Risk assessment of contact allergens.
BACKGROUND
Quantitative risk assessment has been used successfully for a number of human health hazards associated with product use. Dermal contact allergy or sensitization is a relatively late addition to the list.


OBJECTIVE
This article outlines the concepts and operational elements of product safety risk assessment of contact allergens.


METHODS
The basic risk assessment paradigm is presented along with various dermal dose metrics in the context of their application in describing the dose response or risk of allergic response per unit dose of a product. This analysis of toxic effect is then combined with an assessment of exposure in the real world to estimate the risk of elicitation of active skin disease.


RESULTS
Human health risk assessment in general and as it is applied to contact allergy in particular is an emerging science. As with any real science, it allows for the formulation and testing of hypotheses that elucidate a model or description of reality. The model, in turn, allows for predictions that, in this case, are the risk assessments. Of course, the elements of this model and its predictions are also then testable in successive rounds of hypothesis formation and investigation. The entire system runs on data, and a lack of data with a concomitant abundance of scientific uncertainty limits the utility and ultimately the credibility of the process.


CONCLUSIONS
Uncertainty from variability and lack of knowledge notwithstanding, the risk assessment paradigm and its scientific construct are valuable in gauging and ultimately controlling the risk of contact allergy from products.
Jayjock
M A
MA
Toxicology Department, Rohm and Haas Company, Spring House, PA 19477, USA.
D000465:Algorithms; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects*; D000818:Animals; D003257:Consumer Product Safety; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D004781:Environmental Exposure; D005544:Forecasting; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D018448:Models, Immunological; D011336:Probability; D018570:Risk Assessment; D012867:Skin / Q000187:drug effects
D000485:Allergens