Item | Information |
---|---|
CAS RN | 75-21-8 |
Chemical Name | Ethylene oxide |
Substance ID | 23B5506 |
Classification year (FY) | FY2011 |
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 |
Item | Information |
---|---|
Guidance used for the classification (External link) | Physical Hazards & 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 |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Not applicable |
- |
- | - | Gas (GHS definition) |
2 | Flammable gases (including chemically unstable gases) | Category 1 |
Danger |
H220 |
P210
P377 P381 P403 |
A lower explosive limit of 3 vol% (ICSC (2001)) corresponds to Category 1. Besides, it is classified in Division 2.3, Subsidiary Risk 2.1 in UNRTDG (UN1040). |
3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
4 | Oxidizing gases | Not classified |
- |
- | - | It was classified as flammable gases. Besides, it is classified in Division 2.3, Subsidiary Risk 2.1 in UNRTDG (UN1040). |
5 | Gases under pressure | Low pressure liquefied gas |
Warning |
H280 | P410+P403 | A critical temperature is 196 deg C (Hommel (1996)), and it is a gas with a critical temperature above +65 deg C. |
6 | Flammable liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
7 | Flammable solids | Not applicable |
- |
- | - | Gas (GHS definition) |
8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | Gas (GHS definition) |
9 | Pyrophoric liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
10 | Pyrophoric solids | Not applicable |
- |
- | - | Gas (GHS definition) |
11 | Self-heating substances and mixtures | Not applicable |
- |
- | - | Gas (GHS definition) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Gas (GHS definition) |
13 | Oxidizing liquids | Not applicable |
- |
- | - | Gas (GHS definition) |
14 | Oxidizing solids | Not applicable |
- |
- | - | Gas (GHS definition) |
15 | Organic peroxides | Not applicable |
- |
- | - | Gas (GHS definition) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to gas substances are not available. Besides, there is information that steel, stainless steel, and Teflon are resistant as a container (Hommel (1996)). |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 3 |
Danger |
H301 |
P301+P310
P264 P270 P321 P330 P405 P501 |
LD50 values for rats of 72 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)) and 330 mg/kg (NTP TR 326 (1997)) correspond to Category 3 and Category 4, respectively. It was classified in Category 3 for higher hazard in accordance with the GHS classification guidance for the Japanese government. |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Gases) | Category 3 |
Danger |
H331 |
P304+P340
P403+P233 P261 P271 P311 P321 P405 P501 |
Among three LC50 values for rats [4,000 ppm/4 hours, 1,460 ppm/4 hours (the above, ACGIH (2001)), 800 ppm/4 hours (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003))], two correspond to Category 3, and one corresponds to Category 4. It was classified in Category 3, to which most corresponded. |
1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Gas (GHS definition) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Not applicable |
- |
- | - | Gas (GHS definition) |
2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
It is reported that in an irritation test in which absorbent cotton was soaked in a 10% or 50% aqueous solution of this substance and applied to the rabbit skin for 1-60 minutes, inflammatory edema was formed (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)). In humans, the damage is characterized by edema and erythema, which occur 1-5 hours after exposure, followed by blister formation, and the severity of the damage depends on contact time and concentrations. Also, there is a report of skin irritation due to contact with ethylene oxide disinfectant attached to surgical gowns, etc. (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)). Based on the above knowledge, it was classified in Category 2. Besides, it was classified in Xi: R36/37/38 in EU classification (EC-JRC (ESIS) (Access on Sept. 2011)). |
3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
It is reported that in a test in which 0.1 to > 20% of this substance/saline solutions were repeatedly applied to the rabbit eye over 6 hours, congestion, swelling, iritis, and corneal opacity dose-dependently increased, indicating irritating effects on the corneal epithelium and mucous membranes (ACGIH (2001)). In humans, it is reported that severe corneal burns were observed in a worker accidentally exposed to the liquid of the substance, and the liquid of this substance was squirted into one eye, which was treated immediately by copious irrigation with water, but a mild irritation of the conjunctiva lasted only one day (ECETOC 5 (1984)). From the above, because irritation could not be judged as slight, it was classified in Category 2A. Besides, it was classified in Xi: R36/37/38 in EU classification (EC-JRC (ESIS) (Access on Sept. 2011)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. Besides, there is a case report of occupational asthma attributed to exposure to ethylene oxide (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). |
4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
This substance was classified in Category 1 because it is listed as a contact allergen in Contact Dermatitis (4th, 2006) (Contact Dermatitis (4th, 2006), corresponding to List 1), and the Japan Society For Occupational Health (JSOH) classified it as occupational skin sensitizers Group 2 (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2010)). |
5 | Germ cell mutagenicity | Category 1B |
Danger |
H340 |
P308+P313
P201 P202 P280 P405 P501 |
It was classified in Category 1B based on a positive result in a dominant lethal test by inhalation exposure of mice (in vivo heritable germ cell mutagenicity test) (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)). Furthermore, it was also reported to be positive in a chromosomal aberration test and a micronucleus test with rat bone marrow cells (in vivo somatic cell mutagenicity tests) (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)), and in humans, positive results were reported in a chromosomal aberration test, a micronucleus test, or a sister chromatid exchange test with peripheral blood lymphocytes of workers handling this substance (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)). Besides, as for in vitro tests, it was reported to be positive in all of an Ames test (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)), a micronucleus test with Chinese hamster V9 cells (IARC 60 (1994)), and a chromosomal aberration test with human lung fibroblast (IARC 60 (1994)) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). |
6 | Carcinogenicity | Category 1A |
Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
It was classified in Category 1A because it was classified in Group 1 by IARC (IARC 97 (2008)), K by NTP (NTP ROC 12th (2011)), and Group 1 by the Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits Vol. 52 (Japan Society For Occupational Health (JSOH), 2010)). Besides, in a 2-year inhalation exposure test with rats, subcutaneous fibroma, peritoneal mesothelioma, pancreatic adenoma, pituitary adenoma, brain neoplasm, and mononuclear cell leukemia were observed, mononuclear cell leukemia increased dose-dependently in males and females, and it was significant in females at high and mid doses. Males at the high and mid doses had increased incidences of peritoneal mesothelioma originating from the testis, and males at the high dose had an increased incidence of subcutaneous fibroma (ACGIH (2001)). In a 2-year inhalation test with mice, malignant neoplasms of the lung and benign neoplasms of the Harderian gland significantly increased. Also, in females, malignant neoplasms of the uterus, mammary gland, and malignant lymphoma of the hematopoietic system increased (NTP TR 326 (1987)). Furthermore, there are reports of significant increases in leukemia and gastric cancers in epidemiological surveys on workers handling this substance and increases in tumors of the hematopoietic or lymphatic system in many epidemiological studies on workers exposed occupationally (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)). |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
In reproductive/developmental toxicity tests with rats or mice given inhalation exposure from before mating, adverse reproductive effects such as decreased litter size, decreased numbers of implantations, increased embryonic resorptions, and decreased numbers of live pups born were observed at the doses (100-150 ppm) where no general toxicity was seen in parent animals (NTP TR 326 (1987), Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)). Therefore, it was classified in Category 1B. Besides, after exposure of mice to 1,200 ppm after mating, congenital anomalies in live pups born, including omphalocele, eyeball defect (anophthalmia), thoracoschisis, acardia, and cleft palate, were reported (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)), but no teratogenicity was found after exposure of rats or rabbits during the organogenesis period (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)). Furthermore, in an epidemiological survey in humans, the pregnant women exposed to this substance had a higher incidence of miscarriages than those in the control group (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). |
8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system), Category 3 (respiratory tract irritation) |
Danger Warning |
H370
H335 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
Nausea, vomiting, and headache occurred as acute effects on the nervous system in nearly all inhalation human cases, and less frequently reported effects included decreased consciousness (coma), excitement, sleeplessness, muscular weakness, diarrhea, and abdominal discomfort (EHC 55 (1985)). Also, in an inhalation exposure test with mice, dyspnea, lacrimation, incoordination, and semiconsciousness were observed at levels corresponding to the guidance values Category 1 and above LD50 (660 ppm) (NTP TR 326 (1987)). Therefore, it was classified in Category 1 (central nervous system). Furthermore, severe respiratory problems due to inflammatory reactions in the trachea and larynx were reported in 17 hospital patients who had received endotracheal intubation with tubes sterilized with this substance (EHC 55 (1985)). Therefore, it was classified in Category 3 (respiratory tract irritation). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system), Category 2 (blood, kidney, respiratory tract) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
Three out of four young persons who had been intermittently exposed for 2-8 weeks due to leakage from a sterilizer developed reversible peripheral neuropathy accompanied by headache, muscular weakness, decreased reflexes in the extremities, incoordination, etc., and one had acute reversible encephalopathy with an abnormal electroencephalogram (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)). Also, a worker who had been exposed to ethylene oxide adjacent to a sterilizer for ten years developed impaired memory, impaired concentration, and emotional disorder, and the poisoning case report indicates that the substance is toxic not only to the peripheral nerve but to the central nerve (OEL Documentations Vol. 32 (Japan Society For Occupational Health (JSOH), 1990)). In animal tests, neuromuscular effects were observed such as hindlimb ataxia, axonal degeneration of myelinated nerve fibers in the hindlimb after 13-week inhalation exposure of rats (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)), and reduced locomotion and righting reflex after inhalation exposure of mice for 10-11 weeks (ACGIH (2001)). From the above knowledge, it was classified in Category 1 (nervous system). Furthermore, there is a report on anemia after 26-week inhalation exposure of rats to 100-500 ppm and decreases in erythrocyte counts, hemoglobin, hematocrit, bone marrow cell density, and lymphocyte counts after inhalation exposure of mice to 255-600 ppm for 10-13 weeks (Initial Risk Assessment Report 36 (NITE, CERI, NEDO, 2005)), and it is reported that after 14-week inhalation exposure of mice, rhinitis, loss of polarity of olfactory and respiratory epithelial cells, necrosis of epithelium, and transmigration of inflammatory cells with accumulation of purulent exudate were most frequently found at or above 200 ppm in the nasal port of the respiratory tract in addition to renal tubular degeneration at 100-600 ppm and renal tubular necrosis at 600 ppm (NTP TR 326 (1987)). Because all the above effects were seen at doses corresponding to the guidance value range for Category 2, it was classified in Category 2 (blood, kidney, respiratory tract). |
10 | Aspiration hazard | Not applicable |
- |
- | - | Gas (GHS definition) |
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 = 84 mg/L for fish (Pimephales promelas) (EHC 55, 1985, etc.). |
11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Reliable chronic toxicity data were not obtained. It was classified as "Not classified" due to being rapidly degradable (a 4-week degradation rate by BOD: 107% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1995)), and low bioaccumulation (BCF = < 0.36 to 0.88 (2 mg/L), < 3.7 to 6.0 (0.2 mg/L) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1995)), although it was classified in toxicity Category 3 in acute toxicity. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
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