NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	108-38-3
Chemical Name	m-Xylene
Substance ID	m-nite-108-38-3_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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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 27 deg C (closed cup) (ICSC (2002)). Besides, it is classified in Class 3, PG III (UN1307) in UNRTDG.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 527 deg C (ICSC (2002)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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 multiple reports of LD50 values in the range of 4,320–6,700 mg/kg for rats (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007), EPA Pesticide (2005), ACGIH (7th, 2001), OEL Documentations (Japan Society for Occupational Health (JSOH), 2001), EHC 190 (1997), ECETOC JACC (1986)), this substance was classified as "Not classified" (Category 5 in the UN GHS classification or "Not classified").	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on multiple reports of LD50 values in the range of 3,228-14,100 mg/kg for rabbits (ATSDR (2007), EPA Pesticide (2005), ACGIH (7th, 2001), OEL Documentations (Japan Society for Occupational Health (JSOH), 2001), EHC 190 (1997)), this substance was classified as "Not classified" (Category 5 in the UN GHS classification or "Not classified").	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on LC50 values (6 hours) of 5,984 ppm (converted 4-hour equivalent value: 7,329 ppm) (EHC 190 (1997)) and ca. 6,000 ppm (converted 4-hour equivalent value: ca. 7,348 ppm) (Hazard Assessment Report (CERI, NITE, 2008)) for rats, this substance was classified in Category 4. Besides, since the LC50 values (6 hours) were lower than the 90% of the saturated vapour concentration (10,908 ppm) which was obtained from the vapour pressure of this substance (8.29 mmHg, at 25 deg C (HSDB (Access on December 2014))), 4-hour converted LC50 values were calculated and the reference value with ppm as the unit was applied as a vapour without a mist. By adding the new information source (Hazard Assessment Report (CERI, NITE, 2008)) and changing the saturated vapour pressure value, the previous category was revised.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, since the LC50 value became lower than the saturated vapour concentration by changing a saturated vapour pressure, previously adapted data were moved to the Inhalation: Vapours section.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It is reported that after an application to the skin of rabbits (application time unknown), irritation was observed (Hazard Assessment Report (CERI, NITE, 2008)). It is reported that in a test where this substance was applied to both hands of 13 volunteers in a 20-min immersion, they showed a feeling of burns (burning sensation) after a 10-minute application and they recovered within 10 minutes after the end of the application. It is also reported that erythema was observed at the application spot but this disappeared within a few hours (Hazard Assessment Report (CERI, NITE, 2008)). Based on the above results, this substance was classified in Category 2.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	After an application of 0.5 mL (432 mg) of this substance to rabbit eyes, slight to moderate irritation was observed (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007)). Based on this data, this substance was classified in Category 2.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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, a mouse bone marrow micronucleus test was negative (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007), ECETOC JACC 006 (1986), EHC 190 (1997), IARC 71 (1989)). As for in vitro, a bacterial reverse mutation test was negative (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007), ECETOC JACC 006 (1986), IARC 71 (1989), ACGIH (7th, 2001)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	This substance was classified as "Classification not possible" because it was classified in Group 3 by IARC (IARC, 1999), in A4 by ACGIH (ACGIH (7th, 2001)) and as I by EPA (EPA (IRIS, 2003)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a report that in a teratogenicity test with rats by the inhalation route, slight effects on fetuses (decreased body weight in fetuses, delayed ossification and skeletal variations) were observed at a dose where maternal toxicity (decreased body weight gain) was observed (ATSDR, 2007). However, since these effects could not be taken as the evidence of the classification and effects on fertility were unknown due to no data, this substance was classified as "Classification not possible." Besides, this substance was classified in Category 2 in the previous classification because fetal deaths were observed at a dose where general toxicities were observed in maternal animals. As a result of the review, these data were not adopted as the evidence of the classification because the data originated from an abstract of the lecture, and the reliability of the data was not sufficient to use for classification. Other than above, Japan Society for Occupational Health (JSOH) (tentatively) classified industrial xylene (mixed xylene) including ethylbenzene (tentatively classified in reproductive toxicants Group 2) in reproductive toxicants Group 2 (corresponding to Category 1B) in the Recommendation of occupational exposure limits (2014) and also (tentatively) classified xylene (o-, m-, p- isomers and their mixture) in reproductive toxicants Group 3 (corresponding to Category 2). However, the classification by the Recommendation of occupational exposure limits was under a provisional period, therefore, it was not adopted.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	This substance was irritating to the respiratory tract (ATSDR, 2007). In humans, in human volunteer data by inhalation exposure, etc., nausea, short-term memory disorder, decreased reactivity, decreased sense of equilibrium and dysfunction of lungs were observed, and pulmonary congestion and edema were observed in a suicide case by oral ingestion, and the death was caused by centrally mediated respiratory depression (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007), ECETOC JACC 006 (1986)). In experimental animals, inhalation exposure caused narcotic effects in rats, and by inhalation exposure of mice, incoordination at 3,000 ppm, reduced operant behavior at 500 ppm, reduced microsomal enzyme activity (indicating damage of lung tissue) at 75–2,000 ppm, decreased breathing at 500 ppm, posture change, reduced arousal, decreased forelimb grip strength, decreased righting reflex, disorders in walking and activity, increased landing leg width, and suppressed responses to various sensory stimuli at 2,000–8,000 ppm were observed, but these effects disappeared later. In rats and mice (dose unknown), hypotension, labored breathing, hyperreactivity to stimuli, lowered tension, prostration, coma, tremors, impaired visual and auditory senses, decreased acetylcholine in the midbrain, decreased norepinephrine in the hypothalamus (suggestive of effects on motor control, sleep, and memory maintenance), muscular spasms, and respiratory insufficiency occurred, resulting in death (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007), ECETOC JACC 006 (1986), EHC 190 (1997)). No data by an oral route was available. From the above, this substance was classified in Category 1 (respiratory organs) and Category 3 (narcotic effects) because this substance caused narcotic effects and effects on the respiratory organs. (Note that this classification result was based on only m-xylene data, not on data on the other xylene isomers or a mixture. As for other xylene isomers or a xylene mixture, refer to each classification result.)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There is a report that in a test in which human volunteers were exposed to this substance for 5 days, 6 hours/day followed by no exposure in the weekend and a 1-day exposure at the beginning of the next week and were tested for body balance after forced exercise, reduced reaction time at a concentration of 90-100 ppm and a decreased sense of equilibrium at a high concentration of 400 ppm were observed (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007)) and it is considered that these findings suggested effects on the nervous system even in a short-term exposure. Although no information on the long-term effects by exposure to this substance alone was available, this substance was supposed to have similar effects to xylenes (a mixture containing each isomer) (CAS RN 1330-20-7) and it is considered that effects on the nervous system and respiratory system should be concerned. In experimental animals, in tests in which male rats were exposed by inhalation to this substance (assumed as the vapour) for 3 or 6 months, decreased locomotor activity and incoordination were observed at a concentration of 100 ppm (0.43 mg/L/6 hours) which corresponded to Category 2 and these findings were considered to support effects on the nervous system in humans (Hazard Assessment Report (CERI, NITE, 2008)). From the above, this substance was classified in Category 1 (nervous system and respiratory organs) similarly to xylene (mixture).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	This substance is a hydrocarbon and its kinematic viscosity was calculated to be 0.669 mm2/s (25/15 deg C) using data of viscosity, 0.581 mPa (25 deg C) and density, 0.8684 (15 deg C) (original data source: HSDB (Access on December 2014)). Based on these data, this substance was classified in Category 1.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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 = 2.42 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 2000), Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified in Category 3 due to rapid degradability (a degradation rate by BOD: 100% (J-CHECK, 1998)), and 21-day NOEC = 0.407 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 2000), Initial Risk Assessment (NITE, CERI, NEDO, 2005), 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 as "Not classified" due to rapid degradability (a degradation rate by BOD: 100% (J-CHECK, 1998)), and a low bioaccumulation estimate (LogPow = 3.2 (PHYSPROP Database, 2009)) despite 96-hour LC50 = 7.9 mg/L for fish (Morone saxatilis) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)). By drawing a comparison between the above results, it was classified in Category 3.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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