NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	110-05-4
Chemical Name	di-tert-butyl peroxide
Substance ID	m-nite-110-05-4_v2
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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Since its flash point of 18.3degC (Chemical Risk Information Platform (CHRIP), accessed in October 2008) is below 23degC, and its initial boiling point of 109-111degC (Chapman Ver. 16.2, 2008) is above 35degC, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	It is classified as organic peroxide.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified	- -	-	-	Its autoignition point at 230degC (Chemical Risk Information Platform (CHRIP), accessed in October 2008) is above 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Classification not possible	- -	-	-	Organic compounds containing oxygen (but not fluorine or chlorine), which forms an O-O bond. Due to lack of additional information, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Type E	Warning	H242	P370+P378 P210 P234 P235 P240 P280 P403 P410 P411 P420 P501	Since it is rated as UNRTDG 5.2, UN 3107, it falls under type E.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	- -	-	-	Since its rat LD50 is > 25000 mg/kg (DFGOT vol. 3 (1992)), the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Since its mouse LD50 is > 10000 mg/kg (PATTY (5th, 2001), the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	Base on its LC50 of > 4103 ppm (> 24.5 mg/L) documented in 4-hour inhalation using rats (DFGOT vol. 3 (1992)), the substance was classified into the "Not classified" category. Since its saturated vapour concentration is 197 mg/L at 25degC, the study was presumably conducted in a vaporous state.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Since rabbit tests found that the substance is not irritating (DFGOT vol. 3 (1992)), it was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	Since rabbit tests found that the substance is not irritating (DFGOT vol. 3 (1992)), it was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Classification not possible	- -	-	-	In mouse tests (administration route not provided), which was continued for more than 19 months, malignant lymphomas were found in 7 animals and pulmonary adenomas were detected in 1 animal out of 35 treated animals (HSDB (2003)). Without other study results, classification is not possible due to insufficient data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	- -	-	-	Since its 96-hour LC50 is > 1000 mg/L for fish (guppies) (IUCLID 2000), the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Its classification for acute toxicity is the "Not classified" category and its potential for bioaccumulation is presumably low (LogPow = 3.45 (PHYSPROP Database 2008)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.
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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