NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	10031-43-3
Chemical Name	Copper(II) dinitrate trihydrate
Substance ID	R01-B-040
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)	MHLW Website (in Japanese Only)
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 is a chemical group associated with explosive properties (N-O) present in the molecule, but the classification is not possible due to no data.
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 (Merck (15th, 2013)).
8	Self-reactive substances and mixtures	*	- -	-	-	There is a chemical group associated with explosive properties (N-O) present in the molecule, but the classification is not possible due to no data.
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 (Merck (15th, 2013)).
11	Self-heating substances and mixtures	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (Merck (15th, 2013)).
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	It contains a metal (Cu), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from information that it is soluble in water (Merck (15th, 2013)).
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 no halogen), but the classification is not possible due to no data. Besides, it is classified in Division 5.1, PG II and III in UNRTDG (UN1477).
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	*	- -	-	-	It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc. Besides, copper(II) nitrate (CAS RN 3251-23-8), the anhydrate, is classified in Division 5.1 in UNRTDG (UN1477), not applicable to explosives, hazards of the highest precedence.

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. [Evidence Data] (1) LD50 for rats: 940 mg/kg (EHC 200 (1998))
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	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. Besides, as new data were obtained, the classification was changed. [Evidence Data] (1) In an in vitro skin corrosion test, which was conducted in accordance with OECD TG 431 using Human Skin Model, the relative mean viability was 53.4%, 19.9% or 18.2% after 3 minutes, 60 minutes or 240 minutes of exposure period, respectively (REACH registration dossier (Access on August 2019)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Since it was classified in Category 1: in skin corrosion/irritation based on (1), it was classified in Category 1. Besides, as new data were obtained, the classification was changed. [Evidence Data] (1) In an in vitro skin corrosion test, which is conducted in accordance with OECD TG 431 using Human Skin Model, the relative mean viability was 53.4%, 19.9% or 18.2% after 3 minutes, 60 minutes or 240 minutes of exposure period, respectively (REACH registration dossier (Access on August 2019)).
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), it was classified as "Not classified." Besides, as new data was obtained, the classification was changed. [Evidence Data] (1) In a guinea pigs skin sensitization test, which is in accordance with OECD TG 406 (maximization test, intradermal induction: 0.005%, induction (topical application): 50%, challenge: 2.5% and 1.25%), similar reactions were noted between the control group and the treated groups, therefore, it was concluded to be negative (REACH registration dossier (Access on August, 2019)). [Reference Data, etc.] (2) The Japan Society for Occupational Health classified copper and its compounds as occupational skin sensitizers Group 2 (Recommendation of Occupational Exposure Limits (2018)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there is a report that a mammalian cell gene mutation test was positive (EHC 200 (1998)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) There are no epidemiological studies available for the evaluation of the carcinogenicity of copper compounds (DFGOT vol.22 (2006)). (2) The available studies on the carcinogenicity of copper compounds in experimental animals have given no indication that copper salts are carcinogenic. However, the short duration, the small group sizes employed, the limited extent of histopathological examination, or inadequate reporting limits the conclusions which can be drawn from such studies (EHC 200 (1998), DFGOT vol.22 (2006)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There were no data on the reproductive toxicity of this substance. Based on (1) and (2), since this substance is water-soluble and from the data on water-soluble copper sulfate pentahydrate (CAS RN 7758-99-8), it was classified in Category 2. Besides, the classification was revised by adding information on water-soluble copper compounds, and the category was changed. [Evidence Data] (1) This substance is a water-soluble copper salt (copper nitrate trihydrate). (2) In a developmental toxicity study in which copper sulfate pentahydrate (CAS RN 7758-99-8; solubility in water: 3.2x104 mg/L (20 deg C) (HSDB (Access on August 2019))) was administered to two strains of mice by feeding, though there was no description on maternal toxicity, at high doses at which maternal toxicity is likely to be observed, developmental effects including malformations were noted (DFGOT vol.22 (2006), EHC 200 (1998)). [Reference Data, etc.] (3) Copper(II) anhydrate (CAS RN 7758-98-7) was classified in Category 2 in GHS based on the data for pentahydrate in (2).
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	[Rationale for the Classification] Though there were no reports on the effects of single exposure to this substance itself in either humans or experimental animals, based on information of (1)-(4), it was classified in Category 1 (nervous system, blood system, liver, kidney) and Category 3 (respiratory tract irritation). [Evidence Data] (1) There are descriptions that inhalation of copper(II) nitrate (CAS RN 3251-23-8), anhydrate of this substance, causes irritation of the throat and lungs in humans (HSDB (Access on August 2019)). (2) There are reports that adverse effects on the nervous system (delirium, coma), blood system (intravascular hemolysis), liver (jaundice, centrilobular necrosis, biliary stasis) and kidney (oliguria, anuria, congestion of the glomeruli and denudation of tubular cells) were observed in humans after suicidal or accidental ingestion of a single oral dose of copper(II) sulfate anhydrate (CAS RN 7758-98-7), a water-soluble copper compound the same as this substance (ATSDR (2004), HSDB (Access on August 2019)). (3) As for experimental animals, there is a report that after a single oral dose of a water-soluble copper compound, acute toxicity signs of copper toxicity include excessive salivation, vomiting, diarrhoea, gastric hemorrhage, increased heart rate, hypotension, hemolytic crisis, convulsions and paralysis (EHC 200 (1998)). Although there is no detailed description of the dose at which these effects were observed, if they were observed near the LD50 value, the LD50 value of the substance in rats was reported to be 940 mg/kg, which corresponds to Category 2. (4) There is a report that a test with hamsters by a single inhalation exposure of the aerosol of copper(II) sulphate showed respiratory tract irritation (ATSDR (2004)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Though there are no data on a repeated-dose study on this substance itself, based on the information on copper (II) sulfate anhydrate (CAS RN 7758-98-7) in (1), it was classified in Category 1 (respiratory organs). Using data for copper (II) sulfate anhydrate, classification was changed from the previous classification. [Evidence Data] (1) An occupational disease referred to as "vineyard sprayer's lung" (findings similar to silicosis) was observed in vineyard workers spraying an antimildew agent containing 1–2.5% copper sulfate neutralized with hydrated lime. Common findings (obtained by alveolar lavage and biopsy) include interalveolar desquamation of macrophages, formation of histiocytic and noncaseating granulomas containing inclusions of copper, and healing of lesions in the form of fibrohyaline nodules (ATSDR (2004)). [Reference Data, etc.] (2) In a 92-day feeding study with rats for copper (II) sulfate, hyperplasia and hyperkeratosis of the limiting ridge, and inflammation of the liver were seen at or above 2000 ppm (34 mg Cu/kg/day, 129.4 mg/kg/day as copper(II) sulfate) (EHC 200 (1998), DFGOT vol. 22 (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)	-	- -	-	-	-
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.

To GHS Information