Latest GHS Classification Results by the Japanese Government (edited by NITE)
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 111-15-9 |
| Chemical Name | Ethylene glycol monoethyl ether acetate (Cellosolve acetate) |
| Substance ID | m-nite-111-15-9_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) |
| 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 51.1 deg C (closed cup) (ICSC (2003)). Besides, it is classified in Class 3, PG III (UN1172) in UNRTDG. |
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 379 deg C (ICSC (2003)). | 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. Besides, there is information that steel, stainless steel, and aluminum are durable as a container (Hommel (1991)), or that aluminum is unsuitable as a container (GESTIS (Access on Aug 2014)). | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 17 | Desensitized explosives | - |
- |
- | - | - | - | - |
| 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 are 6 reports of LD50 values of 2,700 mg/kg, 2,900 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), 3,900 plus or minus 100 mg/kg (male), 2,900 plus or minus 100 mg/kg (female) (DFGOT vol. 6 (1994), PATTY (6th, 2012)), 5,100 mg/kg (EHC 115 (1990), PATTY (6th, 2012)), 2,900-7,500 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ECETOC TR95 (2005)) for rats. According to the revised GHS classification guidance for the Japanese government, it was classified as "Not classified" (Category 5 in UN GHS classification) to which the larger number of values corresponds. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on LD50 values of 10,227 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), 10,300 mg/kg (ACGIH (7th, 2001), PATTY (6th, 2012)), 10,333 mg/kg (EHC 115 (1990)), 10,500 mg/kg (DFGOT vol. 6 (1994), PATTY (6th, 2012)), 10,300-10,500 mg/kg (ECETOC TR95 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rabbits, it was classified as "Not classified." | 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 an LC50 value (2 hours) of >1,500 ppm for rats (converted 4-hour equivalent value: >1,061 ppm) (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), and on LC50 values (8 hours) of 2,239 ppm (converted 4-hour equivalent value: 3,166 ppm) (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)) and 1,499-2,239 ppm (converted 4-hour equivalent value: 2,119-3,166 ppm) for rats, it was classified in Category 4. Besides, because LC50 values were lower than 90% of the saturated vapor concentration (3,079 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 | Not classified |
- |
- | - | There is a report that in a Draize test with rabbits, slight irritation was observed after application of this substance for 24 hours (ECETOC TR95 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there are multiple reports that in a skin primary irritating test (EEC test method), no irritation was observed after occlusive application for 4 hours (ECETOC TR95 (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and that it was slightly irritating (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), PATTY (6th, 2012)). From the above, it was classified as "Not classified" (Category 3 in UN GHS classification). | 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 a primary irritation test with four rabbits (OECD TG 405, GLP), although corneal opacity of a score 2 in 1 animal, conjunctival redness of a score 1 or 2 in 4 animals, conjunctival edema of a score 1 or 2 in 3 animals were observed after application of 0.1 mL of the undiluted test substance, all of these almost disappeared 7 days after application, and the maximum average score, MMAS (corresponding to AOI) was 15.0 (ECETOC TR 48 (1988)), it was classified in Category 2. Besides, there were multiple reports of other skin irritation tests with rabbits, and there were reports of no irritation results or mild irritation results (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ECETOC TR95 (2005), PATTY (6th, 2012)). | 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 | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, although there is a report that in a Magnusson-Kligman test with guinea pigs, no sensitization was observed after induction with 10% of this substance (ECETOC TR95 (2005)), these data were judged as insufficient for use in the classification since the details of the test conditions, etc. were unknown. The category was changed due to addition of information. | FY2014 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0)) |
| 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, 2008), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). As for in vitro, both negative and positive results were obtained in bacterial reverse mutation tests, and gene mutation tests, chromosomal aberration tests and sister chromatid exchange tests with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), NTP DB (Access on July 2014)). | 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 | Category 1B |
 Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
In a teratogenicity test with rats by the inhalation route, visceral malformations (cardiovascular malformations) and skeletal malformations were observed at a dose where maternal toxicity was not observed (2,140 mg/m3) (ECETOC TR95 (2005), DFGOT vol. 6 (1994)). In addition, in a teratogenicity test with rabbits by the inhalation route, increases in external, skeletal and visceral malformations and in complete resorptions were observed at a dose where maternal toxicity appeared (550 mg/m3) (ECETOC TR95 (2005), DFGOT vol. 11 (1998)). Additionally, in a teratogenicity test with rats by the dermal route, decreased body weights in the fetuses, a decreased number of offspring/litter, an increase in prenatal mortality, visceral malformations (cardiovascular malformations) and skeletal malformations were observed at an extremely high dose where maternal toxicity appeared (5,923 mg/kg bw/day) (ECETOC TR95 (2005), DFGOT vol. 11 (1998)). From the above, there is a report that in a teratogenicity test with rats by the inhalation route, visceral malformations and skeletal malformations were observed at a dose where maternal toxicity did not appear. Therefore, it was classified in Category 1B. |
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), Category 3 (narcotic effects) |
Danger Warning |
H370 H336 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
When rats were exposed by inhalation to 2,000 ppm of this substance for 4 hours, hematuria was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). There was a report on hematuria and hypertrophic kidneys dilated with blood by an oral dose of 2,900 mg/kg to rats (PATTY (6th, 2012)). In addition, there was a report of gastrointestinal tract irritation and mild liver injury (PATTY (6th, 2012)). Moreover, there were descriptions of dizziness, lethargy, headache, loss of consciousness by an inhalation exposure, and of vomiting added to the above symptoms by an oral dose (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). Additionally, although no description of the subjects, it is described that this substance affected blood, and caused blood cell disorder, anemia, and kidney injury, effects on the central nervous system and loss of consciousness at high concentrations (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), and caused injury of the central nervous system, hemal system, lung and kidney at high concentrations (HSDB (Access on June 2014)). Among all the above information, not all the pieces of information are ones by which clear categorization is possible. However, hematuria data by inhalation exposure was observed within the guidance value range of Category 1, and the symptoms by an oral dose were observed within the guidance value range for Category 2. The findings for the liver and kidney by oral dose to rats occurred at doses exceeding the guidance value of Category 2, and the category from the lung findings was unknown. Moreover, since the category from the symptoms such as dizziness by inhalation exposure was unknown, narcotic effects were judged as appropriate based on the type of symptoms. From the above, it was classified in Category 1 (hemal system), Category 3 (narcotic effects). |
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, testis) |
Danger |
H372 | P260 P264 P270 P314 P501 |
This substance is rapidly hydrolyzed via esterase in various tissues in the body to produce ethylene glycol monoethyl ether (EGEE; CAS RN: 110-80-5) (CICAD 67 (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). EGEE is oxidized by alcohol dehydrogenase, via ethoxy acetaldehyde to ethoxy acetic acid (EAA) and excreted in the urine as EAA or its glycine conjugate (CICAD 67 (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). This EAA is a common active metabolite to this substance, the acetate ester of EGEE and EGEE. Since this substance is also hydrolyzed after being absorbed and metabolized to the active metabolite, EAA, the substance is thought to cause similar toxicities to EGEE. In CICAD 67 (2010), both substances were treated in the same group and evaluated together. In fact, as for both this substance and EGEE, there is a report that effects on the hemal system and genetic organs were observed in humans and experimental animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 67 (2010)). In humans, the ability to metabolize to EAA was higher than that in rats, and EAA clearance tended to be delayed than in rats. Therefore, the EAA residence time in the body of humans is longer than in the experimental animals, so it was pointed out that toxic effects might appear from at lower dose (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 67 (2010)). From the above, since the classification of this substance was considered the same as that of EGEE, it was classified in Category 1 (hemal system, testis). Besides, because information sources that were not used in the previous classification were used, the classification result was different. |
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)) |
| 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) | Category 3 |
- |
H402 | P273 P501 |
It was classified in Category 3 from 96-hour LC50 = 41 mg/L for fish (Lepomis macrochirus) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). | FY2012 | GHS Classification Guidance by the Japanese Government （July, 2010） |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Not classified |
- |
- | - | If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 86.9%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and 21-day NOEC = 44 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)). 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 (readily biodegradable (a 2-week degradation rate by BOD: 86.9%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and a low bioaccumulation estimate (log Kow = 0.59 (PHYSPROP Database, 2009)), despite 96-hour LC50 = 41 mg/L for fish (Lepomis macrochirus) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). From the above results, it was classified as "Not classified." |
FY2012 | GHS Classification Guidance by the Japanese Government （July, 2010） |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. | FY2012 | GHS Classification Guidance by the Japanese Government （July, 2010） |
NOTE:
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