Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Aquatic toxicity data on the test substance, 1,3:2,4 -bis-O-(3,4 -dimethylbenzylidene)-D-glucitol, is based on the results of acute tests. All studies have been conducted under GLP according the EU or OECD guidelines, and were obtained via authorities. Even if they lacked details, they were considered as valid.

As the test substance is insoluble in water, the tests were conducted as limit tests, and their results consistently show that there are no acutely toxic effect on aquatic organisms up to the solubility limit, which varied between the tests in the range 0.05 - 0.08 mg/L (without solvent) and 0.1 mg/L (using dimethylformamide as an auxiliary solvent, increasing the soluble concentration but not affecting the observed acute toxicity). Contrary to the general guidance to select the lowest value as the key study, the studies using solvent and demonstrating the 96 h LC50 value for fish and 48 EC50 value daphnids were indeed above the highest achievable water solubility, 0.1 mg/L of the substance. For algae, 72 h ErC50 was > 0.08 mg/L, the highest achievable water soluble concentration. In conclusion, the results of all the limit tests indicate that the test substance has no acute toxicity to aquatic organisms at concentrations soluble in water. The lowest NOEC on algae, 0.08 mg/L was selected for the PNEC assessment.

The 3h IC50 value on STP microbes was > 1000 mg/L. A 3h NOEC value of 100 mg/L was derived. Details on the concentration are missing (most probably nominal concentration).