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Ecotoxicological information

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No experimental data investigating the aquatic toxicity of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acidare available. In order to fulfil the standard information requirements in compliance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, a read across was conducted to evaluate the toxicity of the target substance to fish (short-term), daphnia (short and long-term), algae and microorganism. Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are considered suitable representatives for the assessment of the aquatic toxicity of the target substance. A detailed analogue approach justification is provided in the technical dossier (please refer to IUCLID Section 13).

All experimental studies available for the target and the source substances were performed according to internationally accepted guidelines. They cover all three trophic levels of an aquatic ecosystem.Due to the low water solubility of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid (WS < 0.15 mg/L at 20 °C), all aquatic toxicity tests were performed using water accommodated fractions (WAFs) of the substance. 

For short-term toxicity to fish,a read-across to the structurally related source substances Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5), 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) and Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) was conducted.All studies were performed in a limit test design according to OECD 203 (GLP).No mortality and no behavioural abnormalities were observed in any of the studies. Hence an LL50 (96 h) of > 100 mg/L (nominal loading rate) was determined.

For short-term toxicity to aquatic invertebrates,a read-across to the structurally related source substances Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) and 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was conducted. Both studies were performed in a static test design according to OECD 202 (GLP). No immobility was observed. Hence, an EL50 (48 h) of > 100 mg/L was determined for Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5). An EL50 (48 h) of >1000 mg/L (nominal loading rate) was determined for 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7).

For long-term toxicity to aquatic invertebrates,a read-across to the structurally related source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) was conducted. The study was performed in a semi-static limit test design according to OECD 211 (GLP). No immobility and no sub-lethal effects were observed after an exposure period of 21 days. Hence a NOELR of ≥ 1 mg/L (nominal loading rate) was determined.

For toxicity to algae,a read-across to the structurally related source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was conducted. The study was performedaccording to OECD 201 and EU Method C.3 (GLP). No effects on growth rate or biomass were observed after an exposure period of 72 h. Hence an EL50 (72 h) of > 100 mg/L and a NOELR of ≥ 100 mg/L (nominal loading rate) was determined.

The toxicity to microorganisms was assessed using the toxicity control of the biodegradation test (OECD 301B) for Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid. The toxicity control of the biodegradation study attained 85.5% degradation after 14 days of incubation. Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and a NOEC (14 d) of ≥ 23.2 mg/L was derived.

Based on the results for the structurally related read-across substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that no toxicity ofFatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acidto fish, aquatic invertebrates and algae is expected up to the limit of the water solubility (< 0.15 mg/L). Furthermore, the substance is expected to be non-inhibitory to microorganisms.

No toxicity of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acidis expected below the limit of water solubility (WS < 0.15 mg/L). Thus, the substance is not considered hazardous to the aquatic ecosystem.