NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7758-99-8
Chemical Name	Copper(II) sulfate, pentahydrate
Substance ID	m-nite-7758-99-8_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)	- -	-	-	Containing no chemical groups with explosive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Not classified	- -	-	-	Non-flammable (ICSC, 2004)	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified	- -	-	-	According to Chemical Dictionary (1994), the hydrate form can be dehydrated by heating (3-hydrate when heated at 30degC, 1-hydrate at 110degC, anhydride at 250degC). The kick-off temperature is considered to exceed 75degC.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified	- -	-	-	Non-flammable (ICSC, 2004)	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Non-flammable (ICSC, 2004)	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Stable to water (water solubility: 22.05g/100g (25degC) (anhydride equivalent), Lide (84th, 2003))	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Classified as "solid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Classification not possible	- -	-	-	Classification not possible due to lack of data, though being inorganic compounds containing oxygen	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Not organic compounds	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 the rat LD50 (oral route) value of 960mg/kg (EHC 200 (1998)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. The substance can be "Not classified" or classified into "Category 5" based on the available data (rat LD50 of >2,000mg/kg (dermal route)) (RTECS (2006)). If the study is conducted in accordance with OECD Guideline which specifies the upper limit at 2,000mg/kg, it is reasonable to consider the substance to be "Not classified" unless "there arises an urgent concern to human health," because no study is expected to be conducted with larger doses. However, "classification is not possible" since, in this study report, only numerical results are provided and study details are not available (the priority rating for the study is 2).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Due to the fact that the substance is "solid" according to the GHS definition and inhalation of its gas is not expected.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on the description in the report on human epidemiological studies (ICSC (2001)): "Causes redness and pain" (though the severity of the effects is unknown). The substance is thus considered a skin irritant.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Based on the description in the report on human epidemiological studies (ICSC (2001)): "Causes pain, redness and dimness of sight" (though the severity of the effects is unknown). Although classified into Category 2A-2B, the substance should be placed in Category 2A from the viewpoint of safety if further subclassification is needed.	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Due to the fact that the substance is classified into "Group 2" (as copper and its compounds) by the Japan Society for Occupational Health, and a "Skin Sensitizing Substance" (as copper) by the ad hoc committee of the Japanese Society of Occupational Allergy (2004).	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	Based on the absence of data on multi-generation mutagenicity tests, germ cell mutagenicity tests in vivo and germ cell genotoxicity tests in vivo, and positive data on somatic cell mutagenicity tests in vivo (chromosome aberration tests), described in NTP DB (Access on July, 2006), ATSDR (2004) and EHC 200 (1998).	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible based on expert judgment in the absence of existing classification (though some toxicity data are available).	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Based on the evidence of malformation and adverse effects on postnatal development of pups, described in ATSDR (2004), EHC 200 (1998) and CERI Hazard Data 2001-59 (2002) (though no data are available regarding parental animals).	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 1 (blood system, liver, nervous system, kidney, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Based on the human evidence: "symptoms including vomiting, lethargy, acute hemolytic anemia, renal and liver damage, neurotoxicity, increased blood pressure and respiratory rates" (EHC 200 (1998)), "deaths, probably due to central nervous system depression and hepatic and renal failure, have also been reported," "renal tubular damage was observed" (ATSDR (2004)), and the evidence from animal studies: "acute inflammatory changes were evident in the lungs" (EHC 200 (1998)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, kidney, respiratory organs), Category 2 (liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	Based on the human evidence: "hemolytic anemia was noted," "pathological alterations include pulmonary inflammation, formation of granulomas, fibrohyaline nodules, desquamation of macrophages, and progression of diffuse fibrosis" (ATSDR (2004)). Also based on the evidence from animal studies: "protein droplets in the cytoplasm of cells in the proximal convoluted tubules," "in the kidneys, cytoplasmic protein droplets were evident, and hematological changes indicative of microcytic anemia were observed " (EHC 200 (1998)), "the earliest symptoms of hepatotoxicity are increases in serum chemistry enzymes, particularly alanine aminotransferase" (ATSDR (2004)), "repeated or prolonged exposure to aerosols may result in lung damage" (ICSC (J) (2001)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 1 (kidneys) and Category 2 (liver).	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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	It was classified into Category 1 from 48 hours LC50=0.00272mg/L of the crustacea (Ceriodaphnia) (ECETOC TR91, 2003).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Since acute toxicity was Category 1 and it was a metallic compound, and since an underwater action and bio-accumulation were unknown, it was classified into Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
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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