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 |
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 |
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 | - |
- |
- | - | - |
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 | - |
- |
- | - | - |
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. |
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