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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	75-57-0
Chemical Name	Tetramethylammonium chloride
Substance ID	H30-A-005-METI, MOE
Classification year (FY)	FY2018
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 (FY2013 revised edition (Ver. 1.1))
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ISCS (J) (2003)).
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ISCS (J) (2003)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ISCS (J) (2003)).
12	Substances and mixtures which, in contact with water, emit flammable gases	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 applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which exists as a chloride ion and does not contribute to oxidization.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

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] (1) corresponds to Category 2, and (2) and (3) correspond to Category 3. Therefore, it was classified in Category 3 with more cases. [Evidence Data] (1) LD50 for rats: 47 mg/kg (female, male) (REACH registration dossier (Accessed Oct. 2018)) (2) LD50 for rats: 55 mg/kg (female) (REACH registration dossier (Accessed Oct. 2018)) (3) LD50 for rats: 171.9 mg/kg (female) (REACH registration dossier (Accessed Oct. 2018))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. [Evidence Data] (1) LD50 for rabbits: 200-500 mg/kg (REACH registration dossier (Accessed Oct. 2018))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
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) and (2), it was classified in Category 2. [Evidence Data] (1) There is a report that in an in vitro skin irritation test (OECD TG439, GLP), a result of a cell viability of below 50% (28%) was obtained and this was judged as irritating (REACH registration dossier (Accessed Oct. 2018)). (2) There is a report that in an in vitro skin corrosion test (OECD TG 431, GLP), since the cell viabilities after a 3-minute and 1-hour exposure were 95% and 92%, respectively, which exceeding the criteria of 50% and 15%, respectively, it was concluded that this substance was not corrosive (REACH registration dossier (Accessed Oct. 2018)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) There is a report that in an in vivo eye irritation test (OECD TG405, GLP, n=3) with rabbits, the conjunctival redness score was 1.1 and the conjunctival edema score was 0.3. They resolved in 7 days (REACH registration dossier (Accessed Oct. 2018)). (2) There is a report that in an in vitro corrosion/irritation test (OECD TG437, GLP) with bovine corneas, the IVIS (irritancy score) value was less than 55 (average 7.4), and it was concluded that it was not corrosive nor a severe irritant (REACH registration dossier (Accessed Oct. 2018)).
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] Although (1) is obtained, there are no human data and animal data is limited. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) There is a report that in an LLNA test (OECD TG429, GLP) with mice, as a result of application of 5% and 10% solutions (propylene glycol) of this substance, Since Stimulation Index (SI) was 0.5 and 1.1, both less than 3.0, this substance was determined to be not sensitizing (REACH registration dossier (Accessed Oct. 2018)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) There is a report that it was negative in a bacterial reverse mutation test (OECD TG 471, GLP) (REACH registration dossier (Accessed Oct. 2018)).
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	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) and (2), the central nervous system is considered to be the target based on the symptoms of sedation, convulsions, coma, etc., and these effects occurred within the range of Category 1. Therefore, it was classified in Category 1 (central nervous system). In addition, central nervous system symptoms are also observed in reference data (3) and (4), but no symptoms suggesting other target organs are observed. [Evidence Data] (1) In a single oral administration test with rats, sedation, clonic convulsions, dacryorrhea, and coma (frequently) were observed. There is a report that the LD50 value in this study was 47 mg/kg, and the mortality rates in the 30, 36, 43, 52 and 62 mg/kg dose groups were 0/10, 1/10, 4/10, 7/10 and 7/10, respectively (REACH registration dossier (Accessed Oct. 2018)). (2) There is a report that in a single oral administration test with rats, convulsions, tremors, sagging eyelids, wetness of the nose and mouth area, flaccid muscle tone, prostration, lethargy, spasms, ataxia and eye closure were observed prior to death. The LD50 value in this study was 55 mg/kg, and 1/2 deaths at a dose of 55 mg/kg and 2/2 deaths at 175 mg/kg were observed (REACH registration dossier (Accessed Oct. 2018)). [Reference Data, etc.] (3) There is a report that in a single oral administration test with rats, prostration and lethargy prior to death, and lethargy, few feces and wetness of the anogenital area in the surviving animals were observed. The LD50 in this study was 171.9 mg/kg (REACH registration dossier (Accessed Oct. 2018)). (4) There is a report that in a single dermal administration test with rabbits, lethargy and wetness of the nose/mouth area prior to death, and lethargy, few feces and diarrhea in the surviving animals were observed. The LD50 value in this study was between 200 mg/kg and 500 mg/kg (REACH registration dossier (Accessed Oct. 2018)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system), Category 2 (liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1), since effects on the liver were observed at doses within the range of Category 2, it can be classified in Category 2 (liver). In addition, it can be classified in Category 1 (central nervous system) since lethargy was observed within the dose range of Category 1. Other than these, since atrophy of the thymus is considered to be a nonspecific effect reflecting the general condition, it was classified in Category 1 (central nervous system), Category 2 (liver). [Evidence Data] (1) In a 90-day study with rats dosed by gavage, effects on the liver (increased relative and absolute weight, increases in AST, ALT, ALP, the bilirubin value and bile acid, hepatocytes hypertrophy (female)) were observed at 30 mg/kg/day, which is within the range of Category 2. Hepatocellular hypertrophy was also observed in females in the groups of 3 and 10 mg/kg/day, but increased serum liver-derived enzyme activity was not observed, and the findings of the liver at these doses were considered to be within adaptive changes. In addition, deaths (2 males), decreased thymus weight and thymus atrophy (female), and symptoms such as lethargy, piloerection and ptosis were observed. It is reported that symptoms such as lethargy, piloerection and ptosis were also observed at 10 mg/kg/day within the range of Category 1, but this was less frequent and less severe than in the group of 30 mg/kg/day (REACH registration dossier (Accessed Oct. 2018)).
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 (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 96-hour LC50 = 462 mg/L for fish (Pimephales promelas) (NLM HSDB: 2018, EPA AQUIRE: 2018, Geiger DL et al. (1988)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Chronic toxicity data were not obtained. Although it is not rapidly degradable, because no bioaccumulation is estimated (LogKow: -4.18 (EST, PHYSPROP Database: 2018)), and it was classified as "Not classified" in acute toxicity, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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.

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