Your browser doesn't support javascript.
loading
Binary test battery with KeratinoSens™ and h-CLAT as part of a bottom-up approach for skin sensitization hazard prediction.
Otsubo, Yuki; Nishijo, Taku; Miyazawa, Masaaki; Saito, Kazutoshi; Mizumachi, Hideyuki; Sakaguchi, Hitoshi.
Afiliação
  • Otsubo Y; Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, Haga, Tochigi 321-3497, Japan.
  • Nishijo T; Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, Haga, Tochigi 321-3497, Japan.
  • Miyazawa M; Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, Haga, Tochigi 321-3497, Japan. Electronic address: miyazawa.masaaki@kao.co.jp.
  • Saito K; Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, Haga, Tochigi 321-3497, Japan.
  • Mizumachi H; Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, Haga, Tochigi 321-3497, Japan.
  • Sakaguchi H; Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai, Haga, Tochigi 321-3497, Japan.
Regul Toxicol Pharmacol ; 88: 118-124, 2017 Aug.
Article em En | MEDLINE | ID: mdl-28602621
Skin sensitization is one of the key safety endpoints for chemicals applied directly to the skin. Several integrated testing strategies (ITS) using multiple non-animal test methods have been developed to accurately evaluate the sensitizing potential of chemicals, but there is no regulatory-accepted ITS to classify a chemical as a non-sensitizer. In this study, the predictive performance of a binary test battery with KeratinoSens™ and h-CLAT compared to the local lymph node assay (LLNA) and human data was examined using comprehensive dataset of 203 chemicals. When two negative results indicate a non-sensitizer, the binary test battery provided sensitivity of 93.4% or 94.4% compared with the LLNA or human data. Taking into account the predictive limitations (i.e. high log Kow, pre-/pro-haptens and acyl transfer agents (or amine-reactive)), the binary test battery had extremely high sensitivity comparable to that of the 3 out of 3 ITS where three negative results of the DPRA, KeratinoSens™ and h-CLAT indicate a non-sensitizer. Therefore, the data from KeratinoSens™ or h-CLAT may provide partly redundant information on the molecular initiating event derived from DPRA. Taken together, the binary test battery of KeratinoSens™ and h-CLAT could be used as part of a bottom-up approach for skin sensitization hazard prediction.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Alérgenos / Dermatite Alérgica de Contato / Ensaio Local de Linfonodo Tipo de estudo: Diagnostic_studies / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Japão

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Alérgenos / Dermatite Alérgica de Contato / Ensaio Local de Linfonodo Tipo de estudo: Diagnostic_studies / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Japão