NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	13478-00-7
Chemical Name	Nickel(II) nitrate
Substance ID	m-nite-13478-00-7_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	- -	-	-	There is a chemical group associated with explosive properties (nitrates) present in the molecule, but it does not correspond to explosives which is hazard class with the highest precedence because an anhydrate is classified in Division 5.1, PG III (UN 2725) in UNRTDG.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	Because an anhydrate is not combustible (GESTIS (Access on August 2016)), it is estimated that a hydrate is not combustible either.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	The substance is nitrate containing a chemical group associated with explosive properties, but it is classified in oxidizing solids.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	Because an anhydrate is not combustible (GESTIS (Access on August 2016)), it is estimated that a hydrate is not combustible either.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	Because an anhydrate is not combustible (GESTIS (Access on August 2016)), it is estimated that a hydrate is not combustible either.	FY2016	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 contains a metal (Ni), but it is estimated that it does not react vigorously with water because the measured water solubility data of 94 g/100 g was obtained for an anhydrate (GESTIS (Access on August 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Category 3	Warning	H272	P370+P378 P210 P220 P280 P501	Because an anhydrate is classified in Division 5.1, PG III (UN 2725) in UNRTDG (GESTIS (Access on August 2016)), it is estimated that it corresponds to Category 3.	FY2016	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.	FY2016	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.	FY2016	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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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.	FY2016	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)	FY2016	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)	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, skin irritation of nickel compounds has been tested with nickel sulfate anhydrate, and it is reported that there is no irritation in a primary irritation test using rabbits and in a test with human volunteers (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the eye irritation of nickel compounds has been tested with nickel sulfate anhydrate, and it is described that there is no irritation in a primary eye irritation test using rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Category 1A	Danger	H334	P304+P340 P342+P311 P261 P284 P501	Nickel and its compounds are classified as Group 2 of occupational airway sensitizer according to the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2016). Besides, as for nickel sulfate, from several cases of asthma, it is suggested that nickel sulfate is a respiratory sensitizer (IARC 49 (1990), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, this substance was classified in Category 1A.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Nickel and its compounds are classified in Group 1 of occupational skin sensitizer according to the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2016). 　In addition, in a test with volunteers challenged by occlusive application of the aqueous solution of nickel sulfate, allergic reactions were observed in 12 out of 25 people, and it was concluded that water soluble nickel compounds induce allergic dermatitis in humans (Hazard Assessment Report (CERI, NITE, 2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Moreover, in a skin sensitization test (maximization test) using guinea pigs, there are 2 tests using nickel sulfate, and "slight" to "clear" erythema on the skin was caused in one test and in the other, the incidence of sensitization was 40% as the result of intradermal injection of a 3% aqueous solution of nickel sulfate (Hazard Assessment Report (CERI, NITE, 2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Likewise, also with nickel chloride, in a skin sensitization test (maximization test), the incidence of sensitization was 8 out of 12 animals (66.7%) when induced by intradermal injection of a 1% solution, corresponding to positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, this substance was classified in Category 1A.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	There is no information on the carcinogenicity of this substance itself. However, IARC concluded that as for not only nickel and insoluble nickel compounds but also soluble nickel compounds such as nickel sulfate and nickel chloride, there is sufficient evidence that they cause cancers of the lung and nasal cavity in humans, therefore, all nickel compounds were classified in Group 1 (IARC 100C (2012)). From the above, this substance was classified in Category 1A for this hazard class. 　Besides, ACGIH distinguishes insoluble nickel compounds and water soluble nickel compounds by classifying the former in Category A1 and the latter in Category A4 (ACGIH (7th, 2001)).	FY2016	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 is no data on this substance itself, but it is considered that data on soluble nickel compounds can be used. In a 3-generation study using rats given nickel sulfate hexahydrate by feeding administration, as for the F0 parent animals, only reduced weight gain was observed at the dose of 1,000 Ni ppm (equivalent to 50 mg Ni/kg/day), but as for the F1 pups, the increased number of stillborn pups was observed at doses of 250 - 500 Ni ppm (equivalent to 12.5 - 25 Ni mg/kg/day) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Also, in a 2-generation study using rats given nickel chloride hexahydrate by drinking water administration, for the F0 parent animals, only decreased weight gain was observed at 500 mg Ni/L (52 mg Ni/kg/day), but as for the F1 pups, the decreased number of live pups was observed at doses of 250 mg Ni/L (31 mg Ni/kg/day) or higher (Hazard Assessment Report (CERI, NITE, 2008)). Moreover, in a developmental toxicity study using pregnant mice given nickel chloride hexahydrate by gavage administration on gestation days 6 to 13, dose-dependent low fetal body weight was observed from the dose (46 mg Ni/kg/day) which is lower than the doses (92 mg Ni/kg/day or more) with maternal toxicity (decreases in body weight gain, feed consumption and water intake, the decreased number of implant sites, etc.), and in addition, increases in the frequency of malformations (hydrocephaly, microphthalmia, club foot, umbilical hernia, etc.) and delay in ossification were observed at the doses with maternal toxicity (EFSA (2015)). 　As described above, in reproductive and developmental toxicity tests on soluble nickel compounds, it is reported that an increase in the number of stillborn infants, a decrease in the survival rate and occurrence of malformations in mouse fetuses were observed mostly at the doses where general toxicity in parental animals was manifested. Nickel and its compounds are classified in Group 3 of reproductive toxicants by Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (2016)). Therefore, this substance was classified in Category 2 for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no data for single exposure to this substance itself. 　Besides, nickel nitrate anhydrate (CAS RN: 13138-45-9) (classification in FY2009), as well as nickel sulfate hexahydrate (CAS RN: 10101-97-0) (classification in FY2013) and nickel chloride hexahydrate (CAS RN: 7791-20-0) (classification in FY2013), which are also soluble nickel compounds, were all classified as "Classification not possible" due to lack of data. From the above, this substance was classified as "Classification not possible" due to lack of data.	FY2016	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 (central nervous system, liver, reproductive organs (male))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no information on the hazards of this substance to humans and experimental animals. 　However, in GHS classifications by the Japanese government, nickel chloride was classified in Category 2 (lung, central nervous system) (result of classification in FY2013), and nickel (II) sulfate hexahydrate was classified in Category 1 (respiratory organs) and Category 2 (liver, testis) (result of classification in FY2013). Both of these are soluble nickel compounds as the substance. 　As for nickel chloride, the lung was determined to be the target organ, based on the information that inflammation of the lungs characterized by alveolar accumulation of alveolar macrophages and atrophy of Type II alveolar epithelial cells were observed at 35 mg Ni/kg/day, equivalent to Category 2, in a 90-day toxicity study using rats by oral administration (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, in a 77-day oral administration toxicity test using rats, a decline in perception, a decrease in coordination function and a decrease in food-rewarded lever-pushing reactions (due to decrease in motivation) were observed at 20 mg Ni/kg/day (converted guidance value: 17.1 mg Ni/kg/day), which is equivalent to Category 2. Also in a 90-day oral administration toxicity test using rats, salivation, coordination ataxia, lethargy, etc. were observed at 100 mg Ni/kg/day, which is the upper limit of Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Based on these, the central nervous system was determined to be the target organ. As for nickel (II) sulfate hexahydrate, the respiratory organs were determined to be the target organ based on 90-day or 2-year inhalation tests using rats or mice, in which inflammatory changes in the lungs and bronchi, atrophy of the olfactory epithelium, etc. were observed at 0.0002 mg Ni/L or under, which is in the range of Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)); and the liver and testis were determined to be the target organs, based on a 30-day dermal administration test using rats, in which effects on the liver (hepatocyte swelling, partial necrosis, sinusoidal dilatation and congestion), and testis lesions (edema and degeneration of seminiferous tubules) were observed in addition to skin lesions at a doses (converted guidance value: 20-30 mg Ni/kg/day) equivalent to Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). 　Since this substance is considered to have the similar effects, it was classified in Category 1 (respiratory organs) and Category 2 (central nervous system, liver, genetic organs (men)).	FY2016	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.	FY2016	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)	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2016	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.	FY2016	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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