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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	68515-48-0,28553-12-0
Chemical Name	Diisononyl phthalate [DINP]
Substance ID	H28-A-036, C-085A
Classification year (FY)	FY2016
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
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)
Model SDS by MHLW (External link)
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	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	It corresponds to "Not classified" from a flash point of 240 deg C (GESTIS (Access on June 2016)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
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)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13	Oxidizing liquids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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."
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).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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).
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."
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."
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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."
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."
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.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Although there was no effect on fertility in either a one-generation study or two-generation study using rats administered by the oral route (administered by feeding), in the one-generation study, reduction in survival rate of offspring was observed at a high dose (15,000 ppm) at which general toxicity (suppression in body weight gain, decrease in food consumption and variations of reproductive organ weights) was observed in the parental animals (EU-RAR (2003), NICNAS (2012)). In addition, in a developmental toxicity study using pregnant rats administered by gavage during the organogenesis stage, in fetuses, skeletal variations (rudimentary lumbar and cervical ribs, or accessory ribs) as well as a dilated renal pelvis and hydroureter were observed with a high frequency at 1,000 mg/kg/day at which maternal toxicity (body weight gain suppression, decrease in food consumption) was observed (EU-RAR (2003), NICNAS (2012)). As described above, this substance was classified in Category 2 for this hazard class, since the effects were observed in offspring and fetuses at the general toxic dose of the parental animals.
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."
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."
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)).

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)	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."
11	Hazardous to the aquatic environment (Long-term)	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."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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