SenzaGen has added the new test, dubbed ‘GARDpotency', to its portfolio of testing options.
It says this latest offering can be used to evaluate chemicals according to the EU’s CLP classification
Directives which can benefit from GARDpotency are as follows:
- REACH legislation (Regulation 1907/2006/EC)
- EU Cosmetics Regulation (EC) 1223/2009
- Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures
- Regulation on EC 1107/2009 on Plant Protection Products and Biocidal Products Regulation((EU) No 528/2012.
The new testing method’s development, according to SenzaGen, “means that companies in the chemical, pharmaceutical and cosmetic industries will be able use an animal-free test to get reliant results regarding sensitization and potency, according to current regulations, leading to safer products going to market at a faster pace.”
While GARDpotency has not yet been approved by the relevant regulatory authorities, it has been submitted and is under review, according to SenzaGen.
“Worldwide approval and recommendation from ECVAM (the EU Reference Laboratory for Alternatives to Animal Testing) and OECD regarding the use of GARDskin™ and GARDpotency™ are expected in 2019,” the company says.
Accuracy of 82%
SenzaGen reckons its new testing method is way ahead of other comparable tests.
“Other initiatives to measure potency today, including animal tests, only reach an accuracy of 55%-69%,” it suggests.
“We at SenzaGen are extremely happy to be able to present the final results of the report showing that our test can classify CLP Class 1A and 1B chemical substances, quantifying the risk of causing allergies with an accuracy of 82%, as determined by three laboratories.”
How does it work?
The EU Chemicals Agency ECHA, which regulates chemical use based on the REACH Regulation, requires that chemicals that may induce sensitivity (sensitization) must be potency-classified according to CLP.
This, says SenzaGen, has so far only been possible with a so-called LLNA (Local Lymph Node Assay) evaluation, which is an in vivo test using animals.
SenzaGen's GARD™ test platform, though, is based on human cells in vitro and genomic biomarkers, which SenzaGen says means it is capable of delivering better accuracy than animal tests.