2020
DOI: 10.1186/s12302-020-00369-8
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Environmental hazard testing of nanobiomaterials

Abstract: The European Medicines Agency (EMA) regards the potential risks of human medicinal products to the environment and their impacts are assessed, as well as management to limit this impact. Hazard assessment of novel materials, which differ from conventional chemicals, e.g. nanobiomaterials, poses testing challenges and represents a work-in-progress with much focus on the optimization of required methodologies. For this work-in-progress, we here highlight where changes/updates are required in relation to the main… Show more

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Cited by 16 publications
(10 citation statements)
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“…An important aspect to consider is the suitability of current guidelines to assess the hazard of NPls. As discussed in Amorim et al [43] alternatives for highly durable materials, like plastics, can be studied using i) longer exposure durations and ii) after prior ageing and weathering of materials. These concerns have common aspects with the existing for PBTs (persistent, bioaccumulative and toxic) and vPvBs (very persistent and very bioaccumulative) compounds.…”
Section: Discussionmentioning
confidence: 99%
“…An important aspect to consider is the suitability of current guidelines to assess the hazard of NPls. As discussed in Amorim et al [43] alternatives for highly durable materials, like plastics, can be studied using i) longer exposure durations and ii) after prior ageing and weathering of materials. These concerns have common aspects with the existing for PBTs (persistent, bioaccumulative and toxic) and vPvBs (very persistent and very bioaccumulative) compounds.…”
Section: Discussionmentioning
confidence: 99%
“…The use of several soil organisms is recommended for ecotoxicological models for the risk assessment of chemicals. While adaptations have been proposed for engineered nanomaterials, including some specific applications such as nanobiomaterials [ 102 , 103 , 104 , 105 ], there is no specific standardized methodology to study the toxicity of nanopesticides. The model organisms currently employed in the risk assessment of chemicals include annelids (e.g., Enchytraeus crypticus [ 106 ] and Eisenia fetida [ 107 ]), nematodes (e.g., Caenorhabditis elegans [ 98 ]), and arthropods (e.g., Acanthoscelides obtectus [ 70 ], Folsomia candida [ 108 ], and Hypoaspis aculeifer ).…”
Section: Discussionmentioning
confidence: 99%
“…Although, for FOS, PECs did not cause toxic effects to the tested organisms, for other pesticides, the effects may be detected at environmentally relevant concentrations. Another important aspect is that the toxicity tests should consider longer exposure periods than the ones recommended by the guidelines [59]. In the environment, pesticides (and their metabolites and transformation products) may persist for long periods of time and the organisms may be continuously exposed [57].…”
Section: Integration Of Knowledge For Risk Assessmentmentioning
confidence: 99%