,"Published in October 2025 by ANVISA’s Third Directorate (DIRE3), through the General Management of Cosmetics and Sanitizing Products (GGCOS) and Coordination of Cosmetic and Sanitizing Product Registration (CRCOS), this manual provides technical and regulatory guidance for calculating the Acute Oral Toxicity Estimate (ETA) of sanitizing products.
The document serves as an alternative to in-vivo LD₅₀ testing, promoting non-animal methods aligned with the 3Rs principles (Replacement, Reduction, and Refinement) and the Globally Harmonized System (GHS). It supports the implementation of RDC Anvisa No. 989/2025, which governs the notification and registration of sanitizing products according to health risk categories.
The manual details the legal framework, calculation methodology, and criteria for classification, including the use of GHS toxicity categories and examples of practical application. It establishes clear procedures for determining ETA based on the toxicity data of individual ingredients (ETA) using the GHS additive formula."