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In a move towards reducing animal testing, Taiwan's chemical regulatory authority has recently issued two draft guidance documents. The aim is to assist companies in utilizing non-animal alternative testing methods to fulfill the chemical registration requirements under Taiwan's New and Existing Chemical Registration Regulation.
The two guidance documents are:
Guidance on Alternatives of Dermal Irritation/Corrosion, and
Guidance on Alternatives of Eye Irritation
The first guidance document is for alternatives of skin irritation/corrosion. It adopts in vitro skin corrosion test methods OECD TG 430/431/435, as well as the in vitro skin irritation method OECD TG 439.
The second guidance focuses on alternatives of eye irritation, adopting in vitro test methods including OECD TG 437/438/460/491/492/492B/494/496.
Notably, Taiwan has also recently circulated draft revisions to its GHS-related CNS 15030 serial standards, of which CNS 15030-18 and CNS 15030-19 are for skin corrosion/irritation and serious eye damage/eye irritation respectively. The proposed revisions similarly incorporate the adoption of specific in vitro test methods.
According to insider sources, once the guidance documents are officially published, the authority may potentially mandate the priority use of these in vitro test methods. Any proposals to submit animal test data would require justification that the alternative methods are not feasible or cannot effectively classify the hazards.
