GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 100-41-4 |
| Chemical Name | Ethyl Benzene |
| Substance ID | H27-B-043/C-079B_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 | FY2014 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 2 |
 Danger |
H225 | P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501 |
Based on a flash point of 18 deg C (closed cup) and a boiling point of 136 deg C (ICSC (2007)), it was classified in Category 2. Besides, it is classified in Class 3, PG II (UN.1175) 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 432 deg C (ICSC(2007)). |
| 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 |
- |
- | - | There are 8 reports of LD50 values for rats: 3,500 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)), 3,500 mg/kg (PATTY (6th, 2012), ATSDR (2010), ACGIH (7th, 2001), OEL Documentations (Japan Society For Occupational Health (JSOH), 2001), NTP TR 466 (1999), EHC 186 (1996)), 4,700 mg/kg (EHC 186 (1996)), 4,769 mg/kg (ATSDR (2010)), 3,500-4,700 mg/kg (ACGIH (7th, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), 4,734 mg/kg (PATTY (6th, 2012)), SIDS (2005)), 3,500-5,500 mg/kg (IARC 77 (2000), and 3,500-5,500 mg/kg (PATTY (6th, 2012)). It was classified as "Not Classified" (Category 5 in UN GHS classification) to which most data (5 cases) correspond. Besides, 3 cases were not adopted for classification because they were summarized values from multiple data. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on the reported LD50 values for rabbits of 5,000 mg/kg (PATTY (6th, 2012)), > 5,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)), 15,400 mg/kg (15,433 mg/kg) (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015), PATTY (6th, 2012), ATSDR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 2001)), and 77,400 mg/kg (EHC 186 (1996)), it 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 the reported LC50 value (4 hours) of 4,000 ppm for rats (PATTY (6th, 2012), ATSDR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 2001), IARC 77 (2000), NTP TR 466 (1999), EHC 186 (1996)), it was classified in Category 4. Besides, since the LD50 value was lower than the saturated vapor pressure concentration (12,537 ppm), a reference value in the unit of ppm was applied as vapour without mist. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | There is a report that in a skin irritation test with rabbits, as a result of application of undiluted 0.1 mL of this substance, mild irritation was observed (ATSDR (1999), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). From the above, it was classified as "Not classified" (Category 3 in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
There are reports that in eye irritation tests with rabbits, as a result of application of an undiluted solution of this substance, mild irritation was observed in the conjunctiva, and mild irritation was observed (EHC 186 (1996), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). From the above, it was classified in Category 2B. |
| 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. Besides, there is a report that as a result of a maximization test for 25 volunteers, no sensitization was observed (ACGIH (7th, 2002), SIDS (2005)). However, since details of the test method etc. were unknown, it was judged as insufficient data to be adopted for the classification. |
| 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 micronucleus tests with mouse bone marrow cells and peripheral blood erythrocytes, and an unscheduled DNA synthesis test with mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2005), ACGIH (7th, 2011), IARC 77 (2000), NTP TR 466 (1999), ATSDR (2010), EHC 186 (1996)). As for in vitro, it was negative in bacterial reverse mutation tests, a chromosomal aberration test and a sister chromatid exchange test with mammalian cultured cells, negative and positive in mouse lymphoma tests with mammalian cultured cells, and positive in a micronucleus test with mammalian cultured cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2005), ACGIH (7th, 2011), IARC 77 (2000), NTP TR 466 (1999), ATSDR (2010), ECETOC JACC (1986), EHC 186 (1996)). |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
As for humans, at ethyl benzene manufacturing plants in Czechoslovakia, no excess risk of cancers was seen in workers exposed to this substance, but it was considered that the description was insufficient (IARC 77 (2000), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In addition, there is a description that no excess deaths due to cancer were seen in workers exposed to this substance in a styrene polymerization plant in the United States during 15 years of a follow-up survey (IARC 77 (2000)). On the other hand, for experimental animals, in a 2-year carcinogenicity study by the inhalation route with rats or mice, in rats, increases in incidence of renal tubular adenoma and combined incidence of renal tubular adenoma and carcinoma were found in males (simple slicing method), and by a stepwise slicing method of the kidney specimens, the increased incidence of renal tubular tumors (combined incidence of adenoma and carcinoma) was also confirmed in females (IARC 77 (2000), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). In mice, an increased incidence of alveolar/bronchiolar adenomas was observed in males, and an increase in total incidence of hepatocellular adenomas and hepatocellular carcinomas was observed in females (IARC 77 (2000), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). Furthermore, also in a test with rats given 1-phenylethanol, a metabolite of this substance, by gavage, occurrence of renal tubule adenoma or carcinoma was observed in males (IARC 77 (2000)). Based on the results above, IARC classified this substance in Group 2B because there was insufficient evidence in humans, but sufficient evidence in experimental animals for carcinogenicity (IARC 77 (2000)). As classification results by other organization, it was classified in 2B by Japan Society For Occupational Health (JSOH) (OEL Documentations (2014)), and A3 by ACGIH (ACGIH (7th, 2011)). From the above, it was classified in Category 2. Besides, in the EU CLP classification, this substance is not classified for carcinogenicity (ECHA CL Inventory (Access on August 2015)). |
| 7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
In a 2-generation reproductive toxicity test by the inhalation route with rats, in the dose range of 25-500 ppm (approximately 108-2,150 mg/m3), both F0 and F1 generations showed no adverse effects on sexual function/fertility in male and female parent animals (ATSDR (2010)). However, there is a description that after inhalation exposure to this substance in female rats at a concentration of 100 or 1,000 ppm (about 430, 4,300 mg/m3) for 3 weeks, females were mated with non-exposure males, and the pregnant females were further exposed at the same concentration until day 19 of gestation. As a result, at 1,000 ppm (about 4,300 mg/m3), increased weights of the liver, kidney, and spleen (without a tissue change) were observed in the maternal animals, and increased incidence (14%) of skeletal variations (supernumerary ribs) was observed in fetuses (SIDS (2005)). On the other hand, in a test in which pregnant rabbits were similarly exposed by inhalation at a concentration of 100 or 1,000 ppm (about 430, 4,300 mg/m3) of this substance on day 1-24 of gestation, maternal toxicity (liver weight gain) was only seen at 1,000 ppm (about 4,300 mg/m3), and no developmental toxicity effects were seen in fetuses (SIDS (2005)). Besides this, there are descriptions that in exposure in pregnant rats at 600-2,400 mg/m3 on gestational days 7-15, death, increased embryo absorption, an increased number of delayed ossifications, and malformations (only at higher concentrations) were observed, and that in a study in which pregnant mice were exposed by inhalation at 500 mg/m3 on gestational days 6-15, malformations in fetuses were observed though there is no description of maternal toxicity. However, it was considered that descriptions on inhalation exposure methods, a definition of malformations, and the number of cases in which effects were observed were insufficient in these test reports, so the use of data was limited (SIDS (2005)). On the other hand, the Japan Society for Occupational Health (JSOH) checked the primary sources cited in the reports showing these malformations, and stated that although the details of the description were lacking, the malformations found in rats or mice were primarily urinary tract malformations, and the proportion of the fetuses or pups increased which showed some morphological abnormality including these malformations; and that in a test with pregnant rabbits exposed by inhalation during an organogenesis period, no occurrence of malformation was observed, but the occurrence of developmental effects on fetuses (lower value of fetal weight) was observed at 500 mg/m3, and miscarriages in all the maternal animals were seen at 1,000 mg/m3. With the above descriptions, the Japan Society for Occupational Health (JSOH) considered that although no clear reproductive toxicity effect is reported for humans, it is certain that reproductive toxicity occurs in laboratory animals, and they classified it in reproductive toxicants Group 2 (suspected human reproductive toxicant) (OEL Documentations, 2014). From the above, based on developmental toxicity effects including malformations, it was classified in Category 1B for this hazard class. Besides, it was not classified for reproductive toxicity in the EU CLP classification (ECHA CL Inventory (Access on August 2015)). |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (respiratory tract irritation, narcotic effects) |
Warning |
H335 H336 |
P304+P340 P403+P233 P261 P271 P312 P405 P501 |
This substance shows respiratory tract irritation (ACGIH (7th, 2011), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015), OEL Documentations (Japan Society For Occupational Health (JSOH), 2001), EHC 186 (1996), ATSDR (2010), PATTY (6th, 2012), ECETOC JACC (1986)). For humans, there are reports of coughs, sore throat, dizziness, lethargy, and headaches by inhalation exposure, and of burning sensations in the throat and chest by oral exposure (ACGIH (7th, 2011), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015), OEL Documentations (Japan Society For Occupational Health (JSOH), 2001), EHC 186 (1996), ATSDR (2010), PATTY (6th, 2012)). As for experimental animals, there are reports of reduced respiratory rate by inhalation exposure at 6.2 mg/L, coordination ataxia, central nervous depression, narcotic effects, gait/movement disorder, loss of orthodontia reflex, loss of forelimb grip strength, loss of consciousness, tremor, and limb convulsions by an inhalation exposure at 8.7 mg/L or more, and there are also reports of sedation, closed eyes, sensory paralysis in spite of the dose unknown (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), ACGIH (7th, 2011), ATSDR (2010), EHC 186 (1996), ECETOC JACC (1986)). It was judged that the reduced respiratory rate by inhalation exposure was a secondary effect due to irritation or narcotic effects. In addition, tremor and limb convulsions were findings at high doses, and they were considered as narcotic effects. From the above, the effects of this substance were respiratory tract irritation and narcotic effects, and it was classified in Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (auditory organ) |
Warning |
H373 | P260 P314 P501 |
As for experimental animals, reduced outer hair cells in the organ of corti are reported at 200 ppm (converted guidance value: 0.75 mg/L), which is in the range for Category 2, in a 13-week inhalation toxicity test with rats (ACGIH (7th, 2011), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). Besides, although it is not this substance alone, it was reported in human epidemiological studies that hearing impairment occurred due to occupational exposure to solvents containing ethylbenzene (ACGIH (7th, 2011)). From the above, in humans, the relation between this substance and the impairment of the auditory organs is unclear due to mixed exposures, but the effects on the auditory organs were observed at the dose within the range for Category 2 in experimental animals. Therefore, it was classified in Category 2 (auditory organ). The classification was changed due to the adoption of the new information after the previous classification. |
| 10 | Aspiration hazard | Category 1 |
Danger |
H304 | P301+P310 P331 P405 P501 |
Since this substance is a hydrocarbon, and the kinematic viscosity is 0.738 mm2/sec (25 deg C) which is calculated by the numerical data (viscosity: 0.64 mPa*s (25 deg C), density (specific gravity): 0.867) listed in HSDB, it was classified in Category 1. In addition, there is a description that even when a small amount of ethylbenzene is inhaled, there is a possibility that it diffuses widely to the tissue of the lung surface since the viscosity and the surface tension are low, and it may cause serious damage (HSDB (Access on August 2015)). |
| 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 |
From 96-hour LC50 = 0.42 mg/L for crustacea (Crangon franciscorum) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), it was classified in Category 1. |
| 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 (readily biodegradable, a degradation rate by a standard BOD test: 0% (Official Bulletin of Ministry of International Trade and Industry, 1990)), and 7-day NOEC = 0.956 mg/L for crustacea (Ceriodaphnia dubia) (Environmental Risk Assessment for Chemical Substances vol. 13 (Ministry of the Environment, 2015)). 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 = 3.7 mg/L for fish (Morone saxatilis) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)). From 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. |