ABSTRACT
Introduction 568
Dermatopharmacokinetics: Relation to Predictive Assays 568
In Vivo Percutaneous Absorption Assays 569
In Vitro Percutaneous Penetration Assays 570
Allergic Contact Dermatitis 570
Quantitative Structure Activity Relationships 571
Guinea Pig Sensitization Tests 571
Draize Test 571
Open Epicutaneous Test 572
Buehler Test 573
Freund’s Complete Adjuvant Test 573
Optimization Test 573
Split Adjuvant Test 574
Guinea Pig Maximization Test 574
Human Sensitization Assays 575
Repeat Insult Patch Tests 575
Modified Draize Human Sensitization Test 577
Irritant Dermatitis 577
In Vitro Assays 577
Irritation Tests in Animals 578
Draize-Type Tests 578
Non-Draize Animal Studies 578
Human Irritation Tests 578
Contact Urticaria Syndrome 579
Nonimmunological Contact Urticaria 580
Immunological Contact Urticaria 580
Guinea Pig Ear Swelling Test 581
Trimellitic Anhydride-Sensitive Mouse Assay 581
Subjective Irritation and Paresthesia 581
Human Assay 582
References 582
INTRODUCTION
Cosmeceuticals are presumably relatively “safe”. Adverse skin responses associ-
ated with repetitive, low-dose exposure to consumer products are all too often not
accurately predicted by the required assays. The need to market products with
low risk of producing dermal and systemic injury to increase consumer satisfac-
tion has led to the development of numerous assays to rank chemicals for their
ability to injure the skin. Although these assays are not routinely mandated by
regulatory agencies for cosmetics and skin care, the frequency with which they
are conducted and their utility warrant attention.
