Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The following endpoints were assessed.

Short-term toxicity to fish.A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Results.The 96-Hour LL*50based 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.

Samples of the control and 100 mg/l loading rate WAF were taken at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) for Total Organic Carbon (TOC) analysis. Given the background level of carbon in the control vessels and also the low level of carbon in the test vessels, it was considered that the results gave no evidence of the presence of test item in the WAF.

Therefore, given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, and the dissolved test item was close to or below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.


*LL = Lethal Loading rate

Short-term toxicity to aquatic invertebrates.A study was performed to assess the acute toxicity of the test item toDaphnia magna.  The method followed that described in the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphniasp, Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.

Results.The 48-Hour EL*50for the test item toDaphnia magnabased 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.

Samples of the control and 100 mg/l loading rate WAFs were taken at 0 (fresh media) and 48 hours (old media) for Total Organic Carbon (TOC) analysis. Given the background level of carbon in the control vessels and also the low level of carbon in the test vessels, it was considered that the results gave no evidence of the presence of test item in the WAF.

Therefore, given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, and the dissolved test item was below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.

The 48-Hour EC50for the reference item (potassium dichromate) toDaphnia magnabased on nominal concentrations was 0.65 mg/l with 95% confidence limits of 0.58 – 0.72 mg/l. The No Observed Effect Concentration was 0.32 mg/l.


*EL = Effective Loading rate

Short-term toxicity to aquatic algae and cyanobacteria.A study was performed to assess the effect of the test item on the growth of the green alga Desmodesmus subspicatus. The method followed that described in the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) 440/2008.

Results.Exposure of Desmodesmus subspicatus to the test item gave EL*50 values of 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.

Total Organic Carbon (TOC) analysis of the test preparations was performed at 0 and 72 hours. Given the background level of carbon in the control vessels and also the low level of carbon in the test vessels, it was considered that the results gave no evidence of the presence of test item in the WAF.

Therefore, given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, and the dissolved test item was below the quantifiable limit of the analytical method, the results were based on nominal loading rates only.

The effect of the test item on the growth of Desmodesmus subspicatus has been investigated and gave EL*50 values of greater than 100 mg/l loading rate WAF. Correspondingly the No Observed Effect Loading Rate was 100 mg/l loading rate WAF.

* EL =Effective Loading Rate

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/EECwas not conducted.

In accordance with column 2, adaptation of Annex VIII (section 9.1.4) Column 2 Adaptation:" 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, or the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can beexpected in the influent of a sewage treatment plant. The Lanolin Fatty acids are rapidly biodegradable and highly insoluble in water (0.21 mg/l).

Long-term toxicity studies to aquatic microorganisms (Daphnia) and Fish

In acordance with Column 2 Adaptation of REACH Annex X (section 9.4) the studies do not need to be conducted if direct and indirect exposure of the aquatic compartment is unlikely. As the substance is rapidly biodegradable direct or indirect exposureto aquatic environmentis unlikely, therefore the long-term toxicity studies to aquatic invertebrates (Daphnia) and to fish are waived.

Conclusion on classification

The substance is not classified as 'dangerous' or 'hazardous' to the environment according to the Dangerous Substance Directive (67/548/EEC) or CLP Regulation (EC) No 1272/2008 according to the following:

The substance was found to be non-toxic to fish, Daphnia and algae at the level of water solubility in studies conducted to OECD guidelines.

Furthermore, it has a low water solubility (<1mg/L), is rapidly biodegradable and has a Pow of >6.5.