Browsing by Author "Stepnik, Maciej"
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- In vitro testing strategy for nanomaterials including database (Deliverable 5): final reportPublication . Norppa, Hannu; Siivola, Kirsi; Fessard, Valérie; Tarantini, Adeline; Apostolova, Margarita; Jacobsen, Nicklas Raun; Wallin, Håkan; Goetz, Mario E.; Fieblinger, Dagmar; Stepnik, Maciej; Simar, Sophie; Quarre, Stéphanie; Nesslany, Fabrice; Jong, Wim de; Marcos, Ricard; Vales, Gerard; Troisfontaines, Paul; Guichard, Yves; Tavares, Ana; Louro, Henriqueta; Silva, Maria JoãoWP5 had two objectives: - To generate in vitro genotoxicity data on manufactured MNs (specific objective #3). - To perform a round robin test on in vitro genotoxicity testing of MNs (specific objective #4) WP5 addressed the basic questions of in vitro genotoxicity testing of manufactured nanomaterials (MNs): how well in vitro assays can be used for revealing the genotoxic potential of MNs, which assays are suitable for this task, and which modifications are needed in standard tests when MNs are studied. WP5 aimed at establishing robust methodology to screen the in vitro genotoxicity of MNs in pulmonary, oral, and epidermal cell systems. These assays were to be applied to all MNs included in the project. On the basis of the results obtained, a ring test was to be performed using the most promising approach. Finally, the results were to be evaluated for correlation with in vivo results and used, together with other genotoxicity data available and the kinetic results, to formulate a strategy for genotoxicity testing of MNs (this deliverable).
- Inter-laboratory variation in DNA damage using a standard comet assay protocolPublication . Forchhammer, Lykke; Ersson, Clara; Loft, Steffen; Moller, Lennart; Godschalk, Roger W. L.; van Schooten, Frederik J; Jones, George D. D.; Higgins, Jennifer A.; Cooke, Marcus; Mistry, Vilas; Karbaschi, Mahsa; Collins, Andrew R.; Azqueta, Amaya; Phillips, David H.; Sozeri, Osman; Routledge, Michael N.; Nelson-Smith, Kirsty; Riso, Patrizia; Porrini, Marisa; Matullo, Giuseppe; Allione, Alessandra; Stepnik, Maciej; Komorowska, Magdalena; Teixeira, João Paulo; Costa, Solange; Corcuera, Laura-Ana; Lopez de Cerain, Adela; Laffon, Blanca; Valdiglesias, Vanessa; Moller, PeterThere are substantial inter-laboratory variations in the levels of DNA damage measured by the comet assay. The aim of this study was to investigate whether adherence to a standard comet assay protocol would reduce inter-laboratory variation in reported values of DNA damage. Fourteen laboratories determined the baseline level of DNA strand breaks (SBs)/alkaline labile sites and formamidopyrimidine DNA glycosylase (FPG)-sensitive sites in coded samples of mononuclear blood cells (MNBCs) from healthy volunteers. There were technical problems in seven laboratories in adopting the standard protocol, which were not related to the level of experience. Therefore, the inter-laboratory variation in DNA damage was only analysed using the results from laboratories that had obtained complete data with the standard comet assay protocol. This analysis showed that the differences between reported levels of DNA SBs/alkaline labile sites in MNBCs were not reduced by applying the standard assay protocol as compared with the laboratory's own protocol. There was large inter-laboratory variation in FPG-sensitive sites by the laboratory-specific protocol and the variation was reduced when the samples were analysed by the standard protocol. The SBs and FPG-sensitive sites were measured in the same experiment, indicating that the large spread in the latter lesions was the main reason for the reduced inter-laboratory variation. However, it remains worrying that half of the participating laboratories obtained poor results using the standard procedure. This study indicates that future comet assay validation trials should take steps to evaluate the implementation of standard procedures in participating laboratories.
- SCCS Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6)– SCCS/1669/24Publication . Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Ezendam, Janine; Gaffet, Eric; Galli, Corrado L.; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; Stepnik, Maciej; Vanhaecke, Tamara; Wijnhoven, Susan; Benfenati, Emilio; Corsini, Emanuela; Koutsodimou, Aglaia; Aglaia Koutsodimou; Louro, Henriqueta; Uter, Wolfgang; von Goetz, NatalieHighlights: -o-Phenylphenol (OPP) is safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off cosmetic products; - o-Phenylphenol (OPP) is safe when used as preservative up to a maximum concentration of 0.15 % in leave-on cosmetic products; - Sodium o-Phenylphenate is safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off cosmetic products; - Sodium o-Phenylphenate is safe when used as preservative up to a maximum concentration of 0.15 % in leave-on cosmetic products; - OPP and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.15 % in leave-on cosmetic products; - OPP and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.2 % in rinse-off cosmetic products; - Since this safety dossier related to dermally applied products only, the SCCS did not consider oral and inhalation routes; - This assessment did not cover the safety of O-Phenylphenol and Sodium o-Phenylphenate for the environment.
- Scientific Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products – SCCS/1660/23Publication . Van Haecke, Tamara; Rogiers, Vera; Scientific Committee on Consumer Safety - SCCS; Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Ezendam, Janine; Gaffet, Eric; Galli, Corrado L.; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; Stepnik, Maciej; Vanhaecke, Tamara; Wijnhoven, Susan; Benfenati, Emilio; Cabaton, Nicolas; Corsini, Emanuela; Koutsodimou, Aglaia; Louro, Henriqueta; Uter, Wolfgang; von Goetz, NatalieHighlights: -BZP-4 is safe when used as UV filter up to a max. conc. of 5 % in sunscreen, all leave-on products (tot. dermal aggregate); -BZP-4 is safe when used as UV filter up to a max. conc. of 5 % in sunscreen, all rinse-off products (tot. dermal aggregate); -Same for lipstick, sunscreen propellant and pump spray (separately or in combination based on determ. aggregated exposure); -BZP-4 use as stabiliser when the product is exposed to light should remain within the conc. of. 5 %, incl. UV-filter use; -This assessment did not cover the safety of Benzophenone-4 for the environment.
- Variation in the measurement of DNA damage by comet assay measured by the ECVAG† inter-laboratory validation trialPublication . Forchhammer, Lykke; Johansson, Clara; Loft, Steffen; Möller, Lennart; Godschalk, Roger, W. L.; Langie, Sabine A. S.; Jones, George D. D.; Kwok, Rachel W. L.; Collins, Andrew R.; Azqueta, Amaya; Phillips, David H.; Sozeri, Osman; Stepnik, Maciej; Palus, Jadwiga; Vogel, Ulla; Wallin, Hakan; Routledge, Michael N.; Handforth, Catherine; Allione, Alessandra; Matullo, Giuseppe; Teixeira, João Paulo; Costa, Solange; Riso, Patrizia; Porrini, Marisa; Møller, PeterThe comet assay has become a popular method for the assessment of DNA damage in biomonitoring studies and genetic toxicology. However, few studies have addressed the issue of the noted inter-laboratory variability of DNA damage measured by the comet assay. In this study, 12 laboratories analysed the level of DNA damage in monocyte-derived THP-1 cells by either visual classification or computer-aided image analysis of pre-made slides, coded cryopreserved samples of cells and reference standard cells (calibration curve samples). The reference standard samples were irradiated with ionizing radiation (0–10 Gy) and used to construct a calibration curve to calculate the number of lesions per 106 base pair. All laboratories detected dose–response relationships in the coded samples irradiated with ionizing radiation (1.5–7 Gy), but there were overt differences in the level of DNA damage reported by the different laboratories as evidenced by an inter-laboratory coefficient of variation (CV) of 47%. Adjustment of the primary comet assay end points by a calibration curve prepared in each laboratory reduced the CV to 28%, a statistically significant reduction (P < 0.05, Levene's test). A large fraction of the inter-laboratory variation originated from differences in image analysis, whereas the intra-laboratory variation was considerably smaller than the variation between laboratories. In summary, adjustment of primary comet assay results by reference standards reduces inter-laboratory variation in the level of DNA damage measured by the alkaline version of the comet assay.