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U.S. Department of Health and Human Services

About FDA

Office of Women’s Health Research Projects

Description: Conduct research to identify solutions to women’s health issues.

Definition: These studies will address issues related to metabolism of colorants in cosmetics by bacteria on the skin and the characterization of probiotics for the prevention of TSS and vaginal yeast infections. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit of the host. TSS is a very rare but potentially fatal illness caused by bacterial toxin. Understanding how probiotics may lead to the prevention of TSS and vaginal yeast infections will reduce the number of these cases, thus advancing the health of women.

Public Health Outcome: These studies will address issues related to metabolism of colorants in cosmetics by bacteria on the skin.

Accomplishment: This study contributed to a sound scientific knowledge basis for determining the safety and toxicity of the colorants in cosmetics used by women and provide data for risk assessment of the metabolism of synthetic azo colorants in cosmetics by human skin microflora.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Identify whether the majority of skin bacteria quickly decolorize the azo dyes and determine whether multiple bacterial azoreductases are likely involved in the reduction of the dyes

9/30/2010

Completed 9/30/2010

2. Identify metabolites of aromatic amines produced by human skin bacteria from azo dyes

9/30/2010

Completed 9/30/2010

3. Evaluate the toxicological effects of azo dyes and their metabolites on the skin bacterium path S. aureus; the most common cause of staph infections which causes toxic shock syndrome

9/30/2010

Completed 9/30/2010

4. Complete the assessment of research findings

6/30/2011

Completed 6/30/2011

5. Develop draft technical report/manuscript/publication

9/30/2011

Completed 9/2/2011

6. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publication

10/31/2011

Completed 10/8/2011

7. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

10/31/2011

Completed 10/8/2011

8. Submit final technical report, manuscript and/or publication to a scientific journal

12/31/2011

Completed 10/8/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

TSS

toxic shock syndrome

S. aureus

Staphylococcus aureus

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.