GHS Classification Result

Chemical Name:Ethylene oxide
CAS:75-21-8

Result:
ID: 12
Classifier: Inter-ministerial Committee on GHS
Year Classified: FY2006
Reference Manual: GHS Classification Manual (10 Feb, 2006)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - Classified as "gas" according to GHS definition
2 Flammable gases (including chemically unstable gases) Category 1 Danger H220: Extremely flammable gas P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P377: Leaking gas fire: Do not extinguish, unless leak can be stopped safely.
P381: Eliminate all ignition sources if safe to do so.
P403: Store in a well-ventilated place.
The lower explosion limit is 3 volume % (ICSC 2004)- i.e., Category 1. Classified into Division 2.1and Division 2.3 (UN# 1040), according to UN Recommendations on the Transport of Dangerous Goods.
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not classified - - - - Classified into Division 2.1 and Division 2.3 (UN#1040) (UN Recommendations on the Transport of Dangerous Goods)
5 Gases under pressure Liquefied gas Warning H280: Contains gas under pressure; may explode if heated P410+P403: Protect from sunlight. Store in a well-ventilated place. The boiling point is 11degC (ICSC 2004), and the critical temperature is 196degC(HSDB 2005) -- i.e., liquefied gases. Classified into Category 2.1and Category 2.3 (UN# 1040) (UN Recommendations on the Transport of Dangerous Goods)
6 Flammable liquids Not applicable - - - - Classified as "gas" according to GHS definition
7 Flammable solids Not applicable - - - - Classified as "gas" according to GHS definition
8 Self-reactive substances and mixtures Not applicable - - - - Classified as "gas" according to GHS definition
9 Pyrophoric liquids Not applicable - - - - Classified as "gas" according to GHS definition
10 Pyrophoric solids Not applicable - - - - Classified as "gas" according to GHS definition
11 Self-heating substances and mixtures Not applicable - - - - Classified as "gas" according to GHS definition
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - Classified as "gas" according to GHS definition
13 Oxidizing liquids Not applicable - - - - Classified as "gas" according to GHS definition
14 Oxidizing solids Not applicable - - - - Classified as "gas" according to GHS definition
15 Organic peroxides Not applicable - - - - Classified as "gas" according to GHS definition
16 Corrosive to metals Classification not possible - - - - Test methods applicable to gaseous substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the rat LD50 (oral route) value of 72mg/kg representing the lower of the two testing data, 330mg/kg (CaPSAR, 1999) and 72mg/kg (MOE Risk Assessment Vol. 2, 2003).
1 Acute toxicity (Dermal) Classification not possible - - - - No data available
1 Acute toxicity (Inhalation: Gases) Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the rat LC50 (inhalation route) value of 800ppm representing the lower of the two testing data, 1,460ppm (CaPSAR, 1999) and 800ppm ((MOE Risk Assessment Vol. 2, 2003).
1 Acute toxicity (Inhalation: Vapours) Not applicable - - - - Due to the fact that the substance is "gas" according to the GHS definition and inhalation of its vapour is not expected.
1 Acute toxicity (Inhalation: Dusts and mists) Not applicable - - - - Due to the fact that the substance is "gas" according to the GHS definition and inhalation of its dust/mist is not expected.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
Based on the evidence of "inflammatory edema" from the rabbit skin irritation study (CERI-NITE Hazard Assessment, 2005) and the EU Risk Phrase.
3 Serious eye damage/eye irritation Classification not possible - - - - Although the substance is classified as Category 2 according to EU Risk Phrase and is anticipated to be an irritant based on the rabbit irritation study, the method and the test duration were different from those in normal procedures.
4 Respiratory sensitization Classification not possible - - - - No data available
4 Skin sensitization Classification not possible - - - - Insufficient data available.
5 Germ cell mutagenicity Category 1B Danger H340: May cause genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the positive data on heritable germ cell mutagenicity tests (dominant lethal mutation tests) described in CERI-NITE Hazard Assessment (No.36, 2005) and CICAD 54 (2003).
6 Carcinogenicity Category 1B Danger H350: May cause cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Due to the fact that the substance is classified as Category A2 by ACGIH (2002).
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the evidence of adverse effects on fetal growth at dosing levels not causing abnormal production of male gametes and not toxic to dams, described in CERI-NITE Hazard Assessment (No. 36, 2005) and CICAD 54 (2003).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (respiratory tract irritation) Danger
Warning
H370: Causes damage to organs (central nervous system)
H335: May cause respiratory irritation (respiratory tract irritation)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
Based on the human evidence including "airway irritation", "acute effects on the nervous system represented as nausea, vomiting and headache accompanying almost every case of inhalation exposure, and less frequent cases of impaired consciousness (including one case of coma), excitement, insomnia, weakness, diarrhea and abdominal discomfort" (EHC 55, 1985) and the evidence from animal studies including "dyspnea, watery eyes, poor coordination, clouding of consciousness and diarrhea" (NTP TR326, 1987). The effects on experimental animals were observed at dosing levels within the guidance value range for Category 1.
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, peripheral nervous system, blood), Category 2 (kidney, respiratory system) Danger
Warning
H372: Cause damage to organs through prolonged or repeated exposure (central nervous system, peripheral nervous system, blood)
H373: May cause damage to organs through prolonged or repeated exposure (kidney, respiratory system)
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
Based on the human evidence including "degeneration of the myelin sheath and axon of the sural nerve", "polyneuropahty (mainly characterized by sensory impairment in the lower limbs and unsteady gait)", "declined performance in all psychomotor tests, significantly declined performance in eye-hand coordination test compared to the non-exposed group", "significantly declined performance in various psychomotor skill tests, dysgnosia" and "decreases in hematocrit and hemoglobin (CERI-NITE Hazard Assessment No.36, 2005) and the evidence from animal studies including "axonal dystrophy in the gracile nuculeus of the medulla oblongata, demyelination of the axon terminal of the gracilis, atrophy of skeletal muscles", "ataxia in the hind limbs, axonal degeneration in the myelinated fibers in the nerves of the hind limbs, decreases in RBC, Hb, Ht, bone marrow cell density and lymphocyte count, renal tubular degradation, necrosis of lymphocytes in the spleen and thymus gland, rhinitis" (CERI-NITE Hazard Assessment No.36, 2005). The effects on the central nervous system and blood system of the experimental animals were observed at dosing levels within the guidance value range for Category 1, and the effects on the peripheral nervous system, kidney and respiratory organs of the experimental animals were observed at dosing levels within the guidance value range for Category 2.
10 Aspiration hazard Not applicable - - - - Not applicable

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
It was classified into Category 3 from 96 hours LC50=84mg/L of the fish (Fathead Minnows) (EHC55 (1985) and others.).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Since there was rapidly degrading (the decomposition by BOD: 107% (Existing Chemical Safety Inspections Data)) and the bio-accumulation was low (log Kow=-0.3 (PHYSPROP Database, 2005)), it was claasified into Not classified.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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