The way forward for assessing the human health safety of cosmetics in the EU - Workshop proceedings

Rogiers, Vera; Benfenati, Emilio; Bernauer, Ulrike; Bodin, Laurent; Carmichael, Paul L.; Chaudhry, Qasim; Coenraads, Pieter Jan; Cronin, Mark T.D.; Dent, Matthew; Dušinská, Maria; Ellison, Corie A.; Ezendam, Janine; Gaffet, Éric; Galli, Corrado L.; Goebel, Carsten; Granum, Berit; Hollnagel, Heli M.; Kern, Petra; Kosemund-Meynen, Kirstin; Ouédraogo, Gladys; Panteri, Eirini; Rousselle, Christophe; Stępnik, Maciej; Vanhaecke, Tamara; Goetz, Natalie von; Worth, Andrew

doi:10.1016/j.tox.2020.152421

Cited by 43 publications

(37 citation statements)

References 49 publications

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“…Although scientific challenges remain to be tackled before NAMs are used by default in safety evaluations and advantages with their use, such as an increased relevance to human health, becomes evident. Indeed, NAMs have shown great promise to provide a large amount of data to fill information gaps in both hazard and exposure assessments (Rogiers et al 2020). NGRA is anticipated to be hypothesis-driven and exposure-led, including multiple NAMs which are integrated and combined in novel approaches (Dent et al 2018).…”

Section: Resultsmentioning

confidence: 99%

Screening of repeated dose toxicity data in safety evaluation reports of cosmetic ingredients issued by the Scientific Committee on Consumer Safety between 2009 and 2019

et al. 2020

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A focal point in the safety evaluation of cosmetic ingredients includes oral repeated dose toxicity testing, which is intended to address the most complex human endpoints. Seven years after the full implementation of the animal testing ban for cosmetic ingredients in the EU, there are still no alternative methods available capable of fully replacing oral repeated dose toxicity testing. Until this issue is resolved, the development of new cosmetic ingredients remains seriously hampered. The present paper describes a thorough screening of the oral repeated dose toxicity data included in safety evaluation reports of cosmetic ingredients addressed in the Annexes of the Cosmetics Regulation (EC) No 1223/2009, issued by the Scientific Committee on Consumer Safety between 2009 and 2019. The liver and the haematological system were identified as the potentially most frequently affected organs upon oral administration of cosmetic ingredients to animals. Evaluation of altered biochemical, morphological, and histopathological parameters related to hepatotoxicity indicated that the most recurrent events are liver weight changes, elevated liver enzymes, and alterations in serum cholesterol and bilirubin levels. Combined listing of affected parameters associated with steatosis and cholestasis indicated the possible occurrence of cholestasis, provoked by a limited number of cosmetic ingredients. The most frequently affected parameters related to the haematological system were indicative of anaemia. An in-depth analysis allowed characterisation of both regenerative and non-regenerative anaemia, pointing to direct and indirect haematotoxicity, respectively. The results presented in this study call for prioritisation of research targeted towards the development of new approach methodologies fit for animal-free repeated dose toxicity evaluation of cosmetic ingredients.

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Section: Resultsmentioning

confidence: 99%

Screening of repeated dose toxicity data in safety evaluation reports of cosmetic ingredients issued by the Scientific Committee on Consumer Safety between 2009 and 2019

et al. 2020

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“…VEGA-QSAR ((http://www.vega-qsar.eu/) is integrating In silico QSAR models and read-across method for a number of toxicological data outcomes (Rogiers et al 2020). The molecules can be analyzed for calculating toxicological properties by either inserting SMILES notations or uploading SDF files and then selecting toxicological models for generating numerous information about structure related effects.…”

Section: Adme and Toxicity Studiesmentioning

confidence: 99%

Exploring the active constituents of Oroxylum indicum in intervention of novel coronavirus (COVID-19) based on molecular docking method

Shah¹,

Chaple²,

Arora

et al. 2021

Netw Model Anal Health Inform Bioinforma

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The severe acute respiratory syndrome COVID-19 declared a global pandemic by WHO has become the present wellbeing worry to the whole world. There is an emergent need to search for possible medications. We report in this study a molecular docking study of eighteen Oroxylum indicum molecules with the main protease (M pro) responsible for the replication of SARS-CoV-2 virus. The outcome of their molecular simulation and ADMET properties reveal four potential inhibitors of the enzyme (Baicalein-7-O-diglucoside, Chrysin-7-O-glucuronide, Oroxindin and Scutellarein) with preference of ligand Chrysin-7-Oglucuronide that has the second highest binding energy (− 8.6 kcal/mol) and fully obeys the Lipinski's rule of five.

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“…This requires development of integrated, tiered and iterative strategies that integrate various types of experimental studies, such as high-throughput studies (HTS) and omics analyses with computational techniques, such as quantitative structure-activity relationships (QSAR), threshold of toxicological concern approach (TCC), quantitative in vitroin vivo extrapolation (QIVIVE), physiological-based pharmacokinetics modeling (PBPK) and read-across. [47][48][49] As mentioned above, the revised Annex VI of REACH [50] introduced the concept of nanoform into the regulation, which addresses the information requirements concerning nanoscale variants of chemical substances, such as NMs. The introduction represents an increase in requirements for the authorization and possibility to commercialize NMs and products containing them.…”

Section: Governance Of Emerging Technologiesmentioning

confidence: 99%

Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials

Isigonis

Afantitis

Antunes³

et al. 2020

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Nanotechnologies have reached maturity and market penetration that require nano‐specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)‐by‐Design (SbD) concepts. This paper provides an overview of the state‐of‐the‐art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re‐thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science‐based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally.

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The way forward for assessing the human health safety of cosmetics in the EU - Workshop proceedings

Cited by 43 publications

References 49 publications

Screening of repeated dose toxicity data in safety evaluation reports of cosmetic ingredients issued by the Scientific Committee on Consumer Safety between 2009 and 2019

Screening of repeated dose toxicity data in safety evaluation reports of cosmetic ingredients issued by the Scientific Committee on Consumer Safety between 2009 and 2019

Exploring the active constituents of Oroxylum indicum in intervention of novel coronavirus (COVID-19) based on molecular docking method

Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials

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