GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 106-42-3 |
| Chemical Name | p-Xylene |
| Substance ID | H27-B-048/C-084B_P |
| Classification year (FY) | FY2015 |
| 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 (Ver. 1.1)) |
| 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 |
| 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 |
Based on a flash point of 25 deg C (closed cup), it was classified in Category 3. Besides, it is classified in Class 3, PG 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 528 deg C (HSDB (Access on August 2015)). |
| 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 | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on LD50 values for rats of 4,029 mg/kg (EHC 190 (1997)), 3,900-4,030 mg/kg (Hazard Assessment Report (CERI, NITE, 2008)), and 5,000 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2001)), this substance was classified as "Not classified" (Category 5 in UN GHS classification). |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 (4 hours) of 4,550 ppm (OEL Documentations (Japan Society For Occupational Health (JSOH), 2001)), 4,740 ppm (EHC 190 (1997)), and approx. 4,800 ppm (females) (Hazard Assessment Report (CERI, NITE, 2008)) for rats, this substance was classified in Category 4. Besides, a reference value in the unit of ppm was applied as vapour without mist since the LC50 values were less than 90% of the saturated vapor concentration (8,885 ppm). |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
Based on a report that this substance was irritating in a skin irritation test with rabbits exposed to 0.5 ml of this substance for 4 hours (EHC 190 (1997)), this substance was classified in Category 2. Besides, it is reported that erythema, edema, desquamation, and necrosis were observed, and this substance showed a moderate to severe irritation of the skin in tests in which xylene mixtures containing this substance were applied to rabbit skin (Hazard Assessment Report (CERI, NITE, 2008)). |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, it was reported that this substance showed a mild irritation of eyes in tests in which xylene mixtures containing this substance were applied to rabbit eyes (Hazard Assessment Report (CERI, NITE, 2008)). The data used in the previous classification was based on mixtures, and was therefore not used for classification. |
| 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 data, a micronucleus test with bone marrow cells of mice dosed intraperitoneally was negative (Hazard Assessment Report (CERI, NITE, 2008), IARC 71 (1999), ATSDR (2007)). As for in vitro data, bacterial reverse mutation tests were negative (Hazard Assessment Report (CERI, NITE, 2008), IARC 71 (1999), ATSDR (2007)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | With regard to classifications by other organizations, this isomer alone was classified in A4 by the ACGIH (ACGIH (7th, 2001)), and mixed xylenes were classified in Group 3 by the IARC (IARC Vol. 71 (1999)) and in "I" (Inadequate for an assessment of the carcinogenic potential of xylenes) by the EPA in 2003 (IRIS Summary (Access on August 2015)). As for test data, in a two-year oral administration study in which rats or mice were dosed by gavage at 500 mg/kg/day or at 1,000 mg/kg/day, respectively, with a xylene mixture consisting of 14% this substance (as well as 60% m-xylene, 9% o-xylene, and 17% ethylbenzene), no increase in the incidence of tumors was seen (NTP TR 327 (1986), IARC 71 (1999), IRIS Tox Review (2003), Hazard Assessment Report (CERI, NITE, 2008)). From the above, due to insufficient data for this substance alone and based on the classification results by other organizations for mixed xylenes, this substance corresponded to "Classification not possible" for this hazard class both in the case of the substance alone and in the case of a mixture. Besides, the ACGIH classified mixed xylenes and the individual isomers in A4, based on the negative results from the NTP carcinogenicity study (ACGIH (7th, 2001)). |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
There was no information on the effects of exposure to this substance alone in humans. It was reported that a group of pregnant women exposed to mixed xylenes showed an increased incidence of spontaneous abortions (odds ratio: 3.1; 95% confidence interval: 1.3-7.5), but this effect could not be attributed to xylene alone because of simultaneous exposure to other solvents and chemicals (not known whether ethylbenzene was present) (ATSDR (2007)). In addition, a case study of spontaneous abortions among Finnish workers proved by a urinary biomarker test to have been given combined exposure to some organic solvents, did not show a statistically significant increase in the odds ratio associated with exposure to xylene either (ATSDR (2007)). Meanwhile, in experimental animals, it was stated that in a study in which this substance was administered by gavage to pregnant mice during the organogenesis period, an increased incidence of cleft palate was observed in the fetuses at a dose inducing no maternal toxicity. However, this was an insufficient description found in a lecture summary (Hazard Assessment Report (CERI, NITE, 2008)), and was not mentioned in ATSDR (2007) or ACGIH (7th, 2001). Therefore, it was judged that this data should not be used for the classification (in the previous classification, it was classified in Category 1B based on this result). As for an inhalation route, it was reported that in a study in which pregnant rats were exposed by inhalation (24 hours/day) to this substance during the organogenesis period, reduced fetal body weights, reduced litter sizes, and extra ribs were observed at a dose (3,000 mg/m3) at which the dams showed reduced food consumption or reduced serum sex hormone levels (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007)). On the other hand, it is reported that in another study in which pregnant rats were exposed at up to 7,000 mg/m3 for 6 hours/day during the organogenesis period, reduced body weight gains in the dams but no adverse effects in the fetuses were observed (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007)). In addition, it is reported that in a study in which pregnant rabbits were exposed by inhalation at up to 1,000 mg/m3 for 24 hours/day during the organogenesis period, mortality and abortion in the dams but no effects in the fetuses were observed (Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2007)). The Japan Society for Occupational Health (JSOH) classified technical-grade xylene containing ethylbenzene (mixed xylenes) in "reproductive toxicants Group 2," and xylenes containing no ethylbenzene (o-xylene, m-xylene, p-xylene, and mixtures thereof) in "reproductive toxicants Group 3" (Recommendation of Occupational Exposure Limits (2015)). From the above, while uncertain information exists that by combined exposure to multiple solvents including mixed xylenes, increased spontaneous abortion is a concern in humans, it was not known whether or not ethylbenzene was included, and it was not possible to classify this substance based on the classification result by JSOH. Nevertheless, given that minor effects of fetal toxicity were observed mostly at the doses with maternal toxicity in multiple studies in which experimental animals were exposed by inhalation to this substance alone, and taking into account the result of classification by JSOH (p-xylene not including ethylbenzene was classified in "reproductive toxicants Group 3"), this substance was classified in Category 2 for this hazard class. |
| 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 |
This substance is irritating to the respiratory tract (ACGIH (7th, 2001)). As for human cases, dizziness was observed in four of six volunteers exposed to this substance by inhalation (Hazard Assessment Report (CERI, NITE, 2008), ACGIH (7th, 2001), ATSDR (2007), EHC 190 (1997)). For experimental animals, it is reported that inhalation exposure (unknown species of animals, and doses corresponding to Category 1) caused incoordination, tremors, reduced axonal transport, and at higher doses, narcotic effects; additionally, while the route(s) of exposure, doses, etc. are not known, tremors, biphasic central nervous system response (depression and excitement), and gastrointestinal-tract damage were reported as toxic symptoms of this substance (Hazard Assessment Report (CERI, NITE, 2008), ACGIH (7th, 2001), ATSDR (2007), EHC 190 (1997)). From the above, this substance is irritating to the respiratory tract, affects the central nervous system, and causes narcotic effects, therefore, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | There was no information on the adverse effects of human exposure to this substance alone. However, with regard to mixtures containing p-xylene, there are reports on effects on the nervous system (headache, anxiety, forgetfulness, insomnia, dysautonomia, inability to concentrate, and muscle weakness), respiratory organs (chest pain, dyspnea, impaired pulmonary function, etc.), and haemal system (anemia, leukopenia, bone marrow hypoplasia, etc.) in humans (Hazard Assessment Report (CERI, NITE, 2008), ACGIH (7th, 2001), ATSDR (2007)). It is written in a part of the reports that these effects were caused by combined exposure including exposure to other solvents such as benzene, toluene, and ethylbenzene (Hazard Assessment Report (CERI, NITE, 2008)). Therefore, these effects could not be regarded as the effects of exposure to mixed xylenes alone. Meanwhile, for experimental animals, in a 10-day oral administration study with rats dosed by gavage, increased liver weights were observed at 250 mg/kg/day (converted guidance value: 27.8 mg/kg/day), but associated findings to suggest hepatic toxicity were not detected in blood chemistry test values, histological changes, etc. (Hazard Assessment Report (CERI, NITE, 2008)). Therefore, including the description above, there was no data on adverse effects in experimental animals that could be used for the classification of this substance. From the above, information on both humans and experimental animals were lacking, for classification as the effects by exposure to this substance alone. As with the other isomers, this substance was classified as "Classification not possible" due to lack of data. |
| 10 | Aspiration hazard | Category 1 |
Danger |
H304 | P301+P310 P331 P405 P501 |
This substance is a hydrocarbon with a calculated kinematic viscosity value of 0.70 mm2sec (25/20 deg C) (viscosity: 0.603 mPa*s (25 deg C); density (specific gravity): 0.861 (20/4 deg C) (HSDB (Access on August 2015))), and was therefore classified in Category 1. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 2 |
- |
H401 | P273 P501 |
From 96-hour LC50 =1.7 mg/L for crustacea (Crangon franciscorum), and 96-hour LC50 = 1.7 mg/L for fish (Morone saxatilis) (both Initial Risk Assessment (NITE, CERI, NEDO, 2005), EHC 190, 1997), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified as "Not classified" from 21-day NOEC = 1.29 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 10 (Ministry of the Environment, 2012), Initial Risk Assessment (NITE, CERI, NEDO, 2005)) although being not rapidly degradable (a degradation rate by BOD: 38%, readily biodegradable (Official Bulletin of Ministry of International Trade and Industry, 1975)). 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 being not rapidly degradable and 96-hour LC50 = 1.7 mg/L for fish (Morone saxatilis) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), EHC 190, 1997). By drawing a comparison between the above results, it was classified in Category 2. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |