We have located links that may give you full text access.
Allergic contact dermatitis: Adequacy of the default 10X assessment factor for human variability to protect infants and children.
Regulatory Toxicology and Pharmacology : RTP 2018 November
When evaluating consumer products for safety, one must consider the heterogeneity of the population that might use those products, including the potential for different sensitivity based on factors such as age, gender, and genetics. For both systemic endpoints and allergic contact dermatitis (ACD), quantitative safety evaluations typically include a default 10-fold uncertainty/assessment factor to account for inter-individual variability. While this factor is intended to include age, the adequacy of the default 10-fold factor has been questioned for infants, for whom a precautionary assumption is often made that they are more sensitive. In-depth evaluations of the adequacy of the 10-fold factor have been published for systemic endpoints, but relatively little has been published to substantiate this for ACD. This paper reviews the state of the science regarding the etiology of ACD and factors that suggest an overall decreased sensitivity associated with early life exposures, thus confirming the sufficiency of the 10-fold inter-individual factor to provide protection for children and infants. While it remains prudent for all age groups to avoid contact with sensitizers, it is concluded that the quantitative methods used in safety evaluation to prevent the induction of skin sensitization are protective for infants, including neonates and premature infants.
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app