A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation

Abstract

The need for alternative approaches to replace the in vivo rabbit Draize eye test for evaluation of eye irritation of cosmetic ingredients has been recognised by the cosmetics industry for many years. Extensive research has lead to the development of several assays, some of which have undergone formal validation. Even though, to date, no single in vitro assay has been validated as a full replacement for the rabbit Draize eye test, organotypic assays are accepted for specific and limited regulatory purposes. Although not formally validated, several other in vitro models have been used for over a decade by the cosmetics industry as valuable tools in a weight of evidence approach for the safety assessment of ingredients and finished products. In light of the deadlines established in the EU Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision-tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. Furthermore, recommendations are given on how remaining data gaps and research needs can be addressed.

Assessment of ocular surface toxicity after topical instillation of nitric oxide donors

“…The Draize rabbit eye test used in the present study has been globally accepted since 1944 as the standard regulatory method for determining the ocular irritation potential of chemical products (27)(28)(29)(30) . However, its use has been criticized on the bases of ethical considerations since it is employed on live animals.…”

“…However, its use has been criticized on the bases of ethical considerations since it is employed on live animals. Alternative methods have been discussed for ocular toxicity assessment (30) . Many tests have been published using ex vivo tissue and cell culture of animal and human tissue (27,30,31) .…”

“…Alternative methods have been discussed for ocular toxicity assessment (30) . Many tests have been published using ex vivo tissue and cell culture of animal and human tissue (27,30,31) . Despite good reproducibility and sensitivity of several in vitro alternative model assays for ocular irritation, their predictive power was not as reliable as the rabbit Draize eye test (30) .…”

“…Many tests have been published using ex vivo tissue and cell culture of animal and human tissue (27,30,31) . Despite good reproducibility and sensitivity of several in vitro alternative model assays for ocular irritation, their predictive power was not as reliable as the rabbit Draize eye test (30) . Moreover, the majority of these tests do not address the issue of ocular irritation reversibility (32) .…”

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

“…Each of the in vitro assays is related to a specific endpoint of ocular irritation and gives only partial information on the mode of action of the material tested. Thus, the weight-of-evidence (WoE) approach and results of multiple selected in vitro tests are needed to accurately estimate the degree of eye irritation caused by cosmetic ingredients [9,11].…”