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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	119-06-2
Chemical Name	Di(tridecyl) phthalate
Substance ID	R02-A-059-METI, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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)
Model SDS by MHLW (External link)
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	From information obtained on a flash point of 243 deg C (open cup) (HSDB (Accessed Aug. 2020)), it is estimated that it exceeds 93 deg C in the prescribed closed-cup method. Therefore, it was classified as "Not classified."
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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.
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 400 deg C (ECHA (Accessed Aug. 2020)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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).
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.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
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.

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 (males): > 2,000 mg/kg (OECD TG 401, GLP) (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law result (Ministry of Health, Labour and Welfare, 1997), DFG MAK (2019)) (2) LD50 for rats (females): > 2,000 mg/kg (OECD TG 401, GLP) (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law result (Ministry of Health, Labour and Welfare, 1997), DFG MAK (2019))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LC50 for rabbits (males): > 19,000 mg/kg (DFG MAK (2019))
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. Besides, (1) was not used for classification because evaluation methods are unknown. [Reference Data, etc.] (1) It is reported that in a skin irritation test with rabbits (n = 5) (open application, 24-hour observation), the primary skin irritation index was 2 (maximum: 10) (MAK DFG (2019)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, (1) was not used for classification because evaluation methods are unknown. [Reference Data, etc.] (1) It is reported that in an eye irritation test with rabbits, the primary eye irritation index was 2 (maximum: 10) (DFG MAK (2019)).
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. [Reference Data, etc.] (1) In a bacterial reverse mutation test, negative results were reported (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (Accessed Sep. 2020), NICNAS (2008), HSDB (Accessed Sep. 2020)). (2) In a chromosomal aberration test using Chinese hamster lung fibroblasts (CHL), negative results were reported (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (Accessed Sep. 2020), NICNAS (2008), HSDB (Accessed Sep. 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
7	Reproductive toxicity	Category 2, Additional category for effects on or via lactation	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2, and effects on lactation were added. [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, GLP, for a total of 42 days from 14 days before mating (males), from 14 days before mating until day 3 of lactation (females)), at 250 mg/kg/day, general toxicity effects (reduced body weight gain (females), effects on the liver and the kidney (males and females)) and nursing failure (2/13 cases) were observed in parental animals; and a significantly lower live birth index and a decrease in viability index of live pups were observed in pups. Concerning the decrease in viability index of live pups, 50% or more of the pups of 2/13 of dams died within several days post partum, and it was considered to be affected by nursing failure (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1996), HSDB (Accessed Sep. 2020)). Based on the decreased amount of lactation observed in female animals, the DFG MAK determined that the NOAEL for the effects on fertility was 50 mg/kg/day (DFG MAK (2019)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage, no developmental toxicity was observed (DFG MAK (2019), GESTIS (Accessed Sep. 2020)). [Reference Data, etc.] (3) The NICNAS determined that the highest dose was the NOAEL because the decreased live birth index (significant), and the lower viability index on postnatal day 4 (not significant) observed in (1), which might be caused by nursing failure of the dams, were very slight changes and no clear reproductive/developmental effect was observed at doses up to the highest dose (NICNAS (2008)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. However, classification was not possibledue to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (OECD TG 401, GLP), no effect was observed at 2,000 mg/kg (upper limit of Category 2) (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1997), DFG MAK (2019)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. Effects on the liver which was considered as a target organ were limited to the hypertrophy of cells, which was determined not to indicate any serious symptoms of toxicity. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, GLP), salivation (males) and liver effects (centrilobular hepatocyte hypertrophy, an increase in weight (females)) were observed at 50 mg/kg/day (converted guidance value: 23.3 mg/kg/day, within the range for Category 2); and liver effects (an increase in weight (males), an increase in ALP, an increase in catalase-positive granules), kidney effects (an increase in weight (males), renal tubular basophilia, renal pelvis epithelial hyperplasia (females), however, there was no finding that suggested a renal dysfunction in a urine analysis), and hyperplasia of the urinary bladder transitional epithelia (females) were observed at 250 mg/kg/day (converted guidance value: 117 mg/kg/day, in the range corresponding to "Not classified"). It was reported that based on the finding that catalase-positive granules increased at 250 mg/kg/day (males), the centrilobular hepatocyte hypertrophy was considered to be attributed to peroxisome proliferation (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1997), DFG MAK (2019), ACIS (previous NICNAS IMAP) (2008)).
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	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It was classified as "Not classified" because it was not rapidly degradable (a 28-day degradation rate by BOD: 42% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1998)) and due to 21-day NOEC > 10 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
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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