Personal care products (PCPs) are non-prescription products applied to the body (e.g., hair colorants, shampoos, conditioners, skin lotions, deodorants, suntan lotions, lipstick, makeups, nail polishes, etc.). Daily, the average consumer uses 10 cosmetic products, totaling 126 ingredients, most not listed on the label. Peer- reviewed papers report that ingestion or absorption of chemicals having estrogenic and/or androgenic activity (EA**/AnA**) by mammals (including humans) can possibly cause various adverse health effects including uterine dysfunction, higher rates of some cancers, reduced sperm count, and abnormal brain maturation, disorders of attention, motivation, emotion, cognitive development, and changes in aggressive behavior and sexual orientation. These adverse effects may sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals. CertiChem's (CCi's) peer-reviewed papers and preliminary data show that PCPs often contain endocrine disrupting chemicals (EDCs), most-commonly having EA**/AnA** that can be orally ingested or absorbed through the skin. Epidemiological studies suggest that such products may be causing significant adverse health effects. Although government agencies and NGOs have acknowledged widespread EA**/AnA** exposure as a cause of concern, PCPs on the US and international markets are not yet required to undergo testing for EA**/AnA**. NIH/NIEHS desire sensitive and accurate assays such as those used by CCi to detect EA**/AnA** in cosmetics and other substances or products. Finally, no commercial or other entity is currently offering EA**/AnA**-free cosmetic formulations to vulnerable populations (e.g., pregnant mothers, juveniles) or EA**/AnA**-limited cosmetic formulations to niche populations with a special need (e.g., postmenopausal females). Given considerations outlined above, there is high scientific, societal, and commercial merit for CCi in this Phase I SBIR application to show that it is feasible to use its novel, sensitive and accurate in vitro assays to quantify the level of EA**/AnA** in chemicals used to formulate PCPs. Using this IP in collaboration with a cosmetics firm (4X Naturals), CCi will use such data on the EA**/AnA** of chemicals to show it is feasible to formulate a commercially viable EA**/ANA**- free PCP for use by pregnant mothers, infants, and/or juveniles that has no detectable EA**/AnA**. CCi will use 4x Natural's IP to insure that the EA**/ANA**-free PCP is also free of metallic, formaldehyde-releasing, allergenic, or skin-irritating substances as well as no or formulations having well-specified levels of EA**/AnA** for consumers in well-identified niche markets. CCi's approach to eliminate all EA**/AnA** in PCPs is a paradigm-shift compared to the current model used by most other commercial entities, regulatory agencies and consumer groups that typically eliminate chemicals having EA**/AnA** one at a time. CCi's novel model meets an NIEHS goal of "developing innovative prevention strategies" for EDC's.

Public Health Relevance

Peer-reviewed papers and CertiChem's CCi's) preliminary data show that various personal care products (PCPs) contain endocrine disrupting chemicals, most-commonly having estrogenic and/or androgenic agonist and/or antagonist activity (EA**/AnA**), that are orally ingested or absorbed through the skin. Many peer-reviewed papers report that ingestion or absorption of chemicals having EA**/AnA** by mammals (including humans) may cause adverse health effects including uterine dysfunction, higher rates of some cancers, reduced sperm count, and abnormal brain maturation leading to pathologies such as learning disabilities, disorders of attention, motivation, emotion, cognitive development, and changes in aggressive behavior and sexual orientation. Given such possible adverse effects of chemicals having EA** and AnA**, there is high scientific, societal, and commercial merit for CCi to use accurate and sensitive in vitro assays to detect EA**/AnA** and use that IP in collaboration with 4X Naturals, a corporate partner, to show that it is feasible to develop PCPs that have no chemicals having detectable EA**/AnA** -- or formulations having well-specified levels of EA**/AnA** -- desired by consumers in well-identified niche markets.

Agency
National Institute of Health (NIH)
Institute
National Institute of Environmental Health Sciences (NIEHS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43ES025075-01
Application #
8832229
Study Section
Special Emphasis Panel (ZRG1-EMNR-S (10))
Program Officer
Shaughnessy, Daniel
Project Start
2014-09-22
Project End
2015-02-21
Budget Start
2014-09-22
Budget End
2015-02-21
Support Year
1
Fiscal Year
2014
Total Cost
$150,955
Indirect Cost
Name
Certichem, Inc.
Department
Type
DUNS #
933351780
City
Austin
State
TX
Country
United States
Zip Code
78758