Performance of the DASF compared to other combinations of OECD NAMs for eye hazard identification of surfactants.

ABSTRACT

Currently, the OECD has adopted three defined approaches (DAs) for eye hazard identification of non-surfactant liquids and solids (TG467) according to the three UN GHS categories (Cat.1, Cat.2, No Cat.). We are now expanding the applicability domain with a new DA for chemicals having surfactant (SF) properties (DASF). It is based on a combination of RhCE test methods (OECD TG492 EpiOcular™ EIT or SkinEthic™ HCE EIT) and a modification of the Short Time Exposure (STE, TG491) method. The aim of the current study was to compare the performance of the DASF with the performance of other NAMs currently included in the OECD TGs and with the classification based on the Draize eye test to identify potential additional DAs. The minimum performance criteria (75% Cat.1, 50% Cat.2, 70% No Cat.) used for the adoption of the DAs currently included in OECD TG467 were used for this purpose. The DASF identified 90.9% of Cat. 1 (N=23), 77.8% of Cat. 2 (N=9) and 76.0% of No Cat. (N=17) surfactants, meeting the minimum performance criteria. Some of the NAMs that are currently included in the OECD TGs seem promising methods to be part of a DA to identify Cat. 1 or No Cat. for eye hazard assessment of surfactants. However, the number of surfactants that have been tested to evaluate reliability and relevance was often too small. To date, the DASF is the only DA that has evaluated a sufficiently large number of surfactants and whose performance met the OECD acceptance criteria.

Three non-animal-based defined approaches (DAs) for eye hazard assessment of non-surfactant liquid and solid chemicals were adopted as full replacements as OECD Test Guideline (TG 467). We now extend the applicability domain to surfactants with a new DA (DASF), which combines OECD-adopted test systems based on human 3D eye models and rabbit 2D corneal cells. The DASF has been shown to provide reliable results in predicting the eye irritation potential of 50 surfactants. The aim of the current study was to compare the performance of the DASF with the performance of other OECD TG new approach methodologies and compare it with the classification based on historical animal test data. Based on this analysis no additional DAs could be derived. Until today, the DASF is the best predicting, human-relevant DA that covers the whole range of eye irritation responses across the different surfactant classes.