NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	68515-48-0,28553-12-0
Chemical Name	Diisononyl phthalate (DINP); Dinonyl phthalate
Substance ID	m-nite-68515-48-0_v2
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)
Sample SDS by MHLW (External link)
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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	It corresponds to "Not classified" from a flash point of 240 deg C (GESTIS (Access on June 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 375 deg C (GESTIS (Access on June 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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 liquid 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)	- -	-	-	Not containing 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)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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	- -	-	-	No data 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)	Not classified	- -	-	-	Based on four reported LD50 values of > 9,800 mg/kg (EU-RAR (2003), Evaluation of effects on food safety (Food Safety Commission, 2015), HSDB (Access on August 2016)), > 10,000 mg/kg (EU-RAR (2003), NICNAS (2012), PATTY (6th, 2012), Evaluation of effects on food safety (Food Safety Commission, 2015), HSDB (Access on August 2016)), > 40,000 mg/kg and > 50,000 mg/kg (EU-RAR (2003), NICNAS (2012), Evaluation of effects for food safety (Food Safety Commission, 2015)) for rats, it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a reported LD50 value of > 3,160 mg/kg (EU-RAR (2003), NICNAS (2012), PATTY (6th, 2012), Evaluation of effects on food safety (Food Safety Commission, 2015), HSDB (Access on August 2016)) for rabbits, it was classified as "Not classified" (Category 5 in UN GHS classification).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	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: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There are three reports of LC50 values (4 hours) of > 0.067 mg/L, > 0.07 mg/L (EU-RAR (2003), Evaluation of effects on food safety (Food Safety Commission, 2015)), > 4.4 mg/L (EU-RAR (2003), NICNAS (2012), Evaluation of effects on food safety (Food Safety Commission, 2015)) for rats, however, since it is not possible to specify the category only from these values, it was classified as "Classification not possible." 　Besides, the reference value in the unit of mg/L was applied as mist since these LC50 values are higher than the saturated vapor pressure level (11.2 ng/L).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test (OECD TG 404, applied for 4 hours) using rabbits, very slight erythema (score 1) was observed after 24 hours but disappeared after 48 hours. Also in a test with a severe condition of 24-hour occlusive application, transient slight erythema and edema were observed but quickly disappeared, and the mean score was less than 1.0 for both (EU-RAR (2003), NICNAS (2012)). In addition, skin irritation was not observed in a human patch test on volunteers (EU-RAR (2003), NICNAS (2012)). From these results, it was concluded that skin irritation was very slight (EU-RAR (2003), NICNAS (2012)), and it was classified as "Not Classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In an eye irritation test (OECD TG 405) using rabbits, slight to medium conjunctival redness (score 4.3) was observed after 1 hour, but was relieved after 24 hours (score 0.33) and disappeared thereafter. In addition, also in eye irritation tests (2 tests) using rabbits, transient conjunctival redness or discharge was observed, but disappeared after 48 hours (EU-RAR (2003), NICNAS (2012)). From these results, it was concluded that eye irritation was very slight (EU-RAR (2003), NICNAS (2012)), and it was classified as "Not classified."	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	- -	-	-	In a skin sensitization test (Buehler test) using guinea pigs, although a challenge after 2 weeks was negative, slight erythema was observed in 14 out of 20 animals and slight edema was observed in 1 animal at the re-challenge after 3 weeks, and weak sensitization was suggested (EU-RAR (2003), NICNAS (2012)). On the other hand, another skin sensitization test (Buhler method) using guinea pigs was negative (EU-RAR (2003), NICNAS (2012)). Additionally, in a human patch test on volunteers, skin reaction was not observed in either the pilot study with 28 subjects or the definitive study with 76 subjects (EU-RAR (2003), NICNAS (2012)). Because conflicting results were obtained, it was classified as "Classification not possible."	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 chromosome aberration test using bone marrow cells of rats is negative (NICNAS (2012), EU-RAR (2003)). As for in vitro, bacterial reverse mutation tests, mouse lymphoma assays and a chromosome aberration test using cultured mammalian cells are negative (NICNAS (2012), EU-RAR (2003), NTP DB (Access on July 2016)). From the above, it was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In 2-year carcinogenicity studies using rats or mice administered by feeding, increased incidence of liver neoplasms such as hepatocellular carcinomas was observed. This is thought to be due to peroxisome proliferation (EU-RAR (2003), NICNAS (2012), PATTY (6th, 2012)). It is thought that from the studies using DEHP (bis (2-ethylhexyl phthalate)), liver tumor induction by peroxisome proliferation-mediated mechanism is a rodent-specific phenomenon and does not occur in humans (EU-RAR (2003)). In addition, mononuclear cell leukemia (MNCL) was observed in two 2-year tests using Fischer 344 rats administered by feeding, but MNCL is a common neoplasm in this strain of rats. IARC categorized MNCL as an unclassified leukemia with no known human counterpart and it is concluded that the possibility of extrapolation to humans is low (EU-RAR (2003), NICNAS (2012), PATTY (6th, 2012)). Other than these, renal tubular neoplasm was found in one study in male rats, but it is thought that it is due to the alpha 2u-globulin-mediated mechanism and is not relevant to humans (EU-RAR (2003), NICNAS (2012), PATTY (6th, 2012)). As above, in experimental animals, tumors in the liver and the kidneys, and leukemia were observed, however, all of them are considered to be specific to experimental animals and not relevant to humans. Human carcinogenicity of this substance is still unknown, and it was classified as "Classification not possible" for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There is no data on single exposure of this substance in humans. As for animal studies, poor health state, respiratory difficulties, and altered appearance (piloerection, dirty fur, etc.) were observed after oral administration to rats of a very large amount of this substance exceeding guidance value range of Category 2. However, there were no deaths, and abnormality was not observed even at necropsy (EU-RAR (2003)). Skin erythema was observed by dermal administration to rabbits of the amount exceeding the guidance value range of Category 2, but all animals survived and systemic toxicity symptoms were also not observed (EU-RAR (2003)). Furthermore, in acute inhalation studies using rats at doses of the guidance value ranges of Category 2, except for slight lacrimation and nasal discharge, weight loss and macroscopic lesions were not observed, and no abnormal findings were observed by microscopic observation of the lung, liver and kidneys (EU-RAR (2003)). From the above, the effects of this substance in animal experiments were observed only when they were exposed to a very large amount of this substance. Therefore, it was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	As for humans, there is no information with clear relevance to this substance. 　As for experimental animals, repeated dose toxicity tests etc. using rats, mice, dogs, and monkeys administered by the oral route have been plurally carried out, and lesions in the liver, kidneys, testis, etc. have been reported, however, no toxic effects which can be evidence of the classification were observed within the range of Category 2 (NICNAS (2012), Risk Assessment Report (Apparatuses, Containers and Packages) (Food Safety Commission of Japan, 2015), EU-RAR (2003)). 　Therefore, it was classified as "Classification not possible."	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. Besides, there is data that the kinematic viscosity at around 40 deg C is 37 mm2/sec (37.8 deg C) (HSDB (Access on July 2016)).	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)	Not classified	- -	-	-	From 48-hour EC50 >= 0.086 mg/L for crustacea (Daphnia magna) and 96-hour LC50 >= 0.14 mg/L for fish(Pimephales promelas) (both EU-RAR, 2003), it was classified as "Not classified."	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" for acute toxicity, and it was a poorly water-soluble substance (water solubility 0.2 mg/L (PHYSPROP Database 2009)) but rapidly degradable (a degradation rate by BOD: 74 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)). Therefore, it was classified as "Not classified."	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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