NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	84-66-2
Chemical Name	Diethyl phthalate
Substance ID	m-nite-84-66-2_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 molecules.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified	- -	-	-	Flash point: >93degC	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified	- -	-	-	Flash point: 457degC (ICSC (J), 2001)	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 metaloids(B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen (but not chlorine and fluorine) chemically bonded only to carbon and hydrogen (but not to other elements).	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Containing no -0-0- structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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	- -	-	-	Rat LD50 value: 8600mg/kg (MOE Risk Assessment the 3rd volume (2004), NTP TR429 (1995)), 9200 - 9500mg/kg (CICAD 52 (2003)) and 9500 - 31000mg/kg (ACGIH 7th (2001), Advice of Sanei Society (1995)). Based on the values above, it was considered as out of category.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on rat LD50 value: >22400mg/kg and >11200mg/kg (IUCLID, 2000), it was set as the outside of Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	From description that death was not acknowledged in the test using the rat (PATTY 4th (1994)) by 511ppm of 6-hour exposure (4-hour equivalent 6.95mg/L), it was set as the outside of Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	There is description that human skin is not stimulated (NTP TR429 (1995) and PATTY (4th, 1994)), and that the irritation in the examination which used the animal is slight (NTP TR429 (1995), ATSDR (1995), and PATTY (4th, 1994)). But also there is description that irritation was admitted in 2 examples among 143 examples by the patch test for the humans (the 3rd volume of MOE Risk Assessment (2004) and CICAD 52 (2003)), and that dermatitis and eczema were admitted by adhesion on the skin (the 3rd volume of MOE Risk Assessment (2004) and Occupational Health Recommendation of Occupational Exposure Limits (1995)). So it was judged that there was skin irritation in some humans, and it was set as Category 2.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	We found a description that it had no irritant property in the test applied to the eyes of the rabbits (CICAD 52 (2003)), and a description that very slight irritation was acknowledged in the eyes of the rabbits (CICAD 52 (2003) and ATSDR (1995)). However, we found a description that it stimulated the eyes of the rabbits slightly and it stimulated the human eyes (NTP TR429 (1995)). Therefore we classified it as Category 2B.	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	We found the description that sensitizing property was not acknowledged in Buehler test which used the guinea pigs, Draize test, Freund's complete adjuvant test, maximization test and open epicutaneous test in IUCLID (2000) or BUA 104 (1994), and we found the description that the allergic reactions was not acknowledged by the patch test for human in MOE Risk Assessment The 3rd volume (2004), CICAD 52 (2003), ATSDR (1995) and it is enrolled in PATTY (4th, 1994) that it has no sensitizing property, however, according to the descriptions of MOE Risk Assessment the 3rd volume (2004), CICAD 52 (2003), and ATSDR (1995), the allergic reactions was acknowledged by one example respectively in patch tests in different institutions, therefore we classified it as 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Not classified	- -	-	-	Since it was classified into A4 (ACGIH 7th, 2001) in ACGIH and D (IRIS, 2005)in EPA, it was considered as the outside of Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Not classified	- -	-	-	It was considered as out of category based on the description that specific reproductive toxicity was not observed at the dose in which general toxicity is observed in parental animals in an oral administration examination during the pregnancy and a two-generation reproductive study using the rat and mouse (MOE Risk Assessment the 3rd volume (2004), CICAD 52 (2003), ACGIH (7th, 2001), NTP TR429 (1995), industrial hygene academic recommendation (1995) and ATSDR (1995)).	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	From description in MOE Risk Assessment the 3rd volume (2004), ACGIH (7th, 2001), Society for Occupational Health Recommendation of Occupational Exposure (1995) and PATTY (4th, 1994) that vapor stimulates respiratory tracts, description in MOE Risk Assessment the 3rd volume (2004) that when inhaling, giddiness and hypesthesia will be caused, and description in PATTY (4th, 1994) that the central nervous system may be restrained. So it was set as Category 3 (respiratory irritation, anesthesia action).	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Not classified	- -	-	-	It was considered to be the Out Of Category based on the descriptions that toxic effects were not observed for the high doses which exceeds the guidance value range of Category 2 in oral or the dermal administration tests using the rat or mouse (MOE Risk Assessment 3rd volume (2004), CICAD 52 (2003), ACGIH (7th, 2001), NTP TR429 (1995), ATSDR (1995), and IRIS (2005)).	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 1.2 mg/L for fish (Oncorhynchus mykiss) (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It was classified as "Not classified" due to rapid degradability (readily biodegradable, an average degradation rate by BOD: 88% (J-CHECK, 1999)), 21-day NOEC (reproduction inhibition) = 3.8 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)), and 72-hour EC10 (growth rate) = 22.9 mg/L for algae (Pseudokirchneriella subcapitata) (EPA AQUIRE: 2018, Jonsson, S. et al. (2003)).	FY2018	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.	FY2018	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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