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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	22898-01-7
Chemical Name	Sodium 2,2,3,3-Tetrafluoropropionate (synonym: Tetrapion)
Substance ID	R03-A-012-METI, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains metals (Na), but it is estimated that it does not react vigorously with water from data obtained: water solubility of > 1,370,000 mg/L (25 deg C) (Ministry of the Environment (2014)).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing fluorine and oxygen (but not chlorine), and the fluorine is chemically bonded only to carbon or hydrogen. And the oxygen is chemically bonded to the element other than carbon or hydrogen (Na), but it is ionically bonded and does not contribute to oxidization.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats (males): 12,000 mg/kg (Pesticides Safety Evaluation Report (Central Environment Council, 2014)) (2) LD50 for rats (females): 10,600 mg/kg (Pesticides Safety Evaluation Report (Central Environment Council, 2014)) (3) LD50 for rats: 11,900 mg/kg (Pesticides Safety Evaluation Report (Central Environment Council, 2014))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Pesticides Safety Evaluation Report (Central Environment Council, 2014)) (2) LD50 for rabbits: > 4,000 mg/kg (Pesticides Safety Evaluation Report (Central Environment Council, 2014))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, in (1), the exposure time was unknown. [Reference Data, etc.] (1) LC50 for rats: > 1.74 mg/L (Pesticides Safety Evaluation Report (Central Environment Council, 2014)).
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, since the details of the findings in (1) were unknown, it was not used for classification. [Reference Data, etc.] (1) It was reported that, in an acute dermal irritation/corrosion test (patch application for 4 hours) with rabbits (n=6), very slight edema and erythema were observed but cleared by the day 5 (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 6 (Japan Crop Protection Association, 1990), Pesticides Safety Evaluation Report (Central Environment Council, 2014)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, since the details of the findings in (1) and (2) were unknown, they were not used for classification. [Reference Data, etc.] (1) It was reported that, in an acute eye irritation/corrosion test with rabbits, after 100 mg of 2% powder of pure substance was applied, corneal opacity was temporarily observed but it disappeared and resolved within 7 days (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 6 (Japan Crop Protection Association, 1990)). (2) It was reported that, in an acute eye irritation/corrosion test with rabbits, 100 mg of 80% aqueous solution was applied, and after 24 hours, slight conjunctival reaction was observed in only one case but it disappeared (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 6 (Japan Crop Protection Association, 1990)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, since the details of the findings in (1) were unknown, it was not used for classification. [Reference Data, etc.] (1) It was reported that, in a Buehler test with guinea pigs, the results were negative (Agricultural Chemicals Times supplement, Agricultural chemicals technology information No. 30 (Japan Crop Protection Association, 2001)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (2,000 mg/kg, dosed once by gavage), negative results were reported (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (2) In a bacterial reverse mutation test, negative results were reported (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (3) In a chromosomal aberration test using the cultured mammalian cells (CHO), negative results were reported (Pesticides Safety Evaluation Report (Central Environment Council, 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, in (1) to (4), the administration during the sensitive period for reproductive and developmental toxicity was insufficient. Therefore, it was judged that it was difficult to assess reproductive and developmental toxicity (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). [Reference Data, etc.] (1) It was reported that, in a test with rats dosed by gavage (1. Group of rats dosed for 6 days before mating (effects on ovulation), 2. Group of rats dosed for 6 days after gestation was confirmed and sacrificed on day 10 of gestation (effects on implantation), 3. Group of rats dosed for 6 days after confirmation of gestation followed by a natural delivery and observed until weaning (effects on gestation, parturition and lactation), 4. Group of rats dosed for 6 days after start of lactation and observed until weaning (effects on development after birth)), no effects on ovulation, implantation, gestation, and lactation were observed in parental animals, and no effects on development and growth were observed in pups (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (2) It was reported that, in a test with rats dosed by gavage (days 9 to 15 of gestation), no effects of administration of the test substance were observed in both dams and fetuses (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (3) In a test with rabbits dosed by gavage (days 6 to 18 of gestation), decreases in body weight, food consumption, etc. were observed in parental animals at 450 mg/kg/day, and lower weights of litters and a slight increase in the incidence of malformations were observed in pups. Besides, it was reported that, although the increased incidence of malformations (6.6%) exceeded the upper limit of the incidence in the historical data (4.4%), there were no significant differences between the control and treated groups, and it was judged that there were no effects of administration of the test substance (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (4) It was reported that, in a test with mice dosed by gavage, no reproductive toxicity was observed (Pesticides Safety Evaluation Report (Central Environment Council, 2014)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 2 (liver, kidney). [Evidence Data] (1) It was reported that, in a 90-day oral toxicity study with rats dosed by feeding, an increase in relative liver/kidney weight (females) was observed at 300 ppm (5 mg/kg/day, within the range for Category 1) and an increase in relative liver weight (males) was observed at 1,000 ppm (50 mg/kg/day, within the range for Category 1) (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (2) It was reported that, in a 90-day oral toxicity study with rats dosed by feeding, luminal calcification in the kidney collecting duct, an increase in relative liver weight (males), reduced body weight gain (females), lower food consumption (females), and an increase in relative kidney weight (females) were observed at 300 ppm (15 mg/kg/day, within the range for Category 2). It was also reported that congestion of the kidney, an increase in hemosiderosis in the spleen and congestion of the spleen, hyalinosis of the splenic follicular arterial walls, reduced body weight gain (males), lower food consumption (males), an increase in relative kidney weight (males), and an increase in relative liver weight (females) were observed at 3,000 ppm (150 mg/kg/day, in the range corresponding to "Not classified") (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (3) It was reported that, in a 90-day oral toxicity study with mice dosed by feeding, a small round cell infiltration in the kidney (females) was observed at 160 ppm (28.2 to 33.0 mg/kg/day (males), 27.6 to 33.2 mg/kg/day (females), within the range for Category 2), and effects on the liver (increases in absolute and relative liver weight, a small round cell infiltration in the liver, focal necrosis of the liver (males)), effects on the kidney (increases in absolute and relative kidney weight (males), hyaline cast in the renal tubules (males), a small round cell infiltration in the kidney (males)), an increase in leukocyte count (males), and hemosiderosis in the spleen (females) were observed at 560 ppm (98.7 to 115.5 mg/kg/day (males), 96.6 to 116.2 mg/kg/day (females), near the upper limit of Category 2) (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (4) It was reported that, in a one-year chronic toxicity study with mice dosed by feeding, effects on the liver (a small round cell infiltration in the liver, increases in relative and absolute liver weight, cholestasis in hepatocytes (males), hepatocellular focal necrosis (females), hypertrophy of Kupffer cells (females)), an increase in leukocyte count, bile duct proliferation (males), increased ALP activity (males), and an increase in glucose (males) were observed at 100 to 400 ppm (15 to 60 mg/kg/day, within the range for Category 2) (Pesticides Safety Evaluation Report (Central Environment Council, 2014)). (5) It was reported that, in a 21-day dermal toxicity test with rabbits, marked scales and slight erythema, skin thickening, cracks, hyperkeratosis and lymphocytic/eosinophilic infiltration in the skin of the treated site, a decrease in food consumption, reduced body weight gain, an increase in relative heart weight, cardiomyocyte swelling and nuclear enlargement, and toxic nephrosis were observed at 500 mg/kg (in the range corresponding to "Not classified") (Pesticides Safety Evaluation Report (Central Environment Council, 2014)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 72-hour ErC50 = 3.54 mg a.i./L for algae (Pseudokirchneriella subcapitata) (Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2016). (a.i.: active ingredient)
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 2 because sufficient data on rapid degradability were not obtained, and it was classified in Category 2 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.
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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