The Institute for In Vitro Sciences (IIVS) is teaming up with BASF and Givaudan to validate a non-animal test for regulatory submissions.
The improved skin sensitization reactivity method will 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 sensitization, allergic reactions in the skin.
Though three other non-animal sensitizer tests have received international acceptance, the Kinetic DPRA could potentially go beyond yes or no, predicting the potency of a sensitizer (a requirement by some regulatory agencies). Previously, this could only be achieved through animal testing.
The validation project, designed by BASF and Givaudan, will be conducted over the course of 2018. Pending a successful outcome, it will be submitted to the Organization for Economic Cooperation and Development (OECD) in 2019.
“Being able to determine potency with minor modifications of the well-established and routinely used DPRA method was highly attractive to us,” said 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.”
“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,” added 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.