NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1119-94-4
Chemical Name	N,N,N-trimethyldodecan-1-aminium bromide
Substance ID	m-nite-1119-94-4_v1
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	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	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	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	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	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Not classified	- -	-	-	It does not self-ignite in tests up to the melting point (217 deg C) (REACH (Accessed May 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	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)	- -	-	-	Solid (GHS definition)	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.	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	- -	-	-	Classification is not possible because test methods applicable to solid substances are not 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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. [Evidence Data] (1) LD50 for rats (females): 300 mg/kg (OECD TG 423, GLP) (REACH registration dossier (Accessed May 2021))	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) to (3), it was classified in Category 2. [Evidence Data] (1) As a result of applying a 7.5% solution of this substance to the skin of the arms of healthy participants for 20 minutes for 8 consecutive days excluding weekends, the amount of irritation increased with time, the transepidermal water loss (TEWL) did not decrease after the weekend break, and it did not return to the base value (before the treatment) on the day 20 after the treatment ended. Erythema on the skin was still present on the day 23 (Int. J. Toxicol., 31 (Suppl. 3) (2012)). (2) It was reported that, in an in vitro skin irritation test (OECD TG 439, GLP) with a reconstructed human epidermis, the average tissue viability was R = 1.1% (REACH registration dossier (Accessed May 2021)). (3) It was reported that, in an in vitro skin corrosion test (OECD TG 431, GLP) with a reconstructed human epidermis, the average tissue viability was R = 86.8% in 3 minutes after the exposure and R = 40.8% in 1 hour after the exposure (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	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was reported that, in an in vitro eye irritation test (OECD TG 437, GLP), the in vitro irritation score (IVIS) = 32.8 (classified as unpredictable) (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in an in vitro Reconstructed human Cornea-like Epithelium (RhCE) test (OECD TG 492, GLP), the tissue viability after 6 hours was 0.9% (classified as unpredictable) (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 also findings (1) and (2) which showed that this substance was not skin sensitizing, but 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 0.05%, 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 the data of N, N, N-trimethyldodecane-1-aminium=chloride, which is an analogous substance of this substance in (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a chromosomal aberration test using the bone marrow cells from rats and mice (five-day oral administration, up to 160 mg/kg/day), 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 study using the mouse lymphoma cells, negative results were reported (AICIS IMAP (2015)). (4) In a UDS assay using 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 lack of 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.	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] Based on (1), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was no information on toxicity in the other routes. Also, based on (1), the purulent inflammation with pustules in the forestomach was considered to be a local effect of irritation. [Evidence Data] (1) It was reported that, in an acute oral toxicity test (OECD TG423, GLP) with rats, salivation and locomotor disturbance were observed at a dose of 300 mg/kg (within the range for Category 1); and in a tissue examination, a severe purulent inflammation with multiple pustules, hemorrhages, and ulceration were observed in the forestomach (REACH registration dossier (Accessed May 2021)).	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 = 0.0599 mg/L for crustacea (Desmodesmus subspicatus) (REACH registration dossier, 2021).	FY2021	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 was not rapidly degradable (BIOWIN), and due to 72-hour NOErC = 0.00158 mg/L for algae (Desmodesmus subspicatus) (REACH registration dossier, 2021). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (crustacea, fish), then it is classified in Category 1 because it was not rapidly degradable (BIOWIN) and due to 48-hour EC50 = 0.135 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021). By drawing a comparison between the above results, it was classified in Category 1.	FY2021	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.	FY2021	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.

To GHS Information