Alcohols, lanolin

Endpoint summary

Additional information

The following short-term toxicity endpoints were assessed.

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 fish

No studies on the chronic toxicity to fish are available for Lanolin alcohols. Nevertheless, the acute aquatic toxicity tests of this test substance on fish and Daphnia showed no effects occurred in the range of water solubility. Furthermore, only negligible releases into surface waters from sewage treatment plants are expected to take place due the high adsorption and low water solubility of this substance, resulting in an effective removal in sewage treatment plants. Therefore chronic exposure of aquatic organisms is expected to be very low. In addition, the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7b (ECHA, 2012b) states that “chronic fish toxicity testing is generally only necessary, when the P and B criteria are fulfilled” and this is clearly not the case. Furthermore, there was no sign that invertebrates are less sensitive than fish in the short-term tests. Thus, it cannot be expected that a long-term test with fish will generate different results than the existing long-term tests with aquatic invertebrates.

Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish is required for Lanolin alcohols.

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.