NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	117-84-0
Chemical Name	Di-n-octyl phthalate
Substance ID	m-nite-117-84-0_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	- -	-	-	From the flash point data of 215 deg C (open-cup) (HSDB (Access on August 2016)), it is estimated that it corresponds to "Not classified" also in the prescribed test method.	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 390 deg C (HSDB (Access on August 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)	- -	-	-	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)	- -	-	-	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	- -	-	-	There are 3 reported LD50 values for rats of 47,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), 53,700 mg/kg (ATSDR (1997), NICNAS (2015), PATTY (6th, 2012)), and 47,000-53,700 mg/kg (Evaluation of effect for the food safety (Food Safety Commission, 2016)). Based on these, 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	- -	-	-	From the LD50 value of 73,350 mg/kg which was converted using specific gravity of 0.978 and the LD50 value of 75 mL/kg (NICNAS (2015), Evaluation of effect for the food safety (Food Safety Commission, 2016), PATTY (6th, 2012)) for guinea pigs, it was classified as "Not classified."	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	In skin irritation tests using rabbits and guinea pigs, irritation was slight (ATSDR (1997), NICNAS (2015)). In addition, because irritation was not observed in a human patch test (NICNAS (2015)), it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In a test using guinea pigs, slight conjunctival irritation was observed, but no effects on the cornea were observed (ATSDR (1997), NICNAS (2015)). Also, it is reported that in tests using rabbits, clear results were not obtained (NICNAS (2015)) or it was negative (PATTY (6th, 2012)). As for humans, it is reported that eye irritation was observed in workers exposed to phthalates including this substance, however, NICNAS evaluated that it was the effect shown by limited data. Based on the above information, it was classified as "Not classified." Since new information was added to the information used for the previous classification and it was reexamined, classification was changed.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	In a study on 102 children of 2-7 years of age who had symptoms of wheezing, rhinitis, and eczema (control group: 82), which examined the relationship with the phthalic diester contained in a dust in the children's bedroom, no association was found between allergic symptoms and this substance (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)). On the other hand, a case is reported who developed asthma by occupational inhalation of dioctyl phthalate vapor (NICNAS (2015)). It was described that overall, data are not sufficient to determine the sensitizing activity of this substance (NICNAS (2015)). Therefore, it was classified as "Classification not possible."	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 using guinea pigs, it was negative though details such as test methods were unknown (ATSDR (1997), NICNAS (2015)). On the other hand, in a patch test conducted on workers who developed contact dermatitis, 6 out of 30 workers showed a positive reaction to dioctyl phthalate (NICNAS (2015)). It was described that overall, data are not sufficient to determine the sensitizing activity of this substance (NICNAS (2015)). Therefore, 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	- -	-	-	Classification not possible due to lack of data. There is no in vivo data. As for in vitro, bacterial reverse mutation tests were negative (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), ATSDR (1997), CEPA (1993), NICNAS (2015), NTP DB (Access on July 2016)).	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, after an intraperitoneal administration of diethylnitrosamine (DEN) following partial hepatectomy of male rats, administration of this substance by feeding for 60 to 65 weeks (5,000, 10,000 ppm) resulted in an increase in the incidence of liver carcinoma in a dose-dependent manner, and an increase in the incidence of liver tumors (adenoma, carcinoma) was also observed at 10,000 ppm in DEN non-exposure groups (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)).	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 a study using mice dosed by gavage at 9,780 mg/kg/day on gestational days of 6 to 13, reduction in the number of pups born and body weight gain was observed (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), ATSDR (1997), NICNAS (2015)). In addition, in a test using rats intraperitoneally dosed at 4,890 or 9,780 mg/kg/day on gestational days of 5, 10 and 15, low fetal body weight and an increase in the incidence of external malformations (tail absence, absence of eyes, hind legs abnormality (twist), etc.) were observed (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), NICNAS (2015)). Based on the above, it was classified in Category 2 for this hazard class. Besides, in a continuous breeding study using mice, no effects on the breeding results of F0 and F1 generations were observed (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), ATSDR (1997), NICNAS (2015)).	FY2016	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. In humans it is described that this substance may irritate the eyes, skin, nose and throat, may cause cough and shortness of breath, and may cause irritation or injury of the lungs at high concentrations (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011)), however, the original information source was HSFS which is listed in List 3, and original article could not be confirmed. Also, there is one case report that the upper respiratory tract irritation was observed in workers (plural) exposed to phthalates including dioctyl phthalate (its isomer was not specified), however, it is concluded that the data are insufficient to determine it as a respiratory irritant (NICNAS (2015)). From the above, it was classified as "Classification not possible." Besides, in the previous classification, it was classified in Category 3 (respiratory irritation) based on the information above, but as a result of re-examination of the information, the classification was changed.	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 a report of polyneuritis due to the exposure to phthalate including this substance (NICNAS (2015)), but there was no information that can identify the effect of this substance. 　In a 21-day repeated dose toxicity test using rats dosed by diet, centrilobular hepatocellular necrosis/lipid droplet, liver glycogen depletion, peroxisome proliferation of the liver, etc. were observed at 2% (converted guidance value: 233.3 mg/kg/day) which is outside of the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 9 (Ministry of the Environment, 2011), NICNAS (2015)). In a 13-week repeated dose toxicity test using rats dosed by diet, liver vacuolation, thyroid follicle size reduction, mild colloid density reduction, etc. were observed at 0.5% (350 to 403 mg/kg/day) (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Evaluation of effect for the food safety (Food Safety Commission) (2016)). In a 12-month repeated dose toxicity study using rats dosed by diet, increase in liver weight, and increase in AST and ALT were observed at 0.35% (175 mg/kg/day) which is outside the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). 　As above, mainly effects on the liver were observed, however, since all of them were observed at doses exceeding Category 2, 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, from the numerical data (viscosity: 39 mPa*s (20 degC), density (specific gravity): 0.978 (20 degC)) listed in HSDB (Access on July 2016), kinematic viscosity is calculated as 39.9 mm2/sec 20/20 degC).	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	- -	-	-	In preparation. Check the Japanese version.	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	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	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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