NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	110-80-5
Chemical Name	Ethylene glycol monoethyl ether
Substance ID	H26-B-019, R-007
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	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 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 (2003)). Besides, it is classified in Class 3, PG III (UN1171) 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 235 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)	Not classified	- -	-	-	Based on several reports of LD50 values within the range of 2,125-5,720 mg/kg (PATTY (6th, 2012), CICAD 67 (2010), EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ECETOC TR95 (2005), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), ACGIH (7th, 2001), DFGOT vol. 6 (1994), EHC 115 (1990)) for rats, it was classified as "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of 3,900 mg/kg for rats (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)), and several reports of LD50 values within the range of 3,311-15,200 mg/kg (CICAD 67 (2010), EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ECETOC TR95 (2005), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), CEPA (2002), EHC 115 (1990)) for rabbits, 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 reports of LC50 values (4 hours) of 15.2 mg/L (=4,119 ppm) (EU-RAR (2008)) and 16 mg/L (=4,336 ppm) (CICAD 67 (2010), ECETOC TR95 (2005)) for rats, it was classified in Category 4. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (4,936 ppm), the reference value in units of ppm was applied as a vapour without a 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 are reports that mild-moderate erythema and mild desquamation were observed in a Draize test with rabbits (EU-RAR (2008)), and that no irritation was observed after application of this undiluted substance in a skin irritation test according to EU guidelines (EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Therefore, it was concluded in EU-RAR (2008) that this substance was not irritating. There were multiple other reports of no irritation or mild irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ECETOC TR95 (2005)). Additionally, there is a description that this substance showed only slight irritation even with the worst conditions in a test with experimental animals (CICAD 67 (2010)). From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification). The category was changed according to the revision of the GHS classification guidance for the Japanese Government.
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	There is a report that in a Draize test with rabbits, although moderate corneal injury, moderate iritis, moderate to severe conjunctival irritation and necrosis of the nictitating membranes were observed, these showed a tendency to disappear within 7 days (EU-RAR (2008)). In addition, in other Draize tests, there are reports that it was moderately irritating (EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), and that this substance was mildly irritating (EU-RAR (2008), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ECETOC TR95 (2005), ECETOC TR64 (1995)). There is a description that this substance showed only slight irritation even with the worst conditions in a test with experimental animals (CICAD 67 (2010)). From the above results, it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	There is a report that no sensitization was observed in a maximization test (Magnusson and Kligman method) according to OECD criteria (EU-RAR (2008)). In addition, there is a description that this substance did not induce skin sensitization (CEPA (2002)). From the above, 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 a mouse bone marrow micronucleus test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), CICAD 67 (2010), EU-RAR (2008)). As for in vitro, it was negative in a bacterial reverse mutation test, and it was negative or weakly positive in mammalian cell gene mutation tests. However, many results were positive in chromosomal aberration tests and sister chromatid exchange tests (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), CEPA (2002), CICAD 67 (2010), EU-RAR (2008), PATTY (6th, 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a reproductive toxicity test by continuous breeding with mice through the oral route (drinking water), a significant decrease in fertility was observed at quite a high dose (1,500 mg/kg bw/day) (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). In a teratogenicity test with mice by the oral route (gavage), at quite a high dose (1,800 mg/kg bw/day), although no maternal toxicity was observed, malformations such as fused or missing digits and kinked tail were observed (PATTY (6th, 2012)). In a teratogenicity test with rats and rabbits by the inhalation route, although maternal toxicity was unknown, resorptions and cardiovascular malformations were observed at concentrations of 743 mg/m3 in rats and 600-688 mg/m3 in rabbits (ECETOC TR95 (2005), EHC 115 (1990)). In a teratogenicity test with rats by the dermal route, at a dose (0.25 mL) where no maternal toxicity was observed, an increase in 100% resorption, an increase in skeletal variations, a decrease in fetal weight, cardiovascular malformations and a decrease in the number of live fetuses per litter were observed (EHC 115 (1990)). From the above, since malformations were observed at doses where no maternal toxicity was observed, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, haemal system, kidney, liver)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In humans, in the case of the oral route, there is a report that loss of consciousness, repeated tonic-clonic spasms and biochemically, metabolic acidosis were observed in accidental ingestion of this substance of ca. 40 mL, and that the person recovered consciousness after treatment, and that there was renal failure the next week, liver injury in the third week, and a complete recovery after 1 month, but complaints like nervous breakdown continued (OEL Documentations (Japan Society For Occupational Health (JSOH), 1985), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), PATTY (6th, 2012)). There is a report that in a case of ingestion of ca. 100 mL, mental confusion, weakness, vomiting, deep and frequent respiration and severe metabolic acidosis were observed 8 hours after ingestion, and then the persons recovered (PATTY (6th, 2012)). In addition, there are reports that by the oral route, severe toxic effects on the gastrointestinal tract, central nervous system, lung and heart of humans (EU-RAR (2008)), and that acute effects on humans were the central nervous system depression and metabolic acidosis (PATTY (6th, 2012)). In experimental animals, in oral administration to rats, dyspnea, piloerection, weakness, lethargy, ataxia, writhing and coma, etc., were observed, and in severe cases or deaths, hemorrhage of the stomach and intestine, mild liver injury, severe kidney injury and hematuria were observed (PATTY (6th, 2012)). Moreover, there is a report that after death, the bladders distended with bloody urine, extreme tubular degeneration with cortical tubular necrosis in the kidney, distention and severe congestion of the Bowman's spaces, etc. were observed. Also, in other experimental animals such as mice, similar toxic effects were observed by the oral route. Also, by the inhalation route, in other experimental animals such as mice, similar effects were observed by the oral route (OEL Documentations (Japan Society For Occupational Health (JSOH), 1985), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), ACGIH (7th, 2001), EU RAR (2008), PATTY (6th, 2012)). Besides, in the case of inhalation exposure, the effects were observed within the guidance value range of Category 1, in the case of oral administration, they were observed within the guidance value range for Category 2. There are descriptions that testicular damage was observed by inhalation exposure in experimental animals (no description of species) (ECETOC TR64 (1995)), and that there was decreased testicular weight by inhalation exposure of male rats at 4,500 ppm for 3 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). However, there was no detailed information, and it was not covered by other assessment reports. Therefore, testicular effects were not adopted because they were unclear. From the above, with emphasis on human effects, it was classified as Category 1 (central nervous system, hemal system, kidney, liver).
9	Specific target organ toxicity - Repeated exposure	Category 1 (haemal system, testis)	Danger	H372	P260 P264 P270 P314 P501	In humans, in reports on occupational exposure by inhalation of this substance, there are multiple reports on the effects on the hemal system and hematopoietic tissue (anemia, decreased hemoglobin concentration and hematocrit value, granulocytopenia and myelosuppression), and effects on sperm production (oligospermia, azoospermia, reduced fertility) (CICAD 67 (2010)). The results of these epidemiological studies showed that there was a high correlation between the exposure concentration of this substance in humans, hematologic toxicities, and inhibition of spermatogenesis, therefore, it is described in the CICAD 67 (2010) that the hemal system and genetic organs were important as target organs of this substance in humans. In experimental animals, in the tests in which rats and mice were exposed by inhalation at the high concentration corresponding to "Not classified" or were administered orally at the high dose corresponding to "Not classified", toxic effects on the hemal system and the male genetic organs such as testis were observed (ECETOC TR 64 (1995), CEPA (2002), CICAD 67 (2010)), and were considered to support effects on humans (CICAD 67 (2010)). From the above, it was classified in Category 1 (hemal system, testis).
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)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour ErC50 > 100 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)), 48-hour EC50 > 89.5 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, 2002), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and 96-hour LC50 > 94.7 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), Initial Risk Assessment (NITE, CERI, NEDO, 2007)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD = 63, 83, 83% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), 72-hour NOEC (growth rate) = 100 mg/L for algae (Pseudokirchneriella subcapitata), and 21-day NOEC > 97 mg/L for crustacea (Daphnia magna) (both Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). 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 = 1000000 mg/L, PHYSPROP Database, 2009). From the above, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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