NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	3825-26-1
Chemical Name	Ammonium pentadecafluorooctanoate
Substance ID	m-nite-3825-26-1_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 molecules.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 metaloids(B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen and fluorine (but not chlorine) and these elements are chemically bonded only to carbon and hydrogen (but not to other elements).	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Containing no -0-0- structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2006	GHS Classification Manual （10 Feb, 2006）
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 4	Warning	H302	P301+P312 P264 P270 P330 P501	Category 4 based on SPECIES: Rat; ENDPOINT: LD50; VALUE: :540mg/kg; REFERENCE SOURCE: ACGIH 7th, 2001),	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	-	- Warning	-	-	Based on rabbit LD50 value: 4300mg/kg and rat LD50 value: 7000mg/kg (ACGIH 7th, 2001), the lower value was adopted and it was set as Category 5.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	There was description that the fatal doses by rat 4-hour inhalation exposure was 0.8mg/L or more (ACGIH (7th, 2001)). But there is no other data. Therefore, it cannot be classified since data is insufficient.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on the description that irritation was not observed in rabbit skin irritation test (ACGIH (7th, 2001)), it was classified as out of Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It was set as Category 2A from description that the moderate irritation was admitted in the test applied to the eye of the rabbit of ACGIH (7th, 2001) and it did not recover within seven days.	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	Category 2 based on "A3" (ACGIH, 7th, 2001)	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Category 1A,	Danger	H360 H362	P308+P313 P201 P202 P260 P263 P264 P270 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.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, endocrine system)	Danger	H372	P260 P264 P270 P314 P501	It was classified in Category 1 (liver, endocrine systems) from description in ACGIH (7th, 2001) that effects on the liver and the endocrine system was seen in the amount of dose of guidance value range of Category 1 in the oral study for 13 weeks using the rat.	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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)	Not classified	- -	-	-	It was classified as "Not classified" from 96-hour LC50 = 140 mg/L for fish (Pimephales promelas) (SIDS, 2009), 48-hour EC50 = 181 mg/L for crustacea (Daphnia magna) (Result of the initial environmental risk assessment of chemicals, Vol. 9, Ministry of the Environment in Japan, 2011), and 72-hour ErC50 > 370 mg/L for algae (Pseudokirchneriella subcapitata) (Result of the initial environmental risk assessment of chemicals, Vol. 9, Ministry of the Environment in Japan, 2011).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Despite lack of rapid degradability (a degradation rate by BOD: 7% (the existing chemicals survey program, 2002)), from 85-day NOEC = 40 mg/L for fish (Oncorhynchus mykiss) (Result of the initial environmental risk assessment of chemicals, Vol. 9, Ministry of the Environment in Japan, 2011; SIDS, 2009), 21-day NOEC = 10 mg/L for crustacea (Daphnia magna) (Result of the initial environmental risk assessment of chemicals, Vol. 9, Ministry of the Environment in Japan, 2011), 72h NOEC = 11.37 mg/L for algae (Pseudokirchneriella subcapitata) (Result of the initial environmental risk assessment of chemicals, Vol. 9, Ministry of the Environment in Japan, 2011), and BCFs of 2.0 to 4.2 and less than 5.1 to 9.4 respectively for PFOA as a dissociation product at concentrations of 50 micro g/L and 5 micro g/L in water (Hazard Assessment Report, NITE, 2005), it was classified as "Not classified."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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