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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	84-75-3
Chemical Name	Dihexan-1-yl phthalate; DnHP
Substance ID	R02-A-013-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 (2011)).
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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats: 29,600 mg/kg (HSDB (Access on August 2020), Patty (6th, 2012)) (2) LD50 for rats: > 29,600 mg/kg (GESTIS (Access on August 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rabbits: > 19,800 mg/kg (GESTIS (Access on August 2020)) (2) LD50 for rabbits: 20,000 mg/kg (HSDB (Access on August 2020)) (3) LD50 for rabbits: 20 mL/kg (LD50 value converted with specific gravity of 1.01: 20,200 mg/kg) (Patty (6th, 2012))
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 slightly irritating to the skin (AICIS (formerly, NICNAS) IMAP (2016)). (2) This substance was slightly irritating in a skin irritation test with rabbits (Draize test) (GESTIS (Access on August 2020)).
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. [Evidence Data] (1) No in vivo data available. (2) As for in vitro, in a bacterial reverse mutation test, negative results were reported (AICIS (previous NICNAS) IMAP (2016), NTP CERHR (2003), CEBS (Access on August 2020)).
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) In a continuous breeding test with mice dosed by feeding, at doses at which no toxicity effects were observed in parental animals, reduced fertility (decreases in the number of live pups per litter and the proportion of live pups) was observed. In a histopathological examination which was conducted only for the control group and the high-dose group, a decrease in testis weight, significant effects on epididymal sperm concentration and motility, and extensive atrophy of the seminiferous tubules were observed in males in the high-dose group, and the result of a crossover mating test showed a decrease in mating capability in males (EU CLP CLH (2011), RAC Background Document (2011)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 20 of gestation, an increase in post-implantation embryo resorption and an increase in fetal death (by 60% compared to the control group) were observed at 750 mg/kg/day, malformations (cleft palate, eye defects) were observed at or above 500 mg/kg/day, and a significant decrease in fetal body weight, etc., increases in delayed ossification and skeletal variations were observed at 250 mg/kg/day. A decrease in anogenital distance in male fetuses was observed at or above 250 mg/kg/day and an increase in undescended testes was observed at or above 500 mg/kg/day (EU CLP CLH (2011), RAC Background Document (2011)). [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. [Reference Data, etc.] (1) Water-insoluble plasticisers for coating raw materials and plastics that include this substance could trigger paraesthesia in the nose and throat as well as bronchitis after the inhalation of the respective aerosols, dusts or vapors (GESTIS (Access on August 2020)).
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 21-day oral toxicity study by administration of this substance to rats dosed at 20,000 ppm (1,824 mg/kg/day, exceeding Category 2) by feeding, an increase in liver weight, centrilobular necrosis, a decrease in glycogen, centrilobular fatty accumulation, proliferation and dilation of smooth endoplasmic reticula in the bile canaliculi, shortening of microvilli in the bile canaliculi, lipid droplets around the central veins, and an increase in peroxisomes were observed (RAC Background Document (2011)). (2) It was reported that in a 21-day oral toxicity study by administration of this substance to rats dosed at 2% (2,000 mg/kg/day, exceeding Category 2) by feeding, a decrease in serum T4 levels, an increase in thyroid activity with histopathological alterations, and fat accumulation in the liver were observed (RAC Background Document (2011)).
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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