GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 109-86-4
Chemical Name Ethylene glycol monomethyl ether
Substance ID 24B6505
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 39 deg C [closed-cup] (ICSC (2003)) >= 23 deg C and <= 60 deg C. Besides, it is classified in Class 3, PG III in UNRTDG (UN1188).
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 285 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 and stainless steel are durable as containers, and it corrodes copper and aluminum (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 six LD50 values for rats [2,370 mg/kg, 2,460 mg/kg (the above two, Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), 3,250 mg/kg, 3,400 mg/kg (the above two, ECETOC TR 95 Volume II (2005)), 2,300 mg/kg, 3,900 mg/kg (the above two, PATTY (5th, 2001))] corresponded to "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Category 4


Warning
H312 P302+P352
P362+P364
P280
P312
P321
P501
Among five LD50 values for rabbits [1,280 mg/kg, 2,000 mg/kg (the above two, Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), 1,300 mg/kg (ECETOC TR 95 Volume II (2005)), 1,290 mg/kg, 3,900 mg/kg (the above two, PATTY (5th, 2001))], four corresponded to Category 4, and one corresponded to "Not classified." Therefore, it was classified in Category 4 to which most corresponded.
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 LC50 value of 4,700 mg/m3 for rats by 7-hour inhalation exposure (converted 4-hour equivalent value: 6.218 mg/L = 1,998 ppm) (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). Besides, because the LC50 value (4.7 mg/L/7 hours) was lower than 90% of the saturated vapour pressure concentration (38.9 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
-
-
- - On the basis that it was not irritant in a test in which 0.5 mL of undiluted this substance was applied to the rabbit skin for 4 hours (ECETOC TR95 Volume II (2005)), it was classified as "Not classified." Besides, in other tests with rabbits, it was reported that the application of 483 mg for 24 hours was slightly irritating (IUCLID (2000)), and that repeated and prolonged exposure to the rabbit skin resulted in no irritation (PATTY (5th, 2001)).
3 Serious eye damage/eye irritation Not classified
-
-
- - In a test in which 0.1 mL of undiluted this substance was applied to the conjunctival sac of rabbits (OECD TG 405), the average irritation scores 24 hours to 72 hours after application were 1.3-1.1 for conjunctival redness, 0.5-0.2 for chemosis, and 0.2-0.0 for corneal opacity, and it was judged as not irritant (ECETOC TR 95 Volume II (2005), BUA 198 (1996)). Therefore, it was classified as "Not classified." Besides, as information in humans, there is a report on the person who developed eye irritation after exposure but fully recovered after 48 hours (PATTY (5th, 2001)), but it was not adopted for classification because it was a report on one person.
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - It is described that this substance was not a skin sensitizer in a maximization test with guinea pigs (CICAD 67 (2010)), but because there were no further descriptions, and the details such as test conditions and test results are unknown, it was classified as "Classification not possible."
5 Germ cell mutagenicity Not classified
-
-
- - There are reports on multiple dominant lethal tests with mice or rats by oral or inhalation exposure (in vivo heritable germ cell mutagenicity tests), most of them gave negative results although some weakly positive ones, and negative results were reported in some chromosomal aberration tests (in vivo mutagenicity tests) by oral or inhalation exposure of mice or rats (the above, Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). Therefore, it was classified as "Not classified." Besides, two micronucleus tests with mice (in vivo mutagenicity tests) were negative and weakly positive (ECETOC TR 95 Vol. II (2005)). As for in vitro tests, all of an Ames test, a mouse lymphoma test, an HGPRT test and a GPT test with Chinese hamster CHO cells gave negative results, and a chromosomal aberration test with humans lymphocytes was negative after 1-hour culture but positive after 24-hour culture (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)).
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 based on the following reasons. In reproductive tests according to the NTP continuous breeding protocol in which male and female mice or rats were dosed by drinking water before mating, through mating, parturition, and nursing periods, decreased numbers of live births, decreased fertility index, and decreased numbers of pregnancies were seen (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). A decrease in fertility index was not severe in the drinking water administration test with rats, but it was clearly observed in reproductive tests by gavage, inhalation, or dermal administration (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). Furthermore, in developmental toxicity test by administration to pregnant animals mainly during the organogenesis period, there are reports on fetal deaths, increased incidences of malformations in the fingers of the extremities (syndactyly, brachydactyly, ectrodactyly, polydactyly), skeletal malformations (bifurcated or split cervical vertebral arch), and external malformations (exencephaly) in mice, resorptions, increased incidences of external malformations (arthrogryposis, club foot, anonychia, brachydactyly, ectrodactyly, etc.), visceral malformations (ventricular septal defect, aplasia of the subclavian artery, renal agenesis, renal malformations, dilatation of the renal pelvis, diaphragmatic hernia, ovarian aplasia, etc.), and skeletal malformations (missing phalanges) in rabbits, fetal deaths and the malformations that did not occur spontaneously in the cardiovascular system in rats, and increased fetal deaths in rhesus monkeys (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). Besides, it was classified in R60-61 in the EU (EC-JRC (ESIS) (Access on May 2012)).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, kidney, testis)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
It was classified in Category 1 (central nervous system) based on the following descriptions. As human case reports, a 44-year-old man who drank brandy contaminated by this substance developed coma followed by loss of consciousness (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)), two men (23-year-old, 41-year-old) who mistakenly drank 100 mL of this substance had neurological symptoms such as confusion and excitement (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)), and congested edema was found in the brain and meninx as acute effects of this substance (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). And it was classified in Category 1 (kidney) based on the following reports. In the above cases, necropsy of the 44-year-old man revealed blackening of the kidney and degeneration of the renal tubules, oxalate in the urine was seen in one of the two men of accidental drinking, suspected of having renal disorders, and renal disorders were observed in other three men (18 to 58-year-old) (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)). On the other hand, as for animal tests, degeneration and necrosis of the spermatocytes were found after a single dose of 150 mg/kg to rats (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)), and degeneration of the seminiferous germinal epithelium with damage to the primary spermatocytes was reported in rats after 4-hour inhalation exposure to 1,000 ppm (3.11 mg/L) (ACGIH (2006)). Because the doses corresponded to the guidance values for Category 1 in both routes, it was classified in Category 1 (testis).
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, hematopoietic system, testis)


Danger
H372 P260
P264
P270
P314
P501
It was classified in Category 1 (central nervous system, hematopoietic system) based on the results of multiple epidemiological surveys and case reports such as the following. As knowledge in humans, 12 out of 19 workers who used a mixture of this substance (33%) and ethanol for processing collars of shirts developed neurological symptoms such as severe fatigue, lethargy, tremor, and abnormal reflexed anomaly, blood tests revealed many immature leukocytes, and macrocytic anemia considered to be due to effects on the bone marrow was observed in about half of the workers (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), anemia and central nervous system disorders were found in a worker exposed to this substance in a microfilm production facility (ACGIH (2006)), and five persons with encephalopathy and anemia were seen in the workers who used this substance, but after the workplace was improved, and air concentrations of this substance were reduced, no further ill effects were noted (ACGIH (2006)). And it was classified in Category 1 (testis) because oligozoospermia, aspermatogenesis, and a decrease in sperm counts per ejaculation were observed in male shipyard painters, and because, also in animal tests, testicular atrophy and degeneration of the germinal epithelium were found at or 750 ppm (about 70 mg/kg/day) in a 13-week drinking water administration test with rats (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)), and severe degeneration of the seminiferous tubules was reported at or above 100 ppm (0.31 mg/L) in a 13-week inhalation exposure test with rabbits (Initial Risk Assessment Report 88 (NITE, CERI, NEDO, 2007)).
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) Not classified
-
-
- - It was classified as "Not classified" from 96-hour LC50 > 88.9 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), 48-hour EC50 > 84.8 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and 72-hour ErC50 >= 93.2 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)).
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: 73, 82, 94%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1988)), 21-day NOEC > 84.8 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and 72-hour NOECr >= 93.2 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)).
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 96-hour LC50 > 88.9 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2007)), and being not water-insoluble (water solubility = 1000000 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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