Skin Irritation OECD439

A dermal irritation assay is a cornerstone of product development and regulatory compliance. It guarantees the safety of any substance that contacts human skin—cosmetics, pharmaceuticals, chemicals, and medical‑device ingredients.
Our MIVO® skin‑on‑Chip platform delivers a human‑relevant, in vitro solution that meets the OECD 439 guideline while providing data that regulators and clients trust.

It enables rapid risk identification and early identification of non‑irritant compounds, allowing the correct UN‑GHS categorization and saving both time and cost. The platform also offers fast turnaround, a collaborative study design, and quantitative results that support clear, data‑driven decision‑making.

Purpose of the Test: Human‑Relevant Skin Irritation (OECD 439)

The MIVO-based skin irritation assay uses the MIVO® skin-on-Chip platform to evaluate the safety of testing substances in a more reliable and human-relevant manner than traditional in vitro models. MIVO®skin-on-Chip platform’s ability to faithfully recreate the complex dynamic fluid-flow structure of the human skin, along with its compatibility with Reconstructed Human Esophageal (RhE) tissue models:

  • Accurately mimics human skin structure and barrier function.
  • Predicts skin responses (irritation, inflammation, barrier loss) in a physiologically relevant environment.
  • Supports early‑stage safety assessments for cosmetics, pharmaceuticals, chemicals and medical devices.

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The MIVO® Advantage: Dynamic Fluid Flow

MIVO® organ-on-chip technology enhances traditional RhE models by introducing dynamic fluid flow, creating a more accurate simulation of physiological skin conditions. This dynamic interaction improves the prediction of local skin toxicity, providing a comprehensive, accurate solution for early dermal testing.

Our Unique Value Proposition

Realistic, 3D, Humanized tissue Model: The MIVO® platform integrates a 3D RhE with dynamic fluid flow, simulating real-life skin conditions more effectively than static systems. This enhanced physiological accuracy allows for a more precise prediction of irritation potential and local skin toxicity.
Dynamic Fluid Flow for Better Precision, long term irritation tests and repeated doses treatments: Unlike static models, MIVO® incorporates dynamic fluid flow, ensuring that substances interact with the skin model in a way that mimics real human exposure (Pulsoni et al. 2022), leading to more accurate and predictive results. Moreover, the flow enables to significantly prolong the survival of Rhe in vitro, for testing long term irritation and repeated doses treatments.
Regulatory Compliance: MIVO® innovative configuration is fully aligned with OECD 439 for in vitro skin irritation testing. It provides a robust, reliable method for regulatory compliance in safety testing.
Versatile Applications: This system is highly adaptable, making it ideal not only for irritation and toxicity testing but also for cosmetic, pharmaceutical, and medical device product evaluations.
Throughput: the platform enables to carry out simultaneusly up to 12 independent experiments, supporting multiples doses evaluation of the testing compounds.

Skin irritation assay

In summary

Skin irritation assay summary 1
skin irritation

READOUTS

  • Epithelial barrier integrity (TEER measurement) 
  • Tissue viability (MTT) and EC50 evaluation
  • Inflammation (i.e. IL6, IL8)
Skin irritation teer
Epitelial barrier integrity

TEER measurement is performed before and after chemical exposure, as indirect measurement of barrier integrity.

Skin irritation MTT
Tissue viability

Cell viability after exposure to substance is assessed through MTT assay, according to OECD439 TG.

Skin irritation IL-6
Inflammatory response

Inflammation induced after exposure to substance is
assessed by quantification of pro-inflammatory cytokines (i.e. IL6) through ELISA assay.

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