GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 79-01-6 |
| Chemical Name | Trichloroethylene |
| Substance ID | H29-B-019 |
| 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) | MHLW Website (in Japanese Only) |
| 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 |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Classification not possible |
- |
- | - | There is the information of being poorly flammable (Hommel (1991)), but the classification is not possible due to no data for the conclusive judgment. |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Type G |
- |
- | - | There is a chemical group associated with self-reactive properties (ethylene group) in the molecule, but because it is classified in Division 6.1, PG III in UNRTDG (UN 1710), it does not correspod to self-reactive substances and mixtures, hazard class with the highest precedence. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 410 deg C (ICSC (J) (2013)). |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not 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 |
- |
- | - | The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on reported LD50 values of 5,400-7,200 mg/kg (EU-RAR (2004), ATSDR (2014)) for rats, it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a reported LD50 value of 29,000 mg/kg (NICNAS (2000)) for rabbits, it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Category 4 |
 Warning |
H332 |
P304+P340
P261 P271 P312 |
There are reports of LC50 values of 4,800 ppm (NICNAS (2000), EU-RAR (2004)) and 12,000 ppm (EU-RAR (2004)) in 4-hour inhalation tests with rats, an LC50 value of 5,918 ppm (converted 4-hour equivalent value: 7,248 ppm) in a 6-hour inhalation test with rats (EU-RAR (2004)), and an LC50 value of 26,000 ppm (converted 4-hour equivalent value: 13,000 ppm) in a one-hour inhalation test with rats (NICNAS (2000)). All values correspond to Category 4, therefore it was classified in Category 4. Besides, since the LC50 values were lower than 90% of the saturated vapor pressure concentration (77,227 ppm), a reference value in the unit of ppm was applied as vapour with little mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | 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 |
From a report that in the case of humans, dermatitis and erythema were caused by exposure to this substance in an occupational environment (ASTDR (1997)) and a report that marked skin irritation was observed in skin irritation tests with rabbits and guinea pigs (EU-RAR (2004)), it was classified in Category 2. Besides, in EU CLP classification, this substance was classified as Skin Irrit. 2 (ECHA CL Inventory (Access on May 2017)). |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
From a report that in an accident case in humans, droplets of an undiluted solution entered into the eyes and caused pain of the eye and damage to the corneal epithelium, but these completely resolved after a few days (EU-RAR (2004)), and a report that in eye irritation tests with rabbits, mild to moderate conjunctivitis occurred, epithelial keratinization was observed after 7 days but this became normal after 2 weeks (EU-RAR (2004)), it was classified in Category 2A. Besides, in EU CLP classification, this substance was classified as Eye Irrit. 2 (ECHA CL Inventory (Access on May 2017)). |
| 4 | Respiratory sensitization | Not classified |
- |
- | - | There is no report that indicates respiratory sensitization in humans. In addition, from a description that from the case of inhalation exposure in humans, all the evidence indicates that this substance is not a respiratory sensitizer (EU-RAR (2004)), it was classified as "Not classified." |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
This substance was classified in occupational skin sensitizers Group 1 by Japan Society for Occupational Health (JSOH). In humans, patch tests were conducted with this substance and chloral hydrate (CH), trichloroethanol (TCOH) and trichloroacetic acid (TCA), which are metabolites of this substance, targeting 19 patients with hypersensitivity syndrome to this substance, and 22 healthy subjects who had been exposed to this substance for 12 weeks or more. In the result, the hypersensitivity syndrome patients showed positive for all substances, and the healthy persons were negative (OEL Documentations (Japan Society For Occupational Health (JSOH), 2016)). In addition, there are reports of multiple cases including animal testing suggesting that that this substance is sensitizing (OEL Documentations (Japan Society For Occupational Health (JSOH), 2016)). Therefore, it was classified in Category 1. Besides, because the report on the symptoms of skin sensitization for this substance in humans is sporadic, and development of sensitization is a symptom of idiosyncratic humans, it is pointed out that it should not be concluded that this substance has skin sensitizing potential (EU-RAR (2004)). The category was revised based on the information obtained in this research. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, a dominant lethal test with mice was negative, gene mutation tests with the kidney, spleen, liver, lung and so on of transgenic mice were negative, a mouse spot test was negative, micronucleus tests with bone marrow cells of rats and mice, peripheral blood of rats, and hepatocytes of rats were positive and negative results, chromosomal aberration tests with the peripheral blood of rats and mice, and bone marrow cells of mice were negative, a micronucleus test with spermatid of mice was negative, unscheduled DNA synthesis tests with hepatocytes of rats and mice were negative, DNA damage tests (including a comet assay) with the kidney, liver, spleen, lung and so on of rats and mice were positive and negative results, sister chromatid exchange tests with the peripheral blood of rats, and spleen cells of mice were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2004), ATSDR (2014), IARC 106 (2014), DFGOT vol. 24 (2007), IRIS Tox. Review (2011), ACGIH (7th, 2007)). As for in vitro, bacterial reverse mutation tests gave positive and negative results, a mouse lymphoma test with mammalian cultured cells was positive, a gene mutation test was negative, a micronucleus test was positive, a chromosomal aberration test was negative, sister chromatid exchange tests were positive and negative results (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2014), IRIS Tox. Review (2011), EU-RAR (2004), IARC 106 (2014)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government. |
| 6 | Carcinogenicity | Category 1A |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
Since this substance caused kidney cancer in humans, and a positive association was observed between exposure to this substance and non-Hodgkin lymphoma and liver cancer, IARC concluded that there is sufficient evidence in humans, and there is sufficient evidence on carcinogenicity also in experimental animals, therefore, it classified this substance in Group 1 (IARC 106 (2014)). Other than this, it was classified in CaH (Carcinogenic to humans) by EPA (IRIS (2011)), in K in NTP (NTP RoC (14th, 2016)), in A2 by ACGIH (ACGIH (7th, 2007)), in Carc. 1B by EU (ECHA CL Inventory (Access on May 2017)), and in Group 1 by Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (2016): proposal in 2015). From the above, based on the classification results of IARC and so on, it was classified in Category 1A. |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In human cases or epidemiological studies, there is no report clearly showing reproductive toxicity of this substance (OEL Documentations (Japan Society For Occupational Health (JSOH), 2014)). In addition, there is also a report that no adverse effects on fertility in men and women were observed within the concentration range in the workplace where no systemic effects were caused (SCOEL/SUM/142 (2009)). As for experimental animals, in continuous breeding tests with mice or rats administered by feeding, in mice, at the high dose (0.6%), no reproductive effects were observed except for decreased testicular weight in F0 parental animals and decreased sperm motility in F1 parental animals observed. Also in a rat test, decreased testicular weight and spermatogenesis abnormality in the F1 generation were observed, but no effect on fertility was observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2014), ATSDR (2014)). On the other hand, there is a report that as a result of oral dosing during the organogenesis period (gestational day 6-9) of pregnant rats, at the dose (1,125 mg/kg/day) where a significant maternal toxicity (decreased body weight gain, a decrease in locomotor activity, dyspnea and so on) was observed, complete resorption of the embryo and fetal malformations (anophthalmia, microphthalmia) were observed (ACGIH (7th, 2007), ATSDR (2014)). There is a report that as a result of administration by drinking water at 1,000 ppm to pregnant rats during the gestational period, no maternal toxicity and an increase of cardiac malformations in fetuses were observed (ACGIH (7th, 2007)). In addition, there is a report that as a result of administration by gavage at 1,000 mg/kg/day to pregnant rats from 2 weeks before mating to day 21 of gestation, a decrease in neonatal survival along with maternal toxicity was observed (ACGIH (7th, 2007), ATSDR (2014)). As for classification results by other organizations, Japan Society For Occupational Health (JSOH) classified it in reproductive toxicant Group 3 (OEL Documentations (2014)). From the above, based on the reports that developmental toxicity effects including malformations were shown generally at doses with maternal toxicity in animal tests, and the classification result of Japan Society For Occupational Health (JSOH), it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects) |
Danger Warning |
H370
H335 H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
In humans, there is a report that three men who entered a tank containing this substance while at work lost consciousness within five minutes, and complained of headaches, vertigo, lacrimation and eye pain even after recovering consciousness about four hours later (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In addition, there is a report that in an inhalation study with volunteers, after a 2-hour inhalation exposure of 1,000 ppm, symptoms of central nervous system depression (light-headedness, dizziness, lethargy) were observed (EU-RAR (2004)). As for experimental animals, there is a description that the main symptoms of a single inhalation exposure in rats were anesthesia, irritation of the eyes and respiratory tract, decreased motor coordination, central nervous system depression and respiratory failure, and that no macroscopic changes were observed in the lung, liver and kidney (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). From the above, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, liver) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
As for humans, there is a description as follows: the chronic toxicity of this substance often appears as neuropathy; persons chronically exposed to this substance often complain of subjective symptoms in the nervous system (headache, dizziness, sleepiness, malaise, finger tremors, nervousness, nausea, anorexia, etc.); such complaints were observed in workers who were exposed to this substance above 50 ppm for a long time (OEL Documentations (Japan Society For Occupational Health (JSOH, 1997))). There is a description as follows: as for repeated toxicity in humans, there are many reports on exposure that caused depression of the central nervous system; the common symptoms were fatigue, confusion, dizziness, headache, memory loss, and lack of concentration, in addition, irritation of the skin and eye; as other symptoms, drug dependence and alcohol intolerance (hypersensitivity) were observed in persons who were occupationally exposed to trichloroethylene and subjects (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). As for experimental animals, there is a report that in a 30-day continuous inhalation toxicity study with mice, increased relative liver weight, hepatocellular hypertrophy and vacuolation were observed at 37 ppm (converted guidance value as 24 hours/day by the description of continuous exposure: 49.3 ppm) within a guidance value range for Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Other than this, in experimental animals, at doses exceeding the guidance value range for Category 2, effects on the central nervous system, vision, and hearing, and effects on the kidney (transformation into giant cell and macronucleus of the renal tubule epithelium) were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). From the above, it was classified in Category 1 (central nervous system, liver). Other than effects on humans, effects on the liver in mice were adopted as the evidence for the classification, therefore, the classification result was different from the previous classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, in the previous classification, it was classified in Category 2 based on the information described in ICSC (J) (2002), but it was not used for this classification because ICSC is an information source in List 3, and original information could not be confirmed. In addition, by setting the Japanese Industrial Standard (JIS) for GHS classification (JIS Z7252:2014), there is Category 1 alone for this hazard class (no Category 2). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 2 |
- |
H401 |
P273
P501 |
From 48-hour EC50 = 7.75 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 2.4% (J-CHECK, 1979)), 21-day NOEC (reproduction inhibition) = 2.1 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)), 96-hour NOEC (growth rate) = 17.8 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and 28-day NOEC (survival rate) = 10.6 mg/L for fish (Jordanella floridae) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), 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. |