Assessment of skin and eye irritation of 14 products under the stepwise approach of the OECD

Abstract

The determination of acute eye and skin irritation is included in international regulatory requirements for the testing of chemicals, because of the possibility of exposure during the production, transport, marketing, and disposal of products. Although there have been some advances in the areas of refinement and reduction, no single battery of tests has emerged as being acceptable as a complete replacement for the conventional Draize rabbit eye and skin irritation tests. Currently, dermal irritation and ocular irritation are generally evaluated in a sequential manner in the context of tiered assessment strategies. In this work, we show how 14 products, mostly designed to be used in agriculture, were evaluated in the Center of Experimental Toxicology of the Center for the Production of Laboratory Animals (Centro Nacional para la Producción de Animales de Laboratorio; CENPALAB) in order to assess their acute dermal and ocular effects. The performed studies include the acute dermal toxicity test, the acute dermal irritation/corrosion test, the hen's egg test-chorioallantoic membrane (HET-CAM) method, and the acute eye irritation/corrosion test. In general, it could be concluded that of the 14 products assessed, none of them showed systemic effects, but local reactions mainly to the eyes. The most significant effects were apparently related to the effects of azadirachtin, an active principle of 2 tested neem derivatives.

Non-target toxicity of novel insecticides

“…What we know is that azadirachtin has no genotoxic effect on human cells, but may have antiproliferative effects, as evidenced by the changes in the cell cycle of human lymphocytes, some of which also displayed aberrant mitoses and poliploidy with multipolar spindles (208). One study reported that an azadirachtin-based nematicide caused eye irritation but no systemic effects (209). There is also a case report of a 35-year-old woman showing transient signs of neurotoxicity after ingesting azadirachtin in a suicide attempt (210).…”

Developing a quick and inexpensive in vitro (non‐animal) bioassay for mascara irritation

“…Numerous cosmetics, including mascara, are common causes of ocular irritation, producing mild to vision‐threatening conditions such as blepharitis, contact dermatitis and madarosis . Presently though, reliance on in vivo tests to evaluate such irritation is highly controversial ; there remains substantial dependence on the in vivo rabbit‐based Draize eye test , which since its development 40 years ago has been increasingly criticized for its inherent subjective scoring system, questionable extrapolation to humans, time‐consuming and expensive nature, ability to indicate ocular irritation and ethical acceptability . Criticism of the Draize test further extends to its poor ability to detect effects of mild ocular irritants such as mascara, where results are characterized by high variability and low reproducibility .…”