Registration Dossier

Administrative data

acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because skin contact in production and/or use is not likely
the study need not be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
Due to REACH Regulation, Annex VIII, 8.5, the performance of a third acute toxicity test beyond the already tested oral and inhalation route is not mandatory.
Furthermore, it can reasonably be deduced that 2,2,4,4-Tetramethyl-7-oxa-3,20-diazadispiro[]-henicosan-21-one does not exert systemic toxic effects after dermal application and thus does not have to be classified, because the oral LD50 derived for this substance is greater than 2,000 mg/kg bw in female rats. Furthermore the substance does not have to be classified as skin irritating. Due to its molecular structure it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 5,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion