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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	78-92-2
Chemical Name	2-Butanol
Substance ID	H26-B-080, R-034
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	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

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 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 24 deg C (closed cup) (ICSC (2005)). Besides, it is classified in Class 3, PG III (UN1120) in UNRTDG.
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 406 deg C (ICSC (2005)).
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	- -	-	-	Based on reports of LD50 values of 2,193 mg/kg (SIDS (2009), ECETOC JACC (2003)), 4,400 mg/kg (ACGIH (7th, 2002)) and 6,500 mg/kg (PATTY (6th, 2012), SIDS (2009), ECETOC JACC (2003), ACGIH (7th, 2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 1987), EHC 65 (1987)) for rats, it was classified as "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of > 2,000 mg/kg for rats (SIDS (2009), ECETOC JACC (2003)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on a report of an LC50 value (4 hours) of 8,000-16,000 ppm (25-49 mg/L) for rats (SIDS (2009), ECETOC JACC (2003)), it was classified in Category 4. Besides, the lowest value of LC50 values was lower than 90% (15,1038 ppm) of the saturated vapour concentration (16,782 ppm), and the maximum value of LC50 value was higher than 90% of the saturated vapour concentration. However, based on a description that the test was conducted with the saturated vapour (SIDS (2009)), the reference value in units of ppm was applied. New information sources (SIDS (2009), ECETOC JACC (2003)) were added, and the category was revised.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a skin irritation test (OECD TG 404) with rabbits, the primary irritation score was 0, and it was not irritating (SIDS (2012), ECETOC JACC (2003)), and there are descriptions that it was not irritating to the skin (EHC 65 (1987), ACGIH (2002), DFGOT vol. 19 (2003)), and that it was very slightly irritating (PATTY (6th, 2012)). From the above results, it was classified as "Not classified."
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is described that in an eye irritation test with rabbits (OECD TG 405), since moderate conjunctival inflammation, transient injury in the iris and corneal opacity were observed, and the symptoms did not disappear on the 7th day in 1 animal, it was corrosive (SIDS (2009), DFGOT vol. 19 (2003)). This substance was judged to be "moderately to severely irritating" in SIDS (2009), and to be "an irritant or corrosive substance" in DFGOT vol.19 (2003). In addition, there are descriptions that the vapour of this substance caused severe corneal injury (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987)), and that it was moderately irritating (PATTY (6th, 2012)). From the above results, although there are descriptions of "corrosive," it was a report with only 1 animal, and the reversibility after 21 days was unknown. Moreover, it was judged to be moderately to severely irritating in each evaluation document. Therefore, it was classified in Category 2A. Besides, this substance was classified as "Xi; R36" in the EU DSD classification, and as "Eye Irrit. 2 H319" in the EU CLP classification.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	There is a report that in a sensitization test with guinea pigs (OECD TG 406, GLP-compliant), no sensitization was observed, and reaction to the positive control group (DNCB) was appropriate (SIDS (2009)). It is concluded in SIDS (2009) that this substance was a non-sensitizer. Moreover, there are reports that also in other sensitization tests (Freund's complete adjuvant test, Maximization test), no sensitization was observed in 20 animals tested (SIDS (2009), DFGOT vol. 19 (2003)). From the above results, it was classified as "Not classified." Since the human data in the previous classification were deleted because the details were unknown, the category was changed based on the information in the animal tests.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There was no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (SIDS (2009), ECETOC JACC (2003), PATTY (6th, 2012), DFGOT vol. 19 (2003), NTP DB (Access on September 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation reproduction toxicity study with rats by the oral route (drinking water), although mild toxicity due to stress was observed in parental animals at a very high dose (3,000 mg/kg/day), there were no effects on the fertility, and only minimum effects (growth retardation of the offspring) were observed (PATTY (6th, 2012), SIDS (2009), DFGOT vol. 19 (2003), ECETOC JACC (2003), IRIS (2003), ACGIH (7th, 2002)). On the other hand, in a teratogenicity test with rats by the inhalation route, at a dose (7,000 ppm) where maternal toxicities (coma, decreased body weight gain, decreased food consumption) were observed, although a reduced number of live fetuses, increased embryo resorptions and reduced fetal body weights were observed, no teratogenicity was observed (PATTY (6th, 2012), SIDS (2009), DFGOT vol. 19 (2003), ECETOC JACC (2003), IRIS (2003), ACGIH (7th, 2002)). Therefore, it was classified in Category 2.
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	This substance was irritating to the respiratory tract (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987), ACGIH (7th, 2002), DFGOT vol. 19 (2003), EHC 65 (1987), SIDS (2009)). In humans, it caused headaches, nausea, dizziness and deep narcotic effects at high concentrations (OEL Documentations (Japan Society For Occupational Health (JSOH), 1987), ACGIH (7th, 2002), DFGOT vol. 19 (2003), EHC 65 (1987)). As for experimental animals, by inhalation exposure to rats and mice at high concentrations there are reports of central nervous system depression effects or deep narcotic effects, such as gait abnormalities, ataxia, collapse, decreased respiratory rate, coma and prostration (SIDS (2009), ECETOC JACC (2003), PATTY (6th, 2012), ACGIH (7th, 2002), DFGOT vol. 19 (2003), EHC 65 (1987)). However, it was judged to be narcotic effects at high concentrations. From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There were no findings from repeated exposure in humans. Also, in experimental animals, there were no standard repeated-dose toxicity study reports available for classification. Therefore, classification was not possible due to lack of data. However, it is described that in a two-generation reproduction toxicity study with rats, by oral administration (drinking water) to F1 generation 12 weeks after weaning, slight effects on the kidney (degeneration, casts, and regeneration, etc. of the renal tubule) were observed at a concentration of 20,000 ppm, and NOAEL was corresponding to 10,000 ppm (equivalent to 1,500-1,771 mg/kg/day) (ECETOC JACC (2003)) (ECETOC JACC (2003), SIDS (2009)). Therefore, it is considered that the toxicity was low by the oral route. In addition, by the inhalation route, there is a description that when mice were exposed by inhalation to the vapour of this substance at a high concentration of 20,000 ppm (62 mg/L) for 117 hours (about 5 days), there were no death animals, and narcotic effects were observed (ECETOC JACC (2003), ACGIH (7th, 2001)).
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	- -	-	-	It was classified as "Not classified" from 48-hour EC50 = 4227 mg/L for crustacea (Daphnia magna) and 96-hour LC50 = 3670 mg/L for fish (Pimephales promelas) (both SIDS, 2002).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Because it is not water-insoluble (water solubility = 181000 mg/L, PHYSPROP Database, 2009) and was classified as "Not classified" in acute toxicity, 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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