GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 110-49-6
Chemical Name Ethylene glycol monomethyl ether acetate
Substance ID H26-B-023, -
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 FY2011   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 45 deg C (closed cup) (ICSC (2003)).
Besides, it is classified in Class 3, PG III (UN1189) 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 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 in the molecule
16 Corrosive to metals Not classified
-
-
- - Stainless steel, steel, copper, and aluminum are durable as a container (Hommel (1991)).

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 LD50 values of 2,900 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)), 3,390 mg/kg (PATTY (6th, 2012)), 3,930 mg/kg (EHC 115 (1990), ACGIH (7th, 2006), DFGOT vol. 6 (1994), PATTY (6th, 2012)), 3,930-4,300 mg/kg (ECETOC TR95 (2005)), 4,300 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on reports of LD50 values of 5,214 mL/kg (5,285 mg/kg) (DFGOT vol. 6 (1994)), 5,290 mg/kg (PATTY (6th, 2012)), 5,557 mg/kg (ACGIH (7th, 2006), EHC 115 (1990), ECETOC TR95 (2005)), 5,240-5,560 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rabbits, it was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, in the previous classification, based on a report of an LC50 value (4 hours) of 700 ppm for rats (HSDB (Access on July 2014)), it was classified in Category 3. However, a cited reference of HSDB (Access on July 2014) was PATTY (5th, 2001), and this data was deleted when the PATTY (5th, 2001) was revised to the PATTY (6th, 2012), additionally, it was described that the LC50 value (4 hours) was 7,000 ppm in the original source of the PATTY (5th, 2001) (Journal of Industrial Hygiene and Toxicology. 30, 63, 1948). Therefore, without adopting HSDB (Access on July 2014) report, it was classified as "Classification not possible." Besides, because the LC50 value was lower than 90% of the saturated vapour concentration (2,665 ppm), the reference value in units of ppm was applied as a vapour without a mist.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - Based on a report of an LCLo value (4 hours) of 7,000 ppm (=33.8 mg/L) for rats (Environmental Risk Assessment for Chemical Substances Vol.2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)), it was classified as "Not classified." Besides, because the LCLo value was higher than the saturated vapour concentration (2,665 ppm=12.9 mg/L), the reference value of the mist was applied.
2 Skin corrosion/irritation Not classified
-
-
- - Since there is a report that, when 0.5 mL was applied to the shaved ventral side by 4-hour occlusive application in a skin irritation test with rabbits (EEC method), it was not irritating (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), it was classified as "Not classified." Besides, there was a result of mild irritation in a 24-hour occlusive application test (Draize test method) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
Since there is a report on mild irritation in an eye irritation test with rabbits (ACGIH (7th, 2006), DEFGOT vol.6 (1996)), it was classified in Category 2B.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, a case of a 58-year-old woman was reported who developed dermatitis on her nose in contact with her glasses, and this was considered to be due to the 2-methoxyethyl acetate used to glue the pads to the body of the glasses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), PATTY (6th, 2012)). However, because it was a report on only one case, it was judged to be insufficient data for classification.
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, there was a negative result in a micronucleus test with bone marrow cells by intraperitoneal administration to Chinese hamsters (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ECETOC TR95 (2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 2009)). As for in vitro, although there were negative or positive results in bacterial reverse mutation tests, chromosome aberration tests and sister chromatid exchange tests with cultured mammalian cells, positive results were reported at high doses (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ECETOC TR95 (2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 2009), NTP DB (Access on July 2014)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Category 1A


Danger
H360 P308+P313
P201
P202
P280
P405
P501
In a teratogenicity test with mice by the oral route (gavage), complete embryo resorptions were observed at a dose (1,225 mg/kg bw/day) where no maternal effects developed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ECETOC TR95 (2005)). There was a little information on the reproductive effects of ethylene glycol monomethyl ether acetate (EGMEA). However, EGMEA is rapidly metabolized to ethylene glycol monomethyl ether (EGME) in the body (OEL Documentations (Japan Society For Occupational Health (JSOH), 2009)). In addition, it was listed in the reproductive toxicants Group 1 (Substances known to cause reproductive toxicity in humans) in the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2009) (provisional proposal in 2013). Therefore, it was classified in Category 1A.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, haemal system, kidney), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
There are no data on the acute effects of this substance by a single exposure to humans.
It was reported that in an 8-hour inhalation exposure test with cats and rabbits at a concentration of 450 ppm, they died due to the kidney injury (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). There were no reports by other routes.
Besides, although it is described in DFGOT vol. 6 (1994) that the causes of death due to acute toxicity of this substance in rats, guinea pigs and rabbits were metabolic acidosis, nephrotoxicity and effects on the central nervous system, there were no detailed descriptions.
In the ECETOC TR95 (2005), there was a description that "this substance is rapidly cleaved to ethylene glycol monomethyl ether (EGME; CAS RN: 109-86-4). Since EGME has distinct central nervous system toxicities, effects on the central nervous system may also be assumed for this substance."
Effects on the central nervous system, hemal system, respiratory tract irritation and narcotic effects were confirmed in ethylene glycol monomethyl ether. Therefore, although there was no direct information of this substance, this substance may have effects by EGME, and then it seemed reasonable to regard EGME's Category 1 (central nervous system, hemal system, kidney) and Category 3 (respiratory tract irritation, narcotic effects) as the category for this substance. However, since it is assumed that this substance changes to EGME after absorption, Category 3 (respiratory tract irritation) was not adopted. From the above, it was classified in Category 1 (central nervous system, hemal system, kidney), Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal system, testis)


Danger
H372 P260
P264
P270
P314
P501
This substance is the acetate of ethylene glycol monomethyl ether (EGME; CAS RN 109-86-4) and is hydrolyzed in vivo to produce EGME quickly, and then oxidized via alcohol dehydrogenase and aldehyde dehydrogenase to transfer to 2-methoxyacetic acid (MAA). It is considered that MAA or MAA conjugated with glycine are active metabolites (ECETOC TR 95 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 96 (2010)). Since it is considered that also this substance shows behavior and vital reaction like EGME after absorption into the body, it is considered that repeated dose toxicity of this substance is not different from that of EGME. However, the findings of repeated exposure to this substance were extremely limited, and there were no reliable findings on humans.
In experimental animals, there is a report that testis atrophy and leukopenia were observed at a high dose (500 mg/kg/day: 192 mg/kg/day (converted guidance value)) corresponding to "Not classified" in a 5-week oral dose test with male mice (DFGOT vol. 6 (1994), ECETOC TR 95 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 96 (2010)).
Since the elimination half-life of active metabolites is quite longer in humans than in experimental animals (pregnant rats and pregnant monkeys) and residual time in the body is long (CICAD 67 (2010)), it is considered that toxicities may appear stronger than in experimental animals. From the above, although there was no direct evidence other than data on mice, it was concerned that testicular toxicities and effects on the hemal system might develop like EGME, and then it was classified in Category 1 (hemal system, testis).
Besides, because in the previous classification, it was classified by using only data on experimental animals from the information source not listed in the GHS classification guidance for the Japanese government, and this time, it was judged by using the knowledge of metabolism and pharmacokinetics. The classification result was changed.
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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