OptiSafeTM added to OECD 496 as an independently validated test method to identify ocular irritants.

The OptiSafe Eye Irritation TestTM (OS) method consists of a macromolecular test matrix composed of plant derived proteins, lipids and nucleotides that does not include any animal ingredient or component.  The method measures the extent of damage of the macromolecular matrix upon exposure to a test chemical and the measured extent of macromolecular damage is used to predict the toxicity of the tested chemical to the eye. The OS test method has procedures that increase the sensitivity, specificity, and accuracy and expand the applicability domain. These include tear levels of ascorbic acid that lower the false-positive rate, a pretest for solubility and specific physicochemical handling procedures (PCHPs) for materials with different solubilities to reduce the false-negative rate, a chemical buffering pretest and specific PCHPs for materials with different buffering capacities to reduce the false-negative rate and expand the applicability domain, and a PCHP for surfactants that reduces the false-negative rate for nonionic surfactants. At this time, the applicability domain OECD Test Guideline 496 for the OS test method only includes soluble test chemicals that do not foam and have little or no buffering capacity (the majority of products fall within the application domain). 

The OS assay is an independently validated macromolecular test assay within OECD 496 for product saftey evaluation and regulatory use is to identify chemicals that do not require classification for eye irritation or serious eye damage as defined by the UN GHS (UN GHS No Category).  

OS is a validated ocular irritation test. When used to identify chemicals within the MA PCHP applicability domain that do not requireclassification for eye irritation and serious eye damage, the OS test method was found to have an accuracy of 90.0% (63/70), a sensitivity of 100% (31/31), and a specificity of 82.1% (32/39), calculated based on a majority prediction approach compared to in vivo rabbit eye test method data classified according to UN GHS. Notably, OS has the highest senstivty and accuracy of all the OECD accepted nonanimal eye irritation tests.  

Visit InChemico.com for further information or to buy OptiSafeTM kits. 

Previous PostLebrun Labs receives 4 new trademarks, will start selling test kits through In ChemicoTM
Next PostLebrun Labs LLC Awarded SBIR Fast-Track Grant to Develop Skin Corrosion Test.