GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 107-21-1 |
| Chemical Name | Ethylene glycol |
| Substance ID | H26-B-017, R-061 |
| 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 | FY2007 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 |
| 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 | Not classified |
- |
- | - | It was classified as "Not classified" based on a flash point of 111 deg C (closed cup) (ICSC (1999)). |
| 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 398 deg C (ICSC (1999)). |
| 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | There are 10 reports of LD50 values within the range of 4,000-13,400 mg/kg for rats. It was classified as "Not classified" to which the greatest number of data (6 cases) (6,140 mg/kg (PATTY (6th, 2012)), 8,540 mg/kg (DFGOT vol. 4 (1992), PATTY (6th, 2012)), 10,800 mg/kg (DFGOT vol. 4 (1992), PATTY (6th, 2012)), 11,300 mg/kg (PATTY (6th, 2012)), 13,000 mg/kg, 5,890-13,400 mg/kg (SIDS (2009))) corresponded according to the revised GHS classification guidance for the Japanese government. Besides, 3 cases corresponded to Category 5 in UN GHS classification, one case to Category 5 in UN GHS classification or "Not classified." New information sources (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), ATSDR (2010), PATTY (6th, 2012), DFGOT vol. 4 (1992), CEPA (2000), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2009)) were added, and the classification was revised. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | There are 4 reports of an LD50 value of 2,800 mg/kg for rats (ACGIH (7th, 2001)), and LD50 values of 9,530 mg/kg (ACGIH (7th, 2001), PATTY (6th, 2012)), 10,600 mg/kg (CICAD 45 (2002), CEPA (2000), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)) and 10,612 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)) for rabbits. One case corresponded to Category 5 in UN GHS classification, and 3 cases to "Not classified." It was classified as "Not classified" to which the greatest number of data (3 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) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 4 |
 Warning |
H332 |
P304+P340
P261 P271 P312 |
Based on an LC50 value (one hour) of 10.9 mg/L (converted 4-hour equivalent value: 2.7 mg/L) for rats (PATTY (6th, 2012)), it was classified in Category 4. Besides, since the LC50 value was higher than the saturated vapor concentration (0.2 mg/L), the reference value as a mist was applied. A new information source (PATTY (6th, 2012)) was added, and the category was revised. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
Since in a patch test with 103 subjects, irritation was observed by application of 0.2 mL of the undiluted liquid of this substance (SIDS (2009)), it was classified in Category 2. In addition, there are reports that slight skin irritation was observed in skin irritation tests with rabbits and guinea pigs (CICAD 45 (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CEPA (2000)). The findings in humans were added and the category was revised. |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
There was a report of no irritation in an eye irritation test in which the undiluted solution was applied to rabbits (SIDS (2009)). In addition, there is a report that single or short-term exposure to the liquid or vapour produced minimal conjunctival irritation without permanent corneal damage in rabbits (CICAD 45 (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), CEPA (2000)). As an accident case in humans, there is a report that on exposure of the eyes to this substance (unknown concentration), conjunctival congestion, edema, reduced light reflex and severe keratitis were observed but these resolved after 4 weeks (DFGOT vol. 4 (1992)), but the details such as concentrations were unknown. From the above results, 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 |
- |
- | - | There are 2 reports in humans. When a 5% or 25% aqueous solution of this substance was applied to 11 subjects, although a severe allergic reaction was observed in 1 subject (a 31-year-old woman who developed dermatitis in the arms, chest and abdomen after handling a 25% aqueous solution during a cutting operation of a lens, she had a nickel allergy), no allergic reaction was observed in an other 10 subjects (DFGOT vol. 4 (1992)). In addition, when a 1% or 5% aqueous solution of this substance was applied to 10 subjects, although no allergic reaction was observed in 1 subject (a 17-year-old man who handled a 25% aqueous solution during a cleaning operation of optical lenses for 4 months and in whom exanthema was observed), slight irritation, erythema and swelling were observed with an ethanol solution containing 3% of this substance. As for the other 9 subjects, no response other than slight irritation to alcohol was observed (DFGOT vol. 4 (1992)). Besides, there is a report that no sensitization was observed in a maximization test with guinea pigs (SIDS (2009)). Although there are negative results in animal studies, there are cases of allergic reactions in the cases in humans, it was classified as "Classification not possible." |
| 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 all negative in a dominant lethal test with rats, and a micronucleus test and a chromosomal aberration test with mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2009), ACGIH (7th, 2001), ATSDR (2010), CEPA (2000)). As for in vitro, it was all negative in a bacterial reverse mutation test, a mouse lymphoma test, a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2009), ACGIH (7th, 2001), ATSDR (2010), CEPA (2000)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Since it was classified in A4 by ACGHI (ACGIH (7th, 2001)), it was classified as "Classification not possible." |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
There are reports that in a three-generation reproductive toxicity study with rats by the oral route (feeding), no effects on reproductive and developmental toxicities were observed (ATSDR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), CICAD 45 (2002)), and that in a continuous breeding study with mice by the oral route (drinking water), although there was no material toxicity, at a very high dose (1,640 mg/kg bw/day), effects on the fetuses (decreased pups' body weight, slight decreases in litter size and live pups, although the number of occurrences was unknown, unusual facial features and skeletal changes in the skull, sternebrae, ribs and vertebrae) were observed (ATSDR (2010), CICAD 45 (2002)). In teratogenicity studies by the oral route (gavage) with rats or mice, effects on pups (decreased fetal body weight, delayed ossification and skeletal malformations) were observed at high doses (1,000 mg/kg bw/day or above) where no maternal toxicity was observed (ATSDR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), CICAD 45 (2002)). From the above, although effects on pups, mainly including skeletal malformations, were observed at doses where no maternal toxicity was observed, they were very high doses, and no clear evidence that the mechanism of actions of evidence in the previous classification did not apply to humans was obtained. Therefore, it was classified as "Classification not possible." |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, haemal system, kidney), Category 3 (respiratory tract irritation, narcotic effects) |
 Danger Warning |
H370
H335 H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
In humans, toxic effects after oral ingestion could be divided into three main stages as follows: in Stage 1 (0.5-12 hours after ingestion) effects on the central nervous system (intoxication, lethargy, seizures and coma) and metabolic disturbances (acidosis, hyperkalemia, hypocalcemia), in Stage 2 (12-24 hours after ingestion) effects on the heart and lung (tachycardia, hypertension, severe metabolic acidosis with compensatory hyperventilation, hypoxia, congestive heart failure and adult respiratory distress syndrome), in Stage 3 (24-72 hours after ingestion) renal toxicities (calcium oxalate deposition, hematuria, acute tubular necrosis and renal failure) were observed (SIDS (2009), CEPA (2000), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)). In addition, there is also a report that Stage 4 was set, at which the effects observed 6-14 days after ingestion or later, neurological effects (including facial paralysis, slurred speech, loss of motor skills and impaired vision) in addition to effects on the central nervous system, were observed, which were suggestive of cranial nerve deficits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001), DFGOT vol. 4 (1992), CEPA (2000)). Besides, there are reports that the lethal doses by oral ingestion in humans were about 0.4-1.3 g/kg bw (CEPA (2000)) and 1.6 g/kg bw (SIDS (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001)). Although there was little information by the inhalation route in humans, there is a report that pain in the throat and upper respiratory tract developed 1.5 minutes after exposure to 55ppm, and severe pain at or above 79 ppm developed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001)). By the inhalation route, there was pain in the throat and upper respiratory tract 1.5 minutes after the start of inhalation in an inhalation exposure test of 55 ppm by the volunteer, and at or above 79 ppm, the pain was very intense, and could not be tolerated for less than 1 minute (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), ACGIH (7th, 2001)). In rats and mice, there was a dose-related central nervous system depression action, and by a large amount of oral administration, coma, paralysis and ataxia developed, resulting in death. In addition, tachycardia, tachypnea, bronchopneumonia, pulmonary edema, congestive heart failure, metabolic acidosis, polydipsia and polyuria with renal impairment, and deposition of calcium oxalate crystals in the urine were reported. Histopathologically, degeneration of the renal tubular epithelium, interstitial edema and hemorrhagic necrosis of the renal cortex due to deposition of calcium oxalate crystals were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2009), CEPA (2000), ACGIH (7th, 2001)). Besides, these effects were not observed within the guidance value range. From the above, it was classified in Category 1 (central nervous system, hemal system, kidney), Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
In humans, although male volunteers were exposed by inhalation at concentrations up to 69 mg/m3 daily for 20-22 hours for 1 month, no systemic effects were observed (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2009), ATSDR (2010)). In addition, in reports of occupational exposure in Canada and Finland, no kidney effect of concern by exposure to this substance was observed (SIDS (2009)). Other than these, there are no findings in repeated exposures to this substance at high concentrations in humans that are apparently repeated exposure. As for experimental animals, based on the descriptions in SIDS (2009) and ATSDR (2010), the kidney was considered to be the most sensitive target organ, and in a 16-week, 1-year or 2-year feeding study with rats judged to be the most reliable in SIDS (2009), although toxic lesions (nephropathy, kidney calculi and urinary crystals, etc.) of the kidneys were severely developed in males in all studies, the doses were far beyond the range of Category 2 (minimum LOAEL value based on nephrotoxicity: 300 mg/kg/day (1-year feeding study with male rats)) (SIDS (2009)). On the other hand, by the inhalation route, although repeated inhalation exposure test to this substance itself were not conducted, in the description in SIDS (2009), the toxicity of ethylene glycols was generally assumed to be low since the effect concentrations of inhalation exposure of rats exceeded 1,000 mg/m3 for Diethylene glycol (DEG), triethylene glycol (TEG), and PEG 200, substances of the category for assessment in SIDS. From the above, including the findings of substances of the category, this substance was considered to show low toxicity by repeated exposure via both the oral and inhalation routes in experimental animals, but there are inadequate findings on the effects of repeated exposure to high concentrations in humans. Therefore, it was classified as "Classification not possible" due to lack of data. Besides, although in the previous classification, it was classified based on symptoms in human exposure described in Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), these findings were not adopted since all were observed in a small proportion of the subjects and were not judged to represent a specific hazard associated with exposure to this substance. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 72-hour ErC50 > 1000 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 > 1120 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (all Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2001), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), Initial Risk Assessment (NITE, CERI, NEDO, 2007)). |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | It was classified as "Not classified" due to rapid degradability (14-day degradation rate by BOD: 90% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1988)), and 7-day MATC = 4.2 mg/L for crustacea (Ceriodaphnia dubia) (Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004)). |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
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