Registration Dossier
Registration Dossier
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EC number: 411-930-5 | CAS number: 106917-31-1 SANDUVOR 3058; SANDUVOR 3058 LIQ.
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Due to REACH Regulation, Annex VIII the performance of a third acute toxicity test beyond the already tested oral and inhalation route is not mandatory. It can reasonably be deduced that Hostavin 3058 does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of 3,000 mg/kg bw in rats. Furthermore the substance does not have to be classified as eye irritating. Due 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 3,000 mg/kg bw/d) will be systemically available via the intact skin. Furthermore, the LC50 of an acute inhalation toxicity study was greater than 2.61 mg/L. Therefore, testing is not scientifically necessary.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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