Registration Dossier

Administrative data

fish early-life stage toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
Justification for type of information:
The substance has negligible water solubiltiy (~0.72 ug/L), adsorbs to surfaces, is not expected to partition to water, and is challenging to analyze. Because of these properties, stable and quantifiable water concentrations could not be measured for performance of the aquatic acute studies. Thus, the WAF methodology was used, and DBDPEthane was found not to be acutely toxic to fish, algae or daphnia at load levels of 110 mg/L. Chronic studies in aquatic organisms would face similar analytical challenges. The inability to generate and quantify stable aqueous concentrations, the minimal expected distribution of the substance to water in the environment (see section on Environmental Fate), and limited bioavailability of the substance indicate chronic toxicity in aquatic organisms is not expected. Bioavailablity could not be demonstrated in a rat study using 14C-EBP. A lack of toxicity was observed in an 8-wk fish bioconcentration study (Test article was added to water with the assistance of a dispersant, and measurement was via non-specific methods. This is not the preferred approach today). Similarikly in the recently performed dietary bioconcentration study according to OECD TG 305 with a prolonged uptake phase of 56 days, negligible uptake of the substance from the diet to fish was demonstrated, confirming the limited bioavailability in fish. No signs of toxicity were observed in this study at 100 and 1000 micro-g test substance per kg food. The substance is expected to partition to sediments, and chronic testing in 2 sediment-dwelling organisms has been performed (see section on sediment-dwelling organisms). Toxicity was not observed in sediment organisms.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion