NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	576-26-1
Chemical Name	2,6-Xylenol
Substance ID	m-nite-576-26-1_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.	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	- -	-	-	There is the information that it is combustible (HSDB (Access on 2015)), 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 > 500 deg C (GESTIS (Access on November 2015)).	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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on a report of an LD50 value for rats of 296 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)), this substance was classified in Category 3.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	There are reports of an LD50 value for rats of 2,325 mg/kg and an LD50 value for rabbits of 1,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). The value for rats corresponds to "Not classified," while that for rabbits corresponds to Category 3. Adopting the category to which the smallest LD50 value corresponds, this substance was classified in Category 3.	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)	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: 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	There are descriptions that this substance is corrosive to the skin (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)) and may cause chemical burns (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). There are also descriptions that topical application of this substance on the skin of rats, rabbits, and guinea pigs causes irritation and produces ulcers in the application site (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there is a description that this substance is corrosive when applied to rabbit skin (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, this 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, 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 are descriptions that this substance is irritating to rabbit eyes (Risk Assessment Report (NITE, CERI, NEDO, 2008)) and it shows a corrosive effect to the eyes (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). In addition, this 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.	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 negative, a mammalian cell chromosome aberration test was positive, and a sister-chromatid exchange test with human lymphocytes was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), HSDB (Access on October 2015), NTP DB (Access on November 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%, papilloma was observed in an incidence of 8% at the application site after 20 weeks but cancer was not observed (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, in a test in which this substance was dermally applied repeatedly (2 times/week) 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 30% and cancer in 4% occurred in the application site after 15-week administration, and the incidence of cancer was 11% after 23-week administration. Meanwhile, in the control group with only DMBA application, after 15 weeks, the incidence of papillomas and cancer was 13%, 0%, respectively, and the incidence of cancer after 53 weeks was 6%. In addition, papilloma was observed in 11% after 24 weeks in the group of repeated application of only benzene after DMBA application (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, together with the result of 2,4-xylenol concurrently tested, the authors suggested that this substance has a weaker promoter effect than 2,4-xylenol has. As against the suggestion, it is described in Environmental Risk Assessment for Chemical Substances that it is difficult to interpret whether it has a promoter effect from the results 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 is 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	- -	-	-	There is no information on reproductive effect in humans. As for experimental animals, there is a description that in a developmental toxicity test with pregnant rats dosed by gavage during organogenesis period (Gestational Day 6-15), reduced body weight gain at or more than 180mg/kg/day and deaths (2 out of 24 animals) at 540 mg/kg/day in the maternal animals were observed, while in the pups, low values of body weights were observed at 540 mg/kg/day (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). Even when this substance was administered at up to doses where a significant toxicity manifested in maternal animals, in fetuses, as the developmental effects, observed were only minor changes that were not included in findings to be classified. However, there are no results of tests evaluating the effects on sexual function and fertility. Therefore, the classification was not possible due to a lack of data for this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There are no data on this substance in humans. As for experimental animals, there is a report that respiratory disturbance and spastic tremors were observed in inhalation exposure to this substance (0.27 mg/L, corresponding to Category 1) in rats and mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), HSDB (Access on October 2015)). It was reported that this substance shows similar toxicity to phenol (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), HSDB (Access on October 2015)). It is described that the expected effects of the toxicity of this substance based on those of phenol include burning sensations due to mucosal corrosion, headache, dizziness, nausea, abdominal pain, vomiting, diarrhea, muscle spasms, central nervous system depression, and loss of consciousness by oral or dermal exposure; and respiratory tract irritation, headache, cough, weakness, nausea, vomiting, paresthesia, and albuminuria (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), HSDB (Access on October 2015), Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). From the above, this substance is irritating to the respiratory tract and, in addition, the central nervous system. Therefore, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, respiratory organs, liver, kidney), Category 2 (blood system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	No information was obtained in humans. As for experimental animals, as for the oral route, it is reported that, in a 28-day toxicity test with rats dosed by gavage, a significant increase in liver weights, ataxia, salivation, and extramedullary hematopoiesis in the spleen in both sexes and anemia in the females were observed at 400 mg/kg/day (converted guidance value: 88.9 mg/kg/day), which is within the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). In 8-month repeated oral dose toxicity tests with rats, in the group of 6 mg/kg/day, which is within the range of Category 1, histopathological changes are reported mainly in the liver, kidneys and spleen (fatty degeneration of hepatocytes, hyaline droplet degeneration in the kidneys, increases in myeloid cells and reticuloendothelial system cells in the spleen, and atrophy of splenic lymphoid follicles) (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), IRIS Summary (1988)). As for the inhalation route, in a 4.5-month inhalation toxicity test with rats, in the group of 22 mg/m3 (converted guidance value: 0.015 mg/L/6hr/day), which is within the range of Category 1, a significant increase in hexobarbital sleeping time, inhibited swimming ability, significant decreases in activities of blood catalase and blood cholinesterase, significant decreases in body weight and liver weight, peritracheal and perivascular lymphocyte cellular infiltration in the respiratory tract, degeneration of tracheal and main bronchial mucosa, alveolar bleeding, alveolar wall damage, round cell infiltration or fatty degeneration in the liver, degenerative changes in the kidney, an increase in white pulp and congestion of red pulp, and thickening of capillary vessels in the spleen are reported (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). As the above, in the oral route, effects on the haemal system were seen within the range of Category 2, and effects on the liver, kidney, and spleen were seen within the range of Category 1; in the inhalation route, effects on the central nervous system, respiratory organs, liver, kidney, and spleen were seen within the range of Category 1. However, the spleen was not adopted as a target organ because the observed effects were considered to be secondary or non-specific changes occurring in response to anemia. Therefore, this substance was classified in Category 1 (central nervous system, respiratory organs, liver, kidney), Category 2 (haemal system).	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 = 2.2 mg/L for crustacea (Artemia salina) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), 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 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (non-biodegradable, a degradation rate by 28-day BOD = 2%, a degradation rate by HPLC = 1% (Official Bulletin of Economy, Trade and Industry, 2003)), and 21-day NOEC (reproduction) = 0.538 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). 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, and 96-hour LC50 = 15.4 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). By drawing a comparison between the above results, it was classified in Category 2.	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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