NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	11070-44-3
Chemical Name	Tetrahydromethylphthalic anhydride
Substance ID	R02-B-002-MHLW, MOE
Classification year (FY)	FY2020
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 FY2015 FY2016
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" from a flash point of 164 deg C (closed cup) (GESTIS (Access on April 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties, an unsaturated bond, present in the molecule, but the classification is not possible due to no data.
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 415 deg C (GESTIS (Access on April 2020)).
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] Because (2), (3), (4) are the results of non-guideline tests, it was classified as "Not classified" based on information of (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (AICIS IMAP (Access on April 2020), Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), SIAR (2005), JECDB (Access on April 2020)) (2) LD50 for rats: 2.14 g/kg (2,140 mg/kg) (ACGIH (7th, 2019)) (3) LD50 for rats: 1,900 mg/kg (AICIS IMAP (Access on April 2020), Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), SIAR (2005)) (4) LD50 for rats: 1,900-2,590 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] It was classified in Category 4 from (1) - (4). [Evidence Data] (1) LD50 for rabbits: 1.14 mL/kg (converted value: 1,368 mg/kg) (ACGIH (7th, 2019), OEL Documentations (Japan Society For Occupational Health (JSOH), 2002)) (2) LD50 for rabbits: > 1,706 mg/kg (AICIS IMAP (Access on April 2020)) (3) LD50 for rabbits: 1,710 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) (4) LD50 for rats: > 2,000 mg/kg (AICIS IMAP (Access on April 2020))
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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). [Evidence Data] (1) It is reported that in a skin irritation test in which an unknown amount or 0.01 mL of undiluted substance was applied to rabbits, there was moderate irritation or no irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) It is reported that there was moderate irritation in a skin irritation test with rabbits according to Federal Regulations, Title 16, Section 1500.41 (SIAR (2005), REACH registration dossier (Access on May 2020)). (3) It is reported that it was moderately irritating to the rabbit skin, and PII was 3.5 (ACGIH (7th, 2019), SIAR (2005)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2A from (1) - (3). [Evidence Data] (1) In an eye irritation test in which 0.1 mL or 0.005 mL of undiluted substance was applied to rabbits, iridial congestion and great corneal injury were reported after 24 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). (2) It was reported to be irritating in an eye irritation test with rabbits according to Federal Regulations, Title 16, Section 1500.41 (SIAR (2005)). (3) In an eye irritation test with rabbits according to OECD TG 405, corneal opacity was observed after 1 hour, and after 24 hours, petechia on the iris was seen, but there was no change in the conjunctiva. No lid closure or bleeding was found, there was no full recovery after 10 days, but eyes recovered within 14 days (REACH registration dossier (Access on May 2020)). [Reference Data, etc.] (4) It was classified in Eye Dam. 1 (H318) in EU CLP classification (EU CLP classification (Access on May 2020)).
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (3). [Evidence Data] (1) This substance was classified in occupational sensitizers to the airway Group 1 by the Japan Society For Occupational Health (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2019)). (2) In workers handling this substance, multiple cases with symptoms such as nasal discharge, wheezing, dermatitis, and shortness of breath were reported, and IgE antibodies to this substance were detected in prick tests or RAST (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2019), MAK (DFG) vol.10 (1998)). (3) This substance is a potent sensitizer causing the development of IgE and IgG antibodies (ACGIH (7th, 2019)).
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1). Besides, sub-categorization was not conducted because the strain of mice used was not from the recommended ones. [Evidence Data] (1) In a local lymph node assay (LLNA) with BALB/c mice, it was positive, and the EC3 value was 1.37 (ACGIH (7th, 2019)). [Reference Data, etc.] (2) It was classified in Skin Sens. 1 (H317) in EU CLP classification (EU CLP classification (Access on May 2020)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Evidence Data] (1) As for in vitro, it was reported to be negative in a bacterial reverse mutation test and negative (false positive for inducing numerical anomaly) in a chromosomal aberration test in cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIAR (2005), JECDB (Access on April 2020), OEL Documentations (Japan Society For Occupational Health) (2002)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] In (1), even at a dose at which toxicity effects (mainly lesions in the forestomach) were observed in parental animals, no reproductive toxicity was observed. However, since this test was a screening test, and there was no sufficient data available on developmental toxicity, classification was not possible due to lack of data. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), even at dose at which toxicity effects (such as squamous epithelium hyperplasia and submucosal granulomatous inflammation of the forestomach) were observed in parental animals, no reproductive toxicity was observed (JECDB (Access on April 2020), Initial Risk Assessment Report (NITE, CERI, NEDO), 2008), SIAR (2005), ACGIH (7th, 2019)).
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), it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) This substance caused eye and nasal symptoms such as pain in the eyes, pain in the pharynx, sneeze, nose secretion, nose blockage, cough, and asthma (SIAR (2005)). [Reference Data, etc.] (2) In humans, cyclic acid anhydrides including this substance can cause irritation and sensitization after direct contact with the skin and the mucous membranes or after exposure by inhalation. Irritation is caused by the dicarboxylic acid that is formed when cyclic acid anhydrides interact with water (CICAD 75 (2009)). (3) The ACGIH has set TLV-TWA for the purpose of minimizing the occurrence of sensitization, eye and nasal symptoms, and asthma (ACGIH (7th, 2019)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was considered to be "Not classified" in the oral route. For the other routes, classification was not possible due to lack of data. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage, lesions in the forestomach, which were considered to be caused by irritation, were observed, but there was no effect that could be adopted as the basis for classification (JECDB (Access on April 2020), SIAR (2005), Initial Risk Assessment Report (NITE, CERI, NEDO), 2008), Environmental Risk Assessment for Chemical Substances, Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), ACGIH (7th, 2019)).
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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 72-hour EC50 = 81 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	It was classified in Category 2 because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC = 0.94 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), SIAR, 2005).
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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