Latest GHS Classification Results by the Japanese Government (edited by NITE)
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 111-76-2 |
| Chemical Name | Ethylene glycol mono-n-butyl ether (Butyl cellosolve) |
| Substance ID | m-nite-111-76-2_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) |
| 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 4 |
Warning |
H227 | P370+P378 P210 P280 P403 P501 |
It was classified in Category 4 based on a flash point of 62 deg C (closed cup) (SIDS (2006)). | 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 238 deg C (ICSC (2003)). | 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) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. | 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 | - |
- |
- | - | - | - | - |
| 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) | Category 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
There were 10 reports of LD50 values within the range of 470-3,000 mg/kg for rats. According to the revised GHS classification guidance for the Japanese government, it was classified in Category 4 to which most data (470 mg/kg, 917 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)), ca. 1,500 mg/kg (NTP TR484 (2000)), 1,746 mg/kg (SIDS (1997), NICNAS (1996))) corresponded. Besides, 2 data sets corresponded to "Not classified" (Category 5 in UN GHS classification) and 4 data sets corresponded to Category 4 or 5. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 1 | Acute toxicity (Dermal) | Category 3 |
 Danger |
H311 | P302+P352 P361+P364 P280 P312 P321 P405 P501 |
There were 3 reports of LD50 values within the range of >2,000 mg/kg for rats. There were 16 reports of LD50 values within the range of 72 mg/kg to >2,000 mg/kg for rabbits, so there was a total of 19 reports. According to the revised GHS classification guidance for the Japanese government, it was classified in Category 3 to which most data (9 data) (220 mg/kg (ATSDR (1998)), 220 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)), ca. 400 mg/kg (ACGIH (7th, 2003)), 435 mg/kg (SIDS (2007), NICNAS (1996)), 404-502 mg/kg (CICAD 67 (2010)), 405-504 mg/kg (DFGOT vol. 6 (1994), ECETOC TR95 (2005)), 567 mg/kg (male), 636 mg/kg (female) (NICNAS (1996)), 612 mg/kg (DFGOT vol. 6 (1994)), 841 mg/kg (1,060 mg/kg (male), 667 mg/kg (female)) (EU-RAR (2006), ECETOC TR95 (2005))) corresponded. Besides, 2 data corresponded to Category 2, 2 data corresponded to Category 2 or 3, 1 data corresponded to Category 3 or 4, and 2 data corresponded to "Not classified." By adding new information sources (ACGIH (7th, 2003), ATSDR (1998), CICAD 67 (2010), DFGOT vol. 6 (1994), ECETOC TR95 (2005), EU-RAR (2006), NICNAS (1996), NTP TR484 (2000), SIDS (2006), SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)), the classification was revised. | 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 2 |
Danger |
H330 | P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501 |
Based on reports of LC50 values (4 hours) of 450 ppm (SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)), 486 ppm (male), 450 ppm (female) (ACGIH (7th, 2003), ATSDR (1998), CICAD 67 (2010), ECETO TR95 (2005), NICNAS (1996), NTP TR484 (2000), SIDS (2006)), 500 ppm (ATSDR (1998)) for rats, it was classified in Category 2. | 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. | 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 |
There were multiple reports of skin irritation test with rabbits. It was reported that, in 2 tests equivalent to OECD TG 404, it was irritating (SIDS (2006), ECETOC TR95 (2005), NICNAS (1996)), and that although severe and persistent erythema and severe edema were observed as the findings, they disappeared after 7 days (SIDS (2006)). It was reported that in other skin irritation tests by 4-hour application, it was "mildly irritating" or "irritating" (SIDS (2006), ECETOC TR95 (2005), EU-RAR (2006)). In addition, after applying to rabbits under semi-occlusive conditions for 24 hours, mild to moderate erythema (5/6 animals) and mild edema (4/6 animals) were observed immediately after application, and mild to moderate erythema (4/6 animals) and mild edema (3/6 animals) were observed 48 hours after application (EU-RAR (2006)). The primary irritation score was 1.5 in this test. Additionally, there is a result that it was irritating in a skin irritation test with guinea pigs (SIDS (2006), EU-RAR (2006)). Based on the above results, it was classified in Category 2. Besides, this substance was classified in "R38" by EU DSD classification, and in "H315 Skin Irrit. 2" in EU CLP classification. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
There are reports that, in eye irritation test with rabbits (OECD TG 405, GLP-compliant), although 24-27 hours after administration, corneal opacity score was 0.9, iritis score was 0.6, conjunctivitis score was 2.6, and conjunctival edema score was 1.8, they disappeared within 21 days (ECETOC TR95 (2005), EU-RAR (2006)). Moreover, there were several other reports of eye irritating tests with rabbits, and there is a report that it was severely irritating in a Draize test (SIDS (2006), EU-RAR (2006)). In addition, it is described that, in humans, although it caused painful irritation and sometimes with corneal clouding, the symptoms generally disappeared within a few days (DFGOT vol. 6 (1994)). Based on the above result, it was classified in Category 2A. | 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 | Not classified |
- |
- | - | There is a report that it was negative in a maximization test with guinea pigs (OECD TG 406, GLP) (SIDS (2006), ECETOC TR95 (2005), NICNAS (1996)). There is a report that it was negative also in another maximization test (SIDS (2006), ATSDR (1998), NICNAS (1996)). In addition, there is a report that, when a patch test (GLP-compliant) of a 10% aqueous solution of this substance was conducted in 200 volunteers, it was negative (SIDS (2006)). Additionally, there is a report that it was negative in a patch test to 214 volunteers (ATSDR (1998), ECETOC TR95 (2005)). Based on the above results, it was classified as "Not classified." | 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, it was negative in bone marrow micronucleus tests with rats and mice (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008), SIDS (2007), EU-RAR (2006), NICNAS (1996)). As for in vitro, there were both negative and positive results in bacterial reverse mutation tests, and gene mutation tests and sister chromatid exchange tests with cultured mammalian cells, and it was negative in a chromosomal aberration test and a micronucleus test (EU-RAR (2006), NICNAS (1996), SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | It was classified in group 3 by IARC (IARC 88 (2006)), in A3 by ACGIH (ACGIH (7th, 2003)), and as group C by EPA (IRIS (1999)), showing different carcinogenicity assessments among institutions. However, in a subsequent evaluation, EPA expressed the view that this substance was not likely to be a carcinogen for humans (IRIS TR (2010)), and also SIDS (2007) similarly described that there was no evidence for it being a carcinogen. From the above, according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
In a teratogenicity test with rats by the inhalation route, a teratogenicity test with rabbits by the inhalation route (OECD TG 414) and a teratogenicity test with rats by the oral route (gavage) (OECD TG 414), developmental effects (such as decreased numbers of implantations and increased resorptions) were observed at doses (200 ppm (970 mg/m3) by inhalation and 200 mg/kg bw/day by gavage) where maternal toxicities (decreased body weight gain, changes in organs' weight and hemal parameter) developed (SIDS (2006)). Therefore, it was classified in Category 2. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (blood system, respiratory organs, liver, kidney), Category 3 (narcotic effects) |
Danger Warning |
H370 H336 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
In humans, respiratory tract irritation, vomiting, dizziness, lethargy, coma, dyspnea, mydriasis, metabolic acidosis, decreased hemoglobin and hematuria were reported by the inhalation and oral route, and hypokalemia, increased serum creatinine concentration, significantly increased urinary excretion of oxalate ester crystals, hypoxemia, pulmonary edema, adult respiratory distress syndrome (ARDS) and nonhemolytic hypochromic anemia with thrombocytopenia were reported by oral ingestion (EU-RAR (2006), SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008), ACGIH (7th, 2003)). By inhalation exposure to rats, rapid and shallow breathing, loss of coordination, red staining around the urogenital area, enlarged and discolored kidneys and red fluid in the bladder at 450 ppm (SIDS (2007)), severe hemoglobinuria, dyspnea, changes in the lung, kidney, liver and spleen (no specific description) at 486 ppm (ACGIH (7th, 2003)), and bloody urine and poor coordination at 475 ppm were observed. At or above 560 ppm by inhalation exposure of mice, dyspnea, severe hemoglobinuria, follicular phagocytosis and congestion of the veins in the spleen, focal necrosis, lymphoid hyperplasia, interstitial nephritis and bronchopneumonia were observed (EU-RAR (2006)). In the case of oral exposure, there are reports that sluggishness, prostration, narcosis, hemorrhaged lungs, severely congested kidneys, hemoglobinuria, bloody urine and mottled livers were observed at 1,120-1,420 mg/kg with rats, and that inactivity, labored breathing, dyspnea, anorexia, tremors, hematuria at a high dose, blood in the stomach and intestines in dead animals were observed at 1,519-2,005 mg/kg with mice (EU-RAR (2006)). In the case of dermal application, there is a report that prostration, hypothermia, hemoglobinuria, narcosis, failure of respiration, renal impairment, modified lungs (no detail description), congestion of the liver, necrotic foci with mesenchymatous reactions, inconstant steatosis, congestion of the spleen, enlarged kidney with hemoglobinemic nephrosis and cutaneous lesions including necrosis were observed at 72-225 mg/kg for rabbits (EU-RAR (2006)). Besides, these findings were confirmed within the guidance value range of Category 1. From the above, it was classified in Category 1 (hemal system, respiratory organs, liver, kidney), Category 3 (narcotic effects). |
FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
There was no available information on effects from repeated exposure in humans (SIDS (2007), CICAD 67 (2010)). In experimental animals, in a 13-week administration test with rats by drinking water, effects on the hemal system (such as decreased erythrocyte counts) and decreased sperm concentrations were observed at a dose (ca. 70 mg/kg/day) equivalent to Category 2 (CICAD 67 (2010)). By the inhalation route, in 14-week or 2-year inhalation exposure tests with rats or mice, findings of anemia (decreases in erythrocytes, hemoglobin concentration and hematocrit values, increased reticulocyte count, etc.) were observed from the low concentration (0.15 mg/L/6 hours) equivalent to Category 1 (SIDS (2007), CICAD 67 (2010)), and the effects tended to be more intense in rats than in mice, and in females rather than in males (CICAD 67 (2010)). In 14-week inhalation exposure tests with rats and mice, secondary changes related to hemal effects, such as an increase in extramedullary hematopoiesis in the spleen, hemosiderin deposition in the spleen, liver and kidneys, hematopoietic cell proliferation in the bone marrow, were observed at high concentrations corresponding to "Not classified"(CICAD 67 (2010)). Besides, this substance caused no obvious effects on the testis both in human and experimental animals. From the above, it was classified in Category 1 (hemal system). |
FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 10 | Aspiration hazard | 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)) |
| 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) | Not classified |
- |
- | - | Classified into Not classified from its 96h-LC50 >116 mg/L for fish (Sheepshead minnow) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 6 (2008), etc) and 96h-LC50 >130 mg/L for Crustacea (Penaeus) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 6 (2008), etc). | FY2009 | GHS Classification Guidance by the Japanese Government （March, 2009） |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Not classified |
- |
- | - | Classified into Not classified since it is rapidly degradable (BOD degradation rate: 96% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1976)) and low bioaccumulative potential is estimated (log Kow = 0.83 (PHYSPROP Database, 2009)). | FY2009 | GHS Classification Guidance by the Japanese Government （March, 2009） |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in Annexes to the Montreal Protocol. | FY2009 | GHS Classification Guidance by the Japanese Government （March, 2009） |
NOTE:
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