We have learned over time that the development of successful alternative methods in toxicology testing requires the successful integration of three elements: First, there must be a solid foundation of understanding the basic biology and toxicology of the tissues and organs being studied. Second, in vitro platforms must be available that can be modified to make them amenable for toxicity testing...

For the last three decades we have been dedicated to the development and use of in vitro alternatives to replace and reduce animal testing. the trans-epithelial permeability (teP) assay has been validated internally as an alternative to the Draize rabbit eye test and has been used as part of our safety assessment program for 20 years. Over the last two decades we have compiled a large data set ...

Short time exposure (STE) test using rabbit corneal cell line (SIRC) cells was developed as an alternative eye irritation test. STE test uses relative viability as the endpoint after cells are exposed to the test material at constant concentrations for 5 min. In this inter-laboratory study with 3 laboratories, 44 chemicals with a wide range of classes were evaluated for the transferability, bet...

ECVAM sponsored a formal validation study on three in vitro tests for skin irritation, of which two employ reconstituted human epidermis models (EPISKIN, EpiDerm), and one, the skin integrity function test (SIFT), employs ex vivo mouse skin. The goal of the study was to assess whether the in vitro tests would correctly predict in vivo classifications according to the EU classification scheme, "...

The prediction of side-effects is a key issue in the REACH initiative on chemicals, in the production of cosmetics and in the preclinical testing of drugs. A new ex vivo test for repeated substance application is presented, that is able to identify corrosive and irritant effects on the eye by using crucial endpoints, such as cellular and morphological damage, and healing characteristics. The te...

Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, s...

The bovine corneal opacity and permeability (BCOP) assay is an alternative method to the in vivo Draize eye test in rabbits for evaluating eye irritation in vitro. Here, we compared the numerical results of the BCOP assay with the corresponding histopathology for three different corneas for each test substance, including commercially available shampoos, make-up removers and cleansing foams that...

The objective of the present study was to prepare controlled release formulation of Moxifloxacin hydrochloride ocular nanoparticles. The nanoparticles were prepared by solvent displacement method using Eudragit RL 100 as a polymer. Different formulations were prepared by varying the ratios of drug and polymer and varying the ratios of organic and aqueous phase. The formulations were evaluated i...