U.S. federal agency interests and key considerations for new approach methodologies for nanomaterials.

Details

• Personal Author:
  Allen DG ; Ceger P ; Chang X ; Coyle J ; Derk R ; Garcia-Reyero N ; Gordon, Jane E. ; Kleinstreuer NC ; Matheson J ; McShan D ; Nelson BC ; Patri AK ; Petersen EJ ; Rice P ; Rojanasakul L ; Sasidharan A ; Scarano L
• Description:
  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. [Description provided by NIOSH]
• Subjects:
  Occupational Health Radiation Dosimeters Risk Assessment Safety Toxicology
• Keywords:
  Nanotoxicology; Nanomaterials; In vitro studies; Materials testing; Risk assessment; Risk management; Dosimetry; Guidelines; Safety research
• ISSN:
  1868-596X
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  Arkansas ; District of Columbia ; Maryland ; Mississippi ; North Carolina ; Ohio ; OSHA Region 3 ; OSHA Region 4 ; OSHA Region 5 ; OSHA Region 6 ; West Virginia
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  HELD - Health Effects Laboratory Division
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  183-206
• Volume:
  39
• Issue:
  2
• NIOSHTIC Number:
  nn:20065120
• Citation:
  ALTEX 2022 Apr; 39(2):183-206
• Contact Point Address:
  Xiaoqing Chang, Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC 27709, USA
• Email:
  xchang@ils-inc.com
• Federal Fiscal Year:
  2022
• NORA Priority Area:
  Manufacturing
• Peer Reviewed:
  True
• Source Full Name:
  ALTEX Alternatives to Animal Experimentation
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:be663f6ca273bebcc40f23d3d8a1bee3fa615276f958e05d7df20d997e6c9ab149d0fd1e01109f6b156f31d416777d271e84e1406cab00f8d35ecc5d45279921
• Download URL:
  https://stacks.cdc.gov/view/cdc/248697/cdc_248697_DS1.pdf
• File Type:
  [PDF - 749.25 KB ]