NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	375-95-1
Chemical Name	Perfluorononanoic acid
Substance ID	m-nite-375-95-1_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 molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2016	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.	FY2016	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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen and fluorine (but not chlorine) which are chemically bonded only to carbon or hydrogen.	FY2016	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	FY2016	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.	FY2016	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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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.	FY2016	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)	FY2016	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)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test using rat bone marrow was negative (NTP DB (Access on June 2016)). As for in vitro, a bacterial reverse mutation test was negative (NTP DB (Access on June 2016)). 　From the above, this substance was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, in a Swedish epidemiological study examining a possible association between the exposure to perfluoroalkyl compounds and the onset of prostate cancer, it is described that increases in the risk of prostate cancer were not associated with levels of this substance in serum (draft ATSDR (2015)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 1B,	Danger	H360 H362	P308+P313 P201 P202 P260 P263 P264 P270 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.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (reproductive organs (female))	Danger	H372	P260 P264 P270 P314 P501	It is described in an epidemiological study examining a possible association between the occurrence of endometriosis and exposure to perfluoroalkyl compounds among 373 women living in the United States that significant associations were found between endometriosis and levels of this substance and perfluorooctanoic acid (PFOA) in serum (the odds ratios, after adjustment for age and BMI, were PFOA 1.89 (95% CI 1.17–3.06) and this substance 2.20 (95% CI 1.02–4.75)) (draft ATSDR (2015)). 　Therefore, this substance was classified in Category 1 (genetic organs (women)).	FY2016	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.	FY2016	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)	Classification not possible	- -	-	-	Although 72-hour EC50 = 497 mg/L for algae (Chlorella vulgaris) (AQUIRE, 2016, Latala et al., 2009) and 48-hour EC50 = 151 mg/Lfor crustacea (Daphnia magna) (AQUIRE, 2016, Ding et al., 2012), because appropriate data on water solubility were not obtained, it was classified as "Classification not possible" not as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Because appropriate information on water solubility and bioaccumulation was not obtained, it was classified as "Classification not possible."	FY2016	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.	FY2016	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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