NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	105-67-9
Chemical Name	2,4-Xylenol
Substance ID	m-nite-105-67-9_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	It is combustible, but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 599 deg C (ICSC (2003)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	It is solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data. Besides, there is the information that it is corrosive to aluminum, copper, and copper alloy, and that steel, stainless steel, glass, ceramics, and many synthetic substances are durable (Hommel (1997)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	Based on a report of an LD50 value for rats of 3,200 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)), this substance was classified as "Not classified" (Category 5 in the UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on a report of an LD50 value for rats of 1,040 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)), this substance was classified in Category 4.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data. On top of this, although the exposure time is unknown, there is a report that an LC value for rats was > 30 mg/m3 (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). This substance is a solid in the GHS definition, but it was considered a vapor since the toxicity value is lower than the saturated vapor concentration (0.64 mg/L).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	Because it is reported that in a skin irritation test with rabbits, corrosive action was observed on application of this substance (EPA Pesticide RED (1994)), and it is described in multiple pieces of literature that this substance is corrosive to the skin (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), EPA Pesticide Fact Sheet (1994)), the substance was classified in Category 1. In addition, this substance was classified as "Skin. Corr. 1B H314" in the EU CLP classification (ECHA CL Inventory (Access on October 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	There is a description that this substance is corrosive to the eyes (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). In addition, the substance was classified in Category 1 for skin corrosion/irritation. From the above, this substance was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. In addition, there is a report that an end-use product containing this substance produced skin sensitization in a skin sensitization test with guinea pigs (EPA Pesticide Fact Sheet (1994)). However, as the details of this are unknown, this substance was classified as "Classification not possible." Because what is described in the previous classification is the information listed as List 3, and the details are unknown, it was not used for the classification.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test with mouse bone marrow cells was negative. As for in vitro, bacterial reverse mutation tests were weakly positive (Salmonella typhimurium TA100) and negative results and a sister-chromatid exchange assay with human lymphocytes was negative (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), NTP DB (Access on November 2015), HSDB (Access on October 2015)). Therefore, this substance was classified as "Classification not possible" in accordance with the GHS classification guidance for the Japanese government.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no information on carcinogenicity in humans. As for experimental animals, in a test in which this substance as a benzene solution was applied repeatedly (2 times/week) to the dorsal skin of female mice at 25 microL of a concentration of 10% or 20%, in the group of application of the 10% solution, papillomas were observed after 20 weeks in the application site, and development of cancers after 28 weeks was observed. Also in the group of application of the 20% solution, the incidence of tumors increased compared with the group of 10%, and a dose dependence was observed (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), HSDB (Access on November 2015)). In addition, in a test in which this substance was dermally applied repeatedly (2 times/week) in the same manner at 25 microL of a concentration of 20% in benzene solution after solution of DMBA (9,10-dimethyl-1,2-benzanthracene), which is an initiator, in benzene was applied to the dorsal skin, in the combination group with DMBA, papillomas in 50% and carcinomas in 11% occurred in the application site after 15-week administration, and the incidence of cancer was 18% after 23-week administration (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), HSDB (Access on November 2015)). On the other hand, in the control group only with DMBA application, papillomas in 13% and carcinomas in 0% occurred after 15 weeks and incidence of cancer was 6% after 53 weeks. Also, in the group with DMBA application followed by repeated application of benzene only, papillomas in 11% were observed after 24 weeks. With respect to the above results, it is described in Environmental Risk Assessment for Chemical Substances (Ministry of the Environment) that while the authors suggested that this substance has a promoter effect, it is difficult to evaluate this promoter effect because the benzene used as the solvent is itself carcinogenic. (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). In addition, there are no other animal experiment data available for classification of carcinogenicity. There are also no classification results on carcinogenicity by other organizations. Therefore, the classification was not possible due to lack of data for this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	Although they are not detailed data, this substance shows corrosive action to the respiratory tract, corrosivity was also observed through oral exposure, and inhalation of the aerosol may cause pulmonary edema. There are descriptions of burning sensation, abdominal pain, nausea, and vomiting by ingestion and of burning sensations, cough, sore throat, and shortness of breath by inhalation exposure (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). Therefore, it was concluded that this substance has an effect on the respiratory organs. Since the original article cited in Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006) is ICSC and no detailed data were available, this substance was classified in Category 2 (respiratory organs).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	There was no report in humans. As for experimental animals, in a 4-week toxicity test with rats dosed by gavage, an increase in relative liver weights, sinusoidal dilation and congestion in the liver were observed in the females in the administration group of 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day) within a range for Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). Therefore, this substance was classified in Category 2 (liver). Besides, in the previous classification, since there are descriptions such as "BUN levels significantly increased at final necropsy in the female mid-dose group" and "lethargy, prostration, and ataxia were observed in both females and males" (IRIS (1990)), the kidneys and the nervous system were determined as the target organs. And it was classified in Category 2 (kidneys, nervous system) since they were observed within the range for Category 2. However, subsequent confirmation revealed that increased BUN was seen in the mid-dose group (50 mg/kg/day) but not in the high-dose group (250 mg/kg/day). Also in IRIS (2000), a LOAEL was set as 250 mg/kg/day, and an increased BUN in the mid-dose group was not considered as effects. Meanwhile, effects on the nervous system were seen at the high dose (250 mg/kg/day), which was outside the range of Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 48-hour LC50 (MOR) = 2.1 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), it was classified in Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Due to being rapidly degradable (a degradation rate by 28-day BOD = 91%, a degradation rate by TOC = 98%, a degradation rate by HPLC = 100% (Official Bulletin of Economy, Trade and Industry, 2002)), and 21-day NOEC (reproduction) = 0.27 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 2001), Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), it was classified in Category 3.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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