Background:
The quantitative evaluation of the risk of contact allergy from allergens in products represents an important prerequisite to the appropriate management of that risk in general human use applications.
Objective:
This report seeks to describe an approach for evaluating cutaneous allergen risk based on preclinical human and animal testing that correlates well with eventual clinical experiences.
Methods:
This report uses an approach for low-dose extrapolation and comparison of relative risk (ie, safety factor) using data from human and animal testing. A scheme is used in which, without enough human data to establish a direct dose-response function, information from guinea pig tests can be used to devise a working model to estimate human dose-response.
Results:
Whereas modeling of clinic prevalence rates in different allergen exposure situations in human populations shows a potential set of problems to be dealt with, the predictions of risk (1/safety factor) for various allergens compared with their clinic prevalence rates show a significant correlation.
Conclusions:
Use of preclinical human and animal data to produce safety factor estimates of eventual clinic prevalence rates seems reliable and should be further investigated.
