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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	112-00-5
Chemical Name	N,N,N-trimethyldodecan-1-aminium chloride
Substance ID	R03-A-013-METI
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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 (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)
Model SDS by MHLW (External link)
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
5	Gases under pressure	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
6	Flammable liquids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
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.
9	Pyrophoric liquids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
10	Pyrophoric solids	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification not possible since its physicochemical properties are unknown.
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).
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.
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.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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)).
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)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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.
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)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to no data.
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)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

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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