NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	71850-09-4
Chemical Name	Diisohexyl phthalate
Substance ID	R02-A-005-MHLW, MOE
Classification year (FY)	FY2020
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 (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Classification not possible	- -	-	-	No data available.
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
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. It was classified as "Not classified."
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
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). It was classified as "Not classified."
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. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] No data available.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There was no data on this substance, but based on (1) to (4), it was classified in Category 1B. [Evidence Data] (1) A mixture (mainly DIHP, containing DnHP < 25%) consisting of this substance (DIHP) and linear di-n-hexyl phthalate (DnHP: CAS RN 84-75-3) was dihexyl (branched/linear) = phthalate (DHP: CAS RN 68515-50-4) (RAC (Background Document) (2017)). (2) In the GHS classification by the Japanese Government, DnHP was classified in Category 1B based on toxicity on the male reproductive organs, effects on fertility, and developmental effects (an increase in dead fetuses, cleft palate, abnormality in the eye, a decrease in anogenital distance of male fetuses, an increase in undescended testes, etc.) as evidence (this year (2020)). DHP was classified in Repr.1B by the read-across method based on the data of six kinds of phthalates with similar structure in the EU, and 5 out of 6 kinds were classified in Category 1B in the GHS classification by the Japanese Government, and on the basis of them, it was classified in Category 1B (this year (2020)). (3) For this substance, there was no available fertility or developmental toxicity study with mammals, but it was proposed to classify it in Repr. 1B by the read-across method based on the data of phthalates with similar structure (diisobutyl phthalate (DIBP) (CAS RN 84-69-5), di-n-butyl phthalate (DBP) (CAS RN 84-74-2), diisopentyl phthalate (DIPP) (CAS RN 605-50-5), di-n-pentyl phthalate (DPP) (CAS RN 131-18-0), diethylhexyl phthalate (DEHP) (CAS RN 117-81-7), di-n-hexyl phthalate (DnHP) (CAS RN 84-75-3), 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (DHP) (CAS RN 68515-50-4)) (EU CLP CLH (2017), Classification in EU CLP (Access on June 2020)). (4) Among the phthalates in (3) above, in addition to the substances shown in (2), DIBP, DBP, DPP, and DEHP were classified in reproductive toxicant Category 1B in the GHS classification by the Japanese Government (2018, 2013, 2008, and 2014 respectively). Furthermore, for DEHP, the additional category (effects on or via lactation) was added (Classification in 2014). For DIPP, the GHS classification by the Japanese Government has not been done to date. [Reference Data, etc.] (5) DHP and DnHP were already classified in Repr. 1B as a reproductive toxicant in the EU (Classification in EU CLP (Access on June 2020)). (6) In DPP, DnHp, and DEHP, reproductive toxicity findings (decreases in reproductive capacity and a number of viable pups, effects on the male reproductive organs (testis lesions)) were observed; and in DIBP, DBP, DPP, DnHP, and DEHP, developmental toxicity findings (a decrease in anogenital distance, degeneration of the seminiferous tubules, and damage of the testis) were observed (EU CLP CLH (2017)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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