NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	95-47-6
Chemical Name	o-Xylene
Substance ID	H26-B-028, R-011
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 32 deg C (closed cup) (ICSC (2002)). Besides, it is clasified in Class 3, PG II, III (UN1307) in UNRTDG.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 463 deg C (ICSC (2002)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not 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	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Not classified	- -	-	-	Steel and most of other metals are durable as a container (Hommel (1991)).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on reports of LD50 values of 3,600 mg/kg (Hazard Assessment Report (CERI, NITE, 2008)) and 3,608 mg/kg (EHC 190, 1997) for rats, this substance was classified as "Not classified" (Category 5 in the UN GHS classification).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on an LD50 value of > 3,160 mg/kg for rabbits (HSDB (Access on June 2014)), this substance was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on reports of LC50 values (6 hours) of 4,330 ppm (converted 4-hour equivalent value: 5,303 ppm) (EHC 190 (1997)) and ca. 4,000 ppm (converted 4-hour equivalent value: 4,899 ppm) (Hazard Assessment Report (CERI, NITE, 2008)) for rats, this substance was classified in Category 4. Besides, these LC50 values are lower than 90% of the saturated vapour concentration (6,910 ppm), the reference value with ppm as the unit was applied as a vapour without a mist. The new information source (Hazard Assessment Report (CERI, NITE, 2008)) was added, and the previous category was revised.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that erythema, edema, desquamation and necrosis were observed in a test in which a xylene mixture containing this substance was applied to the skin of rabbits, and this substance was evaluated as a mild to strong skin irritant (Hazard Assessment Report (CERI, NITE, 2008)). The data used in the previous classification was not adopted because the data was data of a mixture.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that slight irritation was shown in a test in which a xylene mixture containing this substance was applied to the eyes of rabbits (Hazard Assessment Report (CERI, NITE, 2008)). The data used in the previous classification was not adopted because the data was data of a mixture.
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.
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 mouse bone marrow micronucleus test (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007), IARC 47 (1989)). As for in vitro, it was negative in a bacterial reverse mutation test and a chromosomal aberration test (NTP DB (Access on July 2014), Hazard Assessment Report (CERI, NITE, 2008), IARC 47 (1989), ACGIH (7th, 2001), OEL Documentations (Japan Society For Occupational Health (JSOH), 2001)).
6	Carcinogenicity	Classification not possible	- -	-	-	This substance was classified as "Classification not possible" because it was classified in Group 3 by IARC (IARC 71, 1989) and in A4 by ACGIH (7th, 2001).
7	Reproductive toxicity	Classification not possible	- -	-	-	In teratogenicity tests with mice and rats by the inhalation route, slight effects in fetuses (decreased fetal body weight and delayed ossification) were observed at doses where maternal toxicities were observed or not observed (Hazard Assessment Report (CERI, NITE, 2008)). Besides, a report, used as the evidence of the previous classification, that in a teratogenicity test with mice by the oral route, toxicities in maternal animals and death and cleft palate in fetuses were observed, originated from an abstract of the lecture, and its reliability was not sufficient. Therefore, the report was not adopted as the information source of evidence of this classification. Consequently, since effects on fetuses were marginal regardless of whether there were maternal toxicities, it corresponded to "Not classified" for teratogenicity. However, due to insufficient information on fertility available, this substance was classified as "Classification not possible."
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	Although data on an isomer mixture (industrial xylene) containing ethylbenzene were available, no human effects' data of o-xylene were found. In experimental animals, by the inhalation exposure of mice to this substance, increased locomotor activity, decreased respiratory rate, biphasic central nervous system response (depression and excitation), and death at 4,600 ppm and a 50% decrease in a respiratory rate at 1,450 ppm were observed (Hazard Assessment Report (CERI, NITE, 2008), ACGIH (7th, 2001), ATSDR (2007), EHC 190 (1997)). In neurobehavioral studies, inhalation in mice caused impaired operant behavior at 5,179 ppm, immobility in a behavioral despair swimming test at 1,010 ppm, and 11% shortened duration of response of extension at 320 ppm, and in an inhalation test with rats, 18.8% shortened duration of hindlimb extension response to an electrical shock was observed at 230 ppm (ATSDR (2007)). In addition, it is reported that in inhalation exposure of mice, excitation of the central nervous system at low concentrations and depression of the central nervous system at high concentrations occurred (EHC 190 (1997)). These findings on the central nervous system were observed within the guidance value range for Category 1. In SIAP (2003) (not described in SIAR), as common effects among xylene isomers, central nervous system depression, incoordination, prostration and coma were described. It was described in ACGIH (7th, 2001) that xylene isomers were irritating to the respiratory tract. Therefore, this substance was classified in Category 1 (central nervous system) and Category 3 (respiratory tract irritation and narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Although no human effects' data by exposure to this substance alone was available, effects on the nervous system (headache, dizziness, confusion, impaired muscle coordination) and effects on the blood system (anemia and decreased number of leukocytes) were known by occupational inhalation exposure to a high concentration of xylene mixture (including partly concomitant exposure to benzene or toluene) (ATSDR (2007), Hazard Assessment Report (CERI, NITE, 2008)). Furthermore, in experiments in which human volunteers were exposed by inhalation to m- or p-xylene, there for a short time (mostly within 5 days), there is a report that neurological symptoms such as decreased response, decreased equilibrium and headaches were observed while there is also a report that such effects were not observed (Hazard Assessment Report (CERI, NITE, 2008)). As for experimental animals, on the other hand, available data by exposure to this substance alone was very limited, and only in a 6-week inhalation test with dogs exposed to the vapour of this substance, tremor was observed in 1 out of 3 animals at a concentration above the upper limit of Category 2 (3.358 mg/L: 1.55 mg/L/6 hours (converted guidance value)) (ATSDR, 2007, Hazard Assessment Report (CERI, NITE, 2008)). From the above, evidence was not sufficient to judge the effects by exposure to this substance alone as the effects on the nervous system, therefore, it was classified as "Classification not possible" due to lack of data.
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	Since this substance is a hydrocarbon and its kinematic viscosity is 0.86 mm2/s (25 deg C, calculated by CERI), it was classified in Category 1.

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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 72-hour ErC50 = 0.799 mg/L for algae (Desmodesmus subspicatus) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012))
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to not known whether it is rapidly degradable, and 21-day NOEC = 0.407 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to rapid degradability (a degradation rate by BOD = 67.8% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)) despite not known whether it is rapidly degradable, and 96-hour LC50 = 7.424 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012), Initial Risk Assessment (NITE, CERI, NEDO, 2005)). By drawing a comparison between the above results, it was classified in Category 2.
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.

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