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2. Alternative approaches for identifying acute systemic toxicity: Moving from research to regulatory testing

Author

Hamm, Jon, Sullivan, Kristie, Clippinger, Amy J., Strickland, Judy, Bell, Shannon, Bhhatarai, Barun, Blaauboer, Bas, Casey, Warren, Dorman, David, Forsby, Anna, Garcia-Reyero, Natàlia, Gehen, Sean, Graepel, Rabea, Hotchkiss, Jon, Lowit, Anna, Matheson, Joanna, Reaves, Elissa, Scarano, Louis, Sprankle, Catherine, Tunkel, Jay, Wilson, Dan, Xia, Menghang, Zhu, Hao, and Allen, David

Published
2017
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5. U.S. Federal Agency Interests and Key Considerations for New Approach Methodologies for Nanomaterials.

Author

Petersen, Elijah J., Ceger, Patricia, Allen, David G., Coyle, Jayme, Derk, Raymond, Garcia-Reyero, Natàlia, Gordon, John, Kleinstreuer, Nicole C., Matheson, Joanna, McShan, Danielle, Nelson, Bryant C., Patri, Anil K., Rice, Penelope, Rojanasakul, Liying, Sasidharan, Abhilash, Scarano, Louis, and Xiaoqing Chang

Abstract

Engineered nanomaterials (ENMs) come in a wide array of shapes, sizes, surface coatings, and compositions, and often possess novel or enhanced properties compared to larger sized particles of the same elemental composition. To ensure the safe commercialization of products containing ENMs, it is important to thoroughly understand their potential risks. Given that ENMs can be created in an almost infinite number of variations, it is not feasible to conduct in vivo testing on each type of ENM. Instead, new approach methodologies (NAMs) such as in vitro or in chemico test methods may be needed, given their capacity for higher throughput testing, lower cost, and ability to provide information on toxicological mechanisms. However, the different behaviors of ENMs compared to dissolved chemicals may challenge safety testing of ENMs using NAMs. In this study, member agencies within the Interagency Coordinating Committee on the Validation of Alternative Methods were queried about what types of ENMs are of agency interest and whether there is agency-specific guidance for ENM toxicity testing. To support the ability of NAMs to provide robust results in ENM testing, two key issues in the usage of NAMs, namely dosimetry and interference/bias controls, are thoroughly discussed. [ABSTRACT FROM AUTHOR]

Published
2022
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7. Revisiting and updating chemical groupings with new approach methodologies

Author

Chang, Daniel, Fay, Kellie, Markey, Kristan, Phillips, Martin, Patlewicz, Grace, Richard, Ann, Scarano, Louis, Shobair, Mahmoud, Lougee, Ryan, Saluck, Ellery, Prindiville, John, Inglis, Christina, Lewis, Mark, and Mansouri, Kamel

Subjects
Toxicology
Abstract

Presentation to the APCRA-5 Virtual Teleconference (Accelerating the Pace of Chemical Risk Assessment) August 2020

Published
2020
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8. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Read Across Workgroup: Towards Guiding Principles for Read-Across Application

Author

Rooney, John, Lizarraga, Lucina, Yamada, Takashi, Allen, David, Babich, Michael, Daniel, Amber, Fitzpatrick, Suzanne, Natàlia Garcia-Reyero, Gordon, John, Hakkinen, Pertti, Karmaus, Agnes, Kleinstreuer, Nicole, Matheson, Joanna, Moiz Mumtaz, Rua, Diego, Ruiz, Patricia, Scarano, Louis, Patra Volarath, and Patlewicz, Grace

Subjects
Toxicology
Abstract

Presentation given to the The American Society for Cellular and Computational Toxicology (ASCCT) annual meeting October 2020

Published
2020
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10. Alternative approaches for identifying acute systemic toxicity: Moving from research to regulatory testing

Author

LS IRAS Tox CMT/ATX, dIRAS RA-1, Hamm, Jon, Sullivan, Kristie, Clippinger, Amy J, Strickland, Judy, Bell, Shannon, Bhhatarai, Barun, Blaauboer, B, Casey, Warren, Dorman, David, Forsby, Anna, Garcia-Reyero, Natàlia, Gehen, Sean, Graepel, Rabea, Hotchkiss, Jon, Lowit, Anna, Matheson, Joanna, Reaves, Elissa, Scarano, Louis, Sprankle, Catherine, Tunkel, Jay, Wilson, Dan, Xia, Menghang, Zhu, Hao, Allen, David, LS IRAS Tox CMT/ATX, dIRAS RA-1, Hamm, Jon, Sullivan, Kristie, Clippinger, Amy J, Strickland, Judy, Bell, Shannon, Bhhatarai, Barun, Blaauboer, B, Casey, Warren, Dorman, David, Forsby, Anna, Garcia-Reyero, Natàlia, Gehen, Sean, Graepel, Rabea, Hotchkiss, Jon, Lowit, Anna, Matheson, Joanna, Reaves, Elissa, Scarano, Louis, Sprankle, Catherine, Tunkel, Jay, Wilson, Dan, Xia, Menghang, Zhu, Hao, and Allen, David

Published
2017

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