NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	156-60-5
Chemical Name	trans-1,2-Dichloroethylene
Substance ID	H26-B-046, R-020
Classification year (FY)	FY2014
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)
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	- -	-	-	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	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of 6 deg C (closed cup) and a boiling point of 48.7 deg C (HSDB (Access on June 2014)). Besides, it is classified in Class 3, PG II (UN1150) in UNRTDG.
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 (unsaturated bond) present in the molecule, but commonly distributed products contain a stabilizer. This substance is classified in Class 3, PG II (UN1150) in UNRTDG. Therefore, the stabilized one was classified in Type G.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 440 deg C (GESTIS (Access on June 2014)).
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	- -	-	-	Test methods applicable to low-temperature-boiling liquids 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 4	Warning	H302	P301+P312 P362+P364 P264 P270 P330 P501	There were 7 reports of LD50 values of 1,235 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)), 1,280 mg/kg (IRIS TR (2010)), 1,275 mg/kg (ACGIH (7th, 2001)), 7,900 mg/kg (male), 10,000 mg/kg (female) (ATSDR (1996)), 7,902 mg/kg (male), 9,939 mg/kg (female) (IRIS TR (2010)), 7,900 mg/kg (male), 9,900 mg/kg (female) (PATTY (6th, 2012)) and 1,235-10,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats. Although the category to which the larger number of values corresponded, was Category 4 or "Not classified" (3 cases each), it was classified in Category 4 to which the minimum LD50 value corresponded. Besides, because the remaining one was aggregated datum, it was not included in the number of applicable data.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of >5,000 mg/kg for rabbits (IRIS TR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	Based on a report of an LC50 value (4 hours) of 95,400 mg/m3 (=24,041 ppm) for rats (IRIS TR (2010)), it was classified as "Not classified." Besides, the LC50 value was lower than 90% of the saturated vapor concentration (435,526 ppm), the reference value in units of ppm was applied as a vapour without a 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	There are reports that mild to moderate erythema was observed in a skin irritation test by 24-hour occlusive application of a 0.5 mL of undiluted liquid of this substance to rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (1996), IRIS TR (2010)). In addition, there is a report that, after application of 5,000 mg/kg of this substance to the skin of rabbits, although severe skin irritation was observed, recovery was unknown (ATSDR (1996)). Moreover, in humans, there is a description that it was irritating to the skin (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). From the above result, it was classified in Category 2.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a report that, in an eye irritation test in which 0.01 mL of the undiluted liquid of this substance was applied to the eyes of rabbits, with eyes washed 20 seconds after application, severe corneal opacity was observed in washed eyes, and although moderate iritis and conjunctivitis were observed whether or not washed, both 2 animals recovered 3 days after application (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (1996), IRIS TR (2010)). Moreover, in humans, there was a report of pain in the eyes with a burning sensation and mild inflammation by exposure to this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). From the above results, it was classified in Category 2A.
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	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test and a chromosomal aberration test with bone marrow cells and peripheral blood erythrocytes of mice, a sister chromatid exchange test with mice bone marrow cells (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), ATSDR (1996), IRIS TR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NTP DB (Access on July 2014)). As for in vitro, although there were positive results in bacterial reverse mutation tests and a mammalian cell chromosome aberration test (heteroploidy), it was negative in other bacterial reverse mutation tests, and a chromosomal aberration test, a sister chromatid exchange test and an unscheduled DNA synthesis test with cultured mammalian cells (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), ATSDR (1996), IRIS TR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NTP DB (Access on July 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	There is a report that, in a teratogenicity test with rats by the inhalation route, decreased fetus body weight was observed at doses where maternal toxicities (decreased body weight, decreased feed consumption, coma, lethargy, salivation, alopecia) were observed (IRIS TR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Since the effects on fetuses were few, they were not adopted. Because effects on fertility were unknown due to lack of data, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs, liver), Category 2 (heart), Category 3 (narcotic effects)	Danger Warning	H370 H371 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, it was irritating to the respiratory tract (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). In addition, by inhalation, there were reports of cough, sore throat, dizziness, nausea, drowsiness, weakness, vomiting, prostration, tremors, hallucinations, false recognition, depressed consciousness and elevated intracranial pressure, which suggested central nervous system depression, and abdominal pain might occur by oral ingestion. Moreover, this substance was used as an anesthetic and causes narcotic effects such as dizziness and nausea (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2001), ATSDR (1996)). As for experimental animals, narcotic effects were observed by inhalation exposure. In addition, there were reports on slight-severe fatty degeneration or fatty accumulation in hepatic lobules and Kupffer cells at 0.79 mg/L in rats, fibrous swelling and hyperemia of the cardiac muscle, disappearance of the striated pattern of the cardiac muscle at 11.90 mg/L, and severe pulmonary hyperemia, alveolar septal distention and pneumonic infiltration at 3.97 mg/L and 11.90 mg/L (whether the trans-isomer or not was unknown) (ACGIH (7th, 2001), ATSDR (1996), PATTY (6th, 2012)). There were reports of decreased activity, ataxia, loss of righting reflex, piloerection, hunched posture, depressed respiration, hyperemia of the mucosal surface of the stomach and small intestine at 1,000 mg/kg by the oral administration to rats or mice. In necropsy findings of rats, severe pulmonary capillary hyperemia, alveolar septal distention, fibrous swelling and hyperemia in the cardiac muscles were observed. In necropsy findings of mice, hyperemia of the mucosal surface of the stomach and small intestine was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2001), ATSDR (1996), PATTY (6th, 2012)). Besides, in the above findings on experimental animals, effects on the respiratory organs and the liver were observed within the guidance value range corresponding to Category 1, and effects on the heart were observed within the guidance value range corresponding to Category 2. From the above, it was classified in Category 1 (respiratory organs, liver), Category 2 (heart), Category 3 (narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In humans, there were no available data for classification. As for experimental animals, in a 90-day administration test with mice by drinking water, or in a 14-week administration test with rats by feeding, effects on the liver (increased weight, increased serum ALP), the blood system (a decrease in erythrocyte counts, hemoglobin, hematocrit value, and leukocyte counts), the immune system (decreased humoral immunity (only mice)) were observed at a high dose (175 mg/kg/day) exceeding Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IRIS TR (2010), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). On the other hand, by the inhalation route, in a test in which rats were exposed to this substance (estimated as the vapour) by inhalation for 16 weeks (8 hours/day), effects on the respiratory organ (pulmonary hyperemia with alveolar septal distention) and the liver (fatty accumulation in hepatic lobules and Kupffer cells) were observed at a concentration (200 ppm: 790-802 mg/m3 (converted guidance value: 1.05-1.07 mg/L/6 hours)) slightly exceeding Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IRIS TR (2010), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). However, in a 90-day inhalation exposure test with rats which was conducted after this test, only a decrease in total leukocyte counts and lymphocyte counts was observed, and no other hazardous effects were found at a high concentration (15.8 mg/L/6 hours) far exceeding the upper limit of Category 2. Therefore, IRIS questioned the reliability of these tests and judged that RfD calculation by the inhalation route was difficult due to lack of information (IRIS (2010)). From the above, although it was corresponding to "Not classified" by the oral route, it was judged that there were no adequate data to use for classification by the inhalation route because there is a lack of consistency in the target organs and effective concentrations between the 2 inhalation exposure tests with rats by the inhalation route. So, it was classified as "Classification not possible" due to lack of data. Besides, it was estimated that although IRIS (1998) was used as an information source in the previous classification, the revised IRIS (2010) was used as an information source this time, therefore, the classification result was changed.
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)	Not classified	- -	-	-	It was classified as "Not classified" from 48-hour LC50 = 220 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (water solubility = 4520 mg/L, PHYSPROP Database 2009), and it was classified as "Not classified" in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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