GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 13478-00-7 |
| Chemical Name | Nickel(II) nitrate |
| Substance ID | H28-A-065, C-124A |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| 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 |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 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 | Not classified |
- |
- | - | Because an anhydrate is not combustible (GESTIS (Access on August 2016)), it is estimated that a hydrate is not combustible either. |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | The substance is nitrate containing a chemical group associated with explosive properties, but it is classified in oxidizing solids. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 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. |
| 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. |
| 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)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Category 3 |
 Warning |
H272 |
P370+P378
P210 P220 P221 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. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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)). |
| 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)). |
| 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. |
| 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. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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)). |
| 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. |
| 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. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs), Category 2 (central nervous system, liver, genetic organs (men)) |
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)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Classification not possible |
- |
- | - | No data available. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data available. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |