Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
No toxic effects to aquatic invertebrates up to the limit of water solubility (WS: < 0.05 mg/L; OECD 201).
Key value for chemical safety assessment
Additional information
In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally similar analogue substance dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) was conducted to fulfill the data requirements according to Annex VII-IX of fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) in regard to toxicity to aquatic algae. This read across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the analogue justification in IUCLID Section 13.The substance consists of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5-9 for the target substance compared to C5-9iso for the source substance).
The study with the source substance dipentaerythritol with fatty acids, C5 and C9 iso was performed according to OECD 201 under GLP conditions (Mead and Mullee, 2000). Scenedesmus subspicatuswas exposed to a water accommodated fraction (WAF) with a limit concentration of 100 mg/L. The test substance concentration was analysed using GC-analysis and resulted in a concentration of < 0.18 mg/L (limit of quantification). No inhibition of growth was observed after 72 h. Therefore, this study resulted in an EL50 of > 100 mg/L (nominal). The NOELR was derived to be ≥ 100 mg/L (nominal).
Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5)characterized by a similar ecotoxicological profile and structure, it can be concluded that fatty acids C5-10 esters with dipentaerythritol will not exhibit toxic effects to aquatic algae up to the limit of water solubility. As it can be seen in the data matrix of the analogue justification in section 13 and the overall summary, all reliable data support the hazard assessment of each analogue member by showing a consistent pattern of results, i.e. no toxic effects to algae or other aquatic organisms were observed up to the limit of water solubility.
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