Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Based on read-across from experimental GLP studies performed on the analogue substance "Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by hexane extraction", the key ecotoxicity values of the registered substance are as follow:

-         Aquatic Invertebrates: 48-h EL50 > 100 mg test material/L (nominal loading rate)

-         Aquatic algae: 72-h ErL50 > 100 mg test material/L (nominal loading rate)

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 Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by ethanol extraction is a Natural Complex Substance (UVCB).

Toxicity studies on aquatic organisms for the registered substance were not available for annex VII endpoints. However, experimental studies performed on an analogue substance (Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by hexane extraction) in order to assess its 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 the related 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. The read-across justification can be found in the relevant iuclid study records.

In the dataset, short-term toxicity to fish was not provided 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 and the lowest acute E(L)C50 > 100 mg/L.