NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	100-21-0
Chemical Name	Terephthalic Acid
Substance ID	H26-B-064, -
Classification year (FY)	FY2014
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	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 (FY2013 revised edition)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition).
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition).
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition).
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition).
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	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 496 deg C (ICSC (1994)).
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 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 applicable	- -	-	-	Solid (GHS definition).
14	Oxidizing solids	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 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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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.
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.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
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.
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.
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.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.
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)).
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.
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.
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).
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.
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
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.

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