Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The key ecotoxicity values of the substance are as follow:

-         Aquatic Invertebrates: 48-h EC50 was 3.32 mg test material/L

-         Freshwater algae: 96-h EC50 was 2.30 mg test material/L (lowest acute E(L)C50)

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, the acute toxicity of the substance to aquatic organisms can be estimated using adequate toxicity data of major constituents. Seven constituents taken from the typical composition provided by the registrant were considered, representing 98.23% of the mixture. The toxicity of these constituents has been predicted using ECOSAR v1.11 from EPISUITE tool.

Then, acute toxicities to aquatic invertebrates (Daphnia magna) and to algae have been determined using the additivity formula hereunder (calculation method), as recommended in the Regulation (EC) No 1272/2008 (CLP).

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

Additivity formula:

∑ 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;

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.