NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	591-78-6
Chemical Name	Methyl n-butyl ketone
Substance ID	m-nite-591-78-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on a flash point of 25 deg C (closed cup) (HSDB (Access on August 2015)), it was classified in Category 3. Besides, it is classified in Class 3, PG III (UN 1224 (KETONES, LIQUID, N.O.S.)) in UNRTDG.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 423 deg C (ICSC (1998)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on a report of an LD50 value of 2,590 mg/kg (PATTY (6th, 2012), IRIS Tox. Review (2009), ACGIH (7th, 2001), ATSDR (1992)) for rats, this substance was classified as "Not classified" (Category 5 in the UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of 5.99 mL/kg (4,944 mg/kg) (PATTY (6th, 2012)) for rabbits, this substance was classified as "Not classified" (Category 5 in the UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a report that as a result of 4-hour inhalation in rats at 4,000 ppm, no death was observed (PATTY (6th, 2012)), but it was not possible to identify the category from this value alone. Besides, since the test concentration was lower than 90% of the saturated vapor pressure concentration (5,000 ppm), a reference value in the unit of ppm was applied as vapor without mist.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a report of an LC50 value (4 hours) of 32.8 mg/L for rats (GESTIS (Access on August 2015), RTECS (Access on August 2015) original reference: Raw Material Data Handbook, Vol.1: Organic Solvents, 1974.), this substance was classified as "Not classified." Besides, the reference value of mist was applied because the LC50 value is higher than the saturated vapor pressure concentration (20.5 mg/L). The new information was added, and the Category was reviewed.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a skin irritation test with rabbits, as the result of application with an undiluted solution of this substance for 24 hours, slight irritation was observed (ATSDR (1992), PATTY (6th, 2012)). From the above, this substance was classified as "Not classified" (Category 3 in the UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a report that moderate irritation was observed in an eye irritation test with rabbits (ATSDR (1992)). In addition, there is a report that as the result of exposure to 1,000 ppm of this substance in volunteers, moderate irritation was observed (ACGIH (7th, 2001), PATTY (6th, 2011)). From the above, this substance was classified in Category 2A based on reports of moderate irritancy.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no information on carcinogenicity in humans. As for experimental animals, there is a description that in a 2-year carcinogenicity study with rats and mice exposed by inhalation, renal tubule hyperplasia and an increase in incidence of adenoma or carcinoma in the renal tubules were observed at 1,800 ppm in rats (ATSDR Addendum (2014)), but the original source was unknown (only the author and title were identified), and it was not possible to confirm detailed content. Other than this, there is no data available. As classification results by other organizations, it was only classified as "I (Inadequate to assess human carcinogenic potential)" in evaluation in 2009 by EPA (IRIS Summary (Access on August 2015)). Therefore, it was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It is described that in tests in which male rats were exposed by inhalation to 700 ppm of this substance for 11 weeks, or orally dosed at 660-1,400 mg/kg/day for 90 days, testicular toxicity (atrophy of testis, degeneration of germinal epithelium, etc.) was observed (ATSDR (1992), ACGIH (7th, 2001), PATTY (6th, 2012)), but there is no study report that considered the effects on fertility on mating with females. However, when pregnant rats were exposed by inhalation at doses of 500-2,000 ppm throughout the gestation period, the F1 pups were maintained and nursed from birth to mature animals (adults), and during this period, behavioral observation was performed at the neonatal period, weaning period, puberty, and maturation period. It is described that as a result, in maternal animals, decreased body weight gain and decrease in the number of litters were observed at or above 1,000 ppm, and in F1 pups, in behavioral tests at or above 1,000 ppm, a decrease in avoidance learning behavior in female animals in puberty, an increase in locomotor activity (open field test) in animals in puberty and maturation period were observed, and a low value of mortality and body weights at 2,000 ppm were observed (ATSDR (1992), ACGIH (7th, 2001), PATTY (6th, 2012)). Considering that this substance is a nervous system acting substance, it was judged to be reasonable to regard the findings by postnatal neurobehavioral examination by fetal exposure as effects of test substance administration. Therefore, it was classified in Category 2 for this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (peripheral nervous system), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There are reports that this substance has respiratory tract irritating potential and narcotic effects in humans (ACGIH (7th, 2001), PATTY (6th, 2012), ATSDR (1992)), and in the case of inhalation and dermal exposure, three workers developed peripheral neuropathy during spray painting of this substance (ACGIH (7th, 2001)). From the above, this substance was classified in Category 1 (peripheral nervous system), Category 3 (respiratory tract irritation, narcotic effects).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system)	Danger	H372	P260 P264 P270 P314 P501	Many cases of workers who were exposed to this substance in solvent painting work etc. and developed peripheral neuropathy are reported. Also, in typical cases, it is reported to follow courses of weakness, feet discomfort, development of muscle weakness progressing from the lower extremities to the lower-body, and to the upper arms, and the lower or diminished reflex function of lower extremities (IRIS Tox Review (2009)). In addition, there is a description that by observation of sural nerve specimens collected by biopsy, diffuse fibrosis, loss of nerve fibers, and swelling of axons with tangles of nerve fibers were observed (IRIS Tox Review (2009)). Moreover, there is a description that although the degree is different, chronic occupational exposure to this substance was associated with the onset and progression of symmetrical central-peripheral distal axonopathy (ACGIH (7th, 2001)). As for experimental animals, there are descriptions that in studies in which male rats or male cynomolgus monkeys were exposed by inhalation of this substance (assumed to be vapor) at 100 or 1,000 ppm for 10 months, a decrease in motor conduction velocity (MCV) for the sciatic-tibial nerves was observed in a dose- and time-dependent manner in both rats and monkeys at or over 100 ppm (0.41 mg/L/6hr) corresponding to Category 2, and a decrease in the induced muscle action potential amplitude in response to the sciatic nerve stimulation was observed at or above 100 ppm in rats and 1,000 ppm in monkeys (IRIS Tox Review (2009)). Also, there is a description that in a 2-year inhalation study with cats, as neuropathological changes, degeneration of nerve axon and swelling of axons with myelin loss were found in both peripheral nerve and central nerve at 330 ppm (1.35 mg/L/6 hr) (IRIS Tox Review (2009)). On the other hand, also in the oral route, in a study in which rats were dosed with this substance in drinking water for 13 months, swelling of peripheral axons and myofibrillar atrophy in skeletal muscle were observed at or above 250 ppm (143 mg/kg/day), and changes in axons in the brain, spinal cord, and peripheral nerve were developed in all, but in the brain, it was less frequent than in the other sites (IRIS Tox Review (2009)). From the above, although it is clear from many epidemiological reports on humans that this substance causes peripheral neuropathy, it is shown from neuropathological examinations of experimental animals that neural axon tissue changes occurred at low frequency also in the central nervous system, therefore, it was considered that effects on the central nervous system develop at least morphologically even in humans. Therefore, it was classified in Category 1 (nervous system) for this hazard class. Besides, Category 2 (testis) was adopted in the previous classification. Although, as described in the hazard class for "reproductive toxicity," testis toxicity was observed in repeated exposure by the inhalation or oral route to this substance, it was excluded from this classification since they are findings at doses exceeding Category 2.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	There are no cases of hazard to the respiratory organs due to aspiration in humans. However, this substance belongs to ketones composed of carbon atoms of 3 or more and not more than 13. The calculated kinematic viscosity value is 0.747 mm2/sec (20 deg C) from the numerical data (Viscosity: 0.62 mPa*s (20 deg C), density (specific gravity): 0.830 g/cm3 (20 deg C)) listed on HSDB (Access on August 2015). From the above, it corresponds to Category 2 in UN GHS classification, but it was classified as "Classification not possible" according to the current GHS classification guidance for the Japanese Government revised after the previous classification.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	From 96-hour LC50 = 428 mg/L for fish (Pimephales promelas) (HSDB, 2006, AQUIRE, 2016), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Due to being not water-insoluble (water solubility = 17200 mg/L, PHYSPROP Database, 2009), and "Not classified" in acute toxicity, it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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