Application of Biotests for the Determination of Soil Ecotoxicity after Exposure to Biodegradable Plastics

Biodegradable plastics are mostly applied in packaging materials (e.g., shopping bags), waste collection bags, catering products, and agricultural applications. In this last case, degradation takes place directly in soil where biodegradable plastic products are intentionally left after use (e.g., mulch films for weeds control). Due to the growing volumes of biodegradable polymers and plastics, interest in their environmental safety is increasing and more research is carried out. Some attempt has been made to apply biotests, used in other sectors of environmental sciences, in the assessment of biodegradable plastics safety. In this work, the quality of soils after biodegradation of the bioplastics Mater-Bi has been assessed with a large array of biotests based on model organisms representative of the different trophic levels in the food chains of the edaphic and aquatic ecosystems. Mater-Bi was degraded under controlled conditions for 6 months at a 1% concentration. The selected organisms included bacteria and protozoa (Vibrio fischeri and Dictyostelium discoideum, respectively), the green alga Pseudokirchneriella subcapitata, plants (the monocotyledon Sorghum saccharatum and the dicotyledon Lepidium sativum), and invertebrates animals (Daphnia magna, a freshwater crustacean, and the Oligochaeta earthworm Eisenia andrei), using both acute and chronic endpoints. The results of the applied ecotoxicological tests showed that the Mater-Bi materials tested at very high doses did not affect the soil quality. Soil exposed to Mater-Bi has no noxious effects on edaphic organisms; in particular, mono and dicotyledon plants results, indicate that Mater-Bi plastic products are innocuous for agricultural uses. The use of more sensitive chronic endpoints allows to exclude possible effects at population level. This is the first time that such a comprehensive approach is applied to the assessment of possible ecotoxicity effects induced by biodegradable plastics in soil and represents a possible starting point for improved standardized testing schemes

Heading towards 100% of renewable energy sources fraction. A critical overview on smart energy systems planning and flexibility measures

The growing penetration of non-programmable energy sources will largely contribute to intensify the renewable capacity firming issues. Providing a higher systems flexibility, i.e. the ability to match the supply and the demand sides as much as possible, is the main challenge to cope with, by adopting new energy planning paradigms. In this framework, different combined strategies, aiming at efficiently integrating that large amount of variable RES (VRES), have to be implemented. In the recent years, the Smart Energy Systems (SES) concept has been introduced to overcome the single-sector approach, promoting a holistic and integrated vision. By that approach, it is possible to exploit synergies between different energy sectors so as to identify the best technical options to globally reduce the primary fossil energy consumption. Starting from a quantitative and qualitative analysis of the most recent international studies dealing with the SES approach, the aim of this paper is to critically review and analyse the role of the main potential flexibility measures applied in the energy planning sector. In detail, Power-to-X and Demand Side Management (DSM) application have been considered, highlighting strengths and weaknesses of such strategies to accomplish the ambitious target of 100% renewable. From this literature review, it emerges how a single strategy adoption is not enough to guarantee the required flexibility level for the whole energy system. Indeed, the best configuration can be attained by integrating different options matching all the external constraints

Adsorption gas Heat Pump fuelled with hydrogen enriched natural gas blends: The analytical simulation model development and validation

This study deals with the implementation of an analytical model to simulate the energy performance associated to a commercial Gas adsorption Heat Pump, when H2NG (Hydrogen Enriched Natural Gas) blends are used as fuel. In detail, a water source heat pump manufactured by Robur (GAHP-WS) has been used as a reference device for building the simulation model within the MATLAB-Simulink environment. Thereafter, the simulation results have been validated by the experimental campaign, testing on field and in actual operating conditions the heat pump. Specifically, the model has been developed by implementing the WaterAmmonia mass and energy balances for each component. It is able to evaluate fuel consumption, efficiency in terms of GUE, required thermal power from the cold heat sink as well as the water outlet temperature at the evaporator, once the heating load is used as the main input. The experimental campaign for the model calibration and validation has been carried out over the winter season. Additionally, the heat pump performance has been detected when it operates to supply hot water at 60 °C and 55 °C, and it is fuelled with growing hydrogen fractions, starting from 0% vol., 5% vol. up to 10% vol. In the end, the standard errors as well as the relative ones affecting the main output parameters have computed for the validation process. From the outcomes it emerges that the average relative standard error related to all load conditions is lower than 2.5% for natural gas operation. On the contrary, it ranges between 2.5% and 4% when H2NG at 5% and 10% by volume have been burnt

Bioaccumulation and Toxicity of Organic Chemicals in Terrestrial Invertebrates

Terrestrial invertebrates are key components in ecosystems, with crucial roles in soil structure, functioning, and ecosystem services. The present chapter covers how terrestrial invertebrates are impacted by organic chemicals, focusing on up-to-date information regarding bioavailability, exposure routes and general concepts on bioaccumulation, toxicity, and existing models. Terrestrial invertebrates are exposed to organic chemicals through different routes, which are dependent on both the organismal traits and nature of exposure, including chemical properties and media characteristics. Bioaccumulation and toxicity data for several groups of organic chemicals are presented and discussed, attempting to cover plant protection products (herbicides, insecticides, fungicides, and molluscicides), veterinary and human pharmaceuticals, polycyclic aromatic compounds, polychlorinated biphenyls, flame retardants, and personal care products. Chemical mixtures are also discussed bearing in mind that chemicals appear simultaneously in the environment. The biomagnification of organic chemicals is considered in light of the consumption of terrestrial invertebrates as novel feed and food sources. This chapter highlights how science has contributed with data from the last 5 years, providing evidence on bioavailability, bioaccumulation, and toxicity derived from exposure to organic chemicals, including insights into the main challenges and shortcomings to extrapolate results to real exposure scenarios

Impact of Vutrisiran on Quality of Life and Physical Function in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

INTRODUCTION: Hereditary transthyretin (ATTRv; v for variant) amyloidosis, also known as hATTR amyloidosis, is a progressive and fatal disease associated with rapid deterioration of physical function and patients' quality of life (QOL). Vutrisiran, a subcutaneously administered RNA interference (RNAi) therapeutic that reduces hepatic production of transthyretin, was assessed in patients with ATTRv amyloidosis with polyneuropathy in the pivotal HELIOS-A study. METHODS: The phase 3 open-label HELIOS-A study investigated the efficacy and safety of vutrisiran in patients with ATTRv amyloidosis with polyneuropathy, compared with an external placebo group from the APOLLO study of the RNAi therapeutic patisiran. Measures of QOL and physical function were assessed. RESULTS: At month 18, vutrisiran improved Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score (least squares mean difference [LSMD] in change from baseline [CFB]: –21.0; p = 1.84 × 10–10) and Norfolk QOL-DN domain scores, compared with external placebo. This benefit relative to external placebo was evident across all baseline polyneuropathy disability (PND) scores and most pronounced in patients with baseline PND scores I–II. Compared with external placebo, vutrisiran also demonstrated benefit in EuroQoL-Visual Analog Scale (EQ-VAS) score (LSMD in CFB: 13.7; nominal p = 2.21 × 10–7), 10-m walk test (LSMD in CFB: 0.239 m/s; p = 1.21 × 10–7), Rasch-built Overall Disability Score (LSMD in CFB: 8.4; p = 3.54 × 10–15), and modified body mass index (mBMI) (LSMD in CFB: 140.7; p = 4.16 × 10–15) at month 18. Overall, Norfolk QOL-DN, EQ-VAS, and mBMI improved from pretreatment baseline with vutrisiran, whereas all measures worsened from baseline in the external placebo group. At month 18, Karnofsky Performance Status was stable/improved from baseline in 58.2/13.1% with vutrisiran versus 34.7/8.1% with external placebo. CONCLUSION: Vutrisiran treatment provided significant clinical benefits in multiple measures of QOL and physical function in patients with ATTRv amyloidosis with polyneuropathy. Benefits were most pronounced in patients with earlier-stage disease, highlighting the importance of early diagnosis and treatment

A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD. © 2021, The Author(s).EU/EFPIA/Innovative Medicines Initiative 2 Joint Undertaking