NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	13770-89-3
Chemical Name	Nickel(II) bis(sulfamidate)
Substance ID	m-nite-13770-89-3_v2
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 (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on October 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on October 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on October 2015)).	FY2015	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 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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound that contains oxygen, but the classification is not possible due to no data.	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	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	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There are no available data for the classification of this substance itself. However, based on (1) to (4), it is considered that the classification of soluble nickel (II) compounds may be assessed by reading across the data among the group compounds, and therefore, this was applied also for this substance, which is a soluble nickel (II) compound, and this substance was classified in Category 2. [Rationale for the Classification] (1) The proposal to include this substance in Annex I of the EU Directive 67/548/EEC was agreed in 2009. As for the classification of this substance, most endpoints (carcinogenicity, reproduction toxicity, mutagenicity, chronic inhalation toxicity, sensitization, and toxicity to the environment) other than acute toxicity were considered to be based on grouping of soluble nickel compounds (ECHA RAC Opinion on OEL evaluation (Background Doc.) (2018)). (2) One group can be formed with soluble nickel compounds. The Ni (II) ion (Ni2+) is the moiety responsible for systemic toxicity and a significant contributor to local toxicity. Additional research has highlighted the importance of bioaccessibility of nickel ions in different biological fluids (gastric fluid, interstitial fluid and sweat). This group of soluble nickel compounds has similar bioaccessibility and bioavailability. These compounds release the Ni (II) ion into biological fluids at similar rates. Therefore, they can be assessed collectively. Considering that nickel sulfate (II) and nickel chloride (II) have similar bioaccessibility and bioavailability in biological fluids to this substance group, data available for nickel sulfate (II) (CAS RN 7786-81-4) and nickel chloride (II) (CAS RN 7718-54-9) can be "read across" when data are lacking for the substance of the group compounds (AICIS (previous NICNAS) IMAP (2020)). (3) In the assessment by the EU on the germ cell mutagenicity of nickel sulfate (II), there is evidence indicating that nickel sulfate is genotoxic in vitro, and as for in vivo, in addition to the most part of the database on in vivo genotoxicity of Ni compounds, it was reported that genotoxicity was shown in the lung cells after inhalation exposure to nickel sulfate, and there was no evidence of germ cell mutagenicity, and therefore, it was classified in Muta. Cat. 3 (previous DSD classification: equivalent to Muta. Cat. 2 of the existing CLP classification) as a somatic cell mutagenic substance (EU RAR (2008)). (4) In the assessment by the EU on the germ cell mutagenicity of nickel chloride (II), as for in vitro, nickel chloride induced DNA strand breaks, and there is clear evidence showing chromosomal aberrations, and as for in vivo, micronucleus test results are conflicting and inconsistent, but show that nickel chloride induced DNA strand breaks and chromosomal aberrations in somatic cells occur, and therefore, it was classified in Muta. Cat. 3 (previous DSD classification: equivalent to Muta. Cat. 2 of the existing CLP classification) as a somatic cell mutagenic substance (EU RAR (2008)). [Reference Data, etc.] (5) In the CLP classification, not only this substance (Muta. 2) but also divalent soluble nickel compounds other than nickel sulfate (II) and nickel chloride (II) are basically classified in Muta. 2. The examples include nickel di (acetate) (CAS RN 373-02-4), nickel diformate (CAS RN 3349-06-2), and nickel bis (tetrafluoroborate) (CAS RN 14708-14-6) (EU-CLP Classification Results (Accessed Oct. 2021)). (6) As for four hydrates of this substance, it was considered that the in vitro bacterial reverse mutation test report was insufficient (reliability = 3 (invalid)) and could not be used (REACH registration dossier (Accessed Oct. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	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, 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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	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.	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	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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