Are current regulatory log Kow cut-off values fit-for-purpose as a screening tool for bioaccumulation potential in aquatic organisms?

Abstract

Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) are regulatory hazard categories that have been set to manage the possible risks to humans and the environment from these chemicals. In industrial chemicals regulations, their aquatic Bioaccumulation potential is usually assessed first with a screening based on the octanol/water partition coefficient (K_ow). However, current log K_ow cut-off values triggering classification, categorisation and/or further fish bioconcentration testing are not harmonised worldwide, and they have never been assessed for their regulatory relevance. In this study, the experimentally determined log K_ow and fish bioconcentration factors (BCF) of 532 chemicals were compared. While the analysis underlined the robustness of using log K_ow as a screening tool (5/532 were false negatives; log Kow: non-bioaccumulative, but BCF: bioaccumulative), it also demonstrated the conservatism of the cut-offs used worldwide. Indeed, many chemicals were deemed potentially Bioaccumulative based on log K_ow when a fish bioaccumulation test showed no concern (false positives), therefore, leading to unnecessary use of vertebrate animals. Our analysis shows that the log Kow cut-off could be increased to 4.5 in all regions for all purposes without leading to a reduced protection of humans and the environment.

Keywords: Bioaccumulation; Harmonisation; Log K(ow); Regulatory cut-off; Vertebrate testing reduction; max 10).