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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	116-14-3
Chemical Name	Tetrafluoroethylene
Substance ID	H30-C-018-MHLW
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2013 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

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	-	- -	-	-	-
2	Flammable gases (including chemically unstable gases)	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	-	- -	-	-	-
5	Germ cell mutagenicity	-	- -	-	-	-
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)).
7	Reproductive toxicity	-	- -	-	-	-
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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