Colab seeks to validate a non-animal test for regulatory submission

Test-tubes-pixabayThe Institute for In Vitro Sciences (IIVS), which has an established track record in the validation of alternatives to animal testing, teamed up with BASF and Givaudan. The collaboration focused on validating an improved skin sensitisation reactivity method to address the needs of toxicologists and regulators.

Scientists at BASF and Givaudan have developed the Kinetic Direct Peptide Reactivity Assay (Kinetic DPRA), a non-animal test, to predict allergic reactions in the skin known as sensitisation. Three other non-animal sensitiser tests have already been accepted internationally. However, the Kinetic DPRA test has the potential to advance beyond providing a yes or no answer to predict the potency of a sensitiser, which is required by some regulatory agencies. Until now, the only way to predict potency classifications was through animal testing.

‘Being able to determine potency with minor modifications of the well-established and routinely used DPRA method was highly attractive to us,’ states Dr Robert Landsiedel, vice president of experimental toxicology and ecology at BASF. ‘Once validated, we hope the Kinetic DPRA will remove the need for further animal testing to determine the potency of chemicals. We are pleased that IIVS is joining our efforts to prove the method’s validity.’

Dr Andreas Natsch, head of in vitro molecular screening at Givaudan, adds: ‘Evaluating the potency of skin sensitisers is an essential step in the risk assessment to determine safe use levels, and we have shown that kinetic data is key for this.’

The validation project, designed by BASF and Givaudan, is being conducted throughout this year. Pending a successful outcome, it will be submitted to the Organization for Economic Cooperation and Development in 2019.

We are pleased to be working with BASF and Givaudan again to validate a technology that will be available for many industry sectors and applications,’ says Erin Hill, IIVS’ president. ‘Our ability to participate in such programmes is made possible through the generous support of our contributors.’

Other participating laboratories include The Procter & Gamble Company (developer of the original DPRA), Charles River and the Czech National Institute of Public health.

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