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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	106-35-4
Chemical Name	n-Butyl ethyl ketone
Substance ID	H26-B-076, -
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 38 deg C (closed cup) (GESTIS (Access on September 2014)).
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 390 deg C (GESTIS (Access on September 2014)).
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 a report of an LD50 value of 2,760 mg/kg (PATTY (6th, 2012), ACGIH (7th, 2001)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on an LD50 value of >20 mL/kg (converted value: >16,000 mg/kg) (PATTY (6th, 2012), ACGIH (7th, 2001)) for rabbits, it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a report that no death occurred at a dose of 2,000 ppm (9.34 mg/L) in a 4-hour inhalation study with rats (PATTY (6th, 2012), ACGIH (7th, 2001)), it was classified as "Not classified." Besides, the reference value for a mist was applied, because the exposure level was higher than the saturated vapor concentration (1,846 ppm (8.62 mg/L)).
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a description that this substance showed only mild irritation to human skin (PATTY (6th, 2012)). In animals, there is a report that slight irritation was observed on the skin of rabbits (PATTY (6th, 2012)), and there is a description that it is slightly irritating to the skin (HSDB (Access on August 2014)). From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification). "Moderate irritation" which was the evidence of the classification in the previous classification was not adopted because it was the result of a 24-hour application.
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on a report that slight irritation was observed in a test in which this substance was applied to the eyes of rabbits (ACGIH (7th, 2001), PATTY (6th, 2012)), it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there is a report that no sensitization was observed in a maximization test in which 4% of this substance was applied to 25 subjects (ACGIH (7th, 2001)), details such as the positive rate were unknown, therefore, the data were judged to be insufficient for classification. Due to reviewing the information in List 1, the category was revised.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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 causes respiratory tract irritation and narcotic effects (at high concentrations) (ACGIH (7th, 2001)). There is a report that coma was observed at high concentrations in a single inhalation exposure test with rats (PATTY (4th, 1994)). 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 finding of hazards in humans. As for experimental animals, although there is description that neuropathy (giant axonal neuropathy, peripheral neuropathy) was observed at or above 2,000 mg/kg in a neurotoxicity study with male rats administered by gavage for 14 weeks (PATTY (6th, 2012)), the presence or absence of general toxic effects is unknown within the dose range up to Category 2. Besides, although the same data was also listed in ACGIH (7th, 2001), it was confirmed in the original source (O'Donoghhue, J. H. et al. (1984)) that ACGIH incorrectly described the dose unit. On the other hand, when male rats were exposed to 700 ppm of the vapour of this substance for 24 weeks through the inhalation route (16-20 hours/day, 5 days/week), at this concentration (converted guidance value: 8.8-11.0 mg/L/6 hours (converted as 1 ppm=4.7 mg/m3)), no clinical signs of systemic toxicity or neurotoxicity occurred, and also the body weight change was similar to that of the control group. However, there was no description of the results of clinical and histopathological examinations, etc. (PATTY (6th, 2012), ACGIH (7th, 2001)), and whether there were effects on general toxicity or not is unknown in the same way as in the oral administration study. As described above, toxicity tests with experimental animals were not appropriate for classification. Therefore, classification was not possible due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	This substance is a ketone composed of no more than 13 carbon atoms, and classification was not possible since it is equivalent to Category 2 in UN GHS classification.

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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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