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 |
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 |
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. |
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. |
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. |
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