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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	111-76-2
Chemical Name	Ethylene glycol mono-n-butyl ether (Butyl cellosolve)
Substance ID	H26-B-021, -
Classification year (FY)	FY2014
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	FY2009 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)
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

PHYSICAL HAZARDS

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 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	It was classified in Category 4 based on a flash point of 62 deg C (closed cup) (SIDS (2006)).
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 238 deg C (ICSC (2003)).
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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P362+P364 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.
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P280 P312 P321 P361 P364 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.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
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.
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	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.
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.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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."
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)).
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."
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.
8	Specific target organ toxicity - Single exposure	Category 1 (haemal 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).
9	Specific target organ toxicity - Repeated exposure	Category 1 (haemal 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).
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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