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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	13770-89-3
Chemical Name	Nickel(II) bis(sulfamidate)
Substance ID	R03-C-034-MHLW
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2015
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	-	- -	-	-	-
2	Flammable gases	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-
17	Desensitized explosives	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	-	- -	-	-	-
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)).
6	Carcinogenicity	-	- -	-	-	-
7	Reproductive toxicity	-	- -	-	-	-
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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