Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The 2 aquatic acute toxicity test performed on algae and daphnia were done in 2008, in a non GLP study.

In the past, based on the previous analysis, the solubility value of the test item was 14 mg/l. The studies were therefore carried out using a stock solution made of 14 mg of substance into ultra-pur water, without filtration. No stirring of the solution is mentionned.

No analytical measurements of the test solution was performed.

The new hydrosolubility study, performed according to a more sensitive and accurate method, demonstrates that the substance is not soluble in water (worst case solubility of 0.00175 mg/l).

The purpose of an aquatic toxicity study is to evaluate the toxicity of a substance effectively dissolved in the test medium. Insoluble substances are identified as being difficult-to-test substances which require modification of the standard testing procedures.

As an example, the tests should be conducted only up to the maximum dissolved concentration and the presence of undissolved particles should be avoid.

In the acute test with daphnia, since no filtration were performed, undissolved substance in the test media may potentially have adverse physical effects on the test organisms which should be distinguished from the intrinsic toxicity of the substance.

In the acute test with algae, also performed at concentrations above the limit of solubility (12.6 mg/L), no toxicity (intrinsic or physical) was observed.

Further information are needed to evaluate the intrinsic aquatic toxicity of the substance.

Additional information