Scientific principles demand that before newly developed alternative methods for safety testing are fully embraced by the industrial or regulatory community, they reliably and reproducibly predict the designated toxic end point. The process used to determine reliability and reproducibility is termed validation, and it generally culminates with a highly controlled, blinded study using multiple c...

Accurate methods that test the eye irritation potential of chemicals, which do not involve the use of animals, are needed to meet new regulatory standards. We evaluated the applicability and predictive capacity of five in vitro tests for eye irritation: the Hen's Egg Test-Chorioallantoic Membrane (HET-CAM) assay; the Chorioallantoic Membrane-Trypan Blue Staining (CAM-TBS) assay; the Fluorescein...

Formaldehyde is a well-studied chemical and effects from inhalation exposures have been extensively characterized in numerous controlled studies with human volunteers, including asthmatics and other sensitive individuals, which provide a rich database on exposure concentrations that can reliably produce the symptoms of sensory irritation. Although individuals can differ in their sensitivity to ...

We have developed the Rabbit Corneal Epithelial (RCE) Model to evaluate the in vitro eye irritation potential of chemicals including pharmaceuticals, cosmetics and their raw ingredients. In the model, a stratified culture of rabbit corneal epithelial cells is grown at the air-liquid interface on an amnion acting as a parabasal membrane. The alkaline exposure was restored each day in the presenc...

Previous reports have indicated the usefulness of Io per cent. Guanethidine eye-drops in reducing lid retraction and relieving symptoms in patients with dysthyroid eye disease (Sneddon and Turner, I966; Gay and Wolksteip, I966; Crombie and Lawson, I967). Administration of these eye drops produces local irritation in about 50 per cent. of patients and, although this is rarely severe, superficial...

The human eye is an organ that reacts to light and has several purposes. As a sense organ, the human eye allows vision. The retina is a light-sensitive layer at the back of the eye that covers about 65% of its interior surface. Rodand cone cells in the retina allow conscious light perception and vision including colour differentiation and the perception of depth. A disease called diabetic retin...

Cyclodextrins are cylindrical oligosaccharides with a lipophilic central cavity and hydrophilic outer surface. They can form water-soluble complexes with lipophilic drugs, which 'hide' in the cavity. Cyclodextrins can be used to form aqueous eye drop solutions with lipophilic drugs, such as steroids and some carbonic anhydrase inhibitors. The cyclodextrins increase the water solubility of the d...

Previous research has shown that undenatured type II collagen is effective in the treatment of arthritis. The present study evaluated the broad-spectrum safety of UC-II by a variety of toxicological assays including acute oral, acute dermal, primary dermal irritation, and primary eye irritation toxicity. In addition, genotoxicity studies such as Ames bacterial reverse mutation assay and mouse l...