NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	116-14-3
Chemical Name	Tetrafluoroethylene
Substance ID	m-nite-116-14-3_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)	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)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Category 1,	Danger	H220 H231	P210 P377 P381 P403 P202	From explosion limit (10.0-50.0% (NFPA (13th,2002))), it was classified in Category 1. Besides, it is classified in Division 2.1 (UN1081) in UNRTDG. It was classified in Category B from the judgment result in UNRTDG Test Manual (2011).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified	- -	-	-	It is a flammable gas classified in Division 2.1 (UN1081) in UNRTDG.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Liquefied gas	Warning	H280	P410+P403	From a critical temperature (33.3 deg C (HSDB (Access on July 2013))) between -50 deg C and +65 deg C, it was classified as liquefied gas.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gas substances are not available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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 (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	It was classified as "Not classified" based on LC50 (4 hours) of 25,000 ppm (ACGIH (7th, 2001)), 31,000 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), 40,000 ppm (ECETOC JACC (2003)), and 45,000 ppm (ACGIH (7th, 2001)) in inhalation exposure tests (gas) with rats.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B from the description of exposure in humans in HSDB (Access on July 2013) that contact with eyes causes slight irritation.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It 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 with mouse peripheral blood erythrocytes (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001), IARC 71 (1999), NTP DB (Access on July 2013)). Furthermore, as for in vitro, it was negative in a bacterial reverse mutation test and a gene mutation test and a chromosomal aberration test with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001), IARC 71 (1999), IUCLID (2000)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Information on carcinogenicity in humans is limited to (4). Based on the IARC's classification result (1) and test results of (2), (3), it was classified in Category 1B. The category was revised as the result of reviewing the previous classification due to the revision of the classification in 2017 by IARC. [Evidence Data] (1) IARC raised the category to 2A based on animal test results that the substance induced neoplasms in multiple sites in both rats and mice, affecting cells of differing embryological origin (IARC 110 (2017)). As for classification results by other domestic and international organizations, it was classified in A3 by ACGIH (ACGIH (7th, 2001)), Group 2B by Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits and so on (Japan Society For Occupational Health (JSOH) 2018): proposed in 2001), R by NTP (NTP RoC (14th, 2014)) respectively. (2) In a 2-year inhalation exposure test in rats, increases in renal cell adenoma and carcinoma and hepatocellular adenoma and carcinoma in males and females and hemangiosarcoma in the liver in females were observed, and increased incidences of mononuclear cell leukemia in males and females and testicular interstitial cell (Leydig cell) adenoma in males were also found (NTP TR450 (1997), IARC 110 (2017)). (3) In a 2-year inhalation exposure test in mice, increases in hemangioma, hemangiosarcoma, hepatocellular adenoma and carcinoma, histiocyte sarcoma were observed in the liver of males and females (NTP TR450 (1997), IARC 110 (2017)). [Reference Data, etc.] (4) In humans, some report that moderately elevated SMRs (standardized mortality ratios) (not significant) were observed for cancer of the liver and kidney, and leukemia from exposure to this substance. It is described in IARC that it is likely to be due to confounders such as exposure to other substances and that the power of the study is not sufficient (IARC 110 (2017)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 2 (kidney, liver)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	As for experimental animals, it is described that increases in blood urea nitrogen, urine volume, urinary excretion of glucose, and alkaline phosphatase and gamma-glutamyl transpeptidase activities were observed after inhalation exposure to 4,000 and 6,000 ppm in rats (ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), therefore the kidney and liver were judged to be the target organs. Besides, these effects in experimental animals were found within the guidance value range corresponding to Category 2. From the above, it was classified in Category 2 (kidney, liver).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney, liver)	Warning	H373	P260 P314 P501	As for experimental animals, it is described that in a 2-year inhalation exposure test with rats, males showed renal tubular degeneration and cystic degeneration in the liver after exposure to 156 ppm (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001)), therefore the kidney and liver were considered to be the target organs. Besides, these effects in experimental animals were observed within the guidance value range corresponding to Category 2. From the above, it was classified in Category 2 (kidney, liver).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Not classified (Not applicable)	- -	-	-	Gas (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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)	Classification not possible	- -	-	-	No data available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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