In vitro and in vivo percutaneous absorption of catechol.
The Cosmetic Ingredient Review Expert Panel found insufficient data to conclude that catechol could be used safely in permanent hair dye products. Information was lacking on the extent of oxidation and skin absorption of remaining catechol. In vitro percutaneous absorption studies were conducted in human and rat skin using a consumer permanent hair dye spiked with 0.6% catechol. A 30-min application demonstrated 0.4% of the applied dose was absorbed through human skin and 0.2% through rat skin. The minimal absorption observed was due to the short exposure time and to partial oxidation of catechol by the dye developer. The fate of catechol remaining in rat skin after exposure in vitro and in vivo was investigated with additional absorption studies using catechol in ethanol. At 72 h, 24-h application of 4% catechol resulted in skin absorption of 81% of the applied dose in vitro and 53% in vivo. Skin levels measured at 24 h remained unchanged after 72 h. Therefore the skin reservoir did not contribute to the estimated systemic absorption. A deconvolution technique employed to predict skin absorption using plasma levels from intravenous and dermal administration overestimated in vivo skin absorption due to volatility of catechol in an ethanolic vehicle.
U.S. Food and Drug Administration, Office of Cosmetics and Colors, Laurel, MD 20708, USA. cjung@cfsan.fda.gov
C T
CT
Jung
R R
RR
Wickett
P B
PB
Desai
R L
RL
Bronaugh
D000279:Administration, Cutaneous; D000818:Animals; D002396:Catechols / Q000008:administration & dosage / Q000378:metabolism* / Q000493:pharmacokinetics; D005260:Female; D006202:Hair Dyes / Q000737:chemistry*; D006801:Humans; D066298:In Vitro Techniques; D010084:Oxidation-Reduction; D051381:Rats; D017207:Rats, Sprague-Dawley; D012867:Skin / Q000187:drug effects / Q000378:metabolism*; D012869:Skin Absorption; D014835:Volatilization
D002396:Catechols; D006202:Hair Dyes; C034221:catechol