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Diss Factsheets

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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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

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters family will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly.

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 within the analogue justification in IUCLID Section 13.

The study with the source substance Dipentaerythritol with fatty acids, C5 and C9 iso was performed according to OECD 201 under GLP conditions. 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.