NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	127-18-4
Chemical Name	Tetrachloroethylene
Substance ID	m-nite-127-18-4_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified	- -	-	-	Not combustible (ICSC (2000))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Not classified	- -	-	-	Classified into Not classified since the substance is classified into Division 6.1 in UNRTDG (UN1897) though it contains unsaturated bond in the chemical structure.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified	- -	-	-	Not combustible (ICSC (2000))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (ICSC (2000))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine which is chemically bonded only to carbon.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Not classified	- -	-	-	Based on LD50 values of 13,000 mg/kg (EHC 31 (1984)) and 2400 - 13000 mg/kg for rats (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 65 (2006)), the substance was classified into "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a LD50 value of 5000 mg/kg for mice (IUCLID (2000)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on LC50 values of 27.8 mg/L (4-hour equivalence: 5013 ppm) (EHC 31 (1984)) and 5000 ppm (4-hour equivalence: 7071 ppm) (IARC vol. 63 (1995)) for rats, the substance was classified into Category 4. Since the LC50 values were lower than 90% of saturated vapour pressure concentration (24342.1 ppmV), the classification criteria for gas (ppm) was adopted.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	There are reports that "In persons whose thumbs were immersed in the substance, a slight, moderate or strong burning sensation persisted for approx. 10 minutes. The pain subsided within one hour. Severe erythema persisted for 1 - 2-hour post exposure in all subjects" (Hazard Assessment Report (CERI, NITE) No. 65 (2005)) and "Extensive skin redness and blistering were seen in two workers who had laid unconscious in the substance-soaked clothes" (CICAD No. 68 (2006)). In a rabbit skin irritation test (4-hour application), "marked irritation" was observed, however, no corrosive effect was observed (CICAD No. 68 (2006)). Based on these information, the substance was classified into Category 2.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In two rabbit eye irritation tests, "moderately irritating" or "mildly irritating" results were reported (Hazard Assessment Report (CERI, NITE) No. 65 (2005)). "The substance (liquid) showed minimal irritation in rabbit eyes" (CICAD No. 68 (2006)). Based on the reports, the substance was classified into Category 2B. As relevant information, exposure to the vapour of the substance (0.52 mg/L) caused transient and mild irritation to the eyes (CICAD No. 68 (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	There are case reports of tetrachloroethene-dependent asthma in a woman who worked for 2 years in a dry cleaning establishment, and an acute asthmatic episode of severe dyspnoea, cough, and chest tightness following a prolonged exposure to tetrachloroethene in an 18-year-old male student (CICAD No. 68 (2006)). However, there is a report that "asthma characterized by a history of high exposure to an irritant product, with respiratory symptoms appearing shortly after the event and in the absence of a previous history of respiratory symptoms, is likely to be an irritant-induced response rather than immunologically based" (CICAD No. 68 (2006)). Classification not possible due to lack of other date such as results of immunological tests.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	2 cases of allergic contact dermatitis were confirmed by patch testing of the substance (CICAD No. 68 (2006)). It is not clear whether the patch test data was obtained from multiple dermatological hospitals. Animal test data is not reported. Classification not possible due to lack of sufficient data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative results from in vivo tests including rat dominant lethal test (Hazard Assessment Report (CERI, NITE) No. 65 (2005)), human lymphocyte chromosomal aberration test and sister chromatid exchange test (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 65 (2006)), mouse bone marrow, erythrocyte and hepatic cell micronucleus test (Hazard Assessment Report (CERI, NITE) No. 65 (2005), NTP DB (access on 7. 2009)) and mouse and rat bone marrow chromosomal aberration test (Hazard Assessment Report (CERI, NITE) No. 65 (2005), NTP DB (access on 7. 2009)), the substance was classified as "Not classified". As relevant information, there are reports of positive and negative in vivo DNA binding tests (Hazard Assessment Report (CERI, NITE) No. 65 (2005)). From in vitro mutagenicity tests, there are reports of negative chromosomal aberration test, gene mutation test, reverse mutation test and sister chromatid exchange test (Hazard Assessment Report (CERI, NITE) No. 65 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO) No. 65 (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on the classifications of "2A" in IARC (IARC vol. 63 (1995)) and "R" in NTP (NTP RoC (11th, 2005)), the substance was classified into Category 1B. In a 104-week inhalation test in rats, an increased incidence of mononuclear cell leukemia in the spleen was observed in both sexes, and the carcinogenicity of tetrachloroethylene in male and female F344/DuCrj (Fischer) rats was indicated. In a 104-week inhalation test in mice, increased incidences of hepatocellular carcinoma, hepatocellular adenoma and Harderian gland adenoma were observed in males and for females, increased incidences of hepatocellular carcinoma and hepatocellular adenoma were observed. The results indicate the carcinogenicity of tetrachloroethylene in male and female Crj:BDF1 mice (Results from Carcinogenicity tests (Ministry of Health, Labour and Welfare) (1992)). Based on the results, the Ministry of Health, Labour and Welfare has made a public announcement on guidelines in order to prevent the impairment of worker's health based on Industrial Safety and Health Act Article 28-3 (1995). For humans, a relationship between cancer occurrence and tetrachloroethylene exposure is not yet verified since no tetrachloroethylene-alone exposure case was reported (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 65 (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2,	Warning	H361 H362	P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501	In a multi-generation test in rats by inhalation exposure, there was no effect on fertility and mating behavior but a decreased proportion of pups born live and an increased incidence of pup mortality during lactation were observed at dose levels in which toxicity (reduced body weight gain) was manifested in parental animals (ATSDR (1997)). In a developmental toxicity test in rats by inhalation exposure, motor dysfunction of the offspring was observed while parental toxicity was not stated (Hazard Assessment Report (CERI, NITE) No. 65 (2005)). Based on the data, the substance was classified s Category 2. In addition, it was reported that a case of obstructive jaundice and hepatomegaly occurred in a six-week-old breast fed infant. The substance was detected in the mother's milk and blood. After breast-feeding was discontinued, clinical and biochemical improvement followed rapidly (IARC vol. 63 (1995)). Based on the data, it was classified as "Effects on or via lactation". In regard to reproductive toxicity for humans, some tests showed an increase in the risk of spontaneous abortions, but other tests did not. These results were not used as the basis of classification since there is a report that "The human reproductive toxicity of the substance is difficult to evaluate accurately from these case reports since there are various problems including effects of other mixtures exposed, inadequate control group setting, and other risk factors of spontaneous abortions such as smoking, alcohol consumption, pregnant woman's workloads" (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 65 (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory organs, liver), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In a test with volunteers, the most frequently reported subjective complaint was central nervous system depression such as light-headedness, dizziness, drowsiness and impaired coordination (EHC 31 (1984)). Acute exposure to the substance by inhalation results in central nervous system depression (IARC 63 (1995)). Based on these reports, the substance was classified into Category 1 (central nervous system). In a report of a death case following exposure to the substance, an autopsy finding of pulmonary edema was noted (Hazard Assessment Report (CERI, NITE) 65 (2005)). In addition, there are case reports of pulmonary congestion following high-concentration exposure (ECETOC TR (1995)). Based on the data, the substance was classified into Category 1 (respiratory system). There is a case report of clouding of consciousness accompanied by hepatic dysfunction occurring 2-3 weeks following exposure (Initial Risk Assessment Report (NITE, CERI, NEDO) 65 (2006)). It was reported that moderate fatty infiltration was noted in the livers of mice after a 4-hour exposure to the substance at concentration of 1,366 mg/L (dose level within the guidance value range for Category 1) (EHC 31 (1984)). Based on the data, the substance was classified into Category 1 (liver). In addition, symptoms of central nervous system depression such as light-headedness, dizziness, drowsiness and impaired coordination, which were reversible, were observed in humans (EHC 31 (1984)). Based on this information, the substance was classified into Category 3 (narcotic effects). In conclusion, the substance was classified into Category 1 (central nervous system, respiratory system, liver) and Category 3 (narcotic effects).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, liver, respiratory organs), Category 2 (kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In a test of 101 dry-cleaning workers who were exposed to the substance, serious disorders in neuropsychological function (sensorimotor response, memory and concentration), autonomic neuropathic symptoms (sensory anesthesia to needle prick, numbness in a limb, rheumatic pain, inebriation and nausea) and personality change such as emotional lability were observed (Hazard Assessment Report (CERI, NITE) (2005)). Based on the data, the substance was classified into Category 1 (nervous system). In an epidemiological test, hepatic dysfunction, liver cirrhosis and hepatomegaly as well as dyspnea, cough and pulmonary edema are reported as findings noted following 3-week to 6-year exposure (Hazard Assessment Report (CERI, NITE) (2005)). Based on the data, the substance was classified into Category 1 (liver, respiratory system). As for the liver, there are reports of fatty infiltration in the liver at 1.356 mg/L/4h following 8-week inhalation (vapour) exposure in rats (EHC 31 (1984)) and centrilobular fatty degeneration at 200 ppm/6h and higher concentrations following 28-day inhalation (vapour) exposure in mice (Initial Risk Assessment Report (NITE, CERI, NEDO) (2006)). Karyomegaly of tubular epithelial cell, kidney cast and nephrosis in the kidney were observed at 100 ppm/6h (0.690 mg/L/6h) and higher concentrations following 2-year inhalation (vapour) exposure in mice (Hazard Assessment Report (CERI, NITE) (2005)). Since these findings were noted at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (kidney). In conclusion, the substance was classified into Category 1 (nervous system, liver, respiratory system) and Category 2 (kidney).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available. There is a report of "effect of short-term exposure. If this liquid is swallowed, aspiration into the lung may result in chemical pneumonitis" (ICSC (J) (2000)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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 1	Warning	H400	P273 P391 P501	Classified into Category 1 from its 48h-EC50 = 0.602 mg/L for Crustacea (Daphnia magna) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2006).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (BOD degradation rate: 11% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1976)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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.

To GHS Information