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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	2795-39-3
Chemical Name	Potassium perfluorooctane-1-sulfonate
Substance ID	R03-C-072-MHLW
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2012
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)	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	-	- -	-	-	-
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	-	- -	-	-	-
17	Desensitized explosives	-	- -	-	-	-

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	-	- -	-	-	-
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)).
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 Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
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.
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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