Alcohols, lanolin

Ecotoxicological Summary

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Testing was carried out on the following endpoints using the following guidelines:

Short-term toxicity to fish: The acute toxicity of the test item Wollwachsalkolhol/ lanolinalkohol to fish (zebra fish) was determined according to the OECD-Guideline for Testing of Chemicals No. 203 (1992) from 14 marhc 2001 to 18 March 2001 at DR.U.Noack Laboratorium Für Angewandte Biologie, 31157 Sarstedt, Germany.

Short-term toxicity to aquatic invertebrates- OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp, Acute Immobilisation Test" referenced as Method C.2 of Commission Directive 92/69/(which constitutes Annex V of Council Directive 67/548/).

Short-term toxicity to aquatic algae and cyanobacteria -The acute toxicity of Wollwachsalkohol/lanolinalkohol (batch number 6480) to the unicellular freshwater green alga Scenedesmus subspicatus was determined according to the principles of OECD- Guideline 201, at DR.U.NOACK-lABORATORIUM FÜR ANGEWANDTE BIOLOGIE in 31157 Sarstedt, Germany from June 12 to 15, 2001.

Short-term toxicity to microorganisms -OECD Guidelines for Testing of Chemicals (1984) No 209 "Activated Sludge, Respiration Inhibition Test", Method C.11 of EEC Commission Directive 88/302/EEC and US EPA Draft Ecological Effects Test Guidelines OPPTS 850.6800.

Long term toxicity to aquatic organisms - The chronic toxicity of Lanolin alcohols towards Daphnia magna was determined according to OECD 211 by Harlan Laboratories, Derbyshere, UK.

The results are as follows:

Short-term toxicity to fish

A static limit test was conducted with the nominal concentration 100 mg/L selected on the basis of a preliminary range finding test. Duration of the test was 96 h. 7 test organisms were exposed to the test concentration and the control. The test item concentration showed turbidity and homogeneous distribution throughout the test. All effect values are based on the nominal concentration of the test item. No concentration control analysis was carried out.

On the basis of the observations made during the test, the NOEC was determined at a concentration of 100 mg/L (nominal concentration) for the test item Wollwachsalkohol/Lanolinalkohol.

Short-term toxicity to aquatic invertebrates

The test item was clearly dissolved at the limit concentration.The study was conducted under static conditions over a duration of 48 hours. 20 test organisms were exposed to the limit test concentration and control.

In the tested limit concentration (0.13 mg DOC/L) there is no biologically significant effect neither in the tested limit concentration nor in control group.

Short-term toxicity to aquatic algae and cyanobacteria

In this study Wollwachsalkohol/lanolinalkohol caused only minor effects on the freshwater green alga Scenedesmus subspicatus when tested up to the saturated aqueous solution. No dose-effect-relationship was observed. The EC₅₀-values for inhibition of biomass growth (E_bC₅₀) and specific growth rate (E_rC₅₀) after 72 h were > 2.5 mg DOC/L for both end points.

Short-term toxicity to microorganisms

The Short-term toxicity to microorganisms according to OECD Guidelines for Testing of Chemicals (1984) No 209 "Activated Sludge, Respiration Inhibition Test", Method C.11 of EEC Commission Directive 88/302/EEC was not conducted.

In accordance with column 2, adaptation of Annex VIII (section 9.1.4) "the study does not need to be conducted if there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water.

Long term toxicity to Daphnia magna

A GLP study according to OECD 211 is available for Lanolin alcohols (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.

Conclusion on classification

The substance is not classified as regards ecotoxicological endpoints. It was found to be non-toxic to fish, aquatic invertebrates and algae and also activated sludge in studies conducted to OECD guidelines.

The substance has a low water solubility. The substance is not readily biodegradable (when classified according to the Dangerous Preparations Directive 99/45/EEC) and has an estimated Log Pow of > 6.5.

However, Lanolin alcohols contain approximately 30% cholesterol and significant fraction of structure-related substances. Cholesterol is widely distributed in animal organisms and may be eliminated from the body via faeces, urine and skin surface. Further, cholesterol may be metabolised to bile acids, steroid hormones and vitamin D3.

Therefore, basing on the available published literature there is abundant evidence that the main components of lanolin alcohols such as cholesterol are readily metabolised in the organism.