The SDA Alternatives Program Phase III: Comparison of In Vitro Data With Animal Eye Irritation Data on Solvents, Surfactants, Oxidizing Agents and Prototype Cleaning Products

Nine in vitro candidate tests for estimating eye irritation potential were evaluated as potential replacements for the Draize test. The tests examined were a cell protein assay, the chorioallantoic membrane vascularization assay, a cell protein assay, a fibroblast cytotoxicity assay, the Living Dermal Model and Living Skin Equivalent, two neutral red assays, an SIRC cytotoxicity assay, and a Tetrahymena thermophila motility assay. The results from these in vitro tests were compared to results from a modified Draize test with 22 test materials. The test materials were selected to represent various classes of cleaning products and ingredients. Ingredients were tested at concentrations representative of concentrations typically found in cleaning products. The correlation coefficients with all test materials considered ranged from 0.58 to 0.91. When only nonalkaline materials are considered, the correlation coefficients of all 10 tests were not significantly different from one another, ranging from 0.8 to 0.9. The assays least affected by the alkalinity of the test substances were the corneal epithelial plasminogen activator assay, the chorioallantoic membrane vascular assay, and the Tetrahymena motility assay. Further, six of the 10 tests were able to identify the five nonirritants in the study, although the relative irritation potentials of the irritants were not accurately predicted by any of the tests. Results from a low-volume eye irritation test (LVET) were also compared to results from a modified Draize test with the same 22 test materials. The LVET had a high correlation with the modified Draize test and will be useful for future comparison with other alternative eye irritation tests. Based on these data, a number of alternative tests developed to replace the Draize eye irritation test included in this phase of research are useful for screening the eye irritation potential of nonalkaline cleaning products, although some tests are better for identifying the eye irritation potential of test materials with alkaline or oxidation potential. Although the ability of the eye to recover from damage was not measured by any test, the tests show promise for the use of determining eye irritation potential.

Use of Read-Across of Existing Hazard Data to Fulfill HPV Chemical Program Requirements without the Need for New Animal Testing

Poster presentation given to the 7th World Congress on Alternatives and Animal Use in the Life Sciences on August 31, 2009 in Rome, Italy.

The Soap and Detergent Association (SDA) is a leading manager of chemical consortia fulfilling commitments to the voluntary global International Council of Chemical Associations (ICCA) and U.S. Environmental Protection Agency (EPA) high production volume (HPV) chemical programs. SDA’s commitment to compile and make publicly available a baseline set of health and environmental effects data covers 291 chemicals sponsored by 62 companies within ten chemical consortia. The chemical categories represented by these consortia include: aliphatic acids, alkoxides, alkyl sulfates, amine oxides, glycerides, hydrotropes, LAS/ABS, long chain alcohols,methyl esters, and triclocarban. Due to the structural similarity of the chemicals within a category their physiochemical and toxicological properties are likely to be similar. This has allowed the utilization of the read-across technique where the data available for some substances satisfy the data need for member chemicals without data. SDAhas found read-across to be especially useful in assigning data for ecotoxicity and human health endpoints tomany chemicals among its 143 completed chemical commitments to date. Consequently, the use of read-across has eliminated the need for new animal testing while allowing SDA consortia to meet those data requirements. The use of thousands of test animals has been avoided. SDA anticipates additional reductions in animal testing by utilizing read-across in ongoing efforts to complete the data sets for the balance of its sponsored chemicals.