Are local tolerance tests in animals always necessary? 1983

G Andermann, and M Erhart

The Draize test was introduced in 1944 as a toxicological standardization method to study irritation and toxicity of substances applied to the eye (and the skin). It has been considered, from that time on, as a routine toxicological protocol by most regulatory agencies to test eye-tolerance of chemicals. The authors think that for ethical and scientific reasons, this test is obsolete and should be changed or eliminated. They suggest the use of cell cultures or an in vitro technique for ocular safety assessment. The described technique uses a bovine cornea clamped in vitro between two chambers and kept alive in physiological conditions during six hours. This in vitro corneal perfusion system replaces in vivo irritation tests and enables quantitation of corneal drug uptake at the same time. This system provides reproducible results and can be used in ocular toxicological studies as well as in pharmacokinetic modeling.

UI MeSH Term Description Entries
D007509 Irritants Drugs that act locally on cutaneous or mucosal surfaces to produce inflammation; those that cause redness due to hyperemia are rubefacients; those that raise blisters are vesicants and those that penetrate sebaceous glands and cause abscesses are pustulants; tear gases and mustard gases are also irritants. Counterirritant,Counterirritants,Irritant,Pustulant,Pustulants,Rubefacient,Rubefacients,Vesicant,Vesicants
D003315 Cornea The transparent anterior portion of the fibrous coat of the eye consisting of five layers: stratified squamous CORNEAL EPITHELIUM; BOWMAN MEMBRANE; CORNEAL STROMA; DESCEMET MEMBRANE; and mesenchymal CORNEAL ENDOTHELIUM. It serves as the first refracting medium of the eye. It is structurally continuous with the SCLERA, avascular, receiving its nourishment by permeation through spaces between the lamellae, and is innervated by the ophthalmic division of the TRIGEMINAL NERVE via the ciliary nerves and those of the surrounding conjunctiva which together form plexuses. (Cline et al., Dictionary of Visual Science, 4th ed) Corneas
D004594 Electrophysiology The study of the generation and behavior of electrical charges in living organisms particularly the nervous system and the effects of electricity on living organisms.
D004848 Epithelium The layers of EPITHELIAL CELLS which cover the inner and outer surfaces of the cutaneous, mucus, and serous tissues and glands of the body. Mesothelium,Epithelial Tissue,Mesothelial Tissue,Epithelial Tissues,Mesothelial Tissues,Tissue, Epithelial,Tissue, Mesothelial,Tissues, Epithelial,Tissues, Mesothelial
D004995 Ethics, Professional The principles of proper conduct concerning the rights and duties of the professional, relations with patients or consumers and fellow practitioners, as well as actions of the professional and interpersonal relations with patient or consumer families. (From Stedman, 25th ed) Professional Ethics,Ethic, Professional,Professional Ethic
D005123 Eye The organ of sight constituting a pair of globular organs made up of a three-layered roughly spherical structure specialized for receiving and responding to light. Eyes
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D014116 Toxicology The science concerned with the detection, chemical composition, and biological action of toxic substances or poisons and the treatment and prevention of toxic manifestations. Toxinology,Evidence Based Toxicology,Evidence-Based Toxicology,Based Toxicologies, Evidence,Based Toxicology, Evidence,Evidence Based Toxicologies,Evidence-Based Toxicologies,Toxicologies, Evidence Based,Toxicologies, Evidence-Based,Toxicology, Evidence Based,Toxicology, Evidence-Based

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