Eye irritation responses in rabbit and man after single applications of equal volumes of undiluted model liquid detergent products

Nanoemulsion as a Potential Ophthalmic Delivery System for Dorzolamide Hydrochloride

“…Taking into consideration that the rabbit eye is more susceptible to irritant substances than the human eye (71), this result would be considered very promising. Figure 4 demonstrates the percentage decrease in IOP of normotensive rabbits after administration of a single dose of dorzolamide hydrochloride nanoemulsions (NEs 3, 5, 6, 10, 12, and 14), drug solution, and the market product.…”

Dermal Toxicity of a Repellent Formulation Containing <i>Piper Aduncum</i> Linnaeus (Piperales: Piperaceae) Essential Oil

“…However, according to Bronaugh et al (1989), the rabbit skin is more sensitive than human skin, thus the results cannot be directly extrapolated to humans. Studies have shown that rabbits exhibit stronger irritation reactions compared to humans (Ishii et al, 2013;Roggeband et al, 2000). Indeed, Basketter et al (2004) reported that 40% of irritants classified by animal testing were not irritants when tested on human skin.…”

A Reassessment of the in vitro total protein content determination (TPC) with SIRC and 3T3 cells for the evaluation of the ocular irritation potential of shampoos: comparison with the in vivo Draize rabbit test

“…Many authors consider that the degree of injury induced in the eye of the rabbit after the application of substances classified as slightly irritant is negligible and represents a low risk situation when extrapolated to the circumstances of human exposure. This is because the experimental conditions of the Draize test is maximized, i.e., the substance-test is applied without dilution, is instilled directly into the conjunctival sac of the animal and the exposure is longer when compared to the exposure situation in humans (Freeberg et al, 1986;Roggeband et al, 2000). Therefore, to establish a cut-off value to carry out a comparison between the in vitro and the in vivo assays, in vivo shampoos were classified as non-irritant and slightly irritant in a single category (called "non-irritants") and the moderate and severe irritant shampoos in another category (called "irritants").…”

“…The ideal is to obtain the data related to different outcomes; for example, vascularization (e.g., HET-CAM), opacity/ permeabilization (e.g., BCOP) and cytotoxicity (e.g., RBC) (Debbasch et al, 2005;Barile, 2010). Studies of new in vitro ocular toxicity methods are, however, still being compared to the data obtained in the tests that have been performed in the rabbits because adequate human data are not available (Roggeband et al, 2000;Princen, 2006). It is important to note that most of these tests are being used to assess the irritation potential of the isolated ingredients, such as the surfactants used in different formulations of shampoos, soaps and other cosmetics (Sina et al, 1995;Gerner et al, 2005;Martinez et al, 2006;Costa et al, 2009).…”