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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 1763-23-1
Chemical Name Perfluoro(octane-1-sulfonate)
Substance ID m-nite-1763-23-1_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) 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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Classification not possible
-
-
- - No data available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Classification not possible
-
-
- - No data available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) substances are not available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Classification not possible
-
-
- - It is an organic compound which does not contain chlorine but contains oxygen and fluorine, and the oxygen is chemically bonded to the element other than carbon or hydrogen (S). However, the classification is not possible due to no data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 		There are three reports of LD50 values for rats of 154 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)), 251 mg/kg and > 50 - < 1,500 mg/kg (OECD ENVJMRD (2002)). Since two cases correspond to Category 3, and it is impossible to allocate a category based on the other case, it was classified in Category 3 to which the largest number of cases corresponds. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312 		Based on a report of an LC50 value (1 hour) of 5.2 mg/L (converted 4-hour equivalent value: 1.3 mg/L) for rats (OECD ENVJMRD (2002)), it was classified in Category 4. Besides, since the test substance is a solid, the reference value of dust/mist was applied. The new information obtained in this research was added, and the category was revised. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Not classified
-
-
- - There is a report that in a skin irritation test with rabbits, as a result of an application of this substance for 24 hours or 72 hours, no irritation was observed (OECD ENVJMRD (2002)). In addition, there are descriptions that this substance is not irritating (HSDB (Access on September 2015)), and that the potassium salt of this substance is not irritating to the skin (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2008)). From the above, it was classified as "Not classified." FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264 		There are reports that in a test in which this substance was applied to rabbits, slight irritation was observed (OECD ENVJMRD (2002), HSDB (Access on September 2015)). From the above, it was classified in Category 2B. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, micronucleus tests with mouse bone marrow cells were negative, a micronucleus test with rat bone marrow cells was positive (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), OECD ENVJMRD (2002), ATSDR draft (2015), HSDB (Access on September 2015)). As for in vitro, bacterial reverse mutation tests and a chromosomal aberration test with human lymphocytes were negative (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), OECD ENVJMRD (2002), HSDB (Access on September 2015)). From the above, there are both positive and negative findings in the micronucleus tests, and the inducibility for micronucleus is not clear (i.e. micronucleus findings are equivocal), therefore, it was classified as "Classification not possible." Besides, this substance was classified by using the data on the substance and its potassium salt. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501 		As for carcinogenicity in humans, in an epidemiological study targeting a cohort in US Alabama, deaths due to bladder cancers were observed in 3 workers employed for 5 years or more, the SMR (Standardized Mortality Ratio) under this condition was calculated to be 25.5 (vs expected value: 0.12), and an increased risk of bladder cancers was reported. However, since these 3 people did not have a long career in a manufacturing department, it was concluded that the relevance to exposure to this substance was not clear (OECD ENV/JM/RD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). Other than this, tumors in the kidney, testis and prostate etc. were suspected among workers in manufacturing plants of a similar substance PFOA or residents around the plants, however, it is described that it should be interpreted as a fortuitous result because the relevance to exposure to this substance was low in any case (draft ATSDR (2015)).
On the other hand, as for experimental animals, in a carcinogenicity study in which the potassium salt of this substance were administered by feeding to rats for 2 years, an increase in the incidence of hepatocellular adenomas (female and male), an increase in the combined incidence of hepatocellular adenomas and carcinomas (female), and an increase in the incidence of thyroid follicular epithelial cell adenomas (male) were observed all significantly at a high dose (20 ppm) (OECD ENV/JM/RD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). Other than these, in the female dosed group, increases in the combined incidence of thyroid follicular epithelial cell adenomas and carcinomas, and increased incidence of mammary gland tumors (mammary fibroadenomas/adenomas, carcinomas) were observed at some of 3 doses of 0.5 to 5 ppm, but a dose-response relationship was lacking (OECD ENV/JM/RD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). As for classification results by other organizations, only EU classified it as "Carc. 2" (ECHA CL Inventory (Access on September 2015)).
From the above, although the evidence for carcinogenicity in humans is inadequate, in experimental animals, tumorigenesis was observed in the liver and thyroid gland in rats. It is pointed out that opinions are divided as to whether tumorigenesis can occur in humans (draft ATSDR (2015)). However, at this time, based on the evidence on experimental animals and the classification result by EU, it was classified in Category 2 for this hazard class.
Besides, PFOA, a similar substance was classified in Category 2 on the basis that IARC classified it as Group 2B (IARC 110 (in prep)), and EU as "Carc. 2" (ECHA CL Inventory (Access on September 2015)) (please refer to this hazard class of PFOA for details). 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Category 1A,


Danger
H360
H362 		P308+P313
P201
P202
P260
P263
P264
P270
P280
P405
P501 		The epidemiological reports on the human reproductive effects of this substance (PFOS) were published mostly after 2007, and relatively recently accumulated findings are listed comprehensively in the draft ATSDR (2015). As a general summary of these, there are descriptions that this substance is detected in human breast milk and umbilical cord blood samples at a similar level to the similar substance perfluorooctanoic acid (PFOA: CAS RN: 335-67-1) (draft ATSDR (2015)), and that there is evidence suggesting that correlation between high concentrations of PFOS and PFOA in the maternal serum and low values of body weight at birth is shown based on the epidemiological study targeting general residents or residents in the high concentration contaminated area (draft ATSDR (2015)).
On the other hand, as for experimental animals, in multiple tests in which the potassium salt of this substance was orally administered to pregnant rats during the organogenesis period, an increase in the incidence of malformations (cleft palate, sternebra defects, generalized edema/subcutaneous edema, ventricular septal defects, etc.) in fetuses were observed, and similar increases in the incidence of malformations were also observed in a test with pregnant mice. Many of these were effects at the doses where maternal toxicity was observed, however, there is a report that a malformation (abnormality) of eyes (lens) was observed in fetuses at or above 1 mg/kg/day where there was no effect in the maternal rats (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), OECD ENV/JM/RD (2002), draft ATSDR (2015)). As for classification results by other organizations, EU classified as "Repr. 1B & Lact." (ECHA CL Inventory (Access on September 2015)).
From the above, since there is a risk that this substance causes low body weight babies after exposure in pregnant women, it is excreted in breast milk, and developmental toxicity including teratogenesis are clear in experimental animals, it was classified in Category 1A, and "additional category for effects on or via lactation" was added to the classification.
Besides, as for a similar structure compound of this substance PFOA, it was classified in Category 1A, additional category: effects on or via lactation on the basis that Japan Society For Occupational Health (JSOH) classified it as "reproductive toxicants Group 1" (Recommendation of Occupational Exposure Limits (2015)), and that effects on lactation are a concern because it is detected in breast milk (please refer to this hazard class of PFOA for details). 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - There is no data on humans. As for experimental animals, there is a report of decreased activity, decreased tonus of limbs, incoordination, gastrectasia, hyperemia of the gastric gland mucosa, and pulmonary congestion by oral administration of the potassium salt of this substance to rats (doses equivalent to Category 1) (Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). However, since there is no data on single exposure except this information source, it was classified as "Classification not possible" due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, blood system)


Danger
H372 P260
P264
P270
P314
P501 		There is no data on this substance.
However, a risk assessment for PFOS was conducted using the data of potassium perfluorooctanesulfonate (CAS RN.: 2795-39-3) in the OECD, Ministry of the Environment and ATSDR (OECD ENVJMRD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008), ATSDR draft (2015)), and also in this hazard class, PFOS was classified using data on potassium perfluorooctanesulfonate.
There is no available data to be used for classification in humans.
As for experimental animals, in a 90-day toxicity test with rats dosed by feeding, at doses within the range for Category 1 (2-6 mg/kg/day), effects on the liver (increases in the absolute and relative liver weights, hypertrophy and focal necrosis of hepatocytes), effects on the blood (significant decreases in erythrocyte count, hemoglobin concentration, hematocrit value, reticulocyte count and leukocyte count), additionally, effects on the gastrointestinal tract (hyperkeratosis and acanthosis of the mucosa in the forestomach, bleeding in the glandular stomach mucosa, decreases in height and density of the villi in the small intestine) were observed (OECD ENVJMRD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). In a 14-week toxicity test with rats dosed by feeding, at doses within the range for Category 1 (0.34-1.56 mg/kg/day), increases in rod nuclear neutrophils, AST activity, and urea nitrogen, a decrease in cholesterol, an increase in the liver weight, hypertrophy and vacuolation of hepatocytes were observed (OECD ENVJMRD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). In a 104-week toxicity test with rats dosed by feeding, at doses within the range for Category 1 (0.064-2.21 mg/kg/day), effects on the liver (hypertrophy of hepatocytes, vacuolization of hepatocytes, eosinophilic granules and pigment deposit in hepatocytes, necrosis of hepatocytes, histiocyte infiltration) were observed (OECD ENVJMRD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)).
In a 90-day toxicity test with monkeys dosed by gavage, at doses within the range for Category 1 (0.5-1.5 mg/kg/day), effects on the gastrointestinal tract (anorexia, diarrhea, mucous stools, bloody stools, dehydration symptoms), tremors, decreases in ALP activity and serum potassium and serum cholesterol, in addition, at 4.5 mg/kg/day, all cases died, and decreased activity, severe rigidity, convulsions, tremors of the whole body, decreased body weight, diffuse fat depletion in the adrenal glands, moderate diffuse atrophy of exocrine cells due to reduction of the enzyme granules in the pancreas, moderate diffuse atrophy due to the reduction of granules of serous cells in the bronchial glands were observed (OECD ENVJMRD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)). In a 6-month toxicity test with monkeys dosed by gavage, at doses within the range for Category 1 (0.75 mg/kg/day), necrosis of the lung with severe acute inflammation in death cases, and hyperkalemia in the case of moribund slaughter were observed. As significant effects, increases in the absolute and relative liver weights, a decrease in total cholesterol in the serum, increased thyroid stimulating hormone (TSH), decreased triiodothyronine (T3) (no evidence of hypothyroidism), decreased estradiol, and hypertrophy and vacuolization of hepatocytes were observed (OECD ENVJMRD (2002), Environmental Risk Assessment for Chemical Substances Vol.6 (Ministry of the Environment, 2008)).
From the above, effects were observed mainly in the liver, haemal system, gastrointestinal tract, and were seen in the range for Category 1. Besides, since the effect on the gastrointestinal tract was considered to be due to irritation, it was not adopted as the target organ.
Therefore, it was classified in Category 1 (liver, haemal system).
Besides, in the previous classification of this substance, data on potassium perfluorooctanesulfonate was used merely as a reference, and potassium perfluorooctanesulfonate itself was classified in Category 1 (liver, haemal system). However, since this substance was classified for this hazard class using the data on the potassium salt this time, the classification was changed from "Classification not possible" in the previous classification. 		FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 		From 96-hour LC50 = 3.34mg/L (data on potassium salt, a converted value equivalent to PFOS: 3.10 mg/L) for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), it was classified in Category 2. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501 		Due to being not rapidly degradable (BioWin), and 35-day NOEC (reproduction) = 0.232 mg/L (data on potassium salt, a converted value equivalent to PFOS: 0.216 mg/L) for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), it was classified in Category 2. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


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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