Dermal toxicity studies: factors impacting study interpretation and outcome
| Autor: | Sundeep A. Chandra, Christine L. Merrill, Richard A. Peterson, Kristina DeSmet, David H. Melich, Katherine Mellon-Kusibab, Rick R. Adler, Alan H. Stokes, Rick Hailey, Sylvia Furst |
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| Rok vydání: | 2014 |
| Předmět: |
Pathology
medicine.medical_specialty integumentary system business.industry Administration Topical Cell Biology Toxicology Bioinformatics medicine.disease_cause Skin Diseases Pathology and Forensic Medicine Oral ingestion Skin toxicity Single species Toxicity Toxicity Tests Medicine Dermal toxicity Animals Irritation business Molecular Biology Skin Skin Tests |
| Zdroj: | Toxicologic pathology. 43(4) |
| ISSN: | 1533-1601 |
| Popis: | The field of dermal toxicity continues to evolve in order to accurately predict dermal (and systemic) responses in humans to topically applied chemicals. Although the testing methods have undergone extensive refinements, idiosyncrasies and unexpected issues during the conduct of these studies are not unusual due to the plethora of new vehicles available for formulating test substances, changing regulatory requirements, and introducting new strain and/or species of laboratory animals as no single species or method seems to suffice for evaluating skin toxicity. The objective of this article is to illustrate some pragmatic issues that should be considered during the conduct as well as interpretation of dermal toxicity studies. Routine procedure-related issues such as hair clipping, tape stripping, and wrapping the animal’s torso to prevent oral ingestion can influence the interpretation. Excipients used in dermal toxicity studies may be nontoxic when used alone but complex dermal formulations can result in unexpected irritation and toxicity. In conclusion, interpretation and risk assessment of dermal toxicity studies should be done in a comprehensive manner, taking into account procedure-related impact on study results, unique species susceptibility, limitation of gross visual (naked eye) observation for evidence of toxicity, and normal anatomical variation. |
| Databáze: | OpenAIRE |
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