GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 109-59-1
Chemical Name Ethylene glycol monoisopropyl ether
Substance ID H26-B-018, R-063
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 FY2009   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 (2004)).
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 240 deg C (ICSC (2004)).
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
-
-
- - There were 6 reports of LD50 values of 500-1,000 mg/kg (ECETOC TR64 (1995)), 500-1,000 mg/kg (ECETOC TR 95 (2005)), 500-1,000 mg/kg (PATTY (6th, 2012)), >2,000 mg/kg (GLP: OECD TG 401 compliant) (JECDB (Access on June 2014), SIDS (2011)), 5,600 mg/kg (ECETOC TR64 (1995), ECETOC TR95 (2005), PATTY (6th, 2012)) and 0.5-5.6 g/kg (DFGOT vol. 5 (1993)) for rats. Based on >2000 mg/kg, the LD50 value based on GLP and OECD TG (JECDB (Access on June 2014), SIDS (2011)), and 5,600 mg/kg, an LD50 value that supported this data (ECETOC TR64 (1995), ECETOC TR95 (2005)), it was classified as "Not classified."
1 Acute toxicity (Dermal) Category 4


Warning
H312 P302+P352
P280
P312
P321
P362
P364
P501
There were 3 reports of LD50 values of 1,440 mg/kg (DFGOT vol. 5 (1993)), 1,600 mg/kg (ECETOC TR64 (1995), ECETOC TR95 (2005)) and 1,080-2,370 mg/kg (PATTY (6th, 2012)) for rabbits. It was classified in Category 4 to which the greatest number of reports (2 cases) corresponded according to the revised GHS classification guidance for the Japanese government.
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 a report of an LC50 value (4 hours) of 4,000 ppm for rats (ECETOC TR64 (1995), ECETOC TR95 (2005), DFGOT vol. 5 (1993)), it was classified in Category 4. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (6,841 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 Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
There is a report that irritation was observed in a skin irritation test (EEC test method) in which this substance was applied to rabbits for 4 hours (SIDS (2011), ECETOC TR95 (2005)). In addition, skin primary irritation score, PII, by the Draize test method was 4.8 (24-hour application) (SIDS (2011), ECETOC TR 95 (2005)). From the above results, it was classified in Category 2.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
Based on a report that in an eye irritation test with rabbits, although conjunctivitis, iritis and corneal damage were observed after application of this substance (undiluted), they resolved within 7 days (SIDS (2011), ECETOC TR95 (2005), DFGOT vol. 5 (1993)), it was classified in Category 2B. Besides, this substance was classified in "Xi; R36" in the EU DSD classification, and in "Eye Irrit. 2" in the EU CLP classification.
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 with guinea pigs (ECETOC TR95 (2005)). In addition, there is a description that this substance did not show sensitization (PATTY (6th, 2012)). From the above, it was classified as "Not classified."
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There were no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (JECDB (Access on June 2014), SIDS (2011), PATTY (6th, 2012)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - In a reproduction/developmental toxicity screening test (OECD TG 421) with rats by the oral route (gavage), no effects on fertility (estrous cycle, copulation, fertility, gestation period, the status of delivery and lactation, etc.) and on offspring toxicities (survival, body weight and morphological observation of born offspring) were observed even at doses where parental toxicities (extramedullary hematopoiesis of the spleen considered to be caused by hemolysis, increased spleen weight and hematuria) were observed (JECDB (Access on June 2014), SIDS (2011)). In teratogenicity tests with rats and rabbits by the inhalation route, decreased weight of fetuses (rabbits) and delayed development were observed at doses where maternal toxicity (hematuria in rats, and decreased food consumption, decreased body weight gain and hemolytic anemia in rabbits) was observed (ECETOC TR95 (2005)).
From the above, no effects on fertility and teratogenicity were observed. In addition, the effects on fetuses were also slight and were only observed at doses where maternal toxicity was observed. Therefore, although it corresponded to "Not classified," it was classified as "Classification not possible" since information on fertility was obtained from the screening test.
8 Specific target organ toxicity - Single exposure Category 1 (haemal system, kidney, liver, spleen), Category 2 (central nervous system)


Danger
Warning
H370
H371
P308+P311
P260
P264
P270
P321
P405
P501
The effects of single exposure to this substance were limited to experimental animals data. Excretion of reddish urine and decrease in fecal volume were reported from 3 or 4 hours after administration to the next day on oral administration of 2,000 mg/kg to rats (JECDB (Access on June 2014), SIDS (2011)). In addition, there was a report of large amounts of hematuria (hemoglobinuria) with findings in the liver, kidneys and spleen, and central nervous system depression and dyspnea by oral administration (500-1,000 mg/kg) to rats (PATTY (6th, 2012), ECETOC TR95 (2005)).
As for the inhalation route, there were reports of an increase in osmotic fragility of the erythrocytes when rats were exposed to 62 ppm for 4 hours (ACGIH (7th, 2001), DFGOT vol. 5 (1993), ECETOC TR4 (1982), ECETOC TR 95 (2005)), of hemolysis with nephropathy by inhalation exposure of rats, blood urine and kidney injury when rats were exposed to 160 ppm for 4 hours (PATTY (6th, 2012)), of hematuria (hemoglobinuria) with associated findings in the kidneys, liver and spleen (DFGOT vol. 5 (1993)), and of the central nervous system depression and dyspnea (exceeding the guidance range of Category 2) (DEFGOT vol. 5 (1993)).
These effects were mainly observed within the range of guidance values corresponding to Category 1 in the case of inhalation exposure and Category 2 in the case of oral administration.
From the above, it was classified in Category 1 (hemal system, kidney, liver, spleen), Category 2 (central nervous system).
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal system)


Danger
H372 P260
P264
P270
P314
P501
In a study in which rats were dosed by gavage for 28 days, changes in the bone marrow myelogram (a decrease in myeloid/erythroid ratio) at or above 30 mg/kg/day (converted guidance value: 9.3 mg/kg/day), anemia-like findings (decreases in red cell count, hematocrit value and hemoglobin content, and an increase in reticulocyte ratio, etc.), enhancement of extramedullary hematopoiesis of the spleen and increased hematopoiesis of erythrocytes of the bone marrow at 125 mg/kg/day (converted guidance value: 38.9 mg/kg/day) were observed (SIDS (2011), JECDB (Access on June 2014)). In the case of the inhalation route, in a study in which rats were exposed by inhalation for 28 days, and in studies in which rats, guinea pigs, rabbits and dogs were exposed by inhalation for 26 weeks, in rats, at concentrations corresponding to Category 1 (0.43 mg/L (converted guidance value: 0.134 mg/L) and 0.1075 mg/L), anemia-like findings (decreases in erythrocyte counts, hemoglobin concentration and packed cell volume (PCV), and increases in MCV) in the 28-day study and osmotic fragility of erythrocytes in the 26-week study were observed (SIDS (2011), ACGIH (7th, 2001), ECETOC TR95 (2005)). Besides, there is a description in SIDS (2011) and ECETOC TR95 (2005) that hemolytic anemia was caused by repeated exposure to this substance, and effects on the spleen and bone marrow were considered to be secondary changes from reactivity associated with anemia. From the above, it was classified in Category 1 (hemal system).
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 96-hour LC50 > 100 mg/L for fish (Oryzias latipes), 48-hour EC50 > 1000 mg/L for crustacea (Daphnia magna), and 72-hour ErC50 > 1000 mg/L for algae (Pseudokirchneriella subcapitata) (all Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001), SIDS, 2011).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" from 21-day NOEC = 98 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, 2001)) although it is not rapidly degradable (28-day degradation rate by BOD: 8% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1998)).
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 = 100000 mg/L, PHYSPROP Database, 2009).
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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