Monday, 28 July 2014 12:37

OECD: New test guideline for skin damage Featured

The OECD has just published a new test guideline that describes an integrated testing strategy for skin corrosion and irritation. The use of animals is only provided for in exceptional cases.

The new test strategy has been published under ENV/JM/MONO(2014)19, (Integrated Approach on Testing and Assessment, (IATA)). It consists of three phases with several modules with the goal of assessing the skin-corrosive or irritant property of a substance. The test is sequential, i.e. if no adequate results can be obtained in a test stage, one then progresses to the next test stage. The new guideline replaces the previous test and evaluation strategy as a supplement to Test Guideline 404. It is also an adaptation to scientific and technical progress.

In the first part (existing data), data already collected and available in publications, databases and other reliable sources is used (modules 1-5). In module 6, physico-chemical properties of the substance are evaluated. In module 7 quantitative structure-activity relationships (QSAR) are considered, chemical category analyses are performed (so-called read-across), and category information and prediction systems are used.

In the third phase, weight-of-evidence analysis, all available and scientifically based information are included to assess the hazard potential, so all the analyses mentioned above, including existing in vitro and animal studies, and human data. The individual results are weighted and evaluated for their importance and significance. Weight-of-evidence analyses are performed before additional data are collected. Only when the data are not conclusive are tests carried out. In principle, validated and accepted in vitro tests must be carried out to prevent in vivo tests. A possible test on animals is considered as a last resort.

Guideline:
http://www.oecd.org/