NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7440-02-0
Chemical Name	Nickel
Substance ID	m-nite-7440-02-0_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	Classification not possible	- -	-	-	Since the shape of the particles of this substance were not specified and no other data is available, the classification of the substance is not possible. In addition, based on the ICSC (2004), the dust of the substance is inflammable, and according to Sax (11th, 2004), the risk of fire and explosion generally increases as powder form of the metal becomes finer. As additional background information, the UNRTDG rated flammable metal powder (Not Otherwise Specified) as Division 4.1 and packing group II and III (UN No. 3089), which falls under Category 1 or 2.	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	- -	-	-	The substance is stable in the air at room temperature (Merck (13th, 2001)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Classified into Not classified since the substance is stable in the air at room temperature and does not react with water (Merck (13th, 2001)) and does not mix with water (Hommel (1996)).	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 applicable)	- -	-	-	The substance does not contain oxygen, fluorine or chlorine.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Atom	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)	Not classified	- -	-	-	A LD50 value of >9000 mg/kg for rats (ECETOC TR No. 33 (1989)) corresponds to "Not classified".	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	- -	-	-	Classification not possible due to lack of animal test data. As relevant information, there is a human case report in which an individual died of respiratory distress syndrome 13 days after a 90-minute exposure to a very high concentration of the substance (estimated 382 mg Ni/m3) (ATSDR (2005)).	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	The substance is classified into Category 2 for respiratory tract sensitizer in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)), and as respiratory tract sensitizer by Japanese Society of Occupational and Environmental allergy (2004) and DFG (MAK/BAT No. 43 (2007)). Based on these information, 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 are human case reports of eczema (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 69 (2008), EHC No. 108 (1991)), contact dermatitis (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 69 (2008), EHC No. 108 (1991), IARC vol. 49 (1990)) and positive results in patch tests (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 69 (2008), EHC No. 108 (1991)). In addition, the substance is classified into Category 1 for skin sensitizer by Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)), and as a skin sensitizer by Japanese Society of Occupational and Environmental allergy (2004) and DFG (2007). Based on the available information, the substance was classified into Category 1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Although there is a positive result in an alveolar macrophage chromosomal aberration test by inhalation exposure to tars (Initial Risk Assessment Report (NITE, CERI, NEDO) ver. 1.0, No. 69 (2008)), the experimental procedures employed are not commonly used. Therefore, classification was not possible due to lack of sufficient data from in vivo mutagenicity tests. As relevant information, from in vitro mutagenicity tests, there are reports of negative human lymphocyte chromosomal aberration test (IARC vol. 49 (1990)) and human lymphoblast TK6 gene mutation test (Risk Assessment Documents (National Institute of Advanced Industrial Science and Technology) 19 (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	Based on the classifications of "2B" in IARC (IARC (1990)), "R" in NTP (NTP (2005)) and "Carcinogenicity. Category 3; R40" in EU classification (EU (2007)), the substance was classified into Category 2. Occurrence of carcinoma and sarcoma is reported in inhalation, subcutaneous, intramuscular, intrathoracic and intraperitoneal administration tests in rats (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 69 (2008), IARC vol. 49 (1990); Risk Assessment Documents (National Institute of Advanced Industrial Science and Technology) 19 (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a report that when rats were exposed to the substance in drinking water for 7 months before pregnancy and during pregnancy, a slight increase in pre-implantation mortality was found and some cases of malformed fetuses were noted (Teratogenic (12th, 2007)). The rat test data was not used for classification purposes since the test details are unknown.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In an inhalation (single intratracheal exposure) test in male rats, cytotoxicity in the alveolar epithelial cells was observed at 0.5 mg and higher concentrations (Initial Risk Assessment Report (NITE, CERI, NEDO) ver. 1.0 No. 69 (2008)). Inhalation exposure of humans induced "alveolar wall damage and edema in alveolar spaces in the lung and marked tubular necrosis in the kidney" (ATSDR (2005)). Based on the data, the substance was classified into Category 1 (respiratory system, kidney).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	It was reported that a high risk of mortality from respiratory disease is found among workers exposed occupationally to nickel oxides and metal nickel at concentrations of 0.04 mg/m3 and higher. In addition, rhinitis, sinusitis, nasal septal perforations and dysplasia of the nasal mucosa were reported in nickel refinery and nickel plating workers (Risk assessment report of nickel and nickel compounds (Ministry of Health, Labour and Welfare) (2009)). Based on the data, the substance was classified into Category 1 (respiratory system). In a 13-week inhalation exposure test in rats (OECD TG413), pulmonary alveolar proteinosis and glanuromatous inflammation in the lung were observed in females, and mononuclear cell infiltration in the lung was observed in males at a concentration of 1 mg/m3 (0.0001 mg/L), which falls within the guidance value range for Category 1, and higher levels (Initial Risk Assessment Report (NITE, CERI, NEDO) ver. 1.0 No. 69 (2008)). In a 21-month inhalation exposure test in rats, pleuritis, pneumonia, congestion and edema were observed at a dose level of 15 mg/m3 (0.015 mg/L) which is within the guidance value range for Category 1 (CaPSAR (1994)). In addition, pneumonia was noted at a dose level of 1 mg/m3 (0.001 mg/L) in a 6-month inhalation exposure test in rabbits. The substance is classified into T; R48/23 in EU classification.	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)	Classification not possible	- -	-	-	No data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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