GHS Classification Result （Revision of the past classification result）

Chemical Name：Ethanol
CAS：64-17-5

Result：
ID: 21B3016
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 2 Danger H225: Highly flammable liquid and vapour P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		Classified into Category 2 since flash point 13 degC is <23 degC and initial boiling point 78.5 degC is >35 degC. The substance is classified into Class 3, PG II in UNRTDG (UN1170).
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 - - - - Auto-ignition point is 422.78 degC (ACGIH (2001)) and it is considered that the substance does not spontaneously ignite at room temperature.
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 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.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - LD50 values of 6200 - 15000 mg/kg bw (DFGOT vol. 12 (1999)), 13.7 g (13700 mg)/kg, 17.8 g (17800 mg)/kg, 11.5 g (11500 mg)/kg (PATTY (5th, 2001)), 9.8 - 11.6 mL/kg bw (7938 - 9396 mg/kg), 15010 mg/kg bw, 7000 - 11000 mg/kg bw, 14.6 mL/kg bw (11826 mg/kg), 7800 mg/kg bw, 11500 mg/kg bw, 11170 - 16710 mg/kg bw, 7060 mg/kg bw and 8300 mg/kg bw (SIDS (J) (2009)) for rats correspond to "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Based on a LDLo value of 20,000 mg/kg bw for rabbits (SIDS (2009)), the substance was classified as "Not classified".
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Not classified - - - - For five LC50 values reported for rats, one value (3837 ppmV (SIDS (2009)) corresponds to Category 4, and four values (63,000 ppmV (4h) (DFGOT vol. 12 (1999)), 20,661 ppmV (4h), 66,181 ppmV (4h) and 22,627 ppmV (4h) (SIDS (2009))) correspond to "Not classified", the substance was classified as "Not classified". Since the saturated vapour pressure concentration of the substance was 78,026 ppmV (147.1 mg/L) and the test concentrations was lower than 90% of saturated vapour pressure concentration (70,223 ppmV (132.4 mg/L)), the classification criteria for gas (ppmV) was adopted.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - Based on a result of "not irritating" in a rabbit 4-hour application test (OECD TG404) where mean score for erythema was 1.0 after 1 and 24-hour and scores for erythema and oedema were 0.0 at all other time points (SIDS (2009)), the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		In rabbit Draize tests (OECD TG405), results of "moderate irritating" was reported (SIDS (2009), DFGOT vol. 12 (1999)). Additionally, there was a report that corneal opacity, iritis, conjunctival redness and chemosis were observed at 1 - 3 days after application. The MMAS (Modified Maximum Average Score: corresponding to AOI) was calculated to be 24.0 (ECETOC TR48 (1998)) and the effects were almost reversed within 7 days (ECETOC TR48 (2) (1998). Based on the data, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - Classification not possible due to lack of data. The mechanism of alcohol-induced bronchial asthma is considered to involve increased acetaldehyde levels in blood. In 2 patients with mild asthma, an inhalation provocation test with aerosolized ethanol resulted in severe bronchoconstriction (DFGOT (1996)). This result does not, however, indicate that the genesis of the reaction is allergic (DFGOT (1996)).
4 Skin sensitization Classification not possible - - - - Although there are various case reports of contact dermatitis caused by an allergic reaction to alcohol (DFGOT (1996)), there is a report of "Cross-reactions with other primary and secondary alcohols were observed in some cases. A significant sensitizing potential cannot be deduced from the available animal data. Sufficient data were not available to recommend skin sensitization" (ACGIH (2001), DFGOT (1996), IUCLID (2000)). Classification was not possible due to lack of other data.
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 positive results in dominant lethal tests by oral and intraperitoneal administration to mice and oral administration to rats (in vivo heritable germ cell mutagenicity tests) (SIDS (2009), IARC (1988)), the substance was classified into Category 1B. As relevant information, from in vitro mutagenicity tests, there are reports of negative Ames tests (DFGOT vol. 12 (1999), SIDS (2009), NTP DB (2009)) and chromosomal aberration tests, and a positive CHO cell chromosomal aberration test (SIDS (2009)).
6 Carcinogenicity Classification not possible - - - - Ethanol is classified into "A3" in ACGIH (ACGIH (2009)) that corresponds to Category 2. However, the classification is based on data of a lifetime test in rats utilizing a large oral dose (10% in water) designed to correspond to intake of alcoholic beverages. In a two-year oral test in male and female rats fed a liquid diet at lower doses (1% and 3%), there was no carcinogenic activity (ACGIH (2009)). Additionally, there is a report the classification is based on the data of animal tests rather than epidemiological researches for occupational exposure therefore, the relevance to humans is unknown. In contrast, alcoholic beverages are classified into Category 1 in IARC based on numerous epidemiological tests on consumption of alcoholic beverages (IARC vol. 44 (1987)). In re-evaluation in 2007, alcoholic beverages and ethanol in alcoholic beverages are classified into "Group 1" (IARC vol. 96 summary (access on Oct. 2009)). The classification is based on the data of preferentially regular consumption in humans (IARC vol. 96). In addition, ethanol is not classified in EU classification. Based on the above information, classification was not possible.
7 Reproductive toxicity Category 1A 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 ... 		There is a large amount of epidemiological data for ethanol. In prospective tests and case-control tests, it was reported that alcohol intake above a certain level significantly increased the incidence or risk of abortion (IARC 44 (1987)) There are numerous reports that fetal alcohol syndrome which is characterized by growth deficiency, microcephaly, characteristic facial characteristics and mental retardation, was observed in the children of alcoholic women (IARC 44 (1987), SIDS (2009), DFGOT vol. 12 (1999)). Other abnormalities associated with pre-natal ethanol exposure include cleft palate, palmar crease abnormalities and septal and other cardiac defects, and eustachian tube defects. Investigations strongly suggest that maternal ingestion of large doses of ethanol is teratogenic and foetotoxic (SIDS (2009)). Since the above epidemiological reports and research are considered to provide clear evidence of human reproductive toxicity, the substance was classified into Category 1A. As relevant information, there were no adverse effects in oral one-generation tests in rats and mice (SIDS (2009)). In a two-generation test in mice, offspring had fewer live pups per litter (SIDS (2009)). In some tests, malformation such as polydactyly and polysyndactyly were reported in the offspring of rats orally adminstered with the substance during the gestation period (IARC 44 (1987)).
8 Specific target organ toxicity - Single exposure Category 3 （Respiratory tract irritation, Narcotic effects） Warning H335: May cause respiratory irritation (respiratory tract irritation, narcotic effects) 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.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In an inhalation exposure test in humans, stupor, drowsiness and slight paralysis were observed (ACGIH (2001)). The acute toxic effects of ingested ethanol on the central nervous system are generally known (DFGOT vol. 12 (1999)). Severe intoxication is characterized by marked muscular incoordination, blurred or double vision, stupor, hypothermia, vomiting and nausea, and convulsions; Following large ingestion of the substance, coma, depressed reflexes, respiratory depression, hypotension, and death from respiratory or circulatory failure or as the result of aspiration of stomach contents in the absence of a gag reflex occur (PATTY (5th, 2001)). In addition to the reported symptoms such as stupor and drowsiness in humans, there are reports of signs of narcosis, drowsiness and ataxia in inhalation exposure tests in rats, mice and guinea pigs (SIDS (2009), DFGOT vol. 12 (1999)). Based on these data, the substance was classified into Category 3 (narcotic effects). By inhalation exposure of the vapour to humans, the respiratory and eye irritant effects occur at low concentrations (ACGIH (2001)). In human subjects, following inhalation exposure, there is a report of coughing and smarting of the eyes and nose (PATTY (5th, 2001)). In an inhalation exposure test in nontolerant subjects, nasal irritation was reported (PATTY (5th, 2001)). Based on the data, the substance was classified into Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver), Category 2 (central nervous system) Danger
Warning 		H372: Cause damage to organs through prolonged or repeated exposure (liver)
H373: May cause damage to organs through prolonged or repeated exposure (central nervous 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 ... 		Long-term consumption of large doses of alcohol causes toxic effects in almost all organ systems. The most affected target organ is the liver; beginning with fatty degeneration, damage can progress via necrosis and fibrotic stages to liver cirrhosis (DFGOT (1996)). Based on this information, the substance was classified into Category 1 (liver). There is a report that patients with severe physical dependence caused by alcohol consumption experience craving and drug-seeking behavior and hyperreflexia with nausea, weakness, anxiety and sweating, in addition to the elicitation of a withdrawal syndrome of tremors, seizures and delirium (HSDB (2003)). Based on this information, the substance was classified into Category 2 (central nervous system). In animal tests, there were little adverse effects. In 90-day repeated oral tests in rats and mice, fatty degeneration of the liver was seen at high dose levels exceeding the guidance value range (SIDS (2009)).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Not classified - - - - Classified into Not classified from its 96h-LC50 >100 mg/L for fish (Fathead minnow) (SIDS, 2005), 48h-LC50 = 5012 mg/L for Crustacea (Cenodaphnia quadrangular) (SIDS, 2005) and 96h-EC50 = 1000 mg/L for algae (Chrollera) (SIDS, 2005).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility = 1000000 mg/L (PHYSPROP Database, 2009).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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