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Ayurveda is one of the oldest systems of traditional medicine that provides treatments for a wide range of acute and chronic health problems. It is a common myth amongst people that Ayurvedic drugs have no side effects, whereas the fact is that these drugs can cause adverse effects. Despite their wide use, the safety data of many Ayurvedic formulations are still unavailable. Tapyadi loha is an Ayurvedic formulation traditionally claimed for iron deficiency anemia in pregnant and non-pregnant patients. However, no scientific study has been conducted to evaluate its oral toxicity. Hence, the present study evaluated the acute and subacute oral toxicity of the Tapyadi loha according to the OECD test guidelines 425 and 407, respectively. Tapyadi loha did not cause mortality nor any signs of toxicity when given once orally at a dose of 2000 mg/kg. Subacute toxicity study showed no mortality as well as no behavioral, hematological, biochemical and histopathological abnormalities in rats treated with Tapyadi loha formulation at 250, 500 and 1000 mg/kg for 28 days. It is concluded that the Tapyadi loha is safe at a single dose of 2000 mg/kg and 28 days repeated dose of 1000 mg/kg by oral route in rats. [ABSTRACT FROM AUTHOR]

AbstractThere has been keen interest on herbs and phytoconstituents with hepatoprotective property to help restore healthy liver function. Ayurveda, the ancient Indian traditional system of medicine mentions about Curcuma longa, Garcinia indica and Piper nigrum which are reported to have hepatoprotective activity. Apart from supporting metabolism, liver plays pivotal role in numerous bodily processes, immune functions to digestion, detoxification, and storage of nutrients. Factors such as sedentary lifestyle, viral infections, drugs/chemicals, high calorie diet, excess intake of alcohol etc have adverse impact on normal functioning of liver. Development of novel herbal combination with standards of safety and efficacy can help manage liver ailments and protect liver health. LivLonga® is a polyherbal combination of scientifically validated ingredients- curcuminoids, garcinol and piperine to support healthy liver function. The present work was conducted to evaluate toxicity of LivLonga® using in vivo models when administered orally. The acute, subacute, and subchronic toxicity studies were carried out in accordance with the test guidelines established by the Organization for Economic Cooperation and Development. A single-dose acute oral toxicity produced no toxic effects after 14 days of treatment. Four-week (subacute) and 3-months (subchronic) oral toxicity studies were conducted and observed no abnormal clinical signs, no alterations in the body weight, hematology and biochemical parameters or gross and histopathological changes. Thus, oral administration of LivLonga® showed no signs of toxicity when dosed orally to rats, with a no observed adverse effect level (NOAEL) of 600 mg/kg/day. [ABSTRACT FROM AUTHOR]

Progress in the business and human rights space can be quite a fickle thing to assess. Despite intensive norm development, many observers emphasise elements of stagnation within the field. This article argues that much of the frustration is caused by the dominance of a linear understanding of progress which is fixated on the dichotomy between soft and hard forms of regulation. This, in turn, obscures much of the dynamism within the field. To better account for progress within the business and human rights space, the article suggests a shift of framing from a linear conception of regulatory change to one that understands the field as an entangled normative network characterised through the connections between norms. By using the norm of human rights due diligence as an example, the article highlights the nuanced developments and linkages between various instruments, systems, and actors that evidence intense norm-making activity within the business and human rights space. The on-going normative-discursive exchange between stakeholders produces a norm that is constituted through an iterative process of entanglement. [ABSTRACT FROM AUTHOR]

The OECD Guidelines for Multinational Enterprises have become increasingly relevant in the debate on the role of business in society. This instrument for responsible business conduct (RBC) is considered to be unique due to its implementation mechanism, the National Contact Point (NCP) procedure. The NCP procedure applies a pragmatic stakeholder engagement approach to contribute to the effectiveness of the OECD Guidelines. However, little is known about the effects of the NCP procedure. To fill this gap, this study provides insights into the ex‐post effects of the Dutch NCP procedure on solving non‐compliance issues, the RBC performance of MNEs, and societal impact. This study developed a framework of different layers of effects. It used this framework to gather and analyze empirical data through interviews with parties that have participated in non‐compliance procedures. The effects found are mainly related to solving issues, while the effects on RBC within MNEs and their societal impact seem limited. Based on the findings, this study concludes that the full potential of the OECD Guidelines remains unrealized in most of the investigated cases. [ABSTRACT FROM AUTHOR]

Withania somnifera (WS) is a valuable medicinal plant that has been used against several ailments. The medicinal properties of WS are ascribed to existence of secondary metabolites which are in great demand in herbal nutraceutical industry. Despite well-known therapeutic effects of WS, it is necessary to assess preclinical toxicity of WS plant on rats and further explore its potential application against treatment of various disorders in humans. The existing study assessed oral acute and sub-chronic toxicities of WS root extract in Sprague Dawley (SD) rats (male and female) for 14 and 90 days, respectively under OECD-423 and -408 guidelines as well as GLP compliance. In acute toxicity, rats of either sex were orally fed a dose of 2,000 mg/kg. In sub-chronic toxicity, animals were orally administered repeated doses of WS root extract at 250, 500, 1,000 mg/kg for 90 days with an additional 14-day recovery period. Two more groups (n=5 animals each) receiving vehicle and 1,000 mg/kg of WS root extract for 90 days were also observed. In acute toxicity, the results revealed that LD50 of WS root extract in SD rats was higher than 2,000 mg/kg. In sub-chronic toxicity, oral administration of extract for 90 days showed no significant toxicological changes in rats. Haematological and serum chemistry markers were found within normal range. Terminal necropsy showed no gross or histopathological outcomes. The no-observed-adverse-effect level (NOAEL) of WS root extract was 1,000 mg/kg body weight, and safe to use at this dose in rats. [ABSTRACT FROM AUTHOR]

Introduction/Background: Curcuma longa, a plant native to the Indian subcontinent has a variety of biological activities. Curcumin is the most abundant and biologically active compound with many therapeutic properties. Demethoxycurcumin (DMC) and bisdemethoxycurcumin (BDMC) – the two other bioactive components present in Curcuma longa, besides curcumin, are collectively termed curcuminoids. Apart from the well-known curcumin, BDMC also has been reported to possess promising biological and pharmacological effects, but very little scientific evidence on its safety assessment has been published.Objective: The present study was undertaken to determine the safety of pure BDMC from Curcuma longa extract in rodents which comprises of general toxicity (both four weeks and three months duration), reproductive/developmental toxicity and genotoxicity studies.Methods: The Good Laboratory Practice studies were carried out in accordance with the test guidelines established by the Organization for Economic Cooperation and Development.Results: No treatment-related adverse findings were seen in general toxicity testing and a no observed adverse effect level (NOAEL) of 1000 mg/kg/day was established after four weeks (sub-acute) and three-months (sub-chronic) dosing. Evaluation of fertility, embryo-fetal, and post-natal reproductive and developmental parameters also showed no adverse findings with a NOAEL of 1000 mg/kg/day established. The results of genotoxicity as evaluated by in vitro reverse mutation assay, and in vivo micronucleus test in mice indicate that BDMC did not induce any genotoxic effects.Conclusion: Oral administration of BDMC is safe in rodents and non-mutagenic, with no adverse effects under experimental conditions. [ABSTRACT FROM AUTHOR]

Almond hull, a substantial byproduct comprising more than half of almond fresh weight, has recently gained attention due to its functionality and sustainability benefits. Despite heightened interest, information regarding its toxicity remains limited. In order to assess its genotoxic potential, we conducted Good Laboratory Practice-compliant in vitro and in vivo studies following Organization for Economic Co-operation and Development (OECD) guidelines. No evidence of toxicity or mutagenicity was observed in a bacterial reverse mutation assay using five tester strains, evaluating almond hull at concentrations up to 5 mg/plate, with or without metabolic activation. Almond hull did not induce chromosome structural damage in a chromosome aberration assay using Chinese hamster ovary cells, nor did it cause any spermatogonial chromosomal aberration in tested male BALB/c mice. To evaluate its ability to induce DNA damage in rodents, a combined micronucleus assay was conducted in KM mice of both sexes. Almond hull was administered at doses of 1250, 2500, and 5000 mg/kg/day via gavage once daily for 2 days. No adverse effects of almond hull were observed in the micronucleus assay. Our results indicate no evidence of the genotoxic potential of almond hull administered up to the maximum concentrations of 5 g/kg, as recommended by OECD guidelines. [ABSTRACT FROM AUTHOR]

In this paper the authors analyse some questions pertaining to the reform of state-owned enterprises in Serbia regarding the compatibility of the new legal regulation of corporate governance in the public sector with the OECD Guidelines. The analysis focuses on the principles and recommendations for more efficient implementation of reforms in state-owned business entities as outlined in the OECD Guidelines, as well as on the provisions of the new Law on the Management of Companies Owned by the Republic of Serbia. The analysis aims to determine whether the new solutions have helped in achieving a uniform legal framework and to what extent these new solutions contribute to the realization of the state's ownership interests, value creation in the public sector, and the public good.

Almond hull, a substantial byproduct comprising more than half of almond fresh weight, has recently gained attention due to its functionality and sustainability benefits. Despite heightened interest, information regarding its toxicity remains limited. In order to assess its genotoxic potential, we conducted Good Laboratory Practice-compliant in vitro and in vivo studies following Organization for Economic Co-operation and Development (OECD) guidelines. No evidence of toxicity or mutagenicity was observed in a bacterial reverse mutation assay using five tester strains, evaluating almond hull at concentrations up to 5 mg/plate, with or without metabolic activation. Almond hull did not induce chromosome structural damage in a chromosome aberration assay using Chinese hamster ovary cells, nor did it cause any spermatogonial chromosomal aberration in tested male BALB/c mice. To evaluate its ability to induce DNA damage in rodents, a combined micronucleus assay was conducted in KM mice of both sexes. Almond hull was administered at doses of 1250, 2500, and 5000 mg/kg/day via gavage once daily for 2 days. No adverse effects of almond hull were observed in the micronucleus assay. Our results indicate no evidence of the genotoxic potential of almond hull administered up to the maximum concentrations of 5 g/kg, as recommended by OECD guidelines.

Thyroid hormones (THs) regulate a multitude of developmental and metabolic processes, which are responsible for vertebrate development, growth, and maintenance of homeostasis. THs also play a key role in neurogenesis of vertebrates and thus affect eye development, which is vital for foraging efficiency and for effective escape from predation. Currently, there are no validated test guidelines for the assessment of TH system-disrupting chemicals (THSDCs) in fish. Consequently, the present study was designed to demonstrate the suitability of novel thyroid-related endpoints in early life-stages of fish. Embryos of a transgenic zebrafish (Danio rerio) line expressing the reporter gene tg:mCherry in their thyrocytes were used to investigate the effects of the environmental THSDCs triclosan (TCS, antibacterial agent) and benzophenone-2 (BP-2, UV filter) on thyroid follicle and eye development. Both BP-2 and TCS caused thyroid follicle hyperplasia in transgenic zebrafish, thus confirming their role as THSDCs. The effect intensity on follicle size and fluorescence was comparable with a 1.7-fold increase for BP-2 and 1.6-fold for TCS. Alterations of the cellular structures of the retina indicate an impact of both substances on eye development, with a stronger impact of TCS. With respect to guideline development, results provide further evidence for the suitability of morphological changes in thyroid follicles and the eyes as novel endpoints for the sensitive assessment of THSD-related effects in fish. [ABSTRACT FROM AUTHOR]

Discussions about generally accepted rules for personal data protection began in the 1970s, and in the early 1980s, the first international instruments appeared. Modern information technologies and crossborder data exchange have led to a discussion of the need to harmonize national laws for personal data protection. This article discusses international instruments for protecting personal data and the works of foreign scholars. The purpose of the study is to analyze international instruments and identify common positions, characteristics and differences. The practical value of the article lies in the fact that it allows us to understand the desire of countries to harmonize their national data protection regimes. The scientific relevance lies in that the existing international legal norms and approaches to regulating personal data protection outside of Kazakhstan have yet to be studied in Kazakhstani legal science. The discussions presented in this article are of scientific and practical interest to undergraduate, graduate and doctoral students. General scientific and particular research methods were used to prepare the study. The normative basis of the study was the OECD Guidelines, Convention 108, UN Guidelines, APEC Framework, DPD, and the GDPR. The theoretical basis is the publications of well-known foreign scholars in the field of privacy, such authors as Graham Greenleaf, Christopher Kuner, Priscilla Regan, Anu Bradford, Colin Bennett and others. As a result of the study, it was concluded that most foreign authors recognize the European data protection model as a globally recognized standard being implemented in many countries. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the impact of different concentrations of copper and zinc on the mortality and bodyweight of juvenile earthworms in artificial soil. Copper was more toxic with complete mortality at the dose rate of 1000 mg/kg. Bodyweight loss of earthworms was observed immediately, after the first week, except at the lowest concentration. In comparison to control, there were significant differences in the bodyweight loss every week in the concentrations of 333 and 666 mg/kg, and also 167 mg/kg in the fourth, sixth, and eighth week. Zinc has not shown a significant effect on mortality, except in the highest concentration, where survival was less than 25%. Statistically significant effect (p < 0.05) on bodyweight was registered only at the highest concentration, every week. The impact of metals on earthworm populations should be more accurately assessed, and data for juvenile earthworms should be considered when proposing a safe concentration of pollutants in the environment, because of the great importance of these animals' presence in the soil.

For toxicology testing of (agro)chemicals, different study types are being performed with general and/or reproductive toxicity endpoints (see Organisation for Economic Co-operation and Development guidelines). In most of these rat studies, vaginal cytology is performed on serial samples (collected by lavage) for evaluation of cycle regularity and evidence of mating, and/or on a single sample collected on the day of necropsy for information on the estrous cycle stage and allowing correlation with histopathology. In the latter case, the utility of vaginal cytology can be argued. In this article, estrous cycle stages based on vaginal cytology of samples taken on the day of necropsy and histopathology of ovaries, uterus, and vagina (gold standard for estrous cycle stage assessment) were compared. The agreement was generally low. Disagreement between the two methods could be explained by time differences between lavage and necropsy, by manipulation of vaginal epithelium during lavage which may impact epithelial morphology on histology, and by misinterpretation of vaginal cytology during or shortly after lactation. Based on the results of estrous staging within different study types, we strongly discourage vaginal cytology from samples collected on the day of necropsy since there is no added value, vaginal manipulation can be stressful and may complicate the histologic diagnosis. [ABSTRACT FROM AUTHOR]

The 21st century has seen a steadily increasing social awareness of animal suffering, with increased attention to ethical considerations. Developing new integrated approaches to testing and assessment (IATA) strategies is an Organisation for Economic Co‐operation and Development (OECD) goal to reduce animal testing. Currently, there is a lack of alternative models to test for ocular surface toxicity (aside from irritation) in lieu of the Draize eye irritation test (OECD guideline No. 405) performed in rabbits. Five alternative in vitro or ex vivo methods have been validated to replace this reference test, but only in combination. However, pathologies like Toxicity‐Induced Dry Eye (TIDE), cataract, glaucoma, and neuropathic pain can occur after exposure to a pharmaceutical product or chemical and therefore need to be anticipated. To do so, new models of lacrimal glands, lens, and neurons innervating epithelia are required. These models must take into account real‐life exposure (dose, time, and tear film clearance). The scientific community is working hard to develop new, robust, alternative, in silico, and in vitro models, while attempting to balance ethics and availability of biological materials. This review provides a broad overview of the validated methods for analyzing ocular irritation and those still used by some industries, as well as promising models that need to be optimized according to the OECD. Finally, we give an overview of recently developed innovative models, which could become new tools in the evaluation of ocular surface toxicity within the scope of IATAs. Until now, the Draize test in rabbits has been the only test performed to anticipate ocular toxicity of pharmaceutical compounds, mainly irritation. However, in the field of alternative approaches, new models must be developed and validated. This review aims to give an overview of the OECD validated methods and of innovative models, which could become new tools in the evaluation of ocular surface toxicity. [ABSTRACT FROM AUTHOR]

The OECD Guidelines for Multinational Enterprises (OECD Guidelines) are one of the few measures that were successfully realised on the international plane in the decades-long pursuit of corporate accountability. For 20 years, the OECD Guidelines and their non-judicial grievance mechanism, the National Contact Point (NCP), have been continuously resorted to by victims and advocates in holding businesses to account for various abuses and misbehaviours. Interestingly, NCP cases (specific instances) have only steadily increased through the years despite the challenges, limitations and criticisms that the mechanism has been confronted with. And more states continue to adhere to the Guidelines, OECD members and non-members alike, and bind themselves to the obligation of establishing an NCP within their territory. Such mechanism accordingly remains relevant, valuable and indispensable. This article seeks to revisit and examine the OECD Guidelines and the NCPs in light of the two United Nations (UN) pathways initiated by the UN Human Rights Council: the UN Guiding Principles on Business and Human Rights (UNGP) and the elaboration of a potential treaty on business and human rights (BHR). It will identify and evaluate three important features that make the mechanism unique vis-à-vis other BHR mechanisms. The article will focus its analysis and discussion on how these features are able to or can meaningfully contribute to the UN pathways, as well as how they could be harnessed to improve existing propositions and drafts leading to the desired legally binding instrument. It will also identify some of the mechanism's shortcomings, and understand some of the points made in this regard. Finally, it will conclude with recommendations on how the mechanism could be improved and how these features could assist in shaping the future of corporate accountability. [ABSTRACT FROM AUTHOR]

The biodegradability of natural gelatin (GEL) and sodium caseinate (SCas) and synthetic poly(vinyl alcohol) (PVA) and poly(lactic acid) (PLA) biopolymers films, were studied in an aquatic system following OECD 301D guidelines. Biodegradation was determined measuring the dissolved oxygen (DO) over 28 days with closed respirometers. Elementary compositions and changes in physicochemical parameters were analyzed. The results demonstrated that carbon (46 to 60%) and oxygen (31 to 44%) were the most important elements in the composition of all films. Moreover, GEL and SCas films were completely biodegraded (100%) on day 1, showing a DO increased (GEL up to 42.5 mg O2/l and SCas up to 34.6 mg O2/l) as a consequence of the biodegradation time. This is in stark contrast to PVA and PLA films, who presented an inverse behavior (PLA up to 1.1 mg O2/l and PVA up to 0.5 mg O2/l), which in fact cannot be classified as "readily biodegradable" according to the results of in this study because they required more time to biodegrade than the rules defined for this aquatic system. PLA film showed a more opaque and whitish color, a clear increase in EM values (day 7 = 85.7 ± 2.0 MPa), Tg temperature (day 28 = 56.8 ± 0.0 °C) and crystallinity (Day 28 = 49.3 ± 0.6%) over the effects of biodegradation times. FTIR analysis showed changes in the intensity of the typical bands of the PLA samples, and the presence of Pseudomonas, was later observed on their surface by SEM studies. [ABSTRACT FROM AUTHOR]

Copyright of Research Papers of the Wroclaw University of Economics / Prace Naukowe Uniwersytetu Ekonomicznego we Wroclawiu is the property of Uniwersytet Ekonomiczny we Wroclawiu and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The dissolution of metal-based engineered nanomaterials (ENMs) in aquatic environments is an important mechanism governing the release of toxic dissolved metals. For the registration of ENMs at regulatory bodies such as REACH, their dissolution behavior must therefore be assessed using standardized experimental approaches. To date, there are no standardized procedures for dissolution testing of ENMs in environmentally relevant aquatic media, and the Organisation for Economic Co-operation and Development (OECD) strongly encourages their development into test guidelines. According to a survey of surface water hydrochemistry, we propose to use media with low concentrations of Ca2+ and Mg2+ for a better simulation of the ionic background of surface waters, at pH values representing acidic (5 < pH < 6) and near-neutral/alkaline (7 < pH < 8) waters. We evaluated a continuous flow setup adapted to expose small amounts of ENMs to aqueous media, to mimic ENMs in surface waters. For this purpose, silver nanoparticles (Ag NPs) were used as model for soluble metal-bearing ENMs. Ag NPs were deposited onto a 10 kg.mol−1 membrane through the injection of 500 µL of a 5 mg.L−1 or 20 mg.L−1 Ag NP dispersion, in order to expose only a few micrograms of Ag NPs to the aqueous media. The dissolution rate of Ag NPs in 10 mM NaNO3 was more than two times higher for ~2 µg compared with ~8 µg of Ag NPs deposited onto the membrane, emphasizing the importance of evaluating the dissolution of ENMs at low concentrations in order to keep a realistic scenario. Dissolution rates of Ag NPs in artificial waters (2 mM Ca(NO3)2, 0.5 mM MgSO4, 0–5 mM NaHCO3) were also determined, proving the feasibility of the test using environmentally relevant media. In view of the current lack of harmonized methods, this work encourages the standardization of continuous flow dissolution methods toward OECD guidelines focused on natural aquatic environments, for systematic comparisons of nanomaterials and adapted risk assessments.

This study was conducted in order to formulate a modification of standard substrate for laboratory bioassays (OECD protocol number 218: ”Sediment water chironomid toxicity test using spiked sediment“), with as few constituents as possible, yet enabling the highest larval survival of model organism: Chironomus tentans (Chironomidae, Diptera). Laboratory experiment consisted of two bioassays: first with substrate mixture of two and more ingredients tested: standard OECD substrate, standard substrate with medical clay, peat + clay, peat + sand, clay + sand; second with every ingredient individually tested: coarse sand, fine sand, peat, clay and no substrate. Highest larval survival was observed in sand + peat (≈85%) and coarse sand substrate (≈82%), whilst clay + peat and peat substrate caused the highest larval mortality (≈65% and 46% respectively). No larvae survived in treatment without any substrata, indicating the absolute necessity and importance of substrate presence for larval survival. [ABSTRACT FROM AUTHOR]

We have witnessed fundamental changes both domestically and internationally due to globalisation and free trade. Multinational enterprises ('MNEs') are at the forefront of these changes. While states in the Global North have benefited broadly from the opportunities offered by free international trade, developing countries in the southern hemisphere have often suffered from the negative impacts of globalisation, notably, serious violations of human rights and working conditions. In order to avoid these adverse side effects, increasing international attention has been devoted to the human rights obligations of corporations over the last 30 years. Particularly useful are the OECD Guidelines for Multinational Enterprises – the only instrument of corporate responsibility formally adopted by governments with a built-in grievance mechanism. As this analysis will show, these Guidelines can have a measurable impact – beyond the traditional categories of soft law and binding state law. In this article, possibilities for innovative national regulatory practice will be considered and light will be shed on the technique of 'social linkage', particularly on public procurement law with its unique mechanisms for social considerations. All these mechanisms lead to more coherence in international law and can be used to strengthen the impact of the OECD Guidelines. [ABSTRACT FROM AUTHOR]

Introduction: Probiotics made from Bacillus subtilis provide a wide spread of health benefits, particularly in the treatment of diarrhea and gastrointestinal problems. Herein, we employed in vitro and in vivo paradigms to assess the potential adverse effects and toxicity of B. subtilis UBBS-14., Materials and Methods: According to Organization for Economic Co-operation and Development (OECD) 423 and 407 requirements, a preclinical investigation was conducted in male and female Sprague-Dawley rats. Acute toxicity was examined following a single peroral (PO) administration of 5,000 mg/kg body weight (bw) i.e. equivalent to 500 billion colony-forming units (CFU) per kg bw. Single administration of B. subtilis UBBS-14 showed no mortality or adverse effects until the 14-day observation period, indicating LD50 is >5,000 mg/kg bw., Results: Incubation of B. subtilis UBBS-14 with Caco2, HT29, and Raw 264.7 cell lines, showed no cytotoxic effects. This probiotic strain was also found responsive to the majority of antibiotics. For a 28-day repeated dose toxicity study, rats were administered 100, 500, and 1,000 mg/kg bw daily once (10, 50, and 100 billion CFU/kg bw/day, respectively) doses of B. subtilis UBBS-14. No notable changes were seen in the morphology, weight, and histopathology of the critical internal organs. The haematological, biochemical, electrolyte (sodium, potassium, chloride, and calcium), and urine analytical results were within the normal range and equivalent to the vehicle-treated group., Conclusion: B. subtilis UBBS-14's no-observed-effect level (NOEL) was thus determined to be >1,000 mg/kg bw/day following a 28-day oral dosing., Competing Interests: YM and SMF are affiliated to Unique Biotech Limited, Hyderabad. This affiliation does not influence the objectivity and integrity of the research findings presented in this work. The research was conducted with the highest scientific rigor, and the authors are committed to transparency in reporting any potential conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Copyright of China Surfactant Detergent & Cosmetics (1001-1803) is the property of China Surfactant Detergent & Cosmetics Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

For reporting toxicology studies, the presentation of historical control data and the validation of the concurrent control group with respect to historical control limits have become requirements. However, many regulatory guidelines fail to define how such limits should be calculated and what kind of target value(s) they should cover. Hence, this manuscript is aimed to give a brief review on the methods for the calculation of historical control limits that are in use as well as on their theoretical background. Furthermore, this manuscript is aimed to identify open issues for the use of historical control limits that need to be discussed by the community. It seems that, even after 40 years of discussion, more issues remain open than solved, both, with regard to the available methodology as well as its implementation in user-friendly software. Since several of these topics equally apply to several research fields, this manuscript is addressed to all relevant stakeholders who deal with historical control data obtained from toxicological studies, regardless of their background or field of research. • Prediction of observations from concurrent control groups based on historical control data: An overview. • Recommendations for the practical application of historical control limits. • Identification of several open issues regarding the use of historical control limits. [ABSTRACT FROM AUTHOR]

(Series Information) European Papers - A Journal on Law and Integration, 2016 1(3), 1259-1261 | European Forum Highlight of 20 September 2016 | (Abstract) In its decision of 30 August 2016, the European Commission found that Ireland granted undue tax benefits to Apple and that the Member State is under the obligation to recover the illegal aids from the beneficiary. The decision is connected to a recent major activity of the Commission directed at investigating the tax ruling practices of Member States, in which the European Commission has heavily relied on the OECD guidelines on transfer pricing. This seems to be due to the fact that the Commission founds it difficult to elaborate a fully "European" notion of fiscal State aid.

En este trabajo se describen algunas de las modalidades más frecuentes de reestructuración de negocios que desde hace ya algunos años vienen acometiendo los grupos multinacionales, así como los cambios en la política de precios de transferencia a través de las que se articulan. Adoptando la perspectiva de la Administración tributaria, a la que incumbe la revisión de estas operaciones, se identifican los principales factores que, a juicio del autor, deben tomarse en consideración en el examen de una reestructuración y se comentan las orientaciones que al respecto se contienen en el capítulo IX de las Directrices de la OCDE incorporado en su versión de 2010. El trabajo concluye comentando el catálogo de posiciones que la Administración tributaria puede adoptar tras la revisión de la reestructuración.

In the last two decades the production and use of nanomaterials (NMs) has impressively increased. Their small size, given a mass equal to that of the corresponding bulk material, implies an increase in the surface area and consequently in the number of atoms that can be reactive. They possess different physical, chemical and biological properties compared to bulk materials of the same composition, which makes them very interesting and valuable for many different applications in technology, energy, construction, electronics, agriculture, optics, paints, textiles, food, cosmetics, medicine... Toxicological assessment of NMs is crucial; the same properties that make them interesting also make them potentially harmful for health and the environment. However, the term NM covers many different kinds of particle , and so there is no simple, standard approach to assessing their toxicity. NMs can enter the cell, interact with cell components and even penetrate the nucleus and interfere with the genetic material. Among the different branches of toxicology, genotoxicity is a main area of concern since it is closely related with the carcinogenic potential of compounds. The Organisation for Economic Co-operation and Development (OECD) has published internationally agreed in vitro and in vivo validated test methods to evaluate different genotoxic endpoints of chemicals, including chromosome and gene mutations, and DNA breaks. However not all the assays are suitable to study the genotoxic potential of NMs as has been shown by the OECD Working Party on Manufactured Nanomaterials (WPMN). Moreover, alterations to DNA bases, which are precursors to mutations and of great importance in elucidating the mechanism of action of NMs, are not covered by the OECD guidelines. The in vivo standard comet assay (which measures DNA breaks and alkali-labile sites) was included in the OECD assays battery in September 2014 while the in vitro standard comet assay is currently under validation. The comet assay has not been yet proposed as an appropriate test to check the genotoxic potential of NMs, though at a research level it is the most used in vitro assay and the second most used in vivo assay. Moreover, the combination of the comet assay with enzymes that convert altered bases to breaks allows the identification of DNA damage induced by secondary mechanisms (e.g. oxidative stress induced by inflammation), which is very relevant in the case of NMs. Possible problems with the use of the comet assay have been suggested: NMs have been detected in close association with comets, and might interact with the DNA; or NMs might inhibit the action of enzymes. However, control experiments have not confirmed that these interactions are significant.

In this work, the environmental compatibility of a biosurfactant produced by aBacillus subtilisstrain isolated from the soil of a Brazilian mangrove was investigated. The biosurfactant, identified as surfactin, is able to reduce surface tension (ST) to 31.5 ± 0.1 mN m−1and exhibits a lowcritical micelle concentration (CMC) value (0.015 ± 0.003 g L−1). The highest crude biosurfactant concentration (224.3 ± 1.9 mg L−1) was reached at 72 h of fermentation. Acute toxicity tests, carried out withDaphnia magna, Vibrio fischeri and Selenastrum capricornutumindicated that the toxicity of the biosurfactant is lower than that of its chemically derived counterparts. The results of the biodegradability tests demonstrated that the crude surfactin extract was degraded by bothPseudomonas putidaand a mixed population from a sewage-treatment plant, in both cases the biodegradation efficiency being dependent on the initial concentration of the biosurfactant. Finally, as the biodegradation percentages obtained fall within the acceptance limits established by the Organization for Economic Co-operation and Development (Guidelines for Testing of Chemicals, OECD 301E), crude surfactin can be classified as a “readily” biodegradable compound. [ABSTRACT FROM PUBLISHER]

Fluoroquinolone antibiotics (FQs) are of concern due to their disrupting effects on environmental bacterial communities. Evaluating FQ sorption by soil components is important to understand their interaction with soils and to address their environmental (bio)availability. However, data in soil organic components, especially humic acids, are scarce. Batch experiments following OECD guidelines are suitable for testing the sorption of pollutants in solid matrices. Here, we applied this methodology, with specific changes in the experimental setup, to derive sorption data and to identify the factors affecting sorption of four common FQs in seven humic acids with contrasting properties. The effect of shaking time, pH, calcium concentration in solution and dissolved organic carbon (DOC) content on the quantification of the solid-liquid distribution coefficient (K d ) of norfloxacin in three reference humic acids was evaluated. Sorption reversibility and sorption analogy of four FQs were additionally assessed in these three reference materials, whereas the effect of initial norfloxacin concentration was evaluated in the overall set of seven humic acids. Sorption was fast, strong, non-linear, irreversible and affected by changes in the pH and calcium levels in solution. The bell-shaped sorption trend at varying pH values confirmed the key role of FQ speciation in sorption and the high K d values indicated a positive effect of soil organic matter components on FQ sorption in bulk soils at environmentally relevant pH values.•Relevant factors affecting sorption of pollutants in environmental matrices must be considered to derive K d values with low variability and high representativeness.•In this article we modify the experimental conditions of standard batch tests to identify the factors that affect the sorption of FQs in humic acids.•The methodological approach followed can be extrapolated to the evaluation of other combinations of pollutant and environmental matrix., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Background: Enicostemma axillare (Lam.) Raynal is used in traditional practice for the treatment of diabetes, malaria and liver disorders. No systematic toxicity study was described for this plant and hence the present was undertaken to evaluate acute and sub-acute toxicity of aqueous extract of Enicostemma axillare (AEEA). Objective: The acute oral toxicity study of AEEA was carried out as per the OECD guidelines 423 in mice and the sub-acute toxicity was carried out as per the guidelines set by OECD 407 in male and female rats. Materials and Methods: Body weight, food and water consumption, hematological parameters, biochemical parameters, organ weight and histopathological analysis were carried out. Results: No gross toxicity and mortality was observed upto a dose of 2000 mg/kg. For sub-acute toxicity test, 200 mg/kg and 400 mg/kg daily dose of AEEA administered orally for 28 days in male and female group of rats not exhibited any signs of toxicity and mortality. Conclusion: In acute oral toxicity study, the oral administration of AEEA in mice was found to be safe up to a dose of 2000 mg/kg. Both male and female treated rats showed no change in hematological, biochemical and histological investigations and no signs of toxicity were observed upto the dose of 400 mg/kg in rats. [ABSTRACT FROM AUTHOR]

Allura Red AC (Food Red No. 40) is a red azo dye that is used for food coloring in beverage and confectionary products. However, its genotoxic properties remain controversial. To clarify the in vivo genotoxicity, we treated mice with Allura Red AC and investigated the induction of DNA damage (liver, glandular stomach), clastogenicity/anuegenicity (bone marrow), and mutagenicity (liver, glandular stomach) using Comet assays, micronucleus tests, and transgenic gene mutation assays, respectively. All studies were conducted in accordance with the Organization for Economic Co-operation and Development (OECD) guideline. Although Allura Red AC was administered up to the maximum doses recommended by the OECD guideline, no genotoxic effect was observed in any of the genotoxic endpoints. These data clearly show no evidence of in vivo genotoxic potential of Allura Red AC administered up to the maximum doses in mice. [ABSTRACT FROM AUTHOR]

Nanosponges ( NS) show promising results in different fields such as medicine, agriculture, water purification, fire engineering and so on. The present study was designed to evaluate toxicity of different NS formulations (namely, S1- S6) synthesized with different cross-linking agents such as carbonyl diimidazole, pyromellitic dianhydride and hexamethylene diisocynate; and preparation methods in experimental animals. Acute and repeated dose toxicity studies of formulations were carried out as per OECD guidelines 423 and 407, respectively. For acute toxicity study, formulations were administered to female rats at doses of 300 and 2000 mg/kg orally. The general behaviour of the rats was continuously monitored for 1 h after dosing, periodically during the first 24 h and daily thereafter for a total of 14 days. On day 14, animals were fasted overnight, weighed, and sacrificed. After sacrification, animals were subjected to necropsy. For repeated dose toxicity study, rats of either sex were orally administered with formulations at the dose of 300 mg/kg per day for a period of 28 days. The maximally tolerated dose of all formulations was found to be 2000 mg/kg. Repeated administration of formulations for 28 days did not show any significant changes in haematological and biochemical parameters in experimental animals. These results indicate that the formulations are safe, when tested in experimental animals. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:1856-1863, 2015 [ABSTRACT FROM AUTHOR]

Human pharmaceutical active ingredients that are orally or parenterally administered may be metabolised in the body and after excretion may be further transformed in the receiving environmental compartments. The optimal outcome from an environmental point of view-complete mineralisation-is rarely observed. Small molecule pharmaceuticals are commonly not readily biodegradable according to Organisation for Economic Cooperation and Development (OECD) 301 tests. However, primary transformation is often observed. To gain information on the transformation of active ingredients in the environment, long-term studies like transformation in aquatic water/sediment systems according to OECD guideline 308 are required for the environmental risk assessment for human active pharmaceutical ingredients. Studies received until mid 2010 as part of the dossiers for marketing authorisation applications were evaluated concerning transformation products. The evaluation revealed that in 70 % of the studies, at least one transformation product (TP) is formed above 10 % of the originally applied dose, but in only 26 % of the studies are all TP identified. The evaluation also revealed that some TP of pharmaceutical active ingredients show a considerably longer DT compared to the parent compound. An example is the TP (val)sartan acid that is formed from an antihypertensive compound. [ABSTRACT FROM AUTHOR]

Abstract: To assess the toxic effects of three pesticides on non-target organism, we exposed the earthworm Eisenia fetida (Savigny 1826) to artificial soil supplemented with different concentrations of the examined pesticides based on the recommended agricultural doses (RAD). Their commercial formulations are: Galition G-5 (insecticide: active ingredient, a.i., malathion and fenitrothion), Terbis (herbicide: a.i. terbuthylazine), and Gardene (limacide: a.i. metaldehyde). The laboratory test was conducted according to the OECD guidelines. Mortality, biomass, and growth inhibition were chosen as toxic endpoints. No death was recorded at the lowest concentration (1/4 RAD) of the insecticide or the limacide after 7- and 14-day exposures, nor was it recorded at the highest concentration (4× RAD) of the insecticide or the limacide after 7-day exposure. Triazine herbicide Terbis was found the most toxic and ecologically dangerous to E. fetida, because it LC50 value (1.26 mg kg−1) was very close to the respective RAD and the growth inhibition in all concentrations was significantly positive. Although E. fetida was found susceptible to the organophosphorus insecticide Galition, due to the significant positive growth inhibition at the highest concentration, the value of LC50 was higher than its RAD. On the other hand, metaldehyde limacide Gardena was found ecologically safe because the LC50 value was higher than its RAD and weight was not significantly changed. [Copyright &y& Elsevier]