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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	56-93-9
Chemical Name	Trimethylbenzylammonium chloride
Substance ID	H29-B-081
Classification year (FY)	FY2017
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2010
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)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	Classification not possible	- -	-	-	No data available.
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	Classification not possible	- -	-	-	No data available.
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 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 applicable	- -	-	-	It is an organic compound which does not contain fluorine or oxygen but contains chlorine, and the chlorine is ionically bonded to the element other than carbon or hydrogen (N) and does not contribute to oxidation.
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	Based on a report of an LD50 value of 250 mg/kg (NTP TOX 57 (2000)) for rats, it was classified in Category 3. Besides, although it was not an acute toxicity test, there is a report that in a 16-day oral dose test with rats, in the 125 mg/kg administered group, all the animals died after the first administration, but in the 63 mg/kg administered group, all survived until the end of the test (NTP TOX 57 (2000)). From this result, the LD50 value is suggested to be between 63 mg/kg and 125 mg/kg and also corresponds to Category 3.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a description that the solution of this substance is irritating to the skin in humans (HSDB (Access on June 2017)). However, it was classified as "Classification not possible" because the details were unknown.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a description that the solution of this substance is irritating to the eyes in humans (HSDB (Access on June 2017)). However, it was classified as "Classification not possible" because the details were unknown.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, a micronucleus test with mouse peripheral blood was positive (NTP DB (Access on July 2017), NTP TOX 57 (2000)). As for in vitro, a bacterial reverse mutation test was negative, and a chromosomal aberration test with mammalian cultured cells was weakly positive (JECDB (Access on July 2017), NTP DB (Access on July 2017)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government. Besides, there was a negative view of the positive result in a mouse micronucleus test in the previous classification, and it was concluded that classification was not possible. However, since this positive result was judged as valid in NTP TOX 57 (2000), it was adopted, and the category was changed this time.
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a reproduction/developmental toxicity screening test (OECD TG 421) with rats dosed orally, in parental animals, salivation and reddish tears were observed at or above 50 mg/kg/day, and deaths (male 2/12 cases, female 10/12 cases), decreased body weight gain, and decreased food consumption were observed at 100 mg/kg/day. Although the 100 mg/kg/day administered group cannot be regarded as a target of the evaluation for this hazard class because the number of surviving cases was small, no reproductive and developmental effects were observed in the groups at or below 50 mg/kg/day (JECDB (Access on June 2017)). However, it is impossible to classify it as "Not classified" based on only this result since this test is a screening test, and there is no other information available for classification. Therefore, classification was not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is no single exposure data to this substance in humans. As for experimental animals, there is a report that in a single oral dose test with rats, death cases were observed at or above 175 mg/kg within the range of Category 1, in addition, salivation and chromodacryorrhea which are muscarinic cholinergic symptoms were observed, and a report that these symptoms were relieved by atropine injection (NTP TOX 57 (2000)). In addition, there is a report that in a 16-day oral dose test (16-250 mg/kg) with rats, after the first administration, all cases died, and as clinical symptoms, abnormal breathing, ataxia, nasal and eye discharge and tremors were observed at or above 125 mg/kg (NTP TOX 57 (2000)). It is described that this substance stimulates both the nicotinic and muscarinic receptors and acts at the same ganglionic site as acetylcholine (NTP TOX 57 (2000)). From the above, it was classified in Category 1 (nervous system). Since the effects on experimental animals were observed at the doses within the guidance value range for Category 1, the category was changed from the previous classification.
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system)	Warning	H373	P260 P314 P501	No information on humans is available. As for experimental animals, in a 28-day repeated oral dose toxicity test with rats, within the guidance value range for Category 2, salivation was observed at or above 60 mg/kg/day (converted guidance value: 19 mg/kg/day), and lacrimation, staining of the fur, piloerection, death (1/5 cases), decreased body weight gain, decreased food consumption, slight increases in hemoglobin content, mean corpuscular volume, and mean corpuscular hemoglobin content, and symptoms in the dead animal of slight hepatocellular swelling and eosinophilic body were observed at 120 mg/kg/day (converted guidance value: 37 mg/kg/day) (JECDB (Access on June 2017)). In addition, in 13-week repeated oral dose toxicity tests with rats or mice, rats were more sensitive than mice, and in rats, lacrimation was observed at or above 12.5 mg/kg/day (converted guidance value: 9 mg/kg/day) within the guidance value range for Category 1, pupillary constriction was observed at or above 50 mg/kg/day (converted guidance value: 36 mg/kg/day) within the guidance value range for Category 2, and at the highest dose of 100 mg/kg/day (converted guidance value: 72 mg/kg/day), deaths (the results of pharmacologic effects on the cardiovascular system), tremors, chromodacryorrhea, salivation, abnormal gait, abnormal posture, etc. were observed. In mice, at 100 mg/kg/day (converted guidance value: 72 mg/kg/day) which is the highest dose, deaths, and hyperactivity immediately after administration were observed (NTP TOX 57 (2000)). Moreover, it is described that this substance stimulates both the nicotinic and muscarinic receptors and acts at the same ganglionic site as acetylcholine (NTP TOX 57 (2000)). Among the above, since only lacrimation was observed within the guidance value range for Category 1, findings showing clear effects observed within the guidance value range of Category 2 were adopted as the classification evidence. In addition, slight effects on the haemal system, and the effects on the liver in the one dead animal were not adopted as evidence of the classification. Therefore, it was classified in Category 2 (nervous system).
10	Aspiration hazard	Classification not possible	- -	-	-	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)	Classification not possible	- -	-	-	Reliable acute toxicity data were not obtained.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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