatum-containing mix of this substance was applied for 24-48 hours in patch tests (EHC 200 (1998)). Also copper and its compounds are classified in occupational skin sensitizers Group 2 by Japan Society for Occupational Health (JSOH). Therefore, this substance was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, this substance showed positive and negative results in micronucleus tests with mouse bone marrow cells, and positive in a chromosome aberration test with mouse bone marrow cells (ATSDR (2004)), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015). However, the positive results of the in-vivo micronucleus test and chromosomal aberration test were done by intraperitoneal administration. As for in vitro, bacterial reverse mutation tests gave negative results (ATSDR (2004), SIAP (2014)). In SIAP (2014), based on the negative findings on the pentahydrate of this substance in in-vivo micronucleus tests with mice and an in vivo unscheduled DNA synthesis test with rats, it was evaluated that "Copper and copper compounds are not genotoxic." From the above, this substance was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no epidemiological report available for evaluation regarding the carcinogenicity of copper compounds (DFGOT Vol. 22 (2006)). In carcinogenicity-related studies with experimental animals, there is no evidence that copper or inorganic copper compounds are carcinogenic. However, it is considered that there are no test reports that can draw conclusions because of reasons such as the short test period, the small number of animals used, the narrowness of the range of histopathological examinations, and insufficient description in any of the reports (EHC 200 (1998), DFGOT Vol. 22 (2006)). Therefore, classification was not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There are no data on this substance itself (anhydrate), but there are data of its hydrate. In a developmental toxicity test in which copper sulfate pentahydrate (CAS RN 7758-99-8) was given by feeding to two strains of female mice (C57BL, DBA) from one month before mating to day 19 of pregnancy, at or more than 123 mg Cu/kg/day, an increased number of dead fetuses (C57BL), decreased litter size (both strains), and the low incidence (1.8 to 8.9%) of malformations (hydrocephalus, encephalocele, skeletal abnormality: both strains) was observed (DFGOT Vol. 22 (2006), EHC 200 (1998)). Although there is no description on maternal toxicity, it was considered to be a dose highly likely to cause maternal toxicity from results of subchronic and chronic toxicity tests (DFGOT Vol. 22 (2006)). As described above, because in the test on mice using the pentahydrate, developmental effects including malformations were observed at a dose highly likely to cause maternal toxicity, this substance was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, blood system, liver, kidney), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, multiple cases are reported where in a single oral intake in a suicide attempt or accidental ingestion of this substance, nausea, vomiting, upper abdominal pain, diarrhea, hematemesis or melena, reduced blood pressure, delirium, coma, jaundice, intravascular hemolysis, oliguria, and anuria were caused. In addition, multiple cases were reported in which centrilobular necrosis and biliary stasis in the liver, and renal glomerular congestion and detachment of renal tubule cells in the kidney were observed (ATSDR (2004), HSDB (Access on June 2017)). As for inhalation exposure, although it is not this substance, there is a description that the inhalation of fine particulate dust containing copper oxide (II) (CAS RN 1317-38-0) and copper acetate (II) (CAS RN 142-71-2) may cause sneezing, coughing, disorders of the digestive system and fever (DFGOT vol. 22 (2006)). As for experimental animals, it is reported that acute toxicity symptoms due to single oral intake of copper compounds including this substance are salivation, vomiting, diarrhea, gastric hemorrhage, increased heart rate, hypotension, hemolytic anemia, convulsions, and paralysis etc. (EHC 200 (1998), DFGOT Vol. 22 (2006)). Although there is no detailed description of the dose at which these effects were observed, assuming that they were observed around the LD50 value, since the LD50 value for rats was reported as 300 mg/kg, it is considered to be in the near upper limit of the range of Category 1 (EHC 200 (1998)). In addition, there is a report that in a single exposure test in which guinea pigs were exposed by inhalation to the aerosol of this substance, decreased cilia movement in the respiratory tract was observed (ATSDR (2004)). Together with the above information, it is considered that this substance has effects on the nervous system, haemal system, liver, kidneys and gastrointestinal tract and also causes respiratory tract irritation. Among these, the effects on the gastrointestinal tract were excluded from the target organs because this was considered to be due to irritation from this substance. Therefore, this substance was classified in Category 1 (nervous system, haemal system, liver, kidney), Category 3 (respiratory tract irritation).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs), Category 2 (liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	As for humans, there is a report that an occupational disease called "vineyard sprayer's lung" was seen in vineyard workers spraying antifungal agents containing 1-2.5% of copper sulfate neutralized with slaked lime, and findings similar to silicosis were observed, and as common findings from alveolar lavage and biopsy, intraalveolar desquamation of macrophages, histiocytic and noncaseating granulomas containing inclusions of copper, and restorative lesions in the form of fibrohyaline nodules were included (ATSDR (2004)). In addition, there was also a report that in a case of a debilitated child with severe burns, in whom copper sulfate crystals were applied to the granulation tissue, hemolytic anemia was observed, and an increase in copper content in the serum and urine was observed (ATSDR (2004)). There is a report that in a 92-day repeated oral toxicity study with rats dosed by feeding, at or above 2,000 mg/kg diet (34 mg Cu/kg/day: 85.4 mg/kg/day as copper sulfate anhydrate), which is within the guidance value range for Category 2, hyperplasia of the limiting ridge and hyperkeratosis of the forestomach, and hepatic inflammation were observed (EHC 200 (1998), DFGOT vol. 22 (2006)). From the above, although there are effects on the respiratory and haemal systems in humans, since the number of case for the haemal system was only one, it was not adopted as evidence of classification. In addition, since the findings on the forestomach in experimental animals are considered to be due to the irritation, they were not adopted as evidence of classification. Therefore, this substance was classified in Category 1 (respiratory organs), Category 2 (liver). The classification results were changed from the previous classification because new information sources were used, and the observed effects were reexamined, etc.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	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)	Category 1	Warning	H400	P273 P391 P501	From 96-hour LC50 = 0.006 [converted value 0.00258 mgCu/L] for fish (Thymallus arcticus) (WHO EHC: 1998), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Although the behavior of a metal salt in water is unknown, metal is regarded to be non-biodegradable due to an element, and water solubility is 220,000 mg/L, and 72-hour NOEC (growth inhibition) is 0.013 mg/L [converted value 0.005 mgCu/L] for algae (Chlamydomonas reinhardtii). Therefore, it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	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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