In silico assessment of developmental and reproductive toxicity
Chemicals leaching from medical devices are toxicologically not always fully characterized. Supplementary approaches are therefore needed to allow for a detailed hazard assessment. In this article the use of in silico toxicology to identify and quantify the developmental and reproductive toxicity (DART) potential of substances is investigated. Reproductive toxicity represents the harmful effects of chemical exposure on the offspring and/or impairment of male and female reproductive functions, whereas developmental toxicity involves any adverse effect induced prior to attainment of adult life (Peters
Genotoxicity assessment of medical devices
If chemical analytical testing and the toxicological risk assessment fails to demonstrate that leachables of a medical device are associated with an acceptable risk for genotoxicity, genotoxicity tests are required to assess the potential presence of toxins that can impact the genetic material of cells. Since no single test can detect all genotoxins, the standard for medical device genotoxicity testing (ISO 10993-3) describes an approach that considers a battery of in vitro and under certain circumstances also in vivo tests. The standard test battery comprises
Regulatory framework for identification and characterization of endocrine disrupters
For decades, studies of endocrine disrupters (EDs) have challenged traditional concepts in toxicology, in particular the dogma “the dose makes the poison” as they can have effects at low doses that are not predicted by effects at higher doses. At the beginning of the 90s the term endocrine disruption first appeared in scientific literature and a workshop sponsored by US environmental protection agency (US EPA) that gathered experts on the topic described an endocrine disrupter (ED) as “An exogenous agent that interferes
European water legislation framework and ecotoxicological potential of diclofenac in the aquatic system of the Rhine
Due to the ever increasing use of pharmaceuticals in human and veterinary medicine, pharmaceutical contamination of aquatic ecosystems is considered an emerging problem (Hejna et al., 2022; Rzymski et al., 2017). Back in 2006, the annual per capita consumption of pharmaceuticals has been estimated to be 15 g on average worldwide and as high as 50 to 150 g in industrialized countries (T. Ternes & Joss, 2006). Once administered, a great portion of their active ingredients is excreted unaltered or as
Upcoming universal restriction of Per- and polyfluoroalkyl substances (PFAS) in EU and EEA
The main concern related to per- and polyfluoroalkyl substances (PFAS) is their environmental persistence. If release continues the abundance in the environment and hence exposure to organisms including humans will increase. The EU Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) have provisionally concluded on four sectors. The planed universal restriction aims to restrict around 10.000 PFAS, both in the EU and EEA. The restriction considers their persistence nature, as they contaminate water sources and can cause toxic
Potential of alkyl glycol ethers to cause endocrine disruption
An endocrine disruptor is defined as “an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations” (WHO/PCS, 2002). In recent years publications have appeared that mention individual glycol ethers or glycol ethers in general amongst those substances with potential to cause endocrine disruption in humans, particularly in relation to reproductive effects (Cecchi, 2014; Dodson et al., 2012; Fort et al., 2018; Helm et