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We describe the case of a rudimentary horn pregnancy coexistent with an intrauterine pregnancy. This situation is usually associated with rupture of the rudimentary horn and death of the correspondent twin. This is the first report on a multiple gestation with the two siblings successfully delivered by caesarean section in the two horns of a unicornuate uterus with rudimentary horn before any complication. Since the maternal mortality is higher in this situation, early ultrasound diagnosis is important to make the right decisions. [Copyright &y& Elsevier]

A prospective study of the Bovine Corneal Opacity and Permeability (BCOP) Laser Light-Based Opacitometer (LLBO) test method was conducted to evaluate its usefulness to identify chemicals as inducing serious eye damage (Cat. 1) or chemicals not requiring classification for eye irritation (No Cat.) applying United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). The aim was to demonstrate the reproducibility of the BCOP LLBO protocol for liquids and solids and define its predictive capacity. Briefly, 145 chemicals were simultaneously tested with BCOP LLBO and OP-KIT (OECD TG 437), one to two times in one laboratory. When used to identify Cat. 1, the BCOP LLBO has a false negative rate (FNR) of 24.1% (N = 56) compared to 34.8% (N = 56) for the BCOP OP-KIT, with a comparable false positive rate (FPR, N = 89) of 18.5% and 20.8%, respectively. When used to identify chemicals not requiring classification (No Cat.) the BCOP LLBO and BCOP OP-KIT had a FNR (N = 104) of 6.2% and 7.2% and a FPR (N = 41) of 45.1% and 42.7%, respectively. The OP-KIT and LLBO devices are interchangeable at no cost to data quality and reliability. The OP-KIT and LLBO devices are interchangeable at no cost to data quality and reliability. The performance of the LLBO is at least as good as the OP-KIT, both methods can be used to identify UN GHS Cat. 1 and UN GHS No Cat. chemicals. • Performance of the BCOP Laser Light-Based Opacitometer (LLBO) test method • Test Method for Identifying Chemicals Inducing Serious Eye Damage • Test Method for Identifying Chemicals Not Requiring Classification for Eye Irritation/Serious Eye Damage [ABSTRACT FROM AUTHOR]

At a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology. In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro , in chemico or in silico methods. A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance. • Validation in the context of defined approaches or testing strategies was discussed. • In a revolutionary approach, validation is knowledge-based, flexible, iterative. • A thorough description of biological domain and toxicological effects is needed. • Multi-stakeholder involvement is required in evaluation of new methodologies. • Case studies are showcases to build confidence in new approaches and technologies. [ABSTRACT FROM AUTHOR]

The focus of Cosmetics Europe's ocular toxicity programme is on development of testing strategies and defined approaches for identification of ocular effects of chemicals in the context of OECD's Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation. Cosmetics Europe created a comprehensive database of chemicals for which in vitro data are available with corresponding historical in vivo Draize eye data and physicochemical properties. This database allowed further exploration of the initially proposed strategies from the CON4EI project and to identify opportunities for refinement. One key outcome of this project is that combining in vitro test methods (RhCE and BCOP LLBO) with physicochemical properties in a two-step Bottom-Up approach applicable to neat liquids, resulted in an improvement of the specificity, without reducing the sensitivity, when compared to the combination of in vitro methods alone. The Bottom-Up approach proposed here for neat liquids correctly predicted 58.3% (EpiOcular™ EIT followed by BCOP LLBO) to 62.6% (SkinEthic™ HCE EIT followed by BCOP LLBO) of No Cat., 59.1% to 68.7% of Cat. 2, and 76.5% of Cat. 1. Incorporating specific physicochemical properties with this Bottom-Up approach increased the correct identification of No Cat. neat liquids to between 72.7% and 79.7%. • Develop defined approach (DA) for assessment of serious eye damage/eye irritation • Development of exclusion rules for physicochemical properties to identify No Cat. • Proposed DA's: 2 combinations of RhCE test methods with the BCOP LLOB • Incorporation of physicochemical property exclusion rules with DA's improve their specificity. [ABSTRACT FROM AUTHOR]

This report describes the proceedings of the BfR-RIVM workshop on validation of alternative methods which was held 23 and 24 March 2017 in Berlin, Germany. Stakeholders from governmental agencies, regulatory authorities, universities, industry and the OECD were invited to discuss current problems concerning the regulatory acceptance and implementation of alternative test methods and testing strategies, with the aim to develop feasible solutions. Classical validation of alternative methods usually involves one to one comparison with the gold standard animal study. This approach suffers from the reductionist nature of an alternative test as compared to the animal study as well as from the animal study being considered as the gold standard. Modern approaches combine individual alternatives into testing strategies, for which integrated and defined approaches are emerging at OECD. Furthermore, progress in mechanistic toxicology, e.g. through the adverse outcome pathway approach, and in computational systems toxicology allows integration of alternative test battery results into toxicity predictions that are more fine-tuned to the human situation. The road towards transition to a mechanistically-based human-focused hazard and risk assessment of chemicals requires an open mind towards stepping away from the animal study as the gold standard and defining human biologically based regulatory requirements for human hazard and risk assessment. [ABSTRACT FROM AUTHOR]

The subhepatic abscess due to retained fecalith is a rare complication following appendicectomy. The incidence of this complication is probably going to increase due to high rate of laparoscopic appendicectomy. We report 2 cases of subhepatic abscess 1 and 2 years after laparoscopic appendectomies. This potentially serious complication could be preventing with technical recommendations. When it occurs, this complication has to be directly treated by surgical drainage, percutaneous drainage couldn’t be successful because it leaves fecalith in its place which is a cause of recurrence. Our reports are the first to use a laparoscopic treatment of this complication. [Copyright &y& Elsevier]