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<p>The <i>Celtis iguanaea</i> (Jacq.) Sarg., Cannabaceae, standardized spray-dried extract, underwent acute safety evaluation using a range of alternative toxicological models in alignment with Organization for Economic Co-operation and Development Test Guidelines. Acute aquatic toxicity was assessed using the <i>Artemia salina</i> lethality test (LC<sub>50</sub> 418.4&#xa0;μg/ml) and the zebrafish (<i>Danio rerio</i>) embryo toxicity test (OECD TG 236; LC<sub>50</sub> 1116.0&#xa0;μg/ml). According to the Globally Harmonized System aquatic toxicity categories, <i>C. iguanaea</i> spray-dried extract is classified as non-hazardous (LC<sub>50</sub> &gt; 100&#xa0;μg/ml). <i>In vitro</i> assays included cytotoxicity (methyl thiazolyl tetrazolium assay –in WI-38 and HaCaT cells; resazurin in Caco-2 and HT-29 cells), cell adhesion genotoxicity (comet assay; OECD TG 489), and mutagenicity (cytokinesis-block micronucleus assay; OECD TG 487). <i>Celtis iguanaea</i> spray-dried extract showed no cytotoxic, genotoxic, or mutagenic effects up to 250&#xa0;μg/ml and enhanced HaCaT cell viability and adhesion at higher concentrations (100&#xa0;μg/ml), suggesting potential support for wound healing. No antimicrobial activity was observed against <i>Candida</i> spp., ESKAPE pathogens, or bacteria associated with urinary tract infections (MIC &gt; 1024.0&#xa0;μg/ml). This weight-of-evidence assessment supports the safe use of <i>C. iguanaea</i> spray-dried extract in topical or oral formulations and provides data suitable for regulatory hazard characterization and acute risk assessment.</p> Graphical Abstract <p></p>

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Alternative Model-Based Safety Assessment of a Celtis iguanaea Standardized Spray-Dried Extract

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月6日

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  • Kátia Regina Ribeiro,
  • Rúbia Bellard e Silva,
  • Jéssica Thaianny Ferreira Souza,
  • Laura Jéssica Pereira,
  • Yasmim Raffaela Soares Santos,
  • Emmilly de Oliveira Alves,
  • Jicaury Roberta Pereira da Silva,
  • Mairon César Coimbra,
  • Marina Andrade Rocha,
  • Carolina Girotto Pressete,
  • Zakariyya Muhammad Bello,
  • Ralph Gruppi Thome,
  • Hélio Batista dos Santos,
  • Lusânia Maria Greggi Antunes,
  • Magna Cristina de Paiva,
  • Karina Marjorie Silva Herrera,
  • Jaqueline Maria Siqueira Ferreira,
  • Farah Maria Drumond Chequer,
  • Rosy Iara Maciel Azambuja Ribeiro,
  • Renê Oliveira do Couto

摘要

The Celtis iguanaea (Jacq.) Sarg., Cannabaceae, standardized spray-dried extract, underwent acute safety evaluation using a range of alternative toxicological models in alignment with Organization for Economic Co-operation and Development Test Guidelines. Acute aquatic toxicity was assessed using the Artemia salina lethality test (LC50 418.4 μg/ml) and the zebrafish (Danio rerio) embryo toxicity test (OECD TG 236; LC50 1116.0 μg/ml). According to the Globally Harmonized System aquatic toxicity categories, C. iguanaea spray-dried extract is classified as non-hazardous (LC50 > 100 μg/ml). In vitro assays included cytotoxicity (methyl thiazolyl tetrazolium assay –in WI-38 and HaCaT cells; resazurin in Caco-2 and HT-29 cells), cell adhesion genotoxicity (comet assay; OECD TG 489), and mutagenicity (cytokinesis-block micronucleus assay; OECD TG 487). Celtis iguanaea spray-dried extract showed no cytotoxic, genotoxic, or mutagenic effects up to 250 μg/ml and enhanced HaCaT cell viability and adhesion at higher concentrations (100 μg/ml), suggesting potential support for wound healing. No antimicrobial activity was observed against Candida spp., ESKAPE pathogens, or bacteria associated with urinary tract infections (MIC > 1024.0 μg/ml). This weight-of-evidence assessment supports the safe use of C. iguanaea spray-dried extract in topical or oral formulations and provides data suitable for regulatory hazard characterization and acute risk assessment.

Graphical Abstract