Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Bioaccumulation: aquatic / sediment

The bioconcentration factor (BCF) of the test substance was determined by three different QSAR model tools, which are scientifically accepted calculation methods and can therefore be assigned with reliability 2 (reliable with restrictions). No GLP criteria are applicable for the usage of these tools, but the predictions can be used for the chemical safety assessment.

Using the regression-based estimate (traditional method) BCFBAF v3.01 (EPIWIN software) a Bioconcentration Factor (BCF) of 105.5 L/kg wet-wt was calculated for the test substance. Using the less relevant Arnot-Gobas method, which is based on mechanistic first principles, an aquatic BCF of 1.77E+4 L/kg wet-wt is the result.

The CAESAR QSAR model version 1.0.0.11 predicted a BCF of 143 L/kg body weight. This value is also predicted by the VEGA BCF model, which is based on the same principles as CAESAR.

However, based on weight of evidence bioaccumulation is expected to be below the criterion of concern.

Bioaccumulation: terrestrial

Data on terrestrial bioaccumulation are not considered to be required for the substance. In accordance with REACH legislation the test does not need to be conducted if direct and indirect exposure to the terrestrial compartment is unlikely. In addition, the results of the CSR for this substance and the PEC/PNEC ratios for the local and regional terrestrial compartment indicate no risk. ECHA REACH Chapter R.7B guidance states that if the PEC/PNEC ratio is below 1, then no risk for the compartment is indicated and there is no need to perform further tests. Furthermore, this substance does not meet the B or vB criterion and it is not considered to be a PBT.