NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	527-60-6
Chemical Name	2,4,6-Trimethylphenol
Substance ID	m-nite-527-60-6_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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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	- -	-	-	It was classified as "Not classified" because there were no deaths in a test by the administration of 2,000 mg/kg to rats, and an LD50 value was > 2000 mg/kg (OECD TG423, GLP) (USEPA/HPV (2003), corresponding to List 1). Besides, as for health hazards, also refer to 2,3,6-trimethylphenol (CAS RN 2416-94-6), the isomer.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" because there were no deaths in a test by the administration of 2,000 mg/kg to rabbits (OECD TG402, GLP), and an LD50 value was > 2,000 mg/kg (USEPA/HPV (2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In an acute dermal toxicity test with rabbits (OECD TG402, GLP), as a result of a 24-hour occlusive application of 2,000 mg/kg of this substance, necrosis was found in 6/10 animals after the removal of the patch and remained during a 14-day observation period. Slight to moderate erythema and edema were observed in the remaining four animals, but these disappeared by day 11 of observation (USEPA/HPV (2003)). From the above report, necrosis was seen in 6/10 animals after a 24-hour application, but because the application amount (2,000 mg/kg) was high, and it was an application for over 4 hours (24 hours), it was classified in Category 2.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Data are lacking. Besides, it is described that it strongly irritates the skin, eye, and mucous membranes and causes inflammation and chemical burns (Safety Test (Ministry of Economy, Trade and Industry) (Access on Sep. 2012) Summary Report, corresponding to List 2), but the details are unknown.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that it was negative in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (OECD TG474, GLP) (in vivo somatic cell mutagenicity test) (USEPA/HPV (2003)). Besides, as for in vitro tests, it is reported that it was negative in an Ames test (JECFA 1156 (2011)) and positive in a chromosomal aberration test with CHO cells (USEPA/HPV (2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats (OECD TG422, GLP), no changes due to the test substance were observed in reproductive parameters (such as estrous cycle, mating index, fertility index, and delivery index) and observation of lactation, and on the examination of neonates, no effects were found on developmental parameters (such as the number of offspring, the number of live offspring, sex ratio, and live birth index) and general conditions (Safety Test (Ministry of Economy, Trade and Industry) (Access on Sep. 2012)). And it is also reported that there were no effects on reproductive and developmental parameters in another reproductive toxicity test (HPVIS (2006)), and no adverse effects were seen on sexual function/fertility. However, because data are insufficient on effects on the development of offspring, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	It is reported that there were no deaths, and no abnormalities were observed in general signs or necropsy findings after the administration of 2,000 mg/kg in either an acute oral toxicity test with rats (OECD TG423, GLP) or an acute dermal toxicity test with rabbits (OECD TG402, GLP) (USEPA/HPV (2003)), therefore it corresponds to "Not classified" in the oral and dermal routes. However, because of no report in the inhalation route, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG422, GLP) (doses: 10, 60, 300 mg/kg/day), salivation and transient abnormal gait were sporadically observed in the 300 mg/kg group, but there were no deaths. Pathological examination revealed squamous hyperplasia in the forestomach in the groups at or above 60 mg/kg, and hyperplasia and erosion in the foveolar epithelium as changes in the glandular stomach in the 300 mg/kg group, but these were estimated to indicate irritation of the stomach by this substance (Safety Test (Ministry of Economy, Trade and Industry) (Access on Sep. 2012)), and they were not used for classification. No treatment-related changes were observed on other test items such as behavioral tests, body weights, hematological tests, blood biochemistry tests, and urine tests (Safety Test (Ministry of Economy, Trade and Industry) (Access on Sep. 2012)). From the above, because no adverse effects were observed at 300 mg/kg/day (converted guidance value: 142 mg/kg/day) above the guidance value range, it corresponds to "Not classified" in oral administration. However, due to no report in the other administration routes, it was classified as "Classification not possible" in this hazard class.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 3.3 mg/L for crustacea (Daphnia magna) (AQUIRE, 2013).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (a degradation rate by BOD: 7% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1982)), and 21-day NOEC = 0.1 mg/L for crustacea (Daphnia magna) (AQUIRE, 2013). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (a degradation rate by BOD: 7% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1982)), and 96-hour LC50 = 13 mg/L for fish (Pimephales promelas) (AQUIRE, 2013). From the above results, it was classified in Category 1.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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