NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	110-49-6
Chemical Name	2-Methoxyethyl acetate; Ethylene glycol monomethyl ether acetate
Substance ID	23B5509
Classification year (FY)	FY2011
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)	Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th 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 corresponds to Category 3 from a flash point of 44 deg C [closed-cup] (IMDG (2010)), which is >= 23 deg C and <= 60 deg C. Besides, it is classified in Class 3, PG III in UNRTDG (UN1189).
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 380 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.
16	Corrosive to metals	Not classified	- -	-	-	It was classified as "Not classified" from information that stainless steel, steel, and aluminum are resistant as a container (Hommel (1996)).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	All of three LD50 values for rats (4,300 mg/kg (Initial Risk Assessment Report 101 (NITE, CERI, NEDO, 2008)), 3,930 mg/kg (EHC 115 (1990)), 3,390 mg/kg (PATTY (5th, 2001))) correspond to "Not classified" in the Classification JIS (Category 5 in UN GHS classification). Besides, this substance is rapidly hydrolyzed to ethylene glycol monomethyl ether. Therefore, as for health hazards, please also refer to those for ethylene glycol monomethyl ether (CAS RN 109-86-4).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 values for rabbits of 5,600 mg/kg (ACGIH (2006)) and 5,290 mg/kg (PATTY (5th, 2001)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	It was classified in Category 3 based on an LD50 value of 700 ppm/4 hours for rats (HSDB (2009)). Besides, because the LC50 value was lower than 90% of the saturated vapour pressure concentration (5,276 ppm), the reference value of gasses was applied.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	An LC50 value was thought to exceed 5 mg/kg because two out of six animals died after 4-hour exposure of rats to 34.4 mg/L (Netherlands assessment document (2011), corresponding to List 2). Therefore, it was classified as "Not classified." Besides, because the test concentration was higher than the saturated vapour pressure concentration (25.5 mg/L), the reference value of mists was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because no irritation was seen in a test by 4-hour occlusive application of 0.5 mL to the rabbit skin (EEC test). Besides, 24-hour occlusive application resulted in slight irritation (Initial Risk Assessment Report 101 (NITE, CERI, NEDO, 2008)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B because this substance in liquid form was mildly irritating in a test by application to the rabbit eye (ACGIH (2006)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow after intraperitoneal administration to Chinese hamsters (in vivo somatic cell mutagenicity test) (ECETOC TR95 (2005)). Besides, as for in vitro tests, it was reported that it was negative, weakly positive, or positive in Ames tests (ECETOC TR95 (2005), NTP DB (1988)) and positive in a chromosomal aberration test with CHO cells (NTP DB (1988)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 1B because it is reported that resorptions were observed in the uteri of all maternal animals at the dose (1225 mg/kg/day) where no effects, no general toxicity, were seen in parent animals in a developmental toxicity test by oral administration to mice on gestational days 6-13 (Initial Risk Assessment Report 101 (NITE, CERI, NEDO, 2008)). Besides, the EU classified it in Repr. Cat. 2: R60-61 (EC-JRC (ESIS) (Access on Aug. 2011)). Furthermore, as information in humans, a woman who had engaged in cleaning using this substance since she was 15 years old delivered the first boy at the age of 22 and a second boy at the age of 25, and malformations such as hypospadias and bifid scrotum were seen in both the boys. She had used 2-methoxyethyl acetate at an average of 1-2 L per day for 1-4 hours. Because she had no family history of malformations, it is reported that malformations seen in the children were caused by 2-methoxyethyl acetate (Initial Risk Assessment Report 101 (NITE, CERI, NEDO, 2008)). However, the case was not adopted because its number was small, and no causal relationship was proven.
8	Specific target organ toxicity - Single exposure	Category 1 (kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It is reported that rabbits and cats died of kidney disorders after 8-hour inhalation exposure to the vapour of 450 ppm (converted value: 2.17 mg/L/8 hours = 3.01 mg/L/4 hours) (Initial Risk Assessment Report 101 (NITE, CERI, NEDO, 2008)), and after 3-day oral administration of 507 mg/kg or 1007 mg/kg to rabbits, all showed kidney injury and had albumin and casts in the urine (PATTY (5th, 2001)). The doses were within the guidance value range for Category 2 in the 3-day oral administration test with rabbits, but the concentration for inhalation exposure corresponded to the guidance values for Category 1. Therefore, it was classified in Category 1 (kidney). Besides, it is described in ACGIH (2006) that it irritated the mucous membranes in an animal inhalation test (mice, guinea pigs, rabbits), but it is mentioned in the Netherlands assessment document (2011) that there was no respiratory tract irritation in a test with mice.
9	Specific target organ toxicity - Repeated exposure	Category 2 (central nervous system)	Warning	H373	P260 P314 P501	It is reported that after 2-week inhalation exposure of rats to 1,244 mg/m3/6 hours (converted guidance value: 0.191 mg/L: (vapour)), the animals partially lost motor function of the hindlimb, the hindlimb paralysis was accompanied by glia cell toxicity and did not fully disappear 2 weeks after the end of exposure, remaining slightly in the high dose animals (Netherlands assessment document (2011)). Because this substance is rapidly cleaved in vivo to ethylene glycol monomethyl ether (EGME), which shows distinct central nervous system toxic properties, this effect may also be assumed for the substance (ECETOC TR95 (2005)). The dose in the rat test corresponded to the guidance values for Category 1, but data in List 2 alone are available, and the test did not meet the decision criteria 1b3) (OECD TG and GLP). Therefore, it was classified in Category 2 (central nervous system) according to the GHS classification guidance for the Japanese government. Besides, after 5-week oral administration to rats, marked decreases in seminiferous tubules, sperms, spermatids, spermatocytes, etc. were observed at or above 500 mg/kg/day (converted guidance value: 192 mg/kg), loss of sperms and spermatid and increased interstitial cells were found at or above 1,000 mg/kg/day, and loss of spermatids in the seminiferous tubules (only Sertoli cells remained), decreased seminal vesicle weight, decreased hemoglobin level, etc. were seen at 2,000 mg/kg/day (Initial Risk Assessment Report 101 (NITE, CERI, NEDO, 2008)). However, these doses exceeded the upper limit of the guidance value range.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 40 mg/L for fish (Menidia beryllina) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
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 rapidly degradable (a 2-week degradation rate by BOD: 95% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 7-day EC10 = 0.06 mg/L for crustacea (Ceriodaphnia dubia) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)). 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" due to being rapidly degradable (a 2-week degradation rate by BOD: 95% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and a low bioaccumulation estimate (log Kow = 0.1 (PHYSPROP Database, 2009)), despite 96-hour LC50 = 40 mg/L for fish (Menidia beryllina) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)). By drawing a comparison between the above results, it was classified in Category 2.
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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