NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	100-21-0
Chemical Name	Terephthalic Acid
Substance ID	m-nite-100-21-0_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 496 deg C (ICSC (1994)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	There are reports of LD50 values of > 5,000 mg/kg (SIDS (2004)), > 6,400 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)) and 1,900-18,800 mg/kg (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats. It was classified as "Not classified" to which the larger number of values corresponds. New information sources (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)) were added, and the category was revised.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of > 2,000 mg/kg (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)) for rabbits, it was classified as "Not classified." New information sources (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)) were added, and the category was revised.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there are reports of LC50 values (2 hours) of > 2.02 mg/L (converted 4-hour equivalent value: > 1.01 mg/L) (DFGOT vol. 25 (2009), SIDS (2004)) and > 295 ppm (> 0.4 mg/L) (converted 4-hour equivalent value: > 0.1 mg/L) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats, it was classified as "Classification not possible" since it was not possible to determine which category these LC50 values correspond to.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	There are multiple reports of skin primary irritation tests (administration time unknown) with rabbits and these resulted in "no irritation" or "slight irritation" (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)). In addition, also in rats, there is a report that no irritation was observed after application of 0.2 mL of this substance (ACGIH (7th, 2001)). Based on these results, it was classified as "Not classified" (Category 3 in UN GHS classification) since it is considered to be slightly irritating. The category was changed according to the GHS Classification Guidance for the Japanese Government.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Since there are reports of "no irritation" or "slight irritation" in eye irritation tests with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004), ACGIH (7th, 2001)), it was considered to be slightly irritating, and it was classified in Category 2B.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that no sensitization was observed in a skin sensitization test with guinea pigs (SIDS (2004)). However, since the test conditions, details of the results, etc. were unknown, it was judged to be insufficient data for classification.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test with mouse bone marrow cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004), HSDB (Access on August 2014), DFGOT vol. 25 (2009)). As for in vitro, it was all negative in bacterial reverse mutation tests, a micronucleus test and a chromosomal aberration test with human peripheral blood lymphocytes, and a chromosomal aberration test with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2004), NTP DB (Access on September 2014), HSDB (Access on August 2014)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	There are no carcinogenicity classification results by international organizations. In a 2-year toxicity study in which this substance (1,000 mg/kg/day) was dosed by feeding to rats, urinary bladder calculi, hyperplasia of the urinary bladder, and tumors of the urinary bladder were reported (SIDS (2004)). However, it was classified as "Classification not possible" since carcinogenicity in humans cannot be evaluated.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a one-generation reproductive toxicity test with rats by the oral route (feeding), deaths of offspring, decreased survival rates and decreased body weight gain of neonates, and calculi of the kidney and urinary bladder in pups were observed at doses (930-1,219 mg/kg/day) where toxicity of the parental animals (decreased body weight gain, decreased food consumption, diarrhea, calculi of the kidney and urinary bladder, difficult lactation condition, and deaths). Besides, no teratogenicity was observed in a teratogenicity test with rats by the inhalation route (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)). Although in the previous classification, it was classified in Category 2 using the same one-generation test data, doses where parental animal toxicity and pup toxicity were observed were extremely high doses. Therefore, it was changed to "Classification not possible" from Category 2.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is a report that this substance was slightly irritating to the respiratory organs (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2004), HSDB (Access on August 2014)). There are no other toxicity data on single exposure. From the above, it was classified in Category 3 (respiratory tract irritation).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There are no hazard findings by repeated exposure in humans. As for experimental animals, in studies where rats were exposed by inhalation to this substance (estimated as the dust) for 28 days or 6 months, effects on the respiratory organs (irritation changes of the respiratory organs (exposure for 6 months), tracheal epithelial degeneration (exposure for 28 days)) were observed at or less than concentrations corresponding to Category 1 (0.52 mg/m3 (converted guidance value: 0.00017 mg/L/6 hours) in 28-day treatment, 10 mg/m3 (0.01 mg/L/6 hours) in 6-month treatment) (SIDS (2004)). In the oral route, in studies where rats were dosed by feeding for 2 weeks, 15 weeks, or 2 years, calculi in the urinary bladder and hyperplasia of the transitional epithelium were observed at doses exceeding Category 2 (converted guidance value: 581-4,523 mg/kg/day) (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, it was classified in Category 1 (respiratory organs). Besides, the previous classification was conducted based on an information source in List 3, and it was classified in "Category 2 (bladder)," but, in the original data (CIIT (1982)) described in the BUA report (1991) which is the reference source, it is assumed to rely on information at doses where urinary bladder calculi with a no dose relationship and low frequency (male rats, 1/10 animals) occurred. This information however, was not adopted in the hazard assessment by BUA and was judged to be not available for classification.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	Since it was suggested from 96-hour LC50>10mg/L of the fish (Oryzias Latipest) (MOE Eco-Toxicity Tests of Chemicals, 2002) that relevant toxicity is not indicated in the water solubility (15mg/L(PHYSPROP Database, 2005)) of this substance, it was classified into Not classified.	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Although acute toxicity was not reported within the aqueous solubility concentrations and there was rapidly degrading (the decomposition by BOD: 74.7% (Existing Chemical Safety Inspections Data)), since the bio-accumulation (log Kow=2 (PHYSPROP Database (2005))) was low, it was classified into Not classified.	FY2006	GHS Classification Manual （10 Feb, 2006）
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.

To GHS Information