What Is the In Vitro Skin Sensitization Test?

The In Vitro Skin Sensitization Test is one of the advanced cell culture and molecular biology-based testing methods used to assess the potential of a substance or product to cause an allergic reaction following skin contact. These studies play a significant role in the safety assessment of cosmetic products, biocidal products, chemical substances, medical devices, and raw materials.

Skin sensitization refers to a substance’s potential to trigger the immune system and cause allergic contact dermatitis following repeated exposure. Thanks to in vitro methods developed today, this risk can be assessed using alternative approaches to animal testing.

As NanoTox, we offer reliable and scientifically validated in vitro skin sensitization test services within our In Vitro Cell Culture Unit, in accordance with international standards.

Purpose of the In Vitro Skin Sensitization Test

These tests aim to determine the skin sensitization potential of a product or chemical substance.

Through these studies:

• The risk of causing an allergic reaction is assessed,
• Product safety is verified,
• Chemical classification processes are supported,
• Regulatory requirements are met,
• Scientific data is provided for product development studies.

Modern Approaches in Skin Sensitization Assessment

Skin sensitization is a complex biological process, and therefore, assessment studies are conducted using test methods that examine various biological mechanisms.

Thanks to modern in vitro methods:

• Alternative testing strategies to animal use are applied,
• Results closer to human biology are obtained,
• Reliable and reproducible data are provided,
• Internationally recognized testing approaches can be utilized.

These methods enable the evaluation of different stages of the skin sensitization process.

Studies in Compliance with OECD Guidelines

In Vitro Skin Sensitization tests conducted at NanoTox are carried out in accordance with internationally recognized OECD guidelines.

The primary methods used are:

• OECD 442C – Direct Peptide Reactivity Assay (DPRA)
• OECD 442D – ARE-Nrf2 Luciferase Test Method (KeratinoSens™)
• OECD 442E – Human Cell Line Activation Test (h-CLAT)

are listed.

By using these methods together, it is possible to comprehensively assess the potential for skin sensitization.

Test Principle

In In Vitro Skin Sensitization studies, it is evaluated whether the tested substance triggers the fundamental biological events involved in the skin sensitization process.

Studies frequently examine:

• Protein binding potential,
• Cellular stress responses,
• Keratinocyte activation,
• Dendritic cell activation,
• Cellular biomarker analyses

are investigated.

The data obtained helps determine the product’s potential to cause allergic reactions.

Reliable Cell Culture Studies with NanoTox

NanoTox conducts In Vitro Skin Sensitization tests in accordance with international standards using modern cell culture laboratories and a team of experts. We ensure the reliable acquisition of scientific data required for product safety and regulatory processes.

For detailed information about In Vitro Skin Sensitization tests and our other cell culture services, please contact NanoTox.