GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 105-67-9 |
| Chemical Name | 2,4-Xylenol |
| Substance ID | H27-B-03-METI/M-024B_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 |
- |
- | - | It is combustible, 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 599 deg C (ICSC (2003)). |
| 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) | Not classified |
- |
- | - | Based on a report of an LD50 value for rats of 3,200 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)), this substance was classified as "Not classified" (Category 5 in the UN GHS classification). |
| 1 | Acute toxicity (Dermal) | Category 4 |
 Warning |
H312 | P302+P352 P362+P364 P280 P312 P321 P501 |
Based on a report of an LD50 value for rats of 1,040 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)), this substance was classified in Category 4. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. On top of this, although the exposure time is unknown, there is a report that an LC value for rats was > 30 mg/m3 (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). This substance is a solid in the GHS definition, but it was considered a vapor since the toxicity value is lower than the saturated vapor concentration (0.64 mg/L). |
| 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 |
Because it is reported that in a skin irritation test with rabbits, corrosive action was observed on application of this substance (EPA Pesticide RED (1994)), and it is described in multiple pieces of literature that this substance is corrosive to the skin (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), EPA Pesticide Fact Sheet (1994)), the 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 on October 2015)). |
| 3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 | P305+P351+P338 P280 P310 |
There is a description that this substance is corrosive to the eyes (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). In addition, the 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. In addition, there is a report that an end-use product containing this substance produced skin sensitization in a skin sensitization test with guinea pigs (EPA Pesticide Fact Sheet (1994)). However, as the details of this are unknown, this substance was classified as "Classification not possible." Because what is described in the previous classification is the information listed as List 3, and the details are unknown, it was not used for the classification. |
| 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 weakly positive (Salmonella typhimurium TA100) and negative results and a sister-chromatid exchange assay with human lymphocytes was negative (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), NTP DB (Access on November 2015), HSDB (Access on October 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% or 20%, in the group of application of the 10% solution, papillomas were observed after 20 weeks in the application site, and development of cancers after 28 weeks was observed. Also in the group of application of the 20% solution, the incidence of tumors increased compared with the group of 10%, and a dose dependence was observed (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), HSDB (Access on November 2015)). In addition, in a test in which this substance was dermally applied repeatedly (2 times/week) in the same manner 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 50% and carcinomas in 11% occurred in the application site after 15-week administration, and the incidence of cancer was 18% after 23-week administration (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006), HSDB (Access on November 2015)). On the other hand, in the control group only with DMBA application, papillomas in 13% and carcinomas in 0% occurred after 15 weeks and incidence of cancer was 6% after 53 weeks. Also, in the group with DMBA application followed by repeated application of benzene only, papillomas in 11% were observed after 24 weeks. With respect to the above results, it is described in Environmental Risk Assessment for Chemical Substances (Ministry of the Environment) that while the authors suggested that this substance has a promoter effect, it is difficult to evaluate this promoter effect 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 are 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 |
- |
- | - | Classification not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (respiratory organs) |
 Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
Although they are not detailed data, this substance shows corrosive action to the respiratory tract, corrosivity was also observed through oral exposure, and inhalation of the aerosol may cause pulmonary edema. There are descriptions of burning sensation, abdominal pain, nausea, and vomiting by ingestion and of burning sensations, cough, sore throat, and shortness of breath by inhalation exposure (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). Therefore, it was concluded that this substance has an effect on the respiratory organs. Since the original article cited in Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006) is ICSC and no detailed data were available, this substance was classified in Category 2 (respiratory organs). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (liver) |
Warning |
H373 | P260 P314 P501 |
There was no report in humans. As for experimental animals, in a 4-week toxicity test with rats dosed by gavage, an increase in relative liver weights, sinusoidal dilation and congestion in the liver were observed in the females in the administration group of 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day) within a range for Category 2 (Environmental Risk Assessment for Chemical Substances Vol. 5 (Ministry of the Environment, 2006)). Therefore, this substance was classified in Category 2 (liver). Besides, in the previous classification, since there are descriptions such as "BUN levels significantly increased at final necropsy in the female mid-dose group" and "lethargy, prostration, and ataxia were observed in both females and males" (IRIS (1990)), the kidneys and the nervous system were determined as the target organs. And it was classified in Category 2 (kidneys, nervous system) since they were observed within the range for Category 2. However, subsequent confirmation revealed that increased BUN was seen in the mid-dose group (50 mg/kg/day) but not in the high-dose group (250 mg/kg/day). Also in IRIS (2000), a LOAEL was set as 250 mg/kg/day, and an increased BUN in the mid-dose group was not considered as effects. Meanwhile, effects on the nervous system were seen at the high dose (250 mg/kg/day), which was outside the range of Category 2. |
| 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 (MOR) = 2.1 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 | P273 P501 |
Due to being rapidly degradable (a degradation rate by 28-day BOD = 91%, a degradation rate by TOC = 98%, a degradation rate by HPLC = 100% (Official Bulletin of Economy, Trade and Industry, 2002)), and 21-day NOEC (reproduction) = 0.27 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 2001), Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), it was classified in Category 3. |
| 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. |