Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Based on read-across from experimental GLP studies performed on analogue substances, the key ecotoxicity values of the registered substance are as follow:

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

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

Based on these results, the 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 for the registered substance were not available for annex VII endpoints. However, two experimental studies performed on analogue substances (Cistus concrete and Labdanum gum) in order to assess the toxicity to aquatic invertebrates and to freshwater algae were available. These studies were performed under GLP conditions using Water Accommodated Fractions, in compliance with OECD 201 and 202 guidelines, as well as the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). In addition, these studies have been reviewed and were considered reliable. Indeed, they respected the requirements of both guidelines and the respective validity criteria were fulfilled.

Therefore, it has been decided to use the results from these two studies for the registered substance. Full read-across justifications can be found in the related iuclid study records.

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