NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	68515-50-4
Chemical Name	Di(branched and linear hexyl) phthalate
Substance ID	R02-A-012-MHLW
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
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	Not classified	- -	-	-	It was classified as "Not classified" based on a flash point of 192 deg C (test method: unknown) (RAC Background Document (2013)).
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	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 500 deg C (RAC Background Document (2013)).
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	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) This substance was not irritating in a skin irritation test with rabbits (Patty (6th, 2012)). (2) This substance did not cause skin irritation or sensitization in a test in human volunteers (repeat insult patch tests) (Patty (6th, 2012)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) This substance caused slight conjunctival irritation in an eye irritation test with rabbits, but the score was 0 at 24 hours after application, and there was no chemosis or iridial effects (Patty (6th, 2012)).
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] There is a description of (1), but the classification is not possible due to lack of data. [Reference Data, etc.] (1) This substance did not cause skin irritation or sensitization in a test in human volunteers (repeat insult patch tests) (Patty (6th, 2012)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. [Evidence Data] (1) As for in vivo, in a micronucleus test with mice, negative results were reported (Patty (6th, 2012)). (2) No in vitro data available.
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] Based on (1) and (2), it was classified in Category 1B. [Evidence Data] (1) For this substance (DHP), no fertility or developmental toxicity study with mammals was available, but it was proposed to classify it in Repr. 1B by the read-across method based on the data of six phthalates with a 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, di-n-hexyl phthalate (DnHP) CAS RN 84-75-3, diethylhexyl phthalate (DEHP) CAS RN 117-81-7) (CLH Report (2012)). (2) DIBP, DBP, DPP, DEHP, and DnHP were classified in Category 1B for reproductive toxicity in the GHS classification by the Japanese government (classification in FY 2018, 2013, 2008, 2014, and this fiscal year (2020) respectively). Furthermore, for DEHP, an 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.] (3) In the EU CLP classification, it was classified as Repr.1B (Classification in EU CLP (Access on October 2020)).
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] There was information in (1) and (2), but it was not sufficient for classification. Therefore, classification was not possible due to lack of data. [Reference Data, etc.] (1) It was reported that in a 13-week test with rats dosed by feeding, in a 0.05% group (the dose was increased to 1.0% (776 mg/kg/day) in week 7 and a 3.0% group (2,298 mg/kg/day) in week 12), effects on the male reproductive organs (a decrease in testis weight, atrophy of spermatogenic epithelium) were observed, and reduced body weight gains, a decrease in food consumption, respiratory distress, stiff gait, rigid tail, decreases in weight of the gonad, spleen, kidney, and adrenal gland, an increase in liver weight, eosinophilic areas, variations in the size of the nuclei, etc. in the liver were also observed (CLH Report (2012)). (2) It was reported that in a 13-week test with dogs dosed by feeding, in a 5.0% group (the dose was 0.1% at the start and was increased to 5.0% in weeks 9-13), an increase in liver weight in males and females, and a decrease in testis weight, atrophy of seminiferous tubular epithelium, and enlarged hepatic cells in males were observed (CLH Report (2012)).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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