A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

Basketter, David A.; Clewell, Harvey J.; Kimber, Ian; Rossi, Annamaria; Blaauboer, Bas J.; Burrier, Robert E.; Daneshian, Mardas; Eskes, Chantra; Goldberg, Alan M.; Hasiwa, Nina; Hoffmann, Sebastian; Jaworska, Joanna; Knudsen, Thomas B.; Landsiedel, Robert; Leist, Marcel; Locke, Paul A.; Maxwell, Gavin; McKim, James M.; McVey, Emily; Ouédraogo, Gladys; Patlewicz, Grace; Pelkonen, Olavi; Roggen, Erwin L.; Rovida, Costanza; Ruhdel, Irmela; Schwarz, Michael; Schepky, Andreas; Schoeters, Greet; Skinner, Nigel; Trentz, Kerstin; Turner, Marian; Vanparys, Philippe; Yager, James D.; Zurlo, Joanne; Hartung, Thomas

doi:10.14573/altex.2012.1.003

Cited by 201 publications

(165 citation statements)

References 439 publications

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“…O uso de métodos in vitro pode reduzir a extensão de testes em animais e pode diminuir, significativamente, de uma forma geral o tempo e o custo das análises (PRESGRAVE, et. Al., 2010;BASKETTER et al, 2012;SÀNDOR, 2013;VICTAL et al, 2014). Segundo Barros (2013), o biopolímero de cana-de-açúcar demonstrou-se ser um suporte adequado para o cultivo de células-tronco mesenquimais, que também se caracterizam como células com aspecto fibroblastóide, e foi capaz de sustentar o crescimento das mesmas, favorecendo a remodelação citoplasmática, assim 41 como proporcionando um ambiente adequado para a diferenciação dessas células em queratinócitos (ARAÚJO et al, 2014).…”

Section: Resultsunclassified

“…Neste contexto, deve-se levar em conta também, que modelos de cultura celular estão se tornando prevalentes na investigação da reação dos tecidos a materiais de implantes e que o uso de métodos in vitro pode reduzir a extensão de testes em animais e diminuir significativamente o tempo e o custo das análises de uma forma geral (CARVALHO et al, 2010;PRESGRAVE, et. al., 2010;BASKETTER et al, 2012;VICTAL et al, 2014 -BEEDLE et al, 2000;CASTRO, et al, 2004;CAVALCANTE, et al, 2007;SILVEIRA et al, 2007;MAYER et al, 2011;MARTINS et al, 2013;SILVEIRA et al, 2014;ABREU et al, 2016).…”

Section: Introductionunclassified

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Aspectos Morfológicos E Morfométricos Da Interação De Células Vero Com Membranas De Biopolímero De Cana-De-Açúcar

Muniz-Filho¹,

Ferreira²,

Oliveira³

et al. 2017

Blucher Biophysics Proceedings

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Section: Resultsunclassified

Section: Introductionunclassified

Aspectos Morfológicos E Morfométricos Da Interação De Células Vero Com Membranas De Biopolímero De Cana-De-Açúcar

Muniz-Filho¹,

Ferreira²,

Oliveira³

et al. 2017

Blucher Biophysics Proceedings

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“…Rats and mice, for example, predicted together, only 43% of clinical toxicities of candidate drugs observed later. In toxicology, we have seen that different laboratory species exposed to the same high doses predict each other no better than 60% (Basketter et al, 2012) -and there is no reason to assume that any of them predict human toxicity better at low doses. We lack drug efficacy models for systematically comparing outcomes in different strains or species of laboratory animals.…”

Section: Limited Predictivity For Humansmentioning

confidence: 99%

Evolution of toxicological science: the need for change

Hartung

2017

IJRAM

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Evolution requires change but the field of toxicology has not kept pace. The top ten problems urging change are: 1) disparity of testing requirements and risk acceptance for different products and geographical areas; 2) throughput and testing costs versus testing needs; 3) limited predictivity for humans; 4) precautionary approaches from drug development adapted to other areas; 5) animal use; 6) traditional tests unsuitable for new products; 7) lack of coverage for new hazards; 8) failure to address mixtures of toxicants; 9) lack of coverage for individual susceptibilities and vulnerable subpopulations; 10) poor basic research and publication standards. The intransigence at the root of these problems is discussed with reference to current international toxicological policies and methods. For each, the limitations are reviewed with reference to key literature. While current approaches are still needed, there is room for substantial change. To meet the challenges of the 21st century, revolution rather than evolution is required.

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“…First, as measured by the murine local lymph node assay (LLNA), skin sensitization potency may span four orders of magnitude [14]. Second, existing alternative test methods are deemed as not appropriate for potency predictions [15,16] partly due to an insufficient dynamic range. Third, it is not clear what measurements, other than reaction kinetics, are necessary to predict potency [11,17].…”

Section: Its Approaches State Of the Artmentioning

confidence: 99%

Integrated Testing Strategies for Skin Sensitization Hazard and Potency Assessment—State of the Art and Challenges

Jaworska

2016

Cosmetics

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Abstract:The paper provides an overview of existing Integrated Testing Strategies (ITS) for assessing hazard and potency of skin sensitization. The ITS research is active, diverse and constantly evolving as new assays are being developed and new mechanistic insights are discovered. Despite the need to assess potency, the majority of the ITS approaches developed to date assess hazard only. Reasons for this situation are analyzed and include, for example, the dynamic range of existing alternative assays versus the range of in vivo responses, but also sporadic use of kinetic information and molar units. Depending on the application, regulatory or product development, standardized and nonstandard ITS approaches will be developed. Challenges to practical applications, with focus on regulatory are discussed.

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A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

Cited by 201 publications

References 439 publications

Aspectos Morfológicos E Morfométricos Da Interação De Células Vero Com Membranas De Biopolímero De Cana-De-Açúcar

Aspectos Morfológicos E Morfométricos Da Interação De Células Vero Com Membranas De Biopolímero De Cana-De-Açúcar

Evolution of toxicological science: the need for change

Integrated Testing Strategies for Skin Sensitization Hazard and Potency Assessment—State of the Art and Challenges

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