29-Aug-2018 - BASF SE

IIVS Collaborates with BASF and Givaudan to Validate a Non-animal Test for Regulatory Submissions

The Institute for In Vitro Sciences (IIVS), with an established track record in the validation of alternatives to animal testing, is teaming up with BASF and Givaudan to validate an improved skin sensitization 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 sensitization. Three other non-animal sensitizer tests have been internationally accepted. However, the Kinetic DPRA has the potential to go beyond a yes/no answer and predict the potency of a sensitizer, 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,” stated Dr. Robert Landsiedel, Vice President, Experimental Toxicology and Ecology, BASF. ”Once validated, we hope that the Kinetic DPRA will obviate the need for further animal testing to determine potency of chemicals. We are pleased that IIVS is joining our efforts to prove the validity of the method.”

“Assessing potency of skin sensitizers is an essential step in risk assessment to determine safe use levels, and we have shown that kinetic data are key for this” indicates Dr. Andreas Natsch, Head of in vitro molecular screening at Givaudan.

The validation project, designed by BASF and Givaudan, will be conducted over the course of 2018 and, pending a successful outcome, will be submitted to the Organization for Economic Cooperation and Development (OECD) in 2019.

“We are pleased to be working again with BASF and Givaudan to validate a technology that will be available for many industry sectors and applications,” said Erin Hill, President, IIVS. ”Our ability to participate in such programs is 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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