About FDA
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New Technologies to Assess Food and Cosmetic Safety
Description: CFSAN scientists are developing/using medium throughput biomarker assays and integrated alternative model systems to assess the safety of food and cosmetic components. It is our hope that the identification of medium throughput screening methods and alternative models will improve toxicity characterization, increase efficiency, reduce cost as well as refine, reduce or replace animal use.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
| A. Foods: |
9/30/2015 |
On Track | |
| i. Evaluate liquid chromatography quadripole mass spectrometer (LC/MS/MS)-based global metabolomics in cultured human hepatocyte cell lines and cultured primary human hepatocytes as a method for discovery of biomarkers of liver toxicity |
9/30/2012 (9/30/2013) |
Completed | 9/30/2013 |
| ii. Evaluate the effects of gender on hepatotoxicity using male- and female-derived liver cells in vitro. This includes evaluating the effect of gender specific hormones, their precursors and metabolites on potential liver toxicants on human liver cells |
3/31/2013 |
Completed | 1/26/2013 |
| iii Evaluate the interaction of inflammation including inflammatory cytokines (large molecules that signal changes in the animal's internal environment which creates a hostile environment for an invading organism) and liver toxicants using liver cells in vitro |
9/30/2013 |
Completed | 9/30/2013 |
| iv. Present data collected from these studies at scientific meetings and in scientific publications |
9/30/2015 |
On Track | |
| B. Cosmetics |
9/30/2015 |
On Hold | |
| i. Initiate percutaneous absorption (skin absorption) studies of nanomaterials (dendrimers) with surface modifications with and without radiolabel using diffusion cell techniques. Studies will be conducted using pig and human skin. The ability of the nanomaterial to penetrate the skin will be determined visually using laser confocal microscopy and quantitatively using liquid scintillation counting (a method used to determine how much of the material has penetrated into the skin). |
5/28/2011 (5/28/2013) (5/31/2014) (5/30/2015) |
On Hold | |
| ii. Continue percutaneous absorption studies and analysis of dendrimers including repeat dose studies and enhanced absorption studies of model compounds |
10/31/2011 (10/31/2013) |
Completed | 9/30/2013 |
| iii. Continue analysis of diffusion cell studies of dendrimers, repeat dose studies and model compounds |
4/30/2012 (4/30/2014) (12/30/2014) (5/30/2015) |
On Hold | |
| iv. Complete analysis of diffusion cell studies of dendrimers, repeat dose studies and model compounds |
6/30/2013 (6/30/2014) (5/30/2015) |
On Hold | |
| v. Present data collected from these studies at scientific meetings and in scientific publications |
9/30/2015 |
On Hold |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
