GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 75-50-3 |
| Chemical Name | Trimethylamine |
| Substance ID | H29-B-008 |
| 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 | FY2006 |
| 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) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | Gas (GHS definition) |
| 2 | Flammable gases (including chemically unstable 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). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not classified |
- |
- | - | It is classified in Division 2.1 in UNRTDG (UN 1083). |
| 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))). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 7 | Flammable solids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | Gas (GHS definition) |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 11 | Self-heating substances and mixtures | Not applicable |
- |
- | - | Gas (GHS definition) |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Gas (GHS definition) |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Gas (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Gas (GHS definition) |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to gas substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 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." |
| 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. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Gas (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not applicable |
- |
- | - | Gas (GHS definition) |
| 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. |
| 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. |
| 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 | 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. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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. |
| 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). |
| 10 | Aspiration hazard | Not applicable |
- |
- | - | Gas (GHS definition) |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (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. |
| 11 | Hazardous to the aquatic environment (Long-term) | 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." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |