GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 13770-89-3 |
| Chemical Name | Nickel(II) bis(sulfamidate) |
| Substance ID | H27-A-053/C-131A_P |
| Classification year (FY) | FY2015 |
| 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 applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on October 2015)). |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group present in the molecule associated with self-reactive properties (S=O), but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on October 2015)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on October 2015)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It is estimated that it does not react vigorously with water because there is the observation result of insoluble in water (GESTIS (Access on October 2015)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound that contains oxygen, but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Respiratory sensitization | Category 1 |
 Danger |
H334 | P304+P340 P342+P311 P261 P284 P501 |
Because this substance has high water solubility, and nickel and its inorganic compounds are classified as a respiratory tract sensitizing substance (Group 2) by Japan Society for Occupational Health (The Recommendation of the Japan Society for Occupational Health (2015)), this substance was classified in Category 1. Besides, it is classified in "Resp. Sens. 1 H334" in EU CLP classification (ECHA CL Inventory (Access on December 2015)). |
| 4 | Skin sensitization | Category 1 |
 Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
Because this substance has high water solubility, and nickel and its inorganic compounds are classified as a skin sensitizing substance (Group 1) by Japan Society for Occupational Health (The Recommendation of the Japan Society for Occupational Health (2015)), this substance was classified in Category 1. Besides, it is classified in "Skin Sens. 1 H317" in EU CLP classification (ECHA CL Inventory (Access on December 2015)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 6 | Carcinogenicity | Category 1A |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
There are no test data on this substance itself. However, the following is written in ATSDR: this substance belongs to a divalent soluble nickel compound; the International Committee on Nickel Carcinogenesis concluded that there is a correlation between cancer incidences of human lung and nasal cavity and exposure to insoluble nickel compounds at 10 mg Ni/m3 or higher; and soluble nickel compounds at 1 mg Ni/m3 or higher are possible to enhance carcinogenicity of insoluble nickel compounds (ATSDR (2005)). As for existing classification, EU classified this substance in "Carc. 1A" (ECHA CL Inventory (Access on December 2015)). Moreover, Australian NICNAS also suggested Category 1A classification in carcinogenicity (corresponding to GHS Category 1A) as group evaluation for soluble nickel compounds of nine kinds including this substance (Australian NICNAS (Access on December 2015)). Besides, although IARC did not evaluate this substance itself in carcinogenicity evaluation of nickel compounds in 2012, because there is sufficient evidence showing carcinogenicity in humans for a mixture including nickel compounds and metallic nickel, IARC classified nickel compounds in "Group 1" showing carcinogenicity in humans regardless of the size of evidence in a test using experimental animals (IARC 100C (2012)). As above, from the classifications of this substance by other organizations, it was judged that Category 1A is appropriate in this hazard class. |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
There is no reproductive/developmental toxicity test result of this substance itself. However, it is reported in ATSDR that oral exposure to soluble nickel compounds such as nickel sulfate, nickel chloride, and nickel nitrate causes toxicity in reproductive organs in males, and histological change in epididymis and seminal vesicles, decreased sperm number, decreased motility and morphological abnormality of sperm, and decreased fertility index in males mated with untreated females after exposure were observed. It is written that in multiple tests exposed before mating and through mating, gestation, and a nursing period, a decreased survival rate of the offspring were observed at the dose where weight gain reduction was observed mainly in maternal animals (ATSDR (2005)). As for existing classification, EU classified this substance in "Repr. 1B" (ECHA CL Inventory (Access on December 2015)). Moreover, Australian NICNAS also suggested Category 2 classification in reproductive/developmental toxicity classification (corresponding to GHS Category 1B) as group evaluation for soluble nickel compounds of nine kinds including this substance (Australian NICNAS (Access on December 2015)). From the above, it is thought that the classification result for soluble nickel compounds is applicable in this hazard class. Therefore, this substance was classified in Category 1B in this hazard class. Besides, the GHS classification in Japan (reproductive toxicity) was Category 1B for nickel chloride and Category 2 for nickel sulfate (the 2009 classification result). |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | There are no single exposure data of this substance itself. Besides, as for soluble nickel compounds, both nickel sulfate hexahydrate (CAS 10101-97-0) (the 2013 classification) and nickel chloride hexahydrate (CAS 7791-20-0) were classified as "Classification not possible" due to lack of data (the 2013 classification). 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, testis) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
No test data of this substance itself. However, as for classifications by other organizations, although no target organ itself is specified in either, EU classified this substance in "STOT RE 1" (ECHA CL Inventory (Access on December 2015)), and Australian NICNAS also suggested Category 1 classification in an inhalation route in Specific Target Organ Toxicity (Repeated Exposure) classification (corresponding to GHS Category 1) as group evaluation for soluble nickel compounds of nine kinds including this substance (Australian NICNAS (Access on December 2015)). Moreover, the GHS classification in Japan was Category 2 (lung, central nervous system) for nickel chloride (the 2013 classification result) and Category 1 (respiratory organs), Category 2 (liver, testis) for nickel (II) sulfate hexahydrate (the 2013 classification result), both of which are soluble nickel compounds similarly to this substance. For nickel chloride, the lung was taken as a target organ based on lung inflammation characterized by the intra-alveolar accumulation of alveolar macrophages and atrophy of type II alveolar epithelial cells at 35 mgNi/kg/day corresponding to Category 2 in a 90-day oral administration toxicity test using rats. Moreover, central nervous system was taken as a target organ based on hypesthesia, decreased coordination, and decreased lever-pressing reaction using feed as a reward (due to decreased motivation) observed at 20 mg Ni/kg/day (converted to a 90-day equivalent: 17.1 mgNi/kg/day) corresponding to Category 2 in a 77-day oral administration toxicity test using rats, and salivation, incoordination, lethargy and so on at 100 mgNi/kg/day that is the upper limit of Category 2 in a 90-day oral administration toxicity test using rats. Besides, for nickel (II) sulfate hexahydrate, respiratory organs were taken as a target organ based on inflammatory changes in lung and bronchi, atrophy of olfactory epithelium and so on found at 0.0002 mgNi/L within a range of Category 1 or lower in a 90-day or 2-year inhalation exposure test in rats or mice, and the liver and testis were taken as target organs based on effects on liver (swelling of hepatocytes, partial necrosis, dilatation and congestion of sinusoid), lesions in testis (edema and degeneration in seminiferous tubule) besides skin lesions at a dose corresponding to Category 2 (converted to a Guidance value equivalent:20 to 30 mgNi/kg/day) in a 30-day dermal administration test in rats. Because it is thought that the similar effects are also observed for this substance, it was classified in Category 1 (respiratory organs), Category 2 (central nervous system, liver, testis). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 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. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
NOTE:
| * 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. |