GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 111-15-9
Chemical Name Ethylene glycol monoethyl ether acetate; Cellosolve acetate
Substance ID 24B6519
Classification year (FY) FY2012
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 and 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 47 deg C [closed-cup] (NFPA (14th, 2010)) >= 23 deg C and <= 60 deg C. Besides, it is classified in Class 3, PG III in UNRTDG (UN1172).
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 345 deg C (Ullmanns (E) (6th, 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 Classification not possible
-
-
- - No data available. Besides, there is the information that steel, stainless steel, and aluminum are durable as containers (Hommel (1996)), and aluminum is an unsuitable material for containers (GESTIS (Access on Apr. 2012)).

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 four LD50 values for rats (3,900 mg/kg, 2,900 mg/kg, 5,100 mg/kg (the above, PATTY (5th, 2001)), 2,700 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008))) correspond to "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified
-
-
- - Both LD50 values for rabbits of 10,300 mg/kg (ACGIH (2001)) and 10,500 mg/kg (DFGMAK-Doc. 6 (1994)) correspond to "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
It was classified in Category 4 based on an LC50 value of 12,100 mg/m3/8 hours for rats (converted 4-hour equivalent value: 3,166 ppm) (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)). Besides, because the test concentration was lower than 90% of the saturated vapour pressure concentration (16.6 mg/L), the reference value of gas was applied as a vapour with little mist.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available.
2 Skin corrosion/irritation Not classified
-
-
- - Because multiple primary skin irritation tests by 24-hour occlusive application to rabbits resulted in slight or no irritation (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)), it was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification or "Not classified").
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
In a test in which 0.1 mL of the undiluted test substance was applied to four rabbits (OECD TG 405, GLP), corneal opacity of score 2 in one animal, no iritis, conjunctival redness of score 1 or 2 in four, and chemosis of score 1 or 2 in three were observed and almost disappeared after seven days, and Modified Maximum Average Score, MMAS (equivalent to AOI) was 15.0 (ECETOC TR 48 (2) (1988)). Therefore, it was classified in Category 2B. Besides, there are other skin irritation tests with rabbits, which resulted in no or slight irritation (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)).
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 cells after diet administration to mice (in vivo somatic cell mutagenicity test) (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)). Besides, as for in vitro tests, it is reported that Ames tests were mostly negative, although there were some positive results, and an HGPRT test with CHO cells was negative (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)).
6 Carcinogenicity Classification not possible
-
-
- - No data available.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
In a reproductive toxicity test according to the NTP continuous breeding protocol in which male and female mice were administered by drinking water from before mating through mating, parturition, and nursing period, decreases in numbers of pregnancies and pups born, decreased fertility index, and decreased mating index were observed (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)). And in a developmental toxicity test by inhalation exposure of pregnant rats during the organogenesis period, increased incidences of fetal death and malformations in the large blood vessels of the heart (ringed aortic arch, IV ventricular septal defect) were found, and also in another test, increased incidences of visceral variations (hydronephrosis) and visceral malformations (a ventricular septal defect, ringed aortic arch, an aberrant origin of the right subclavian artery, an aberrant origin of the left subclavian artery) were reported in the 300 ppm group (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)). Furthermore, also in a developmental toxicity test by inhalation exposure of pregnant rabbits during the organogenesis period, increased fetal death, an increased incidence of a ventricular septal defect, which is a visceral malformation, and external malformations of abnormal tail morphology and hypoplasia of the auricle, and a visceral malformation of kidney defect were seen (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)). Because it is unlikely that teratogenicity above in multiple animal species were secondary effects caused by general toxicity in parent animals, it was classified in Category 1B.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
As acute toxicity of this substance, it is described that it affects the central nervous system, high concentrations could cause unconsciousness, and inhalation causes dizziness, drowsiness, headache, and unconsciousness (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), and in an acute toxicity test with rats (LD50 value: 5,100 mg/kg/day), narcosis was observed mostly at or above the LD50 value (PATTY (5th, 2001)). Therefore, it was classified in Category 3 (narcotic effects). Besides, damage to the kidney and liver was also described as toxicity effects in the test but was not used for classification because it was a finding at the dose exceeding the guidance value range.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In a 5-week oral administration test with male mice, testicular effects such as decreases in sperms, spermatids, and spermatocytes at or above 1,000 mg/kg/day and a dose-dependent decrease in leukocyte counts at or above 2000 mg/kg/day were observed (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)), and in 10-month inhalation exposure tests (1.098 mg/L) with rats and rabbits, there was nephritis characterized by degeneration of the tubular epithelium with hyaline and granular casts in the urine in both animal species (Initial Risk Assessment Report 91 (NITE, CERI, NEDO, 2008)). However, all were at doses exceeding the guidance value range. On the other hand, as effects in humans, as a result of investigating blood effects in workers who used this substance at a printing factory, a significant relationship with hemoglobin level, hematocrit values, and erythrocyte counts was found, and it was suggested that exposure to high concentrations could cause anemia (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). And as a result of checking blood effects in shipyard painters, workers in the high exposure group had significant decreases in leukocytes and granulocytes and a significant increase in mean corpuscular volume, bone-marrow puncture in three persons having low leukocyte counts revealed bone-marrow aplasia, and bone-marrow effects of this substance were suggested (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). The workers were also exposed to other chemical substances, and the relation to this substance was unclear. From the above, data in animals humans were insufficient for the rationale for classification. Therefore, it was classified as "Classification not possible" due to lack of data.
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 = 41 mg/L for fish (Lepomis macrochirus) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)).
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 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."
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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