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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	80-43-3
Chemical Name	Bis(1-methyl-1-phenylethyl) peroxide
Substance ID	R03-C-027-MHLW, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
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	-	- -	-	-	-
2	Flammable gases	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-
17	Desensitized explosives	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	-	- -	-	-	-
5	Germ cell mutagenicity	-	- -	-	-	-
6	Carcinogenicity	-	- -	-	-	-
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), the view of the RAC of the ECHA (Committee for Risk Assessment of the European Chemical Agency) was supported, and this substance was classified in Category 1B. It was classified based on the new information source. [Evidence Data] (1) In a developmental toxicity study with female rats dosed by gavage (days 5 to 19 of gestation), an increase in post-implantation embryonic/fetal death, lower fetal weight, and increases in the incidences of external malformations (mal-rotated fore- and hindlimbs) and skeletal malformations (short and/or bent scapula, clavicula, humerus, radius, and ulna) were observed in a group treated with a high dose (450 mg/kg/day) at which death (1/24 animals), clinical signs (such as salivation, piloerection), and decreases in food consumption and body weight gain were observed in dams. It was reported that, also in a group treated with a middle dose (150 mg/kg/day), salivation, and decreases in food consumption and body weight gain were observed in dams, and skeletal malformations (short and/or bent scapula) were observed in fetuses (CLH Report (2014), ECHA RAC (Background Doc.) (2015), REACH registration dossier (Accessed Oct. 2021)). (2) It was reported that the Committee for Risk Assessment of the European Chemical Agency (ECHA RAC) studied the status of fetal death from dams on an individual basis in a high-dose group in (1), and as a result, a total of 20/65 intrauterine deaths were observed in 5 dams with no abnormalities in clinical signs or necropsy findings, which suggested that post-implantation loss and increased intrauterine mortality were not necessarily related to maternal toxicity (ECHA RAC (2015)). (3) Based on the results in (1), the proposers proposed a reproduction classification of Category 2 for this substance, but the RAC of the ECHA expressed the view that Repr. 1B was appropriate, emphasizing an increase in intrauterine death and increased skeletal malformations based on (2) and (1) in which skeletal malformations were observed from the middle dose at which maternal toxicity was not severe (ECHA RAC (2015)). [Reference Data, etc.] (4) In a screening assessment in Canada, LOAEL/NOAEL was judged to be 450/150 mg/kg/day both for maternal toxicity and developmental effects on fetuses because, based on (1), an increase in post-implantation loss, and increased skeletal malformations were observed in fetuses in a group treated with the highest dose (450 mg/kg/day) at which maternal toxicity was apparent (Canada CMP Screening Assessment (2019)). (5) In the EU CLP classification (Accessed Oct. 2021), it was classified as Repr. 1B.
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	-	- -	-	-	-
10	Aspiration hazard	-	- -	-	-	-

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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.262 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1984)) and 21-day NOEC = 0.117 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), EU REACH CoRAP, 2014, SIAP, 2012). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified in Category 1 due to being not rapidly degradable and 96-hour LC50 = 0.469 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)). By drawing a comparison between the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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