GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 1119-94-4
Chemical Name N,N,N-trimethyldodecan-1-aminium bromide
Substance ID R03-A-014-METI, MOE
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
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 Not classified (Not applicable)
-
-
- - Solid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
7 Flammable solids Classification not possible
-
-
- - No data available.
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 Not classified (Not applicable)
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Not classified
-
-
- - It does not self-ignite in tests up to the melting point (217 deg C) (REACH (Accessed May 2021)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data available.
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)
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine.
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
-
-
- - Classification is not possible because test methods applicable to solid substances are not 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 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))
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) 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)).
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)).
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 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.
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)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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)).
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) 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).
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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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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