GHS Classification Result (Revision of the past classification result)

Chemical Name:Nickel
CAS:7440-02-0

Result:
ID: 21C0012
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
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.
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - The substance is stable in the air at room temperature (Merck (13th, 2001)).
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
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)).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance does not contain oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable - - - - Atom
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - A LD50 value of >9000 mg/kg for rats (ECETOC TR No. 33 (1989)) corresponds to "Not classified".
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
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)).
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Category 1 Danger H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled P304+P341: IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P285: In case of inadequate ventilation wear respiratory protection.
P501: Dispose of contents/container to ...
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.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
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.
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)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
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.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory system, kidney) Danger H370: Causes damage to organs (respiratory system, kidney) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory system) Danger H372: Cause damage to organs through prolonged or repeated exposure (respiratory system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - - Classification not possible due to lack of data.
11 Hazardous to the aquatic environment (Long-term) Category 4 - - H413: May cause long lasting harmful effects to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 4 since it is a metal and its behavior in water is unknown though the data (L(E)C50 <=100 mg/L) are available.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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