NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	112-00-5
Chemical Name	Salt of N,N,N-trimethyldodecane-1-aminium; Dodecyl(trimethyl)ammonium chloride
Substance ID	m-nite-112-00-5_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)
Sample SDS by MHLW (External link)
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 associated with explosive properties present in the molecule.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Pyrophoric liquids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded to the element other than carbon or hydrogen (N), but it is ionically bonded and does not contribute to oxidization.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded to the element other than carbon or hydrogen (N), but it is ionically bonded and does not contribute to oxidization.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 800 mg/kg (REACH registration dossier (Accessed May 2021)) (2) LD50 for rats (males): 910 mg/kg (REACH registration dossier (Accessed May 2021)) (3) LD50 for rats (females): about 681 mg/kg (REACH registration dossier (Accessed May 2021)) (4) LD50 for rats: in the range from 490 mg/kg to 560 mg/kg (AICIS IMAP (2015))	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, semiocclusive, 4-hour application, 15-day observation) with rabbits (n=3), erythema and edema were observed, and erythema persisted until 15 days later in 2 cases (erythema score: 3.3/2.3/3.3, edema score: 2.7/0.3/2.7) (REACH registration dossier (Accessed May 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1), eye irritant effects did not disappear within 7 days, and this substance was classified in Category 2A. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, 9-day observation) with rabbits (n=3), eye irritation was observed, and the effects persisited until 9 days later (cornea opacity score: 1/1/1.3, iris score: 0/0/0, conjunctival redness score: 2/2/2.3, chemosis score: 2.3/2.3/2.3), and as an average score on the day 9, cornea opacity score: 2.7, iris score: 0.3, conjunctival redness score: 1.7, chemosis score: 1.3 (REACH registration dossier (Accessed May 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] There were findings (1) and (2) which showed that this substance was not skin sensitizing, however, they were judged to be insufficient evidence because negative results were not shown in all of the 3 tests of OECD TG 442C, D, and E according to the guidance of the Ministry of Health, Labour and Welfare in (3), and therefore, classification was not possible. [Reference Data, etc.] (1) It was reported that, in a chemico skin sensitization test (DPRA method: OECD TG442C, GLP), the rate of decrease in Cysteine and Lysine was 0.59%, and the result was negative (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in an in vitro skin sensitization test (ARE-Nrf2 Luciferase KeratinoSens method: OECD TG442D, GLP), the result was negative according to the standard of the KeratinoSens method (REACH registration dossier (Accessed May 2021)). (3) According to the guidance for the assessment system combining several alternative methods for the skin sensitization test to assess the safety of quasi‐drugs and cosmetics disclosed by the Ministry of Health, Labour and Welfare, the substance is judged to be not sensitizing if the results are negative in all of the 3 tests of OECD TG 442C, D, and E.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a chromosomal aberration test using the bone marrow cells of rats, negative results were reported (AICIS IMAP (2015)). (2) In a bacterial reverse mutation assay (GLP), negative results were reported (REACH registration dossier (Accessed May 2021)). (3) In a gene mutation test using the mouse lymphoma cells, negative results were reported (AICIS IMAP (2015)). (4) In a UDS assay using the rat primary cultured cells, negative results were reported (AICIS IMAP (2015)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to no data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was reported that, in a developmental toxicity study (days 6 to 18 of gestation) with rabbits dosed by gavage, no developmental toxicity was observed. This study was not sufficient because the highest dose to dams was 24 mg/kg/day (AICIS IMAP (2015)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour ErC50 = 0.036 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.01 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 48-hour LC50 = 0.46 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021). From the above results, it was classified in Category 1.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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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