Comprehensive In Vitro Safety Assessment of <i>Acorus calamus</i> Rhizome Oil Using OECD-Compliant New Approach Methods: Classification as a GHS Category 1B Sensitiser and Category 2 Irritant.

ABSTRACT: Background: Acorus calamus (sweet flag) is widely used in traditional medicine, yet its dermal safety profile remains insufficiently defined under modern regulatory standards. Objective: To comprehensively evaluate the skin irritation, corrosion, and sensitisation potential of A. calamus rhizome oil using new approach methodologies' (NAMs) test batteries under GLP conditions. Results: The A. calamus rhizome oil was predicted as a Category 2 skin irritant, non-corrosive and GHS Category 1B skin sensitiser. Chemical analysis revealed β-asarone as the major constituent (~40.75%). The reconstructed human epidermis models established reversible irritation without corrosion. Mechanistic concordance across the Direct Peptide Reactivity Assay, KeratinoSens

SUBMITTER: Desai KR 

PROVIDER: S-EPMC12737251 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature