Abstract

Under the European REACH regulation, chemicals are assessed for persistence as part of weight-of-evidence determinations of persistence, bioaccumulation and toxicity (PBT), as required under Annex XIII and supported by an Integrated Assessment and Testing Strategy (ITS). This study describes the persistence assessment of phenanthrene, a data-rich polycyclic aromatic hydrocarbon (PAH), in accordance with this framework. All available data from screening and simulation tests, for water, soil and sediment compartments, plus other relevant information, have been compiled. These have been evaluated for reliability and relevance, and a weight-of-evidence determination of persistence has been carried out. Aspects relevant to the assessment, such as degradation metabolites, non-extractable residues (NER), test temperature and bioavailability, have also been considered. The resulting assessment considered a wide range of evidence, including 101 experimental data points. Phenanthrene was demonstrated to be readily biodegradable, a first-tier screen for non-persistence in the ITS. Furthermore, weight-of-evidence assessment of data for water, soil and sediment compartments supported a conclusion of “not persistent” (not P). In non-standard soil studies with sludge-amended soils, longer half-lives were observed. This was attributable to pyrogenic sources of and significantly reduced bioavailability of phenanthrene, highlighting the importance of bioavailability as a major source of variability in persistence data. Available simulation test data for the sediment compartment were found to be unreliable due to the anoxic impact of the use of a biodegradable solvent in a closed system, and were inconsistent with the broader weight of evidence. Estimation of photodegradation using AOPWIN and the APEX model demonstrated this to be an important fate process not currently considered in persistence assessments under REACH. The assessment is not in agreement with a recent regulatory decision in which phenanthrene was determined to be very persistent (vP). This assessment provides a case study for persistence assessment using the REACH ITS and highlights the need for improved guidance to improve consistency and predictability of assessments. This is particularly important for complex cases with data-rich chemicals, such as phenanthrene.

Highlights

  • Persistence assessment Characterisation of the risks that anthropogenic chemicals pose to human health and the environment formsHughes et al Environ Sci Eur (2020) 32:148 a fundamental part of chemical management schemes [1]

  • The assessment of persistence in the context of PBT assessment is performed by comparing environmental degradation half-lives to set criteria, which are established both based on science and on the aims of policy [2]

  • The present study provides a critical test of REACH Annex XIII and the European Chemicals Agency (ECHA) Integrated Assessment and Testing Strategy (ITS)

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Summary

Introduction

Persistence assessment Characterisation of the risks that anthropogenic chemicals pose to human health and the environment formsHughes et al Environ Sci Eur (2020) 32:148 a fundamental part of chemical management schemes [1]. As one approach to this effort, focusing on intrinsic hazard properties of substances, the identification and management of the so-called persistent, bioaccumulative and toxic (PBT) chemicals has been a subject of international attention and policy action for several decades [2]. Evaluation, authorisation and restriction of chemicals (REACH) regulation of the European Union, the criteria for persistence are specified for various environmental compartments: marine water halflife > 60 days; fresh/estuarine water half-life > 40 days; marine sediment half-life > 180 days; fresh/estuarine water sediment half-life > 120 days and Soil halflife > 120 days. Article 14 of REACH stipulates that substances manufactured or imported in quantities > 10 tpa must undergo a chemical safety assessment, which includes a PBT and vPvB (very Persistent, very Bioaccumulative) assessment. In the ITS, multiple tiers of testing with increasing complexity are described, ranging from screening tests for ready biodegradability through to higher-tier simulation tests (OECD 307, 308 or 309 guidelines) [10–13]

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