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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	375-95-1
Chemical Name	Perfluorononanoic acid
Substance ID	H30-C-028-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	FY2016
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 1B, Additional category: Effects on or via lactation	Danger	H360 H362	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] As for experimental animals, in multiple oral administration tests in pregnant animals, at doses where maternal animals did not have serious effects, developmental effects (growth retardation, decreased survival rate and so on) were found in offspring (1)-(3). From (4), developmental effects of this substance (perfluorononanoic acid: PFNA) are thought to be practically similar to effects of perfluorooctanoic acid (PFOA), perfluoro(octane-1-sulfonic acid) (PFOS). From the above, although there are extremely few data for this substance when compared with those for PFOA and PFOS, similar developmental toxicity was observed in animal test results available for this substance. However, because there is no sufficient evidence to suggest reproductive developmental effects in humans as shown in (6), it was classified in Category 1B for this hazard class. Besides, the category was revised by considering animal test results. Moreover, on the basis that this substance was detected in serum, cord blood, and human breast milk (5), category for effects on or via lactation was added. [Evidence Data] (1) As the result of administering this substance by gavage to pregnant mice at 0.83-2.0 mg/kg/day on gestational days 1-18 and observing offspring until weaning, at all the doses where increased liver weight was found in maternal animals, increased liver weight was observed in offspring. Moreover, a decrease in litter size at 1.1 and 2.0 mg/kg/day and decreased survival rate and decreased number of live pups per litter at 2.0 mg/kg/day were observed (draft ATSDR (2018)). (2) As the result of administering this substance by gavage to pregnant mice at 1-5 mg/kg/day (the 10 mg/kg/day group, that was the highest dose when the test was started, was terminated on the gestational day 13 due to marked maternal toxicity) on gestational days 1-17 and monitoring offspring for a long time, at the doses (1-5 mg/kg/day) where increased liver weight was found in maternal animals, decreased body weight gain, delayed sexual maturation, and decreased survival rate were observed in offspring (draft ATSDR (2018)). (3) As the result of administering this substance by gavage to pregnant rats at 5 mg/kg/day on gestational days 1-20 and monitoring offspring for a long time, decreased body weight in maternal animals, and decreases in birth weight, increases in blood pressure (at 10 weeks of age), and reductions in nephron endowment in offspring were observed in a dosed group (draft ATSDR (2018)). (4) From oral administration test results in rodents, common adverse effect of many perfluoroalkyl compounds such as this substance (PFNA), pentadecafluorooctanoic acid (PFOA), perfluoro(octane-1-sulfonic acid) (PFOS) are developmental effects, and decreased body weight, decreased survival rate and so on in offspring are reported (draft ATSDR (2018)). (5) Although data on exposure to this substance (PFNA) in humans are limited, it was detected in serum, cord blood, and human breast milk (Proposal for identification of SVHC (2015)). [Reference Data, etc.] (6) By evaluating the whole epidemiology data on 14 kinds of perfluoroalkyl compounds including this substance, PFOA, and PFOS, ATSDR used a weight-of-evidence approach to evaluate whether the available data supported a link between perfluoroalkyl exposure and a particular health effect. As a result, it is concluded that there is sufficient knowledge to support an association between blood levels for PFOA and PFOS and reproductive developmental effects in humans, but there is not yet strong evidence to support an association between exposure to this substance and reproductive developmental effects. Besides, it is reported in a study on general people (n = 473) that a significant association (odds ratio: 2.20) was found between an increased risk of endometriosis and serum levels of this substance, however, after adjustment for a confounder, odds ratio became 1.99, and significance disappeared (draft ATSDR (2018)). (7) It was 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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