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2. Moving forward in carcinogenicity assessment: Report of an EURL ECVAM/ESTIV workshop

Author

Corvi, Raffaella, Madia, Federica, Guyton, Kathryn Z, Kasper, Peter, Rudel, Ruthann, Colacci, Annamaria, Kleinjans, Jos, and Jennings, Paul

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Animal Testing Alternatives, Animals, Breast Neoplasms, Carcinogenicity Tests, Carcinogens, Consensus Development Conferences as Topic, Europe, Female, Humans, Mice, Proportional Hazards Models, Rats, Technology, Toxicogenetics, Carcinogenicity, Alternative methods, Rodent bioassay, Toxicogenomics, Mechanisms, Cancer hallmarks, CTA, Toxicology, Pharmacology and pharmaceutical sciences
Abstract

There is an increased need to develop novel alternative approaches to the two-year rodent bioassay for the carcinogenicity assessment of substances where the rodent bioassay is still a basic requirement, as well as for those substances where animal use is banned or limited or where information gaps are identified within legislation. The current progress in this area was addressed in a EURL ECVAM- ESTIV workshop held in October 2016, in Juan les Pins. A number of initiatives were presented and discussed, including data-driven, technology-driven and pathway-driven approaches. Despite a seemingly diverse range of strategic developments, commonalities are emerging. For example, providing insight into carcinogenicity mechanisms is becoming an increasingly appreciated aspect of hazard assessment and is suggested to be the best strategy to drive new developments. Thus, now more than ever, there is a need to combine and focus efforts towards the integration of available information between sectors. Such cross-sectorial harmonisation will aid in building confidence in new approach methods leading to increased implementation and thus a decreased necessity for the two-year rodent bioassay.

Published
2017

3. Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders

Author

Diemar, Michael G., Vinken, Mathieu, Teunis, Marc, Krul, Cyrille A.M., Busquet, Francois, Zajac, Julia Dominika, Kandarova, Helena, Corvi, Raffaella, Rosso, Matteo Z., Kharina, Anastasiia, Bryndum, Louise Stab, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris P., Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm J., Castell, Jose V., Benfenati, Emilio, Yang, Huan, Perera, Simón, Paini, Alicia, Kramer, Nynke I., Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel G.J., Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, Roggen, Erwin L., Diemar, Michael G., Vinken, Mathieu, Teunis, Marc, Krul, Cyrille A.M., Busquet, Francois, Zajac, Julia Dominika, Kandarova, Helena, Corvi, Raffaella, Rosso, Matteo Z., Kharina, Anastasiia, Bryndum, Louise Stab, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris P., Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm J., Castell, Jose V., Benfenati, Emilio, Yang, Huan, Perera, Simón, Paini, Alicia, Kramer, Nynke I., Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel G.J., Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, and Roggen, Erwin L.

Abstract

The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13–14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a ‘hackathon’ to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.

Published
2024

4. Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders

Author

European Commission, Diemar, Michael G., Vinken, Mathieu, Teunis, Marc, Krul, Cyrille A. M., Busquet, Francois, Zajac, Julia Dominika, Kandarova, Helena, Corvi, Raffaella, Rosso, Matteo Z., Kharina, Anastasiia, Bryndum, Louise Stab, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris P., Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm J., Castell, José V., Benfenati, Emilio, Yang, Huan, Perera-Del-Rosario, Simón, Paini, Alicia, Kramer, Nynke I., Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel G. J., Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, Roggen, Erwin L., European Commission, Diemar, Michael G., Vinken, Mathieu, Teunis, Marc, Krul, Cyrille A. M., Busquet, Francois, Zajac, Julia Dominika, Kandarova, Helena, Corvi, Raffaella, Rosso, Matteo Z., Kharina, Anastasiia, Bryndum, Louise Stab, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris P., Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm J., Castell, José V., Benfenati, Emilio, Yang, Huan, Perera-Del-Rosario, Simón, Paini, Alicia, Kramer, Nynke I., Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel G. J., Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, and Roggen, Erwin L.

Abstract

The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13–14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a ‘hackathon’ to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.

Published
2024

5. Report of the First ONTOX Stakeholder Network Meeting : Digging Under the Surface of ONTOX Together With the Stakeholders

Author

Diemar, Michael, Vinken, Mathieu, Teunis, Marc, Krul, Cyrille, Busquet, Francois, Dominika Zajac, Julia, Kandarova, Helena, Corvi, Raffaella, Rossi, Matteo, Kharina, Anastasiia, Stab Bryndum, Louise, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris, Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm, Castell, Jose, Benfenati, Emilio, Yang, Huan, Perera, Simón, Paini, Alicia, Kramer, Nynke, Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel, Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, Roggen, Erwin L., Diemar, Michael, Vinken, Mathieu, Teunis, Marc, Krul, Cyrille, Busquet, Francois, Dominika Zajac, Julia, Kandarova, Helena, Corvi, Raffaella, Rossi, Matteo, Kharina, Anastasiia, Stab Bryndum, Louise, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris, Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm, Castell, Jose, Benfenati, Emilio, Yang, Huan, Perera, Simón, Paini, Alicia, Kramer, Nynke, Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel, Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, and Roggen, Erwin L.

Abstract

The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13–14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a ‘hackathon’ to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.

Published
2024

6. Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders

Author

IRAS OH Toxicology, Afd Pharmacology, IRAS – One Health Toxicology, Diemar, Michael G., Vinken, Mathieu, Teunis, Marc, Krul, Cyrille A.M., Busquet, Francois, Zajac, Julia Dominika, Kandarova, Helena, Corvi, Raffaella, Rosso, Matteo Z., Kharina, Anastasiia, Bryndum, Louise Stab, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris P., Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm J., Castell, Jose V., Benfenati, Emilio, Yang, Huan, Perera, Simón, Paini, Alicia, Kramer, Nynke I., Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel G.J., Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, Roggen, Erwin L., IRAS OH Toxicology, Afd Pharmacology, IRAS – One Health Toxicology, Diemar, Michael G., Vinken, Mathieu, Teunis, Marc, Krul, Cyrille A.M., Busquet, Francois, Zajac, Julia Dominika, Kandarova, Helena, Corvi, Raffaella, Rosso, Matteo Z., Kharina, Anastasiia, Bryndum, Louise Stab, Santillo, Michael, Bloch, Denise, Kucheryavenko, Olena, Panagiotakos, Demosthenes, Rogiers, Vera, Beekhuijzen, Manon, Giusti, Arianna, Najjar, Abdulkarim, Courage, Carol, Koenig, Torben, Kolle, Susanne, Boonen, Harrie, Dhalluin, Stephane, Boberg, Julie, Müller, Boris P., Kukic, Predrag, Ritskes-Hoitinga, Merel, Grasselli, Elena, Zietek, Tamara, Stoddart, Gilly, Heusinkveld, Harm J., Castell, Jose V., Benfenati, Emilio, Yang, Huan, Perera, Simón, Paini, Alicia, Kramer, Nynke I., Hartung, Thomas, Janssen, Manoe, Fritsche, Ellen, Jennen, Danyel G.J., Piumatti, Matteo, Rathman, James, Marusczyk, Jörg, Milec, Lucia, and Roggen, Erwin L.

Published
2024

9. A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals

Author

Luijten, Mirjam, Corvi, Raffaella, Mehta, Jyotigna, Corvaro, Marco, Delrue, Nathalie, Felter, Susan, Haas, Bodo, Hewitt, Nicola J., Hilton, Gina, Holmes, Thomas, Jacobs, Miriam N., Jacobs, Abigail, Lamplmair, Franz, Lewis, Dick, Madia, Federica, Manou, Irene, Melching-Kollmuss, Stephanie, Schorsch, Frederic, Schütte, Katrin, Sewell, Fiona, Strupp, Christian, van der Laan, Jan Willem, Wolf, Douglas C., Wolterink, Gerrit, Woutersen, Ruud, Zvonar, Zvonimir, Heusinkveld, Harm, and Braakhuis, Hedwig

Published
2020
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11. Use of in vitro 3D tissue models in genotoxicity testing: Strategic fit, validation status and way forward. Report of the working group from the 7th International Workshop on Genotoxicity Testing (IWGT)

Author

Pfuhler, Stefan, van Benthem, Jan, Curren, Rodger, Doak, Shareen H., Dusinska, Maria, Hayashi, Makoto, Heflich, Robert H., Kidd, Darren, Kirkland, David, Luan, Yang, Ouedraogo, Gladys, Reisinger, Kerstin, Sofuni, Toshio, van Acker, Frédérique, Yang, Ying, and Corvi, Raffaella

Published
2020
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12. Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders

Author

Diemar, Michael G., primary, Vinken, Mathieu, additional, Teunis, Marc, additional, Krul, Cyrille A.M., additional, Busquet, Francois, additional, Zajac, Julia Dominika, additional, Kandarova, Helena, additional, Corvi, Raffaella, additional, Rossi, Matteo Z., additional, Kharina, Anastasiia, additional, Bryndum, Louise Stab, additional, Santillo, Michael, additional, Bloch, Denise, additional, Kucheryavenko, Olena, additional, Panagiotakos, Demosthenes, additional, Rogiers, Vera, additional, Beekhuijzen, Manon, additional, Giusti, Arianna, additional, Najjar, Abdulkarim, additional, Courage, Carol, additional, Koenig, Torben, additional, Kolle, Susanne, additional, Boonen, Harrie, additional, Dhalluin, Stephane, additional, Boberg, Julie, additional, Müller, Boris P., additional, Kukic, Predrag, additional, Ritskes-Hoitinga, Merel, additional, Grasselli, Elena, additional, Zietek, Tamara, additional, Stoddart, Gilly, additional, Heusinkveld, Harm J., additional, Castell, Jose V., additional, Benfenati, Emilio, additional, Yang, Huan, additional, Perera, Simón, additional, Paini, Alicia, additional, Kramer, Nynke I., additional, Hartung, Thomas, additional, Janssen, Manoe, additional, Fritsche, Ellen, additional, Jennen, Danyel G.J., additional, Piumatti, Matteo, additional, Rathman, James, additional, Marusczyk, Jörg, additional, Milec, Lucia, additional, and Roggen, Erwin L., additional

Published
2024
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13. Chemical carcinogen safety testing: OECD expert group international consensus on the development of an integrated approach for the testing and assessment of chemical non-genotoxic carcinogens

Author

Jacobs, Miriam N., Colacci, Annamaria, Corvi, Raffaella, Vaccari, Monica, Aguila, M. Cecilia, Corvaro, Marco, Delrue, Nathalie, Desaulniers, Daniel, Ertych, Norman, Jacobs, Abigail, Luijten, Mirjam, Madia, Federica, Nishikawa, Akiyoshi, Ogawa, Kumiko, Ohmori, Kiyomi, Paparella, Martin, Sharma, Anoop Kumar, and Vasseur, Paule

Published
2020
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15. Meeting Report: Validation of Toxicogenomics-Based Test Systems: ECVAM-ICCVAM/NICEATM Considerations for Regulatory Use

Author

Corvi, Raffaella, Ahr, Hans-Jürgen, Albertini, Silvio, Blakey, David H., Clerici, Libero, Coecke, Sandra, Douglas, George R., Gribaldo, Laura, Groten, John P., Haase, Bernd, Hamernik, Karen, Hartung, Thomas, Inoue, Tohru, Indans, Ian, Maurici, Daniela, Orphanides, George, Rembges, Diana, Sansone, Susanna-Assunta, Snape, Jason R., Toda, Eisaku, Tong, Weida, van Delft, Joost H., Weis, Brenda, and Schechtman, Leonard M.

Published
2006

20. Contributors

Author

Austin, Christopher P., primary, Balls, Michael, additional, Blaauboer, Bas J., additional, Botham, Philip, additional, Burt, Tal, additional, Casey, Warren, additional, Červinka, Miroslav, additional, Cheng, Shujun, additional, Combes, Robert D., additional, Corvi, Raffaella, additional, Cronin, Mark T.D., additional, Curren, Rodger D., additional, De Angelis, Isabella, additional, Dehne, Eva-Maria, additional, Doe, John, additional, Eskes, Chantra, additional, Feigenbaum, Alexandre, additional, Forgacs, Zsolt, additional, Forsby, Anna, additional, France, Malcolm P., additional, Freeman Bain, Simon A., additional, Goldberg, Alan, additional, Gruber, Franz P., additional, Guillouzo, André, additional, Hartung, Thomas, additional, Heinonen, Tuula, additional, Hickman, James, additional, Hill, Erin H., additional, Imai, Koichi, additional, Kandarova, Helena, additional, Kavlock, Robert J., additional, Kenna, J Gerry, additional, Knudsen, Lisbeth E., additional, Kojima, Hajime, additional, Kolar, Roman, additional, Leist, Marcel, additional, Lidbury, Brett A., additional, Lowit, Anna, additional, Minor, Philip, additional, Pfaller, Walter, additional, Prieto, Pilar, additional, Ram, Rebecca, additional, Repetto, Guillermo, additional, Rogiers, Vera, additional, Roi, Annett J., additional, Rowan, Andrew, additional, Sakai, Yasuyuki, additional, Sesardic, Thea, additional, Shuler, Michael, additional, Śladowski, Dariusz, additional, Spielmann, Horst, additional, Stephens, Martin L., additional, Tähti, Hanna, additional, Tanaka, Noriho, additional, Testai, Emanuela, additional, Tice, Raymond R., additional, Trigwell, Susan, additional, Verfaillie, Catherine, additional, von Aulock, Sonja, additional, Worth, Andrew P., additional, Yoon, Miyoung, additional, and Zuang, Valérie, additional

Published
2019
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23. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results

Author

Uno, Yoshifumi, Kojima, Hajime, Omori, Takashi, Corvi, Raffaella, Honma, Masamistu, Schechtman, Leonard M., Tice, Raymond R., Burlinson, Brian, Escobar, Patricia A., Kraynak, Andrew R., Nakagawa, Yuzuki, Nakajima, Madoka, Pant, Kamala, Asano, Norihide, Lovell, David, Morita, Takeshi, Ohno, Yasuo, and Hayashi, Makoto

Published
2015
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24. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results

Author

Uno, Yoshifumi, Kojima, Hajime, Omori, Takashi, Corvi, Raffaella, Honma, Masamistu, Schechtman, Leonard M., Tice, Raymond R., Beevers, Carol, Boeck, Marlies De, Burlinson, Brian, Hobbs, Cheryl A., Kitamoto, Sachiko, Kraynak, Andrew R., McNamee, James, Nakagawa, Yuzuki, Pant, Kamala, Plappert-Helbig, Ulla, Priestley, Catherine, Takasawa, Hironao, Wada, Kunio, Wirnitzer, Uta, Asano, Norihide, Escobar, Patricia A., Lovell, David, Morita, Takeshi, Nakajima, Madoka, Ohno, Yasuo, and Hayashi, Makoto

Published
2015
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26. ECVAM and New Technologies for Toxicity Testing

Author

Bouvier d’Yvoire, Michel, Bremer, Susanne, Casati, Silvia, Ceridono, Mara, Coecke, Sandra, Corvi, Raffaella, Eskes, Chantra, Gribaldo, Laura, Griesinger, Claudius, Knaut, Holger, Linge, Jens P., Roi, Annett, Zuang, Valérie, Balls, Michael, editor, Combes, Robert D., editor, and Bhogal, Nirmala, editor

Published
2012
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28. Can in vitro mammalian cell genotoxicity test results be used to complement positive results in the Ames test and help predict carcinogenic or in vivo genotoxic activity? I. Reports of individual databases presented at an EURL ECVAM Workshop

Author

Kirkland, David, Zeiger, Errol, Madia, Federica, Gooderham, Nigel, Kasper, Peter, Lynch, Anthony, Morita, Takeshi, Ouedraogo, Gladys, Parra Morte, Juan Manuel, Pfuhler, Stefan, Rogiers, Vera, Schulz, Markus, Thybaud, Veronique, van Benthem, Jan, Vanparys, Philippe, Worth, Andrew, and Corvi, Raffaella

Published
2014
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33. Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology

Author

Harrill, Joshua A., Viant, Mark R., Yauk, Carole L., Sachana, Magdalini, Gant, Timothy W., Auerbach, Scott S., Beger, Richard D., Bouhifd, Mounir, O'Brien, Jason, Burgoon, Lyle, Caiment, Florian, Carpi, Donatella, Chen, Tao, Chorley, Brian N., Colbourne, John, Corvi, Raffaella, Debrauwer, Laurent, O'Donovan, Claire, Ebbels, Timothy M.D., Ekman, Drew R., Faulhammer, Frank, Gribaldo, Laura, Hilton, Gina M., Jones, Stephanie P., Kende, Aniko, Lawson, Thomas N., Leite, Sofia B., Leonards, Pim E.G., Luijten, Mirjam, Martin, Alberto, Moussa, Laura, Rudaz, Serge, Schmitz, Oliver, Sobanski, Tomasz, Strauss, Volker, Vaccari, Monica, Vijay, Vikrant, Weber, Ralf J.M., Williams, Antony J., Williams, Andrew, Thomas, Russell S., and Whelan, Maurice

Published
2021
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34. Reduction of use of animals in regulatory genotoxicity testing: Identification and implementation opportunities—Report from an ECVAM workshop

Author

Pfuhler, Stefan, Kirkland, David, Kasper, Peter, Hayashi, Makoto, Vanparys, Philippe, Carmichael, Paul, Dertinger, Stephen, Eastmond, David, Elhajouji, Azeddine, Krul, Cyrille, Rothfuss, Andreas, Schoening, Gabriele, Smith, Andrew, Speit, Guenter, Thomas, Claire, van Benthem, Jan, and Corvi, Raffaella

Published
2009
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39. Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010

Author

Adler, Sarah, Basketter, David, Creton, Stuart, Pelkonen, Olavi, van Benthem, Jan, Zuang, Valérie, Andersen, Klaus Ejner, Angers-Loustau, Alexandre, Aptula, Aynur, Bal-Price, Anna, Benfenati, Emilio, Bernauer, Ulrike, Bessems, Jos, Bois, Frederic Y., Boobis, Alan, Brandon, Esther, Bremer, Susanne, Broschard, Thomas, Casati, Silvia, Coecke, Sandra, Corvi, Raffaella, Cronin, Mark, Daston, George, Dekant, Wolfgang, Felter, Susan, Grignard, Elise, Gundert-Remy, Ursula, Heinonen, Tuula, Kimber, Ian, Kleinjans, Jos, Komulainen, Hannu, Kreiling, Reinhard, Kreysa, Joachim, Leite, Sofia Batista, Loizou, George, Maxwell, Gavin, Mazzatorta, Paolo, Munn, Sharon, Pfuhler, Stefan, Phrakonkham, Pascal, Piersma, Aldert, Poth, Albrecht, Prieto, Pilar, Repetto, Guillermo, Rogiers, Vera, Schoeters, Greet, Schwarz, Michael, Serafimova, Rositsa, Tähti, Hanna, Testai, Emanuela, van Delft, Joost, van Loveren, Henk, Vinken, Mathieu, Worth, Andrew, and Zaldivar, José-Manuel

Published
2011
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40. The carcinoGENOMICS project: Critical selection of model compounds for the development of omics-based in vitro carcinogenicity screening assays

Author

Vinken, Mathieu, Doktorova, Tatyana, Ellinger-Ziegelbauer, Heidrun, Ahr, Hans-Jürgen, Lock, Edward, Carmichael, Paul, Roggen, Erwin, van Delft, Joost, Kleinjans, Jos, Castell, José, Bort, Roque, Donato, Teresa, Ryan, Michael, Corvi, Raffaella, Keun, Hector, Ebbels, Timothy, Athersuch, Toby, Sansone, Susanna-Assunta, Rocca-Serra, Philippe, Stierum, Rob, Jennings, Paul, Pfaller, Walter, Gmuender, Hans, Vanhaecke, Tamara, and Rogiers, Vera

Published
2008
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43. Non-animal Methods in Science and Regulation: EURL ECVAM Status Report 2020

Author

ZUANG VALERIE, DURA ADELAIDE, ASTURIOL BOFILL DAVID, BATISTA LEITE SOFIA, BERGGREN ELISABET, BOPP STEPHANIE, CARPI DONATELLA, CASATI SILVIA, COECKE SANDRA, CORVI RAFFAELLA, DECEUNINCK PIERRE, FRANCO ANTONIO, GRIBALDO LAURA, HALDER MARIA ELISABETH, HOLLOWAY MARCELLE, KIENZLER AUDE, LANGEZAAL INGRID, MADIA FEDERICA, MILCAMPS ANNE, MUNN SHARON, PAINI ALICIA, PIERGIOVANNI MONICA, PISTOLLATO FRANCESCA, PRICE ANNA, PRIETO PERAITA MARIA DEL PILAR, VIEGAS BARROSO JOAO FILIPE, WITTWEHR CLEMENS, WORTH ANDREW, and WHELAN MAURICE

Abstract

The annual EURL ECVAM status report describes research, development and validation activities, as well as initiatives that promote the regulatory use and international adoption of non-animal methods and approaches and their dissemination in the regulatory and research arenas. EU policies and legislation call for innovative and more efficient ways of safety testing and chemical risk assessment that do not depend on animal testing. Advanced technologies such as computational models, in vitro methods and organ-on-chip devices are being developed, evaluated and integrated to translate mechanistic understanding of toxicity into safety testing strategies. The ultimate goal is to achieve better protection of human health and the environment while supporting EU innovation and industrial competitiveness, without the use of animals. The development and use of non-animal models and methods are also essential for advancing basic, applied and translational research. Education also plays an essential role in enabling a shift to non-animal methods through the introduction of the Three Rs (Replacement, Reduction and Refinement of animal use in science) into secondary school curricula and programmes of higher education., JRC.F.3-Chemicals Safety and Alternative Methods

Published
2020

44. Establishing the scientific validity of complex in vitro models: Results of a EURL ECVAM survey

Author

BATISTA LEITE SOFIA, ZINCKE DOS REIS FERNANDES CIPRIANO MADALENA, CARPI DONATELLA, COECKE SANDRA, HOLLOWAY MARCELLE, CORVI RAFFAELLA, WORTH ANDREW, VIEGAS BARROSO JOAO FILIPE, and WHELAN MAURICE

Abstract

Complex in vitro models (CIVMs) - such as 3D cell cultures and spheroids, microphysiological systems including organ-on-chip devices, bioreactor cultures or bioprinted tissues – aim to represent higher-level anatomical and physiological aspects of human biology in experimental studies. The underpinning technologies are developing fast and the models and methods being created constitute promising approaches in several different scientific areas with many applications in research and regulatory testing. However, the successful implementation and acceptance of CIVMs is likely to require their proper characterisation, validation or qualification to demonstrate to end-users that they are fit for a particular purpose or context of use. To explore this, the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) of the European Commission's Joint Research Centre (JRC) conducted a survey to investigate stakeholder opinions and perceived needs. The outcome of the survey showed that i) there is high interest in establishing some kind of assessment approaches for CIVMs; ii) assessment approaches (even if conducted differently) should be adequate not only for regulatory use-contexts but also address applications in research; and iii) CIVMs are still under (technological and biological) development and are thus not yet mature or standardised enough to enable a consensus on how their assessment should be conducted., JRC.F.3-Chemicals Safety and Alternative Methods

Published
2020

45. EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches (2019)

Author

ZUANG VALERIE, DURA ADELAIDE, ASTURIOL BOFILL DAVID, BATISTA LEITE SOFIA, BERGGREN ELISABET, BERNASCONI CAMILLA, BOPP STEPHANIE, BOWE GERARD, CAMPIA IVANA, CARPI DONATELLA, CASATI SILVIA, COECKE SANDRA, COLE THOMAS, CORVI RAFFAELLA, DECEUNINCK PIERRE, FORTANER TORRENT SALVADOR, FRANCO ANTONIO, GRIBALDO LAURA, GRIGNARD ELISE, HALDER MARIA ELISABETH, HOLLOWAY MARCELLE, KIENZLER AUDE, MACKO PETER, MADIA FEDERICA, MILCAMPS ANNE, MORATH SIEGFRIED, MUNN SHARON, PAINI ALICIA, PALOSAARI TAINA, PISTOLLATO FRANCESCA, PRICE ANNA, PRIETO PERAITA MARIA DEL PILAR, SUND JUKKA, VIEGAS BARROSO JOAO FILIPE, WITTWEHR CLEMENS, WORTH ANDREW, and WHELAN MAURICE

Abstract

The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) is an integral part of the European Commision's Joint Research Centre. The EURL ECVAM status report informs about research and development activities, test method submissions, validation and peer reviews, activities that promote the regulatory acceptance and international adoption of alternative methods and approaches and their dissemination. Replacement, reduction and refinement of animal testing (Three Rs) in basic, applied and translational research, as well as for regulatory purposes is anchored in EU legislation. Innovative technologies (e.g., computational models, in vitro methods, organ-on-chip devices) are developed, evaluated and integrated in assessment strategies for chemicals and products safety testing in order to preserve a high level of protection for human health and the environment. Important activities to promote the development and use of alternative methods and approaches are also pursued in the areas of basic and applied research as well as for education purposes., JRC.F.3-Chemicals Safety and Alternative Methods

Published
2020

46. How to reduce false positive results when undertaking in vitro genotoxicity testing and thus avoid unnecessary follow-up animal tests: Report of an ECVAM Workshop

Author

Kirkland, David, Pfuhler, Stefan, Tweats, David, Aardema, Marilyn, Corvi, Raffaella, Darroudi, Firouz, Elhajouji, Azeddine, Glatt, Hansruedi, Hastwell, Paul, Hayashi, Makoto, Kasper, Peter, Kirchner, Stephan, Lynch, Anthony, Marzin, Daniel, Maurici, Daniela, Meunier, Jean-Roc, Müller, Lutz, Nohynek, Gerhard, Parry, James, Parry, Elizabeth, Thybaud, Veronique, Tice, Ray, van Benthem, Jan, Vanparys, Philippe, and White, Paul

Published
2007
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49. The 3T3 neutral red uptake phototoxicity test: Practical experience and implications for phototoxicity testing – The report of an ECVAM–EFPIA workshop

Author

Ceridono, Mara, Tellner, Pär, Bauer, Daniel, Barroso, João, Alépée, Nathalie, Corvi, Raffaella, De Smedt, Ann, Fellows, Mick D., Gibbs, Neil K., Heisler, Eckhard, Jacobs, Abigail, Jirova, Dagmar, Jones, David, Kandárová, Helena, Kasper, Peter, Akunda, Jacqueline Kinyamu, Krul, Cyrille, Learn, Douglas, Liebsch, Manfred, Lynch, Anthony M., Muster, Wolfgang, Nakamura, Kazuichi, Nash, Frank J., Pfannenbecker, Uwe, Phillips, Gareth, Robles, Catherine, Rogiers, Vera, Van De Water, Femke, Liminga, Ulla Wändel, Vohr, Hans-Werner, Wattrelos, Olivier, Woods, Julie, Zuang, Valérie, Kreysa, Joachim, and Wilcox, Phil

Published
2012
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