Comparison of species sensitivity distribution modeling approaches for environmental risk assessment of nanomaterials - A case study for silver and titanium dioxide representative materials

Abstract

Species sensitivity distributions (SSDs) are used in chemical safety assessments to derive predicted-no-effect-concentrations (PNECs) for substances with a sufficient amount of relevant and reliable ecotoxicity data available. For engineered nanomaterials (ENMs), ecotoxicity data are often compromised by poor reproducibility and the lack of nano-specific characterization needed describe an ENM under test exposure conditions. This may influence the outcome of SSD modelling and hence the regulatory decision-making. This study investigates how the outcome of SSD modelling is influenced by: 1) Selecting input data based on the nano-specific "nanoCRED" reliability criteria, 2) Direct SSD modelling avoiding extrapolation of data by including long-term/chronic NOECs only, and 3) Weighting data according to their nano-specific quality, the number of data available for each species, and the trophic level abundance in the ecosystem. Endpoints from freshwater ecotoxicity studies were collected for the representative nanomaterials NM-300 K (silver) and NM-105 (titanium dioxide), evaluated for regulatory reliability and scored according to the level of nano-specific characterization conducted. The compiled datasets are unique in exclusively dealing with representative ENMs showing minimal batch-to-batch variation. The majority of studies were evaluated as regulatory reliable, while the degree of nano-specific characterization varied greatly. The datasets for NM-300 K and NM-105 were used as input to the nano-weighted n-SSWD model, the probabilistic PSSD+, and the conventional SSD Generator by the US EPA. The conventional SSD generally yielded the most conservative, but least precise HC₅ values, with 95 % confidence intervals up to 100-fold wider than the other models. The inclusion of regulatory reliable data only, had little effect on the HC₅ generated by the conventional SSD and the PSSD+, whereas the n-SSWD estimated different HC₅ values based on data segregated according to reliability, especially for NM-105. The n-SSWD weighting of data significantly affected the estimated HC₅ values, however in different ways for the sub-datasets of NM-300 K and NM-105. For NM-300 K, the inclusion of NOECs only in the weighted n-SSWD yielded the most conservative HC₅ of all datasets and models (a HC₅ based on NOECs only could not be estimated for NM-105, due to limited number of data). Overall, the estimated HC₅ values of all models are within a relatively limited concentration range of 25-100 ng Ag/L for NM-300 K and 1-15 μgTiO₂/L for NM-105.

Keywords: Data weighting; Nanoecotoxicology; PNEC; Regulatory reliability; Risk assessment.