NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	108-83-8
Chemical Name	Diisobutyl ketone
Substance ID	m-nite-108-83-8_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 49 deg C (closed cup) (ICSC (1997)), it was classified in Category 3. Besides, it is classified in Class 3, PG III (UN 1157) 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 396 deg C (HSDB (Access on August 2015)).	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 LD50 values for rats of > 2,000 mg/kg, 5,285 mg/kg (female), 6,933 mg/kg (male) (SIDS (2004)), and 5,750 mg/kg (5,800 mg/kg) (PATTY (6th, 2012), SIDS (2004), DFGOT vol. 18 (2002), ACGIH (7th, 2001)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports that an LD50 value for rats (OECD TG 402) was > 2,000 mg/kg (SIDS (2004)), and LD50 values for rabbits were 2,888 mg/kg (male), 6,933 mg/kg (female), 10,922 mg/kg (female) (SIDS (2004)), and 16,000 mg/kg (PATTY (6th, 2012), SIDS (2004), DFGOT vol. 18 (2002), ACGIH (7th, 2001)), it was classified as "Not classified."	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. Although there is a report of an LC50 value (4 hours) for rats of > 5 mg/L (> 850 ppm) (OECD TG 403) (SIDS (2004)), it was not possible to identify the category from this value. Besides, since the LC50 value was lower than 90% of the saturated vapor pressure concentration (987-2,172 ppm), a reference value in the unit of ppm was applied as vapour without mist.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	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))
2	Skin corrosion/irritation	Not classified	- -	-	-	As for skin irritation tests (OECD TG404) with rabbits, both results of slight irritation and no irritation are reported as a result of a semi-occlusive application of this substance for 4 hours (SIDS (2004)). In addition, there is a report that in other skin irritation test with rabbits, as a result of a semi-occlusive application of 0.5 mL of this substance for 4 hours, erythema (average score 1.9) and edema (average score 0.4) were observed, but resolved within 14 days after the application (SIDS (2004)). From the above, it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	There is a report that in an eye irritation test (equivalent to OECD TG 405) with rabbits, as a result of application of 0.1 mL of this substance, conjunctival redness (average score 0.3) and edema (average score 0.4) were observed, but resolved after 7 days (SIDS (2004)). In addition, there is a report that in other eye irritation test with rabbits, conjunctival redness, conjunctival edema, and lacrimation were observed, but resolved by day 2 (ECETOC TR48 (1992)). From the above, it was classified in Category 2B.	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	Not classified	- -	-	-	There is a report that in a maximization test (OECD TG 406, GLP-compliant) with guinea pigs, no sensitization was observed in the control group and treated group, and the positive rate in the positive control group was 50% (SIDS (2004), PATTY (6th, 2012)). From the above, it was classified as "Not classified."	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. There was no in vivo data. As for in vitro, bacterial reverse mutation tests and a mammalian cell chromosome aberration test were negative (SIDS (2004), DFGOT vol. 18 (2002), NTP DB (Access on October 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There were no classification results by other organizations. Therefore, classification was not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	There is no information on reproductive effects in humans. As for experimental animals, in a reproduction/developmental toxicity screening test (OECD TG 421) with rats dosed by gavage, at the limit dose of 1,000 mg/kg/day, decreased body weight gain (male) and the death of two maternal animals (2/10) during the lactation period were observed, but there were no effects on fertility of the parental animals, and macroscopic and histopathological changes were not observed in the genetic organs in survivors in both sexes. In addition, no adverse effects were observed in the number of offspring born, a trend in body weight, and a survival rate by postnatal day 5 (SIDS (2004), PATTY (6th, 2012)). However, it was difficult to classify it as "Not classified" with only this result since this test is a screening test. In addition, there is no other available data for classification. Therefore, classification was not possible due to lack of data 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 (central nervous system, liver), 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	This substance is irritating to the respiratory tract (SIDS (2004), ACGIH (7th, 2001), DFGOT vol. 18 (2002), PATTY (6th, 2012)). There is a report of narcotic effects in humans and experimental animals, and it was reported that in inhalation exposure with rats (at doses corresponding to Category 1), central nervous system symptoms such as salivation, hypoactivity, tremors, coordination ataxia, reflex disturbance, and labored breath, and hind-limb paralysis, liver damage, and an increase in hyaline droplets in the proximal tubules of the kidneys (SIDS (2004), ACGIH (7th, 2001), DFGOT vol. 18 (2002), PATTY (6th, 2012)). Since an increase in hyaline droplets in the proximal tubules of the kidneys in rats was a finding only in males, it was not adopted as the target organ. From the above, this substance has effects on the central nervous system and liver in addition to respiratory tract irritation and narcotic effects, therefore, it was classified in Category 1 (central nervous system, liver), 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	Classification not possible	- -	-	-	There is a description that a 60-year-old laboratory assistant who was repeatedly exposed to this substance developed severe headaches and a 20-minute loss of sight after exposure for about a month (DFGOT vol. 18 (2002), PATTY (6th, 2012)). However, it is a case report of only one, and the target organ was not identified based on this information. As for experimental animals, in a test in which rats were exposed to the vapour of this substance for 6 weeks, an increase in liver and kidney weight at or above 252 ppm, and cloudy swelling of the liver and cloudy swelling of the convoluted renal tubules at high concentrations of 925-1,654 ppm were observed. The author judged that NOAEL and LOAEL were 534 ppm and 925 mm respectively, and SIDS also referred to these (SIDS (2004)). If LOAEL is 925 ppm, 1 ppm = 5.81 mg/m3 (ACGIH (7th, 2001)), the dose with effects on the liver and kidney exceeds the range for Category 2 (converted guidance value concentration: 2.07 mg/L/6 hr/day). However, when the increase in organ weight at 252 ppm is considered as an effect, the dose corresponds to the guidance value range for Category 2 (converted to guidance value: 0.56 mg/L/6 hr/day). In addition, there is a description that in a 6-week inhalation study with guinea pigs exposed in the same way, a decrease in liver weight was observed at 252 ppm to the contrary (SIDS (2004), ACGIH (7th, 2001)). On the other hand, there is a description that in the oral route, rats were dosed by gavage at 2,000 mg/kg/day of this substance for 90 days, there were no clear findings other than a decrease in blood sugar level, and neurotoxicity was not observed (DFGOT vol. 18 (2002), PATTY (6th, 2012)). From the above, from the existing findings, no hazard information that can be used for classification was available, therefore, it was classified as "Classification not possible."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	There is no case in humans. Therefore, classification was not possible due to lack of data. Besides, since this substance is a ketone with carbon atoms of 13 or less and the calculated kinematic viscosity is 1.11 mm2/sec (21 deg C) (viscosity: 0.896 mPa*s (70 deg F), density (specific gravity): 0.8062: HSDB (Access on August 2015)), it corresponds to Category 2 in UN GHS classification. According to the current GHS classification guidance for the Japanese government, it was classified as "Classification not possible."	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)	Category 3	- -	H402	P273 P501	From 24-hour LC50 = 65 mg/L for crustacea (Artemia salina) (SIDS, 2004), it was classified in Category 3.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (BioWin), and acute toxicity Category 3, it was classified in Category 3.	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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