Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The key ecotoxicity values are as follow:

-         Fish: study scientifically not necessary

-         Aquatic Invertebrates: 48-h EL50 was > 100 mg test material/L

-         Aquatic algae: 72-h ErL50 was > 1000 mg test material/L

-         Microorganisms: study scientifically not necessary

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).

For annex VII required endpoints, Acute toxicity to aquatic invertebrates (Daphnia magna) has been determined in experimental study on the registered substance using WAFs and performed under GLP compliance in accordance with OECD 202 guideline.

For toxicity to freshwater algae, data on the registered substance was not available. Therefore, in order to assess the toxicity of the registered substance on freshwater algae, the results from an experimental OECD 201 study performed on the analogue substance Labdanum gum have been used. The study was considered reliable for that endpoint and the read-across justification is provided in the dossier.

For annex VIII required endpoints, a study to assess the toxicity of the registered substance to fish was considered scientifically not necessary. Indeed, considering the absence of toxic effects on aquatic invertebrates and algae at tested highest loading rates and the apparent low solubilisation of constituents of the substance, toxicity to fish is not expected. Therefore it was not considered necessary to perform a study on a vertebrate.

Moreover, an ASRIT study was also considered scientifically not necessary, because the registered substance is not toxic to microorganisms. indeed, in the ready biodegradability study performed on the registered substance, the test item was not inhibitory to the aerobic activated sludge microorganisms in the toxicity control (OECD 301F).

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: not classified. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is higher than 100 mg/L.