Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Using a calculation method (additivity formula with data on constituents), the key ecotoxicity values of the registered substance are as follow:

-         Aquatic Invertebrates: 48-h EC50 was 1.06 mg test material/L (lowest acute E(L)C50)

-         Freshwater algae: 96-h EC50 was 2.01 mg test material/L

Based on these results, the lowest acute E(L)C50 is higher than 1 mg/L.

Therefore, the registered substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.

Additional information

The registered substance is a Natural Complex Substance (UVCB) with a well-defined composition.

Therefore, it has been decided that the ecotoxicity of the substance will be derived from knowledge of the constituents. The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents.

Short-term toxicity to fish was not provided in the dataset since the tonnage band (1 -10 tonnes/year) does not require that endpoint.

Acute toxicity to aquatic invertebrates (daphnids) and to algae have been determined in a weight of evidence approach (calculation method) using the following additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP):

∑ Ci / L(E)C50m = ∑ (Ci / L(E)C50i)

Where,

Ci = concentration of component i (weight percentage);

L(E)C50i = LC50 or EC50 for component i, in mg/L;

L(E)C50m = L(E)C50 of the part of the mixture with test data.

The individual toxicities (L(E)C50) of each constituent taken into account in the assessment were predicted using ECOSAR v1.11 from EPISuite tool. All the constituents have the same MoA (Neutral organics, baseline toxicity) and they all fall within the applicability domain of the model.

CLP Classification proposal:

It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.

Chronic aquatic hazard: category 2. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 1 and 10 mg/L, rapidly degradable substance but with Log Kow of some constituents > 4.