Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Data for a bioaccumulation in aquatic sediments was reviewed. In a bioconcentration study performed according OECD Guideline 305 (Bioconcentration: Flow-through Fish Test), rainbow trout (Oncorhynchus mykiss) were exposed to 14-C SP6012 (oil free) at concentrations of 0.001 and 0.01 mg/L under dynamic conditions. 14-C SP6012 (oil free) was not significantly accumulated in fish tissue and was observed to be eliminated over a 61-day depuration period. The calculated BCF was 45 and 38 at 0.001 mg/L (steady state and kinetic state respectively) and 58 and 64 at 0.01 mg/L (steady state and kinetic state respectively).

This toxicity study is classified as acceptable and satisfies the guideline requirement for a fish bioaccumulation study.

Additional information

The prediction of the BCF was performed with the computer program BCFBAF v3.01 (EPIWIN software) by US-EPA (ATL, 2016x). In general, the bioconcentration factor of a substance describes the accumulation potential of a substance dissolved in water by an aquatic organism. BCFBAF v3.01 calculates also the BAF (Bioaccumulation factor) of the chemical, which is defined as the steady-state (equilibrium) ratio of the substance concentration in an organism to the concentration in the surrounding medium. However, this value is not taken into account for the risk assessment and is not relevant for a registration under REACH Regulation (EC) 1907/2006. Using the regression-based estimate (traditional method) of the computer program BCFBAF from US-EPA a Bioconcentration Factor (BCF) of 70.79 L/kg wet-wt was calculated for the test substance. Using the Arnot-Gobas method, which is based on mechanistic first principles, an aquatic BCF of 2.365 was estimated. The whole body primary biotransformation rate estimate for fish results is an estimated half-life of 15.66 days, whereby the bio half-life is normalized to 10 g fish at 15 °C. With the Arnot-Gobas method it is possible to estimate the upper trophic level. For the upper trophic level, the BCF results in a BCF of 2.365. As conclusion it can be stated, that a strong bioaccumulation in aquatic organisms is unlikely