NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	3825-26-1
Chemical Name	Ammonium pentadecafluorooctanoate
Substance ID	H30-C-029-MHLW
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2014 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 (including chemically unstable 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	-	- -	-	-	-

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 1A, Additional category: Effects on or via lactation	Danger	H360 H362	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] From (1), for evaluation of this substance (ammoniumpentadecafluorooctanoate: APFO), data on this substance as well as pentadecafluorooctanoic acid (PFOA) can be used. It is concerned from human data in (2), (3) that exposure to PFOA during a gestation period causes an increase in delivering low body weight babies and acceleration of menopause, and developmental toxicity of this substance (and PFOA) were fully proved in animal tests (5). Therefore, it was classified in Category 1A. Moreover, because PFOA was detected in human breast milk (4), category for effects on or via lactation was added. Besides, the category was revised by the use of new information sources. [Evidence Data] (1) This substance (APFO) is the ammonium salt of pentadecafluorooctanoic acid (PFOA) and dissociates to form PFOA in vivo. Therefore, in vivo fate and effects of this substance are thought to be equivalent to those for PFOA (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). (2) Based on two study reports among many epidemiological study reports on reproductive effects, some evidence was obtained suggesting that increased serum PFOA levels cause early menopause (there is one report in which an association was not found between them). Other than this, there is a report indicating an association between serum PFOA levels and effects on reproductive hormones and sperm, but it was impossible to conclude whether there is an association due to inconsistencies among available data (draft ATSDR (2018)). (3) In an available study report on exposure in general population among many epidemiological study reports on developmental effects, an inverse association was indicated among maternal serum PFOA levels and birth weight of children. Many other studies did not find associations. As the result of a systematic review and multiple analyses of these data, it was concluded that there was sufficient evidence that maternal serum PFOA levels are associated with decreased fetal growth. A slight decrease in birth weight was associated with an increase in maternal serum PFOA levels (< 20 g decrease in body weight per an increase of 1 ng/mL serum PFOA levels) (draft ATSDR (2018)). (4) Numerous perfluoroalkyl compounds including PFOA were detected in breast milk samples in many countries such as Japan, China, Korea, and the USA (draft ATSDR (2018)). (5) As for experimental animals, in many developmental toxicity tests in which mainly pregnant mice were orally dosed with this substance (APFO), prenatal losses, decreases in neonatal body weight, increased pup mortality, and neurodevelopmental toxicity were found in fetuses or live born as characteristic developmental effects, and mammary gland developmental disorder, delays in eye opening, vaginal opening, and a start of the first estrus cycle and so on are further reported. Moreover, these effects occurred mostly in the situations where maternal animals did not show marked toxicity (draft ATSDR (2018), NICNAS IMAP (Accessed Oct. 2018)). [Reference Data, etc.] (6) Japan Society for Occupational Health (JSOH) classified it in reproductive toxicity substance Group 1, by stating that there are many human epidemiological reports on the reproductive toxicity of PFOA and that there are many reports on developmental toxicity in experimental animals (OEL Documentations (Reproductive toxicant classification) (Japan Society For Occupational Health (JSOH)) (2014)). (7) Both this substance (APFO) and PFOA are classified in Repr. 1B & Lact. in EU CLP.
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 (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
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.

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