Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.

Endpoint summary

Description of key information

Studies at three trophic levels are available for hydrolysis products of the substance.

The acute toxicity of the lanolin alcohol to fish (zebra fish) was determined according to the OECD 203. A static limit test was conducted with the nominal concentration 100 mg/L selected on the basis of a preliminary range finding test. In this study lanolin alcohol was not found to be toxic to Zebra fish after 96 h at the nominal concentration 100 mg/L (Scheerbaum 2001).

A study according to OECD 203 was performed to assess the acute toxicity of the lanolin fatty acids to rainbow trout (Oncorhynchus mykiss). The 96-Hour LL50 based on nominal loading rates was greater than 100 mg/l loading rate WAF and correspondingly the No Observed Effect Loading rate was 100 mg/l loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L (Goodband 2010).

In the acute immobilisation test with Daphnia magna (STRAUS) according to OECD 201 the effect of the saturated solution of Lanolin alcohol as limit concentration (0.13 mg DOC / L formulated based on a filtered stock solution at 1000 mg/L) was assessed during 48 hours. No biologically significant effects neither in the tested limit concentration nor in control group were found (Martina 2001).

A study according to OECD 201 was performed to assess the acute toxicity of Lanolin fatty acids to Daphnia magna.  Exposure during 48 hours to a WAF of 100 mg/L loading rate did not lead to any signs of toxicity. No Observed Effect Loading rate was 100 mg/l loading rate WAF (Priestly 2010).

The acute toxicity of Lanolin alcohol to the unicellular freshwater green alga Scenedesmus subspicatus was determined under static conditions over a duration of 72 hours. Exposure concentrations were 0.15, 0.3, 0.6, 1.3 and 2.5 mg/L (as DOC/L) formulated based on a filtered stock solution at 1000 mg/L. No dose-effect-relationship was observed. The EC50-values for inhibition of biomass growth (EbC50 ) and specific growth rate (ErC50) after 72 h were> 2.5 mg DOC/L for both end points (Scheerbaum 2001).

A study according to OECD 201 was performed to assess the effect of the Lanolin fatty acids on the growth of the green alga Desmodesmus subspicatus. The algae were exposed to a WAF at 100 mg/L loading rate during 72 hours. EL50 values were greater than 100 mg/l loading rate WAF. Correspondingly the No Observed Effect Loading Rate was 100 mg/l loading rate WAF (Vrijenhoef 2010).

 

A GLP study according to OECD 211 is available for Lanolin alcohol (Harris 2013). Due to the low aqueous solubility and complex nature of the test item, Water Accommodated Fraction (WAF) were prepared. Based on the results of a preliminary range-finding test, Daphnia magna were exposed (10 replicates of a single daphnid per group) to a Water Accommodated Fraction (WAF) of the test item at single nominal loading rate of 100 mg/L for a period of 21 days. Analysis of the 100 mg/L loading rate WAF on days 0, 5, 14, 16 and 19 (fresh media) showed measured concentrations to range from 0.018 to 0.054 mg/L. A decline in measured concentration was observed in the corresponding old media on days 2, 7, 16, 19 and 21 to between less than the limit of quantification (LOQ) of the analytical method employed, which was determined to be 0.0098 mg/L and 0.017 mg/L. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on the nominal loading rate only. The "No Observed Effect Loading Rate" (NOEL) was 100 mg/L loading rate WAF as there were no significant mortalities (immobilization) observed in the parental generation (P1) and there were no significant differences (P≥0.05) in terms of the number of live young produced per adult when compared to the control after 21 days.

Additional information

The ester of lanolin alcohols and fatty acids is expected to be hydrolysed enzymatically and has been shown to hydrolyse abiotically. Therefore the toxicity of the hydrolysis products lanolin alcohols and lanolin fatty esters is considered representative for the toxicity of the substance.

The available Chironomid study on the structural analogue Fatty acids, C10-30, esters with lanolin alcs. with an EC50 of 15.6 mg/L is considered invalid due to high immobilisation in the solvent control and insufficient validation of the analytical method (Chemex 2018).