GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 576-26-1 |
| Chemical Name | 2,6-Xylenol |
| Substance ID | H27-B-04-METI/M-025B_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/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 |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 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. |
| 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 applicable |
- |
- | - | Solid (GHS definition). |
| 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)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) 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 |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 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)). |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 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. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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)). |
| 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. |
| 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 |
- |
- | - | 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. |
| 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. |
| 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. |
| 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). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, respiratory organs, liver, kidney), Category 2 (haemal 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). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 48-hour LC50 = 2.2 mg/L for crustacea (Artemia salina) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), 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 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. |
| 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. |