NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	120-61-6
Chemical Name	Dimethyl terephthalate
Substance ID	R03-B-007-MHLW
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2015 FY2006
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (GESTIS (Accessed Oct. 2021).
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 (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 520 deg C (GESTIS (Accessed Oct. 2021)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	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.
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	- -	-	-	Test methods applicable to solid substances are not 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] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 4,390 mg/kg (AICIS Existing Chemicals Hazard Assessment (2008), SIAR (2001)) (2) LD50 for rats: 14,400 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)) (3) LD50 for rats: > 3,200 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (4) LD50 for mice: > 3,200 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (5) LD50 for rats: > 6,590 mg/kg (AICIS Existing Chemicals Hazard Assessment (2008), SIAR (2001))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for guinea pigs: >5,000 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), AICIS Existing Chemicals Hazard Assessement (2008), SIAR (2001))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (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)	Not classified	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) LC50 (2 hours) for rats: 6 mg/L (converted 4-hour equivalent value: 3 mg/L) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), SIAR (2001), AICIS ECHA (2008))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified" (Category 3 in the UN GHS classification). [Evidence Data] (1) It was reported that, in a skin irritation test with guinea pigs, this substance was mildly irritating (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) In an acute dermal irritation/corrosion test with rabbits (n=6) (equivalent to OECD TG 404, semiocclusive, 4-hour application, observation for 72 hours), the primary dermal irritation index (PII) was 0 (erythema score: 0/0/0/0/0/0, edema score: 0/0/0/0/0/0) (REACH registration dossier (Accessed Nov. 2021)). (3) It was reported that, in a skin irritation test with rabbits (4-hour application, observation for 24 hours), no irritation was observed during the observation period (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) As a result of application of 0.05 mL powder of this substance to the conjunctival sac of rabbits, a slight and almost unrecognizable redness was observed after 1 hour (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)). (2) In an eye irritation test with rabbits (n=8) (observation for 10 days), no eye irritation findings were observed during the observation period (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), REACH registration dossier (Accessed Nov. 2021)). (3) This substance was slightly irritating to the eyes of rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Patty (6th, 2012)). (4) In two eye irritation tests with rabbits, no effect or a mild irritation was shown (SIAR (2001), NICNAS Existing Chemical Hazard Assessment (2008)).
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. [Reference Data, etc.] (1) It was reported that, in a skin sensitization study with guinea pigs, no skin sensitization was shown, but details such as test conditions were unknown (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Patty (6th 2012)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) As for in vivo, two micronucleus tests using the bone marrow of mice were reported, and positive results were reported in one test by a single intraperitoneal injection (39 to 194 mg/kg), and negative results were reported in the other test by a single intraperitoneal injection (438 to 1,750 mg/kg) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). The vehicles used in the two tests were different, and it was indicated that positive results in the former test might be an effect of the vehicle (DMSO) (the vehicle for the latter test was a corn oil). Regarding the judgment of the former test results, there was also a report that the result was equivocal (NICNAS Existing Chemical Hazard Assessment (2008)). (2) As for in vitro, negative results were obtained in all of multiple bacterial reverse mutation tests, gene mutation tests with the cultured mammalian cells (in vitro mouse lymphoma cells (L5178Y strain)), chromosomal aberration tests using the in vitro CHO cells and CHL cells (only -S9 in the latter test), and two micronucleus tests using the human peripheral blood lymphocytes (only -S9 in one test) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NICNAS Existing Chemical Hazard Assessment (2008), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There were no classification results by domestic or international organizations, but based on (1), negative results were obtained in two animal species, and therefore, it was classified as "Not classified." Also, the classification results were changed in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a carcinogenicity study with rats and mice (50 animals/species/sex/group) dosed by feeding for two years, there was no increase in the incidence of tumors related to administration in either males or females at doses up to 0.5% (5,000 ppm: approx. 250 mg/kg/day) for rats and up to 0.5% (5,000 ppm: approx. 650 mg/kg/day) also for mice (NCI TR121 (1979), OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NICNAS Existing Chemical Hazard Assessment (2008), SIAR (2001)). [Reference Data, etc.] (2) In a group of workers who produced polyester fiber and were considered to be exposed to this substance at the highest concentration, there was no increase in overall mortality, overall cancer mortality, lung cancer mortality, or bladder cancer mortality (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Also, the classification results were changed in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) In a one-generation reproduction toxicity study with rats dosed by feeding (males: 115 days, females: from 6 days before mating to the lactation period), there were no adverse effects on fertility of parent animals at doses up to the highest dose of 1% (approx. 636 mg/kg/day). It was reported that, as a minor effect, only lower body weight at weaning was observed in offspring at or above 0.5% (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NICNAS Existing Chemical Hazard Assessment (2008), SIAR (2001)). (2) It was reported that, in a developmental toxicity study with female rats dosed by gavage (days 7-16 of gestation), no effects were observed in dams or fetuses at doses of 1,000 mg/kg/day (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), NICNAS Existing Chemical Hazard Assessment (2008)). [Reference Data, etc.] (3) In an inhalation exposure test with female rats (1 mg/m3, 24 hours/day, throughout gestation period, test details were unknown), no effects on fetuses were observed (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), NICNAS Existing Chemical Hazard Assessment (2008), SIAR (2001)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) It was reported that, in humans, dermatitis was observed due to exposure to dust of this substance, and irritation to the respiratory organs was observed due to vapor or dust of this substance (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (2) It was reported that, in an acute inhalation exposure test with rats (2 hours), evident respiratory irritation, mucosal hyperemia, increased excitation upon stimulation, irregular breathing, and cyanosis were observed at 6 mg/L (converted 4-hour equivalent value: 3 mg/L, within the range for Category 2) (SIAR (2001), HSDB in PubChem (Accessed Nov. 2021)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data in other routes. [Evidence Data] (1) It was reported that, in repeated dose 13-week and 96-day oral toxicity studies with rats and mice dosed by feeding, symptoms such as reduced body weight gain were observed between 10,000 to 20,000 ppm and 10,000 ppm (in the range corresponding to "Not classified") (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NICNAS Existing Chemical Hazard Assessment (2008)). (2) It was reported that, in a repeated dose 103-week oral toxicity study with rats and mice dosed by feeding, symptoms such as an increase in chronic nephritis were observed at 5,000 ppm (250 mg/kg/day (rats), 650 mg/kg/day (mice), in the range corresponding to "Not classified") (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NICNAS Existing Chemical Hazard Assessment (2008)). (3) It was reported that, in a repeated dose 58-day inhalation exposure test with rats (dust, 4 hours/day, 5 days/week), nose rubbing, preening, and increased blinking were observed at 0.0864 mg/L (converted guidance value: 0.0265 mg/L, within the range for Category 2) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NICNAS Existing Chemical Hazard Assessment (2008)). (4) It was reported that, in a 6-month repeated inhalation exposure test (6 hours/day, 5 days/week) with rats and guinea pigs, no effects were observed at 0.015 mg/L (0.011 mg/L, within the range for Category 1) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2020), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NICNAS Existing Chemical Hazard Assessment (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)	-	- -	-	-	-
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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