In Vitro Dermal Toxicology
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Skin, as the first line of defense against environmental exposure, has multiple physiological functions such as immune defense, body temperature regulation, and chemical barrier. Drugs, chemicals, or cosmetic ingredients may have local irritation/corrosion, sensitization, or other toxicological reactions due to direct contact or systemic absorption, which may bring potential health risks to humans. Consequently, the dermal safety evaluation of chemical substances has become an essential element of product development, regulatory submission, and compliance management.
Based on international standards and the latest technology, our dermal toxicology services offer a full range of accurate skin safety assessment solutions to support pharmaceutical, cosmetic, chemical, and medical device industries to efficiently complete product safety substantiation and compliance.
Our In Vitro Dermal Toxicology Services
- Dermal Corrosion Testing
- Dermal Irritation Testing
- Skin Sensitization Testing
- Dermal Absorption Testing
- 3D Skin Model-Based Dermal Toxicity Assessment Services
Dermal Corrosion Testing
OECD 431: Utilizes a human-derived 3D skin model to determine the potential of a chemical to cause irreversible tissue damage. The test evaluates tissue viability after exposure, and classification is based on viability thresholds.
Applications: Safety classification of raw materials, industrial chemicals, and cosmetic ingredients.
Dermal Irritation Testing
OECD 439: This skin irritation testing method uses Reconstructed Human Epidermis (RHE) models to assess the irritancy of the chemical on the skin. It is one of the most used in vitro skin irritation test methods currently, and it effectively differentiates irritants from non-irritants.
Skin Sensitization Testing
OECD 442C (Direct Peptide Reactivity Assay, DPRA): Predicts the potential sensitizing effects of chemicals by assessing their reactivity with synthetic peptides.
Applications: Sensitizer early screen in an integrated testing strategy.
OECD 442D (KeratinoSens Test): This is a luciferase-based reporter assay developed using a human keratinocyte cell line engineered to detect the activation of the antioxidant/electrophile response element (ARE), a marker of ARE-sensitizer-induced stress response.
Applications: Cosmetics, personal care products, chemicals.
Dermal Absorption Testing
OECD 428: Employs excised human or animal skin mounted in Franz diffusion cells to quantify percutaneous absorption of chemicals. It measures the rate and extent of skin penetration over time.
Applications: Evaluates the extent of dermal absorption of cosmetics, chemicals, pharmaceuticals, etc., especially suited for assessing transdermal drug absorption efficiency.
3D Skin Model-Based Dermal Toxicity Assessment Services
Utilizes our advanced 3D skin models to simulate a real skin environment and comprehensively assess the dermal toxicity of products, including irritation, sensitization, and absorption. The 3D skin model, with both epidermal and dermal structures, offers a more accurate simulation of physiological and toxicological responses of human skin.
Applications: Suitable for evaluating the comprehensive dermal toxicity of cosmetics, chemicals, pharmaceuticals, etc., especially for products requiring a thorough assessment.
Available Skin Models
- Reconstructed Human Epidermis (RHE): Developed using human-derived keratinocytes to mimic the epidermis layer.
- Ex Vivo Skin Models: Utilizes excised animal skin (e.g., pig or rat) for assessing dermal absorption and other skin-related toxicities.
- 3D Skin Models: Sophisticated models that closely resemble the physiological structure and function of human skin, suitable for detailed dermal toxicity assessments.
Why Choose Our Dermal Toxicology Services
Customizable Protocols
Tailored assay design based on compound class, exposure route, and regulatory goals
GLP-Compliant Lab
Reliable data generation under Good Laboratory Practice standards
Rapid Turnaround
Efficient project timelines to support preclinical pipelines
Technical advancement
Utilizing internationally recognized 3D skin models and high-throughput detection platforms to enhance data reliability.
FAQ
What is the difference between dermal corrosion and irritation testing?
Corrosion refers to irreversible skin damage caused by a chemical, such as ulcers or necrosis, typically occurring after a short exposure time. Irritation, on the other hand, causes reversible inflammatory responses (e.g., erythema, edema), which require a longer period of contact.
What are the advantages of 3D skin models compared to traditional animal testing?
In terms of physiological structure, 3D skin models are more similar to human skin, which significantly reduce the interspecies variations. Utilization of these in vitro models is also in line with the 3R principle (Replacement, Reduction, and Refinement of animal use), and they are more compatible with high-throughput screening and mechanistic studies. More importantly, these models allow a much more reliable testing of dermal toxicity.
How do I choose the appropriate testing method?
The selection of a suitable test method for chemicals depends on the specific use of the chemical, the route of exposure, and regulatory guidelines or requirements for the market of interest. For example, for cosmetic ingredients, OECD TG 439 (skin irritation) and DPRA (skin sensitization) testing would be required to comply with the regulations.
What kind of data will I receive?
Clients will be provided with a final report containing detailed information on experimental conditions, raw data, statistical analysis (if applicable), high-resolution images (when applicable) and discussion on the results with reference to regulatory thresholds.
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