Preservatives and skin sensitization quantitative risk assessment.
BACKGROUND
Preservatives are an unfortunately common cause of allergic contact dermatitis (ACD). Often, this is in association with exposure to cosmetics or medicaments. Recently, a quantitative risk assessment (QRA) approach to the quantitation of safe exposure levels for sensitizers has been promulgated as a more effective tool for the identification of acceptable levels of potential sensitizers in consumer products.


OBJECTIVE
To assess this QRA approach, which facilitates the prediction of acceptable exposure levels to skin sensitizers in consumer products, levels that are normally below the threshold for the induction of skin sensitization.


METHODS
Retrospective QRA analysis on four preservatives in five consumer product types.


RESULTS
The analysis shows that functional levels of preservatives may be somewhat above an ideal exposure level for some product types, an outcome that is consistent with the clinical picture.


CONCLUSIONS
QRA represents a new tool that in the future should be used in combination with the assessment of microbiologic protection needs of specific product types to limit the problem of preservative ACD.
Basketter
David A
DA
Unilever, Colworth House, Sharnbrook, Bedfordshire, UK.
Clapp
Catherine J
CJ
Safford
Bob J
BJ
Jowsey
Ian R
IR
McNamee
Pauline
P
Ryan
Cindy A
CA
Gerberick
G Frank
GF
D000287:Administration, Topical; D000485:Allergens / Q000032:analysis / Q000633:toxicity*; D003257:Consumer Product Safety; D003358:Cosmetics / Q000032:analysis / Q000633:toxicity*; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis* / Q000209:etiology / Q000473:pathology / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D004781:Environmental Exposure / Q000517:prevention & control; D004784:Environmental Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D012107:Research Design; D018570:Risk Assessment / Q000379:methods*; D012867:Skin / Q000187:drug effects; D012882:Skin Tests / Q000379:methods; D006113:United Kingdom
D000485:Allergens; D003358:Cosmetics