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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	335-67-1
Chemical Name	Perfluorooctanoic acid
Substance ID	24A6103
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2005)).
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2005)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (J) (2005)).
12	Substances and mixtures which, in contact with water, emit flammable gases	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).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing fluorine and oxygen which are chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Besides, there is the information that it attacks many metals (ICSC (J) (2005)).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	No data available. Besides, as for health hazards, also refer to ammonium perfluorooctanoate (CAS RN 3825-26-1), the ammonium salt of this substance.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	It is reported that there were no deaths at > 18.6 mg/L/1 hour (converted value: 4.65 mg/L/4 hours) in a test with rats (SIDS (2006)), but the category cannot be determined. Therefore, it was classified as "Classification not possible." Because the test was conducted at or below 90% of the saturated vapour pressure concentration (12 mg/L), a reference value of gas was applied.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test report. Besides, as for in vitro tests, there are reports on a negative result in an Ames test (ATSDR (2009) DRAFT), and a positive result in a micronucleus test with HepG2 cells (OEL Documentations Vol. 50 (Japan Society For Occupational Health (JSOH), 2008)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available. Besides, the ammonium salt of this substance was classified in A3 by ACGIH (ACGIH (2001)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a test in which mice were orally administered 5 mg/kg/day during a gestation period, there were no significant effects in body weights of maternal animals, but the administration on gestational days 1-17 caused a significant increase in prenatal losses compared to the control group (ATSDR (2009) DRAFT). And in another test in which mice were orally administered 1-40 mg/kg/day on gestational days 1-17, maternal animals showed reduced weight gain at or above 20 mg/kg/day, there was a significant increase in the incidence of all litter resorptions at or above 5 mg/kg/day, the 20 mg/kg/day group showed a significant decrease in the number of live fetuses and a significant increase in prenatal losses, and there were no live fetuses due to full-litter resorptions in the 40 mg/kg/day group. Furthermore, minor defects such as kinky or bent tails or limbs in fetuses at or above 5 mg/kg/day, and delayed ossification of phalanges and supraoccipital bones and microcardia in fetuses at or above 10 mg/kg/day were observed (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)). On the other hand, in a test to allow a natural delivery at the same conditions, the number of stillbirths and the mortality of newborns were high in the 5 mg/kg/day group, and about half of newborns died within one day at or above 10 mg/kg/day (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011)). From the above, adverse developmental effects such as a decrease in the number of live fetuses and morphological anomalies in offspring were observed at the doses where maternal animals did not show decreased body weights or reduced weight gain, which are general toxicity parameters. Therefore, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	In a 21-day drinking water administration test with mice (doses: 0.5, 2.6, 18, 47 mg/kg/day), there were significant increases in serum ALT at or above 2.6 mg/kg/day (converted guidance value: 0.61 mg/kg/day) and serum AST at or above 18 mg/kg/day (converted guidance value: 4.2 mg/kg/day), and destruction of hepatic plate and remarkable hepatocytomegaly with acidophilic cytoplasm at or above 18 mg/kg/day (converted guidance value: 4.2 mg/kg/day), and diffuse hepatic damage characterized by multifocal coagulation and liquefaction necrosis at or above 47 mg/kg/day (converted guidance value: 11 mg/kg/day) were observed (ATSDR (2009) DRAFT). Because the effects were also seen at the doses within the guidance values for Category 1, it was classified in Category 1 (liver). Besides, in a 2-year diet administration test with rats, at 15 mg/kg/day (no examination at the doses below), there is a report on worsening of liver function test values such as increases in serum ALT and AST, and histologically, focal enlargement and necrosis of hepatocytes, portal mononuclear cell infiltration, slight vacuolization of hepatocytes, etc. (ATSDR (2009) DRAFT), but no apparent liver effects were found in human epidemiological surveys, and it is reported that serum AST and ALT activities increased only in obese workers in a cross-sectional study of 115 workers occupationally exposed (ATSDR (2009) DRAFT).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour EC50 = 90 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011); SIDS, 2009).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour NOEC = 63 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2009), 7-day NOEC (reproduction) = 3.125 mg/L for crustacea (Moina macrocopa), and 39-day NOEC (lethal) > 74.1 mg/L for fish (Pimephales promelas) (both Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), although it is not rapidly degradable (not readily degradable, a degradation rate by BOD: 5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)).
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.

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