GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 108-10-1
Chemical Name Methyl isobutyl ketone
Substance ID R03-C-054-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2015   FY2014   FY2009   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 (FY2019 revised edition (Ver. 2.0))
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 -
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2 Flammable gases -
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3 Aerosols -
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4 Oxidizing gases -
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5 Gases under pressure -
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6 Flammable liquids -
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7 Flammable solids -
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8 Self-reactive substances and mixtures -
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9 Pyrophoric liquids -
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10 Pyrophoric solids -
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11 Self-heating substances and mixtures -
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12 Substances and mixtures which, in contact with water, emit flammable gases -
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13 Oxidizing liquids -
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14 Oxidizing solids -
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15 Organic peroxides -
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16 Corrosive to metals -
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17 Desensitized explosives -
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HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Acute toxicity (Oral) -
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1 Acute toxicity (Dermal) -
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1 Acute toxicity (Inhalation: Gases) -
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1 Acute toxicity (Inhalation: Vapours) -
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1 Acute toxicity (Inhalation: Dusts and mists) -
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2 Skin corrosion/irritation -
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3 Serious eye damage/eye irritation -
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4 Respiratory sensitization -
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4 Skin sensitization -
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5 Germ cell mutagenicity -
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6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501 		[Rationale for the Classification]
Based on (1) and (2), an increase in the incidence of tumors including malign ones was observed in two animal species, and in animal studies, it was considered that there was sufficient evidence of carcinogenicity, and therefore, this substance was classified in Category 1B. Also, based on the new evaluation, the classification result was changed.

[Evidence Data]
(1) In a 2-year inhalation exposure test with rats (6 hours/day, 5 days/week), increased incidences of renal tubular adenomas and renal tubular adenomas or carcinomas combined were observed in males, and malignant renal mesenchymal tumors were observed in females (2/50 animals). It was judged that there was weak evidence for alpha 2mu-globulin-mediated mechanism by which kidney tumor developed in males and that there was a low probability of kidney tumor in females spontaneously occurring because it was a rare tumor in females (IARC 101 (2012)).
(2) In a 2-year inhalation exposure test with mice (6 hours/day, 5 days/week), increased incidences of hepatocellular adenomas and hepatocellular adenomas or carcinomas combined were observed in both males and females (IARC 101 (2012)).

[Reference Data, etc.]
(3) This substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act. Besides, the fact that the IARC had added this substance in Group 2B was the rationale for the designation of this substance as a substance subject to the Guidelines for Carcinogenicity (guidelines in order to prevent the impairment of worker's health, announcement No. 27 on February 7, 2020).
(4) As for classification results by domestic and international organizations, based on (1) and (2), the induction of tumors in experimental animals was judged positive but there was no data available on human carcinogenicity, and therefore, the IARC classified it in Group 2B (IARC 101 (2012)), the ACGIH classified it in A3 (ACGIH (7th, 2010)), and the EU classified it in Carc. 2 (EU CLP Classification Results (Accessed Jan. 2022)).
7 Reproductive toxicity -
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8 Specific target organ toxicity - Single exposure -
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9 Specific target organ toxicity - Repeated exposure -
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10 Aspiration hazard -
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ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) -
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11 Hazardous to the aquatic environment Long term (Chronic) -
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12 Hazardous to the ozone layer -
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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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