NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-50-3
Chemical Name	Trimethylamine
Substance ID	m-nite-75-50-3_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Category 1	Danger	H220	P210 P377 P381 P403	From explosion limit (2.0-11.6% (GESTIS (Access on June 2017))), it was classified in Category 1. Besides, it is classified in Division 2.1 in UNRTDG (UN 1083).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified	- -	-	-	It is classified in Division 2.1 in UNRTDG (UN 1083).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Liquefied gas	Warning	H280	P410+P403	It is partially a liquid at temperatures above -50 deg C. Low pressure liquefied gas (a critical temperature 160.1 deg C (Matheson (2001))).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gas substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

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 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the reports that LD50 values for rats were 396.9 mg/kg (males) (JECDB (Access on May 2017)), 500 mg/kg (ACGIH (7th, 2013)) and 1,200 mg/kg (SIAP (2012)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the reports that an LD50 value for rabbits was 3,300 mg/kg (PATTY (6th, 2012)) and an LD50 value for rats was > 5,000 mg/kg (SIAP (2012)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on the reports that 4-hour LC50 values for rats were > 5.9 mg/L (> 2,441 ppm) (SIAP (2012)), 7,910 ppm (PATTY (6th, 2012)), and a 1-hour LC50 value was 19.1 mg/L (7,900 ppm, converted 4-hour equivalent value: 3,950 ppm) (SIAP (2012)), it was classified in Category 4. Besides, the data of IUCLID (2000) used in the previous classification was not adopted because it could not be obtained, and the details were unknown.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1A	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	There is a description that it is corrosive to human skin (ACGIH (7th, 2013), Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014)). There is a description that after contact with human skin for several minutes, petechial hemorrhages appeared even after washing away with soap and water, and the skin remained tender for 1-2 hours, and desquamation was observed 2-3 hours later (ACGIH (7th, 2013)). Therefore, it was classified in Category 1A.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	This substance is classified in Category 1 for skin corrosion/irritation. There are reports that accidental human eye contact with this substance caused corneal epithelial sloughing, but this disappeared within 4 to 5 days (ACGIH (7th, 2013), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)), and that in an application test on animal eyes, conjunctival hemorrhage, corneal edema and opacities were observed, but they were transient (ACGIH (7th, 2013)). By judging comprehensively, it was classified in Category 1. According to the GHS Classification Guidance for the Japanese Government guidance, the category was revised.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test with mouse bone marrow cells was negative (Environmental Risk Assessment for Chemical Substances Vol. 12 (Ministry of the Environment, 2014), Risk Assessment Report (Food Additives) (Food Safety Commission, 2010)). As for in vitro, a bacterial reverse mutation test was negative, a mammalian cell chromosome aberration test was positive (JECDB (Access on May 2017), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), ACGIH (7th, 2013), PATTY (6th, 2012), HSDB (Access on May 2017)). From the above, it was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, reproductive and developmental effects were not seen at up to 200 mg/kg/day at which deaths (2/13 males and 1/13 females) occurred in the parental animals (JECDB (Access on May 2017), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)). However, since this test is a screening test, it cannot to be classified as "Not classified" with only this result. In addition, it is reported that in multiple developmental toxicity tests with pregnant mice dosed intraperitoneally, slight effects such as reduced fetal body weight and neonatal body weight gain were observed at or below the doses where the toxicity in maternal animals was shown or a lower dose (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)), and that growth inhibition was observed in fetuses in an in-vitro fetus culture test (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)). However, both were considered to be insufficient tests for use in classification due to the administration route, test conditions and the like. Therefore, it was classified as "Classification not possible" due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system, respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	There is no information for single exposure to this substance in humans. As for the experimental animals, there is a report that in a single oral administration test with rats, ataxic gait, lacrimation, salivation and loss of locomotor activity were seen and deaths occurred within about 24 hours in groups dosed at 820-1310 mg/kg within the range for Category 2, and abnormal breathing sound (rales) and abdominal distension were observed at lower doses (JECDB (Access on May 2017)). It is reported that in single inhalation tests, the main symptoms are severe apathy, swelling of the nostrils with scab formation by drying out of the bloody discharge, lacrimation, loss of appetite, wasting, central nervous irritation, and convulsions. Also, it is reported that the majority of animals exposed to lethal-concentrations died within a few hours, and this is considered to be attributed to damage to the central nervous system (DFGOT (2014) (Access on May 2017)). Although there is no detailed description of the doses at which the symptoms were observed, since the 4-hour LC50 value for mice is reported as 4,200 ppm in this test (DFGOT (2014) (Access on May 2017)), the symptoms are considered to be observed in the range for Category 2 near the LC50 value. Furthermore, it is described that this substance is a sensory nervous system irritant, and the RD50 value (concentration at which mean respiratory rate is halved) of the sensory irritation is 61 ppm in mice inhalation exposure (ACGIH (7th, 2013)). Based on the above information, this substance is considered to affect the central nervous system and nasal cavity at a dose equivalent to Category 2 and be irritating to the respiratory tract. Therefore, it was classified in Category 2 (central nervous system, respiratory organs). As respiratory organs were adopted as the target organ, Category 3 (respiratory tract irritation) was excluded according to the GHS classification guidance for the Japanese government. Therefore, the classification result was changed from the previous one.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There is no information on humans. As for the experimental animals, it is reported that in a 2-week inhalation toxicity study (vapor, 6 hours/day, 5 days/week), irritation of the nasal cavity and nasal turbinate (hyperemia/congestion, edema, vacuolation, breakdown of tissue, degeneration/necrosis with epithelial desquamation, atrophy, regeneration or squamous metaplasia, etc. in the nasal mucosa) were observed at doses of 75 ppm or more (converted guidance value: 0.02 mg/L) within the guidance value range for Category 1: an increase in erythrocyte count was observed at doses of 250 ppm or more (converted guidance value: 0.07 mg/L): reduced body weight gain, a decrease in response to auditory stimulation at exposure, increases in hemoglobin concentration/hematocrit value/platelets/neutrophil/urea nitrogen/total protein/creatinine were observed at the dose of 750 ppm (converted guidance value: 0.20 mg/L) which is within the guidance value range for Category 1 (ACGIH (7th, 2013), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)). Besides, in the oral route, there is a report that in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats, squamous metaplasia with inflammatory cell infiltration, submucosal edema, formation of granulation, and erosion/ulcer/hemorrhage, etc. in the forestomach were observed at 200 mg/kg/day (converted guidance value: 93 mg/kg/day) within the guidance value range for Category 2 (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), JECDB (Access on May 2017)). Of the above, the decrease in response to auditory stimulation is considered to be transient, and the effects seen in the oral route are considered to be effects on the gastrointestinal system due to irritation, so they were not adopted as rationale for the classification. Therefore, it was classified in Category 1 (respiratory organs).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 3	- -	H402	P273 P501	From 48-hour EC50 = 28 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)), it was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Due to being rapidly degradable (readily biodegradable, a degradation rate by BOD: 66% (J-CHECK, 1980)), not bioaccumulation (BCF = 3.2 (Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014))), 21-day NOEC (reproduction inhibition) = 8.0 mg/L for crustacea (Daphnia magna), and 72-hour NOEC (growth rate) = 56 mg/L for algae (Pseudokirchneriella subcapitata) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017), Environmental Risk Assessment for Chemical Substances vol. 12 (Ministry of the Environment, 2014)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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