Registration Dossier
Registration Dossier
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EC number: 244-894-2 | CAS number: 22288-43-3
Endpoint summary
Administrative data
Description of key information
The oral LD50 is > 2000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There are no studies available for the inhalation or the dermal route.
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 study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The registered substance was not acutely toxic to rats when tested by the oral gavage route. Based on the pattern of use ingestion by humans is unlikely.
An acute toxicity study via the dermal route was not performed since this is scientifically unjustified, for details see above. A weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 2000 mg/kg bw for the untested organic peroxide.
An acute toxicity study via the inhalation route was not performed and can be waived according to REACH Annex VIII since exposure via this route is unlikely.
Justification for selection of acute toxicity – oral endpoint
K1:The study is performed according to OECD guidelines and GLP. LD50 >2000 mg/kg bw, no mortalities occured.
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 vapour pressure of the substance and/or the possibility of exposure to droplets of an inhalable size. The vapour pressure is very low (see section 4.6) 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 show for this reason an acute dermal toxicity of >2000 mg/kg bw. Therefore, a weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 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, the data is conclusive but not sufficient for classification.
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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