NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	109-59-1
Chemical Name	Ethylene glycol monoisopropyl ether
Substance ID	m-nite-109-59-1_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)

PHYSICAL HAZARDS

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 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 44 deg C (closed cup) (ICSC (2004)).	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 240 deg C (ICSC (2004)).	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	-	- -	-	-	-	-	-

HEALTH HAZARDS

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)	Not classified	- -	-	-	There were 6 reports of LD50 values of 500-1,000 mg/kg (ECETOC TR64 (1995)), 500-1,000 mg/kg (ECETOC TR 95 (2005)), 500-1,000 mg/kg (PATTY (6th, 2012)), >2,000 mg/kg (GLP: OECD TG 401 compliant) (JECDB (Access on June 2014), SIDS (2011)), 5,600 mg/kg (ECETOC TR64 (1995), ECETOC TR95 (2005), PATTY (6th, 2012)) and 0.5-5.6 g/kg (DFGOT vol. 5 (1993)) for rats. Based on >2000 mg/kg, the LD50 value based on GLP and OECD TG (JECDB (Access on June 2014), SIDS (2011)), and 5,600 mg/kg, an LD50 value that supported this data (ECETOC TR64 (1995), ECETOC TR95 (2005)), it was classified as "Not classified."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	There were 3 reports of LD50 values of 1,440 mg/kg (DFGOT vol. 5 (1993)), 1,600 mg/kg (ECETOC TR64 (1995), ECETOC TR95 (2005)) and 1,080-2,370 mg/kg (PATTY (6th, 2012)) for rabbits. It was classified in Category 4 to which the greatest number of reports (2 cases) corresponded according to the revised GHS classification guidance for the Japanese government.	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 4	Warning	H332	P304+P340 P261 P271 P312	Based on a report of an LC50 value (4 hours) of 4,000 ppm for rats (ECETOC TR64 (1995), ECETOC TR95 (2005), DFGOT vol. 5 (1993)), it was classified in Category 4. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (6,841 ppm), the reference value in units of ppm was applied as a vapour without a mist.	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 is a report that irritation was observed in a skin irritation test (EEC test method) in which this substance was applied to rabbits for 4 hours (SIDS (2011), ECETOC TR95 (2005)). In addition, skin primary irritation score, PII, by the Draize test method was 4.8 (24-hour application) (SIDS (2011), ECETOC TR 95 (2005)). From the above results, it was classified in Category 2.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on a report that in an eye irritation test with rabbits, although conjunctivitis, iritis and corneal damage were observed after application of this substance (undiluted), they resolved within 7 days (SIDS (2011), ECETOC TR95 (2005), DFGOT vol. 5 (1993)), it was classified in Category 2B. Besides, this substance was classified in "Xi; R36" in the EU DSD classification, and in "Eye Irrit. 2" in the EU CLP classification.	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 no sensitization was observed in a maximization test with guinea pigs (ECETOC TR95 (2005)). In addition, there is a description that this substance did not show sensitization (PATTY (6th, 2012)). From the above, 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	- -	-	-	Classification not possible due to lack of data. There were no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (JECDB (Access on June 2014), SIDS (2011), PATTY (6th, 2012)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	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))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a reproduction/developmental toxicity screening test (OECD TG 421) with rats by the oral route (gavage), no effects on fertility (estrous cycle, copulation, fertility, gestation period, the status of delivery and lactation, etc.) and on offspring toxicities (survival, body weight and morphological observation of born offspring) were observed even at doses where parental toxicities (extramedullary hematopoiesis of the spleen considered to be caused by hemolysis, increased spleen weight and hematuria) were observed (JECDB (Access on June 2014), SIDS (2011)). In teratogenicity tests with rats and rabbits by the inhalation route, decreased weight of fetuses (rabbits) and delayed development were observed at doses where maternal toxicity (hematuria in rats, and decreased food consumption, decreased body weight gain and hemolytic anemia in rabbits) was observed (ECETOC TR95 (2005)). From the above, no effects on fertility and teratogenicity were observed. In addition, the effects on fetuses were also slight and were only observed at doses where maternal toxicity was observed. Therefore, although it corresponded to "Not classified," it was classified as "Classification not possible" since information on fertility was obtained from the screening test.	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, kidney, liver, spleen), Category 2 (central nervous system)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	The effects of single exposure to this substance were limited to experimental animals data. Excretion of reddish urine and decrease in fecal volume were reported from 3 or 4 hours after administration to the next day on oral administration of 2,000 mg/kg to rats (JECDB (Access on June 2014), SIDS (2011)). In addition, there was a report of large amounts of hematuria (hemoglobinuria) with findings in the liver, kidneys and spleen, and central nervous system depression and dyspnea by oral administration (500-1,000 mg/kg) to rats (PATTY (6th, 2012), ECETOC TR95 (2005)). As for the inhalation route, there were reports of an increase in osmotic fragility of the erythrocytes when rats were exposed to 62 ppm for 4 hours (ACGIH (7th, 2001), DFGOT vol. 5 (1993), ECETOC TR4 (1982), ECETOC TR 95 (2005)), of hemolysis with nephropathy by inhalation exposure of rats, blood urine and kidney injury when rats were exposed to 160 ppm for 4 hours (PATTY (6th, 2012)), of hematuria (hemoglobinuria) with associated findings in the kidneys, liver and spleen (DFGOT vol. 5 (1993)), and of the central nervous system depression and dyspnea (exceeding the guidance range of Category 2) (DEFGOT vol. 5 (1993)). These effects were mainly observed within the range of guidance values corresponding to Category 1 in the case of inhalation exposure and Category 2 in the case of oral administration. From the above, it was classified in Category 1 (hemal system, kidney, liver, spleen), Category 2 (central nervous system).	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	In a study in which rats were dosed by gavage for 28 days, changes in the bone marrow myelogram (a decrease in myeloid/erythroid ratio) at or above 30 mg/kg/day (converted guidance value: 9.3 mg/kg/day), anemia-like findings (decreases in red cell count, hematocrit value and hemoglobin content, and an increase in reticulocyte ratio, etc.), enhancement of extramedullary hematopoiesis of the spleen and increased hematopoiesis of erythrocytes of the bone marrow at 125 mg/kg/day (converted guidance value: 38.9 mg/kg/day) were observed (SIDS (2011), JECDB (Access on June 2014)). In the case of the inhalation route, in a study in which rats were exposed by inhalation for 28 days, and in studies in which rats, guinea pigs, rabbits and dogs were exposed by inhalation for 26 weeks, in rats, at concentrations corresponding to Category 1 (0.43 mg/L (converted guidance value: 0.134 mg/L) and 0.1075 mg/L), anemia-like findings (decreases in erythrocyte counts, hemoglobin concentration and packed cell volume (PCV), and increases in MCV) in the 28-day study and osmotic fragility of erythrocytes in the 26-week study were observed (SIDS (2011), ACGIH (7th, 2001), ECETOC TR95 (2005)). Besides, there is a description in SIDS (2011) and ECETOC TR95 (2005) that hemolytic anemia was caused by repeated exposure to this substance, and effects on the spleen and bone marrow were considered to be secondary changes from reactivity associated with anemia. 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))

ENVIRONMENTAL HAZARDS

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	- -	-	-	It was classified as "Not classified" from 96-hour LC50 > 100 mg/L for fish (Oryzias latipes), 48-hour EC50 > 1000 mg/L for crustacea (Daphnia magna), and 72-hour ErC50 > 1000 mg/L for algae (Pseudokirchneriella subcapitata) (all Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001), SIDS, 2011).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" from 21-day NOEC = 98 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001)) although it is not rapidly degradable (28-day degradation rate by BOD: 8% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1998)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for fish and is not water-insoluble (water solubility = 100000 mg/L, PHYSPROP Database, 2009). From the above results, it was classified as "Not classified."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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