Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The key ecotoxicity values of the registered substance are as follow:

-         Aquatic Invertebrates: 48-h LC50 = 6.343 mg test material/L

-         Aquatic algae: 96-h EC50 = 2.117 mg test material/L

Based on these results, acute EL50 are 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).

Toxicity studies on aquatic organisms performed with the registered substance were not available for annex VII endpoints. However, reliable experimental studies performed on an analogue substance according to OECD 201 and 202 guidelines were available. These studies were performed under GLP conditions using Water Accommodated Fractions, in compliance with the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). In addition, QSAR predictions on benzyl benzoate, the major constituent of the registered substance, were available for ecotox endpoints of annex VII. These QSAR predictions were performed using ECOSAR v 1.11 module from EPISUITE software (US EPA). Results on benzyl benzoate were more conservative than the results from the read-across on the analogue substance. Therefore, toxicity values of benzyl benzoate were selected as key values for the registered substance, as a conservative approach.

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

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: Chronic toxicity data are not available for the registered substance, lowest E(L)C50 between 1 and 10 mg/L, not rapidly degradable substance with log kow of some constituents > 4.