BASF and IIVS Collaborate to Take Skin Sensitisation Test to China

US NGO the Institute for In Vitro Sciences (IIVS) and German chemical company BASF are working together to import an alternative skin sensitisation test into China.

BASF developed the LuSens test, which detects chemicals with the potential to act as skin sensitisers. The IIVS later took part in an inter-laboratory study led by BASF to assess the method's reproducibility and accuracy.

"This is a cell-based assay which can be difficult to import into certain countries," said Erin Hill, president of the IIVS. "In general it's difficult to import cells into countries, US included. But for some countries, such as Brazil and China, it is almost impossible. Therefore you must work collaboratively with the import authorities to achieve it."

BASF will import the cells, in collaboration with the Chinese Academy of Inspection and Quarantine in Beijing. The Chinese Food and Drug Administration (CFDA) National Institute of Food and Drug Control will then distribute the cells to government testing laboratories, including a new alternatives laboratory in Zhejiang.

"BASF has graciously offered to provide training on LuSens in China, but also welcomes Chinese scientists to their alternatives laboratory in Ludwigshafen, Germany," said Dr Hill.

LuSens is a reporter gene bioassay that uses a human keratinocyte cell line. Similar to the KeratinoSens assay, it now comes under the same OECD test guideline (442D), and is licence-free.

BASF and the IIVS have worked together for several years. In 2012, BASF provided lab equipment (opacitometers) for the bovine corneal opacity and permeability assay (BCOP), which tests for eye irritants. The IIVS then placed the units at its training labs in China.

"Our future plans include helping to build capacity and proficiency in alternative methods to government scientists – a key step the CFDA has stated must be achieved before regulations can change," said Dr Hill.

In 2017, the IIVS helped to train staff at the Zhejiang Institute for Food and Drug Control's new alternatives lab, which opened last November.
new alternatives lab, which opened last November.