NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	2795-39-3
Chemical Name	Potassium perfluorooctane-1-sulfonate
Substance ID	m-nite-2795-39-3_v2
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 molecule.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified	- -	-	-	From the information on perfluorooctane sulfonic acid (NFPA Hazard Classification: Flammability: 0. 0 = Materials that will not burn under typical fire conditions (HSDB (2012))), this substance was judged as not combustible similarly.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	From the information on perfluorooctane sulfonic acid (NFPA Hazard Classification: Flammability: 0. 0 = Materials that will not burn under typical fire conditions (HSDB (2012))), this substance was judged as not combustible similarly.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	From the information on perfluorooctane sulfonic acid (NFPA Hazard Classification: Flammability: 0. 0 = Materials that will not burn under typical fire conditions (HSDB (2012))), this substance was judged as not combustible similarly.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	There is a metal (K) present in the molecule, but it is estimated that it does not react vigorously with water from water solubility data of 570 mg/L (SIDS: ENV/JM/RD (2002) 17/FINAL (2002)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing fluorine and oxygen (but not chlorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (S, K). However, the classification is not possible due to no data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	It was classified in Category 3 based on an LD50 value of 251 mg/kg for rats (SIDS: ENV/JM/RD (2002)/FINAL).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	It was classified in Category 4 based on an LC50 value for rats of 5.2 mg/L/1 hour (1.3 mg/L/4 hours) (SIDS: ENV/JM/RD (2002) /FINAL). Because there is a description of exposure to dust as test conditions, a reference value for dust was applied.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	No erythema or edema was observed in any animal in a test in which 0.5 or 1 g of the test substance was applied to the skin of six rabbits for 24 or 72 hours, the primary skin irritation score was 0, and there was no irritation (SIDS: ENV/JM/RD (2002) /FINAL). Therefore, it was classified as "Not classified."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	In a test in which 0.1 g of the test substance was applied to the eyes of six rabbits, the irritation score was maximal 24 hours after the application and then decreased to 0 after 72 hours, and it was concluded that it was irritating (SIDS: ENV/JM/RD (2002) /FINAL). Therefore, it was classified in Category 2B.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow after oral administration to mice (in vivo somatic cell mutagenicity test) (GLP) (SIDS: ENV/JM/RD (2002) 17/FINAL). Besides, as for in vitro tests, it is reported that it was negative in both an Ames test and a chromosomal aberration test with human lymphocytes (SIDS: ENV/JM/RD (2002) 17/FINAL).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	In a test by 104-week diet administration of this substance to rats at concentrations of 0, 0.00005, 0.0002, 0.0005, 0.002%, followed by 52-week diet administration at a concentration of 0.002% and 52-week follow-up, there is a report on increases in the incidences of tumors in the liver, thyroid, mammary gland, but a significant dose-dependent increased trend found in both males and females was limited to hepatocellular adenoma in the liver (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). On the other hand, there is the information on humans that there was no significant increase in the standardized mortality ratio of all cancers (SMR) in the mortality investigation on workers in a PFOS manufacturing plant and a film plant of the same company. And the SMR of bladder cancer in the high exposure group was significantly high (12.77), and the SMR of bladder cancer further increased to 16.12 for workers engaged in the job at least one year, but it is reported that it could not be concluded that this substance was a cause because three male workers with bladder cancer in the high exposure group did not have a longer work history in the department manufacturing this substance (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). From the above, it was classified as "Classification not possible" because the evidence in animals was limited to an increase in hepatocellular adenoma in rats, and there is insufficient evidence of carcinogenicity in humans.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] In the developmental toxicity studies using pregnant animals in (1) to (4), an increase of malformations in fetuses was observed at the doses that caused slight maternal toxicity. In addition, in the two-generation reproduction toxicity study with rats in (5), at the doses that caused slight maternal toxicity, marked reproductive effects such as a decreased number of implantations, a marked reduction of viability index of newborns, and an increase of stillborn pups were observed in maternal parents. Therefore, it was classified in Category 1B. Based on the new information source, the category was changed. [Evidence Data] (1) It was reported that, in a developmental toxicity study with female rats dosed by gavage (1 to 10 mg/kg/day, days 6 to 15 of gestation), in maternal animals, only decreased body weight was observed in the high dose (10 mg/kg/day) group, while in fetuses, abnormalities of the eyes (lens) were observed at or above the low dose (1 mg/kg/day), and a significant increase in abnormalities of the lens was observed in the high dose group (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008), AICIS IMAP (2015), OECD (2002)). (2) It was reported that, in a developmental toxicity study with female rats dosed by gavage (1 to 10 mg/kg/day, days 6 to 15 of gestation), in maternal animals, reduced body weight gain and decreased food consumption were observed at or above the intermediate dose, and death was observed (2/25 animals) in the high dose group. In the high dose group in which maternal animals died, such as external and visceral anomalies (cleft palate, subcutaneous edema, cryptorchism), and skeletal variations were observed, while in the intermediate dose group, only lower body weight was observed (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008), AICIS IMAP (2015), OECD (2002)). (3) It was reported that, in a developmental toxicity study with female rats dosed by gavage (1 to 10 mg/kg/day, days 2 to 20 of gestation), reduced body weight gain and decreased food consumption were observed in maternal animals, but at 10 mg/kg/day at which no excessive toxicity such as death was observed, lower body weight and various malformations (increased incidences of cleft palate, absence of sternebrae, anasarca, enlarged right atrium, ventricular septal defect) were observed in fetuses (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008), DFG MAK (2015)). (4) It was reported that, in a developmental toxicity study with female mice dosed by gavage (1 to 20 mg/kg/day, days 1 to 17 of gestation), at the high dose (20 mg/kg/day) at which only reduced body weight gain and increased liver weight were observed in maternal animals, an increase in the late embryo loss rate was observed; and in fetuses, malformations such as enlarged right atrium were observed at or above 5 mg/kg/day (maternal animals: only increased liver weight) and an increase in the incidences of cleft palate, absence of sternebrae, and ventricular septal defect in two high-dose groups was observed (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008), DFG MAK (2015)). (5) It was reported that, in a two-generation reproduction toxicity study with rats dosed by gavage (F0: 0.1 to 3.2 mg/kg/day, F1: 0.1 and 0.4 mg/kg/day), reduced body weight gain was observed in F0 males at or above 0.4 mg/kg/day and in F0 females at 1.6 to 3.2 mg/kg/day, and prolonged gestation period and a decreased number of implantations were observed at the high dose. In F1 pups, a marked reduction of viability index of newborns and an increase of stillborn pups were observed at two high dose groups (1.6 and 3.2 mg/kg/day), death occurred within 4 days after birth, and it was found at the necropsy that there was no milk in the stomach. In surviving pups, lower body weight, pinna unfolding, eye opening, and delayed surface righting reflex and air righting reflex were observed. These two high dose groups could not be used for evaluation of the mating performance of F1 parental animals and evaluation of F2 pups, and the highest dose was 0.4 mg/kg/day. It was reported that there was no effect of mating between F1 animals on reproductive parameters but reduced body weight gain was observed in F2 at 0.4 mg/kg/day (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008), AICIS IMAP (2015), DFG MAK (2015), OECD (2002)). (6) Female rats were dosed by gavage at 0 (control group) or 1.6 mg/kg/day for 42 days before mating with untreated males and throughout gestation and delivered naturally. The rearing of newborns, including cross-fostering, were conducted by the following four groups: A) control dams with litters from treated dams, B) control dams with litters from control dams, C) treated dams with litters from treated dams, and D) treated dams with litters from control dams. The comparison of mortality rates in these four groups on 2 to 4 days after birth showed that mortality in C) was 19% and A) was 9%, while mortality in groups B) and D) were 1.6% and 1.1%, respectively. It was reported that this result suggested that the reduction in postnatal survival of pups in (5) was an effect caused mainly by in utero exposure in the mother's body (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008), AICIS IMAP (2015), OECD (2002)). [Reference Data, etc.] (7) In the EU, it was classified in Repr. 1B (EU CLP Classification Results (Accessed Dec. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Category 1 (systemic)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In acute toxicity tests with rats, major signs of hypoactivity, flaccid extremities, and ataxia were observed after oral administration (LD50: 251 mg/kg, doses: 100, 215, 464, and 1,000 mg/kg) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), and there is a report on principal signs such as emaciation, red material around the nose or other nasal discharge, dry rales or other breathing disturbances after inhalation administration (dust, LC50 value: 1.3 mg/L/4 hours, doses: 1.89, 2.86, 4.88, 6.49, 7.05, 13.9, 24.09, 45.97 mg/L/1 hour) (SIDS: ENV/JM/RD (2002) 17/FINAL). Doses within the guidance value range for Category 1 were included in both routes, but because it was hard to specify the target organ, it was classified in Category 1 (systemic toxicity).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, systemic)	Danger	H372	P260 P264 P270 P314 P501	In a 90-day repeated oral (feeding) administration test with rats (0, 0.003, 0.01, 0.03, 0.1, 0.3%), all the animals died in the groups at or above 0.03% where emaciation, convulsions, hunchback position, irritability, hypoactivity, etc. were observed, necropsy revealed discoloration and swelling of the liver, and hypertrophy and focal necrosis of hepatocytes were marked in males (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Furthermore, as for the liver, in a 104-week diet administration test with rats at doses all within guidance value range for Category 1 (0, 0.5, 2, 5, 20 ppm), there is a report on significant increases in the incidences of hypertrophy of hepatocytes, vacuolization of hepatocytes, eosinophilic granules, pigment deposit, and necrosis in hepatocytes (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Therefore, it was classified in Category 1 (liver). On the other hand, as for poisoning signs, it is reported that after 90-day repeated oral administration to monkeys, the animals in the 4.5 mg/kg/day group showed toxicity signs in the gastrointestinal tract such as anorexia, vomiting, and blackish feces from the weeks 1-2, and all the animals had decreased activity, severe rigidity, convulsions, whole body trembling, and prone position immediately before deaths, leading to deaths of all in the weeks 5-7 (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). The symptoms were seen within the guidance values for Category 1, but because it was hard to specify the target organ, it was classified in Category 1 (systemic toxicity).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 3.6 mg/L for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008); SIDS, 2002).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to 47-day NOEC = 0.3 mg/L (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)) and 42-day NOEC = 0.3 mg/L (SIDS, 2002) for fish (Pimephales promelas), although it is not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 96-hour LC50 = 3.6 mg/L for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008); SIDS, 2002). By drawing a comparison between the above results, it was classified in Category 2.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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