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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	64-17-5
Chemical Name	Ethanol
Substance ID	25B0007
Classification year (FY)	FY2013
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	FY2009 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
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 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of 13 deg C (closed-cup) and a boiling point of 78.5 deg C (Merck (2006)). Besides, it is classified in Class 3, PG II (UN1170) in UNRTDG.
7	Flammable solid	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 363 deg C (ICSC (2000)).
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.

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 of LD50 values for rats of 6,200 mg/kg, 11,500 mg/kg, 17,800 mg/kg, 13,700 mg/kg (PATTY (6th, 2012)), 15,010 mg/kg, and 7,000-11,000 mg/kg (SIDS (2005)) correspond to "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LDLo = 20,000 mg/kg for rabbits (SIDS (2005)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	Both of LC50 for rats of 63,000 ppmV (DFGOT vol. 12 (1999)) and 66,280 ppmV (124.7 mg/L) (SIDS (2005)) correspond to "Not classified." Besides, because concentrations of test substance were lower than 90% [70,223 ppmV (132.4 mg/L)] of the saturated vapour pressure concentration, 78,026 ppmV (147.1 mg/L), a reference value in the unit of ppmV was used.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because it is assessed in SIDS (2005) that in a 4-hour exposure test with rabbits (OECD TG 404), the average scores at 1 and 24 hours after application were 1.0 for erythema, the average scores at the other time points were all 0.0 for erythema and edema, and it was not irritating.
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was assessed to be moderately irritating in two Draize tests with rabbits (OECD TG 405) (SIDS (2005)). In one test of them, findings of corneal opacity, iritis, conjunctival redness, and chemosis were observed, the average scores on day 1 were 1 or above for corneal opacity, 2 or above for conjunctival redness, and most findings disappeared within seven days (ECETOC TR 48 (2) (1998)). Therefore, it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, alcohol-induced bronchial asthma is considered to involve the increased acetaldehyde levels in the blood. On the other hand, it is reported that two patients with mild asthma developed severe bronchoconstriction in an inhalation provocation test with ethanol (DFGOT vol. 12 (1999)), but it is also described that the result does not indicate that the genesis of the reaction is allergic (DFGOT vol. 12 (1999)).
4	Skin sensitization	Classification not possible	- -	-	-	In humans, it is described that there are case reports of contact dermatitis, etc. by allergic reactions to alcohol (DFGOT vol. 12 (1999)). However, it is described that there are no sufficient data on the skin sensitizing potential of ethanol because cross-reactions with other primary and secondary alcohols were observed in humans, and no significant skin sensitization was found in animal tests (SIDS (2005), DFGOT vol. 12 (1999)). Therefore, it was classified as "Classification not possible" due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	There are in vivo and in vitro negative results or judgments to be negative, therefore it 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. There are positive results in dominant lethal tests with mice and rats by oral administration (also by intraperitoneal administration for mice) (SIDS (2005), IARC (2010), DFGOT vol. 12 (1999), PATTY (6th, 2012)), but these were assessed to be of low or no reliability because inappropriate test conditions, mistakes in test results, etc. were found (SIDS (2005), DFGOT vol. 12 (1999)). And it was negative in micronucleus tests with bone marrow of rats and mice, negative in chromosomal aberration tests with rat bone marrow and peripheral blood lymphocytes (SIDS (2005), PATTY (6th, 2012), IARC (2010), DFGOT vol. 12 (1999)), and negative in a chromosomal aberration test with bone marrow of Chinese hamsters (SIDS (2005)). Furthermore, it was negative in a micronucleus test with mouse spermatid, a chromosomal aberration test with mouse spermatocytes, a chromosomal aberration test with rat spermatogonial cells, and a chromosomal aberration test (aneuploidy) with spermatogonial cells of Chinese hamsters (IARC (2010), DFGOT vol. 12 (1999)). Besides, there are positive reports in sister chromatid exchange tests with rats and mice (DFGOT vol. 12 (1999), PATTY (6th, 2012)), but they were not assessed in SIDS (2005) and others. As for in vitro mutagenicity tests, it was assessed to be negative in all of an Ames test and a mouse lymphoma test and a micronucleus test with cultured mammalian cells (PATTY (6th, 2012), IARC (2010), DFGOT vol. 12 (1999), SIDS (2005), NTP DB (Access on June 2013)), and also in in-vitro chromosomal aberration tests, it was negative in all except for a positive result in one test with CHO cells (SIDS (2005), PATTY (6th, 2012), IARC (2010)). Besides, it is described that this positive result of chromosome aberrations occurred at extremely high concentrations, and it is possible that chromosome damage resulted from non-specific effects such as high osmotic pressure (SIDS (2005)).
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Ethanol is classified in A3 by ACGIH (ACGIH (7th, 2012)). Furthermore, it is described in IARC (2010) that there is sufficient evidence of carcinogenicity for alcoholic beverages from epidemiological data, and it is proven that ethanol and its main metabolite, acetaldehyde induce malignant tumors in the esophagus and other organs by ingestion of ethanol contained in alcoholic beverages. Therefore, it was classified in Category 1A.
7	Reproductive toxicity	Category 1A	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In humans, it is known that prenatal ingestion of ethanol causes congenital malformations that have been collectively termed as the fetal alcohol syndrome in neonates. It includes malformations such as microcephaly, shortened palpebral fissures, joint, limb, and cardiac anomalies, and behavioral/cognitive impairments during development (PATTY (6th, 2012)). Because these are thought to constitute solid evidence on the reproductive toxicity of ethanol in humans, it was classified in Category 1A. Besides, fetal alcohol syndrome is associated with alcoholic women who drank heavily and chronically during pregnancy. There have been no reports of fetal alcohol syndrome by industrial exposure by the oral, dermal, or inhalation routes. Furthermore, also in animal tests, malformations occurred in tests in which pregnant rats were orally administered.
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	Irritation symptoms in the eye and nose are reported after inhalation exposure in humans (PATTY (6th, 2012)). As blood alcohol levels increase, mild intoxication (muscular incoordination, mood, personality, and behavioral changes) progresses to moderate intoxication (visual impairment, sensory loss, slowed reaction time, slurred speech), and then severe intoxication (vomiting, stupor, hypothermia, hypoglycemia, respiratory depression, etc.) occurs. Furthermore, it is described that it leads to death from respiratory or circulatory failure, or as a result of aspiration of gastric content in the absence of gag reflex (PATTY (6th, 2012)). Also, in experimental animals, symptoms of central nervous system depression were observed (SIDS (2005)). From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver), Category 2 (central nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	It is described that long-term consumption of large doses of alcohol in humans causes toxic effects in almost all organ systems, and that the most affected target organ is the liver, and beginning with fatty degeneration, the damage can progress via necrotic and fibrotic stages to liver cirrhosis (DFGOT vol. 12 (1999)). Therefore, it was classified in Category 1 (liver). Furthermore, it was classified in Category 2 (central nervous system) because it is described that three medications were approved by the U.S. FDA for the treatment of alcohol abuse and alcohol dependence (HSDB (Access on June 2013)). Besides, adverse effects were not so severe in animal tests, and steatosis is reported as effects on the liver at high doses much above the guidance value range in a 90-day repeated oral dose test with rats (SIDS (2005), PATTY (6th, 2012)).
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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	- -	-	-	From 96-hour EC50 = 1000 mg/L for algae (Chlorella vulgaris) (SIDS, 2005), 48-hour EC50 = 5463 mg/L for crustacea (Daphnia magna) (ECETOC TR 91 2003), and 96-hour LC50 = 11200 ppm for fish (Oncorhynchus mykiss) (SIDS, 2005), acute toxicity is not reported at 100 mg/L for algae, crustacea, and fish. Therefore, it was classified as "Not classified."
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 rapid degradability (a degradation rate by BOD: 89% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1993)), and 10-day NOEC = 9.6 mg/L for crustacea (Ceriodaphnia sp.) (SIDS, 2005). 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" because it corresponds to "Not classified" in acute toxicity for both algae and fish, and it is not water-insoluble (miscible, ICSC, 2000). 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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