Understanding fragrance allergy using an exposure-based risk assessment approach.
Conducting a sound skin sensitization risk assessment prior to the introduction of new ingredients and products into the market place is essential. The process by which low-molecular-weight chemicals induce and elicit skin sensitization is dependent on many factors, including the ability of the chemical to penetrate the skin, react with protein, and trigger a cell-mediated immune response. Based on our chemical, cellular and molecular understanding of allergic contact dermatitis, it is possible to carry out a quantitative risk assessment. Specifically, by estimating the exposure to the allergen and its allergenic potency, it is feasible to assess quantitatively the sensitization risk of an ingredient in a particular product type. This paper focuses on applying exposure-based risk assessment tools to understanding fragrance allergy for 2 hypothetical products containing the fragrance allergen cinnamic aldehyde. The risk assessment process predicts that an eau de toilette leave-on product containing 1000 ppm or more cinnamic aldehyde would pose an unacceptable risk of induction of skin sensitization, while a shampoo, containing the same level of cinnamic aldehyde, would pose an acceptable risk of induction of skin sensitization, based on limited exposure to the ingredient from a rinse-off product application.
Gerberick
G F
GF
The Procter & Gamble Co., Miami Valley Laboratories, Cincinnati, OH 45253-8707, USA.
Robinson
M K
MK
Felter
S P
SP
White
I R
IR
Basketter
D A
DA
D000171:Acrolein / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives*; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects*; D000818:Animals; D003257:Consumer Product Safety; D017449:Dermatitis, Allergic Contact / Q000209:etiology / Q000517:prevention & control*; D006168:Guinea Pigs; D006203:Hair Preparations / Q000009:adverse effects*; D006801:Humans; D010476:Perfume / Q000008:administration & dosage / Q000009:adverse effects*; D018570:Risk Assessment / Q000379:methods*; D013997:Time Factors
D000485:Allergens; D006203:Hair Preparations; D010476:Perfume; D000171:Acrolein; C012843:cinnamaldehyde