GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 110-05-4
Chemical Name Di-tert-butyl peroxide
Substance ID R03-C-021-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 FY2008  
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 Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501 		[Rationale for the Classification]
Based on the in vivo micronucleus tests in (1) to (3), it was classified in Category 2. It was classified based on the new information source.

[Evidence Data]
(1) As for in vivo, in a mammalian erythrocyte micronucleus test using the mouse bone marrow cells (OECD TG 474, GLP, 2 intraperitoneal injections (at a 24-hour interval) (500 to 2,000 mg/kg)), clearly positive results were obtained, and in a micronucleus test using the mouse bone marrow cells (equivalent to OECD TG 474, single oral gavage administration (1,250 to 5,000 mg/kg)), weakly positive results were obtained. On the other hand, in a mammalian spermatogonial chromosome aberration test (OECD TG 483, GLP, 2 intraperitoneal injections (at a 24-hour interval), up to 2,000 mg/kg) with mice, negative results were obtained (REACH registration dossier (Accessed Oct. 2021), AICIS IMAP (2018), CLH Report (2014)). In addition, in a mammalian erythrocyte micronucleus test using the rat bone marrow cells after 90-day inhalation exposures (65 times) (OECD TG 474, GLP, inhalation (vapor) up to 1,000 mg/m3) and in an in vivo mammalian alkaline comet assay for the nasal tissues of rats after 3-day inhalation exposure (OECD TG 489, GLP, inhalation (vapor) up to 30 ppm), negative results were obtained (REACH registration dossier (Accessed Oct. 2021), AICIS IMAP (2018)).
(2) As for in vitro, negative results were obtained in multiple bacterial reverse mutation assays, and a gene mutation assay using the L5178Y mouse lymphoma cell line (REACH registration dossier (Accessed Oct. 2021), AICIS IMAP (2018), CLH Report (2009)).
(3) In the EU, since this substance was positive in an in vivo micronucleus test using the mouse bone marrow cells and it was negative in a chromosomal aberration test using the mouse spermatogonial cells, it was classified in Category 3 in the previous classification code (Muta. 2 in the current CLP classification) (ECHA RAC Opinion (2010)).
6 Carcinogenicity -
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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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