Registration Dossier
Registration Dossier
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EC number: 257-077-0 | CAS number: 51240-95-0
Endpoint summary
Administrative data
Description of key information
The registered substance, ±70% in phlegmatizer, was not acutely toxic to rats when tested by the oral gavage route. The oral LD50 is > 5000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. Based on the pattern of use ingestion by humans is unlikely.
An acute toxicity study via the dermal route was not performed with the registered substance since this is scientifically unjustified. Numerous organic peroxides, from different organic peroxide categories defined by chemical structure, have been tested in acute dermal toxicity tests (ca. 35 organic peroxides covering all chemical subgroups/families of organic peroxides (dialkyl peroxides, diacyl peroxides, peroxymonocarbonates, ketine peroxides, peroxydicarbonates and peroxyketals). All these organic peroxides did not show toxic effects at dermal application up to the limit dose of 2000 mg/kg bw result in an acute dermal LD50 >2000 mg/kg bw. A weight of evidence approach is therefore scientifically justified for chemically comparable organic peroxides and allows the conclusion the dermal LD50 would be in excess of 2000 mg/kg bw for the untested organic peroxide.
In this dossier the robust study summaries are included for the closest related substances belonging to the family of peroxyesters. CAS# 26748-41-4, 29240-12-3, 13122-18-4, and 22288-41-1. Also for these four substances the dermal LD50 is >2000 mg/kg bw.
Additional testing for the registered substance is therefore not required and would not be in line with animal welfare legislation.
There are no studies available for the inhalation route. In accordance with column 2 of REACH Annex VIII, the test for acute inhalation toxicity (required in section 8.5) does not need to be conducted. Testing by the inhalation route is not appropriate since exposure of humans via inhalation is not likely taking into account the very low vapour pressure and the pattern of use as this does not lead to the formation of droplets of an inhalable size.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Quality of whole database:
- A K1 study is available.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Multiple K1 studies from other peroxyesters.
Additional information
Justification for selection of acute toxicity – oral endpoint
K1: The study was performed according to OECD guidelines and GLP. LD50 >5000 mg/kg bw, no mortalities occurred.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, the test for acute inhalation toxicity (required in section 8.5) does not need to be conducted. Testing by the inhalation route is not appropriate since exposure of humans via inhalation is not likely taking into account the very low vapour pressure of the substance and the pattern of use does not lead to the formation of droplets of an inhalable size.
Justification for selection of acute toxicity – dermal endpoint
Numerous organic peroxides have been tested in acute dermal toxicity tests (41 organic peroxides covering all chemical subgroups/families of organic peroxides, excluding hydroperoxides). Experimental data of all of these organic peroxides, (except hydroperoxides), show no toxic effects at dermal application up to the tested concentration limit of 2000 mg/kg bw and thus an LD50 >2000 mg/kg bw. Data for the analogues closest to the registered substance are included as WoE in the dossier. A weight of evidence approach is scientifically justified for chemically comparable organic peroxides and allows the conclusion the dermal LD50 would also be >2000 mg/kg bw for the untested organic peroxide. Additional testing for such organic peroxides is therefore not required and would not be in line with animal welfare legislation.
Justification for classification or non-classification
Based on the results of the acute oral toxicity study, and other data available, classification for acute toxicity is not warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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