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Environmental fate & pathways

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Assessment of Stability with regards to hydrolysis is waived.

Testing was not carried out according to Method C7 of Commission Directive 92/69/EEC and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 because, in accordance with column 2, adaptation of Annex VIII (section "the study does not need to be conducted if the substance is highly insoluble in water (< 1 mg/l) The test material has a very low water solubility value (0.21mg/l).

The biodegradation of lanolin alcohols is also asseseed.

The test material attained 39 % degradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No 301B.

The 10 % level (beginning of biodegradation) was reached after a adaptation period of 9 days. In the 10 -day-window the mean biodegradation came only to 21 %. The pass level of a biodegradation > 60 % was not reached either in the 10 -day-window or after 28 days.

It is not possible to determine the partition coefficient of the test material by Method A8 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) due to poor solubility and complex nature of the substance (UVCB).

The partition coefficient was, however, estimated by a WSKOW (v1.41); Estimation Programs Interface Suite™ for Microsoft® Windows, v 4.00. United States Environmental Protection Agency.

The partition coefficient calculated for three main components of the test material was found to be > 6.73 (i.e.cholesterol log10Pow = 8.7386; Lanosta-8,24 -dien-3 -ol (lanosterol) log10 Pow = 10.7918 and 1 -Hexadecanol was log10 Pow = 6.73).

Based on the above factors, the substance may cause long-term adverse effects on the aquatic environment.

However, lanolin alcohols contain approximately 30% cholesterol and significant fraction of structure-related substances. Cholesterol is widely distributed in animal organisms. Thus differently to organic xenobiotics, Cholesterol is integrated into metabolic processes and actively regulated in most animals.

A dietary study on Cholesterol is available, revealing a complex uptake and adsorption kinetic in fish. The study evaluation is currently ongoing and results will be integrated in an update dossier as soon as the assessment is finalised.