In Vitro Dermal Irritation Testing

The trend and acceptance of testing cosmetic, and skin care products on live animals has quickly shifted, with more consumers preferring and actively choosing products that have not been tested on animals.  However, the safety and efficacy of products to be used on skin and hair must be studied for bringing the product to market, and for regulatory requirements. That’s where in vitro (or lab-based) testing comes into place.

In vitro testing uses a laboratory setting (not live animals) to test skin and hair products, topical pharmaceuticals like creams and drops, chemicals, household products like detergents or anti-bacterials for their safety on human skin.

Krishgen works with a French company called EpiSkin, a pioneer in the field, that provides reconstructed dermal tissues for testing dermal irritation and corrosion on a variety of samples. Using our training and expertise from technically supporting our customers in India, we provide in vitro dermal irritation testing services, and in vitro dermal corrosion testing services.

These tests from EpiSkin have been endorsed by the ECVAM Scientific Advisory Committee (ESAC), and have been accepted under OECD test guidelines.

Learn more about EpiSkin.

What are reconstructed dermal tissues?

Reconstructed Human Epidermis (RHE) is constructed from normal human keratinocytes cultured on an inert polycarbonate filter at the air-liquid interface, in a chemically defined medium. This model is histologically similar to in vivo human epidermis.

How closely do they behave like human skin?

Histologically, these in vitro tissues have various epidermal markers, which makes them behave similarly to human skin. There are several papers that validate the similarities between the two.

EpiSkin provides a range of tissue types that are each designed for testing specific sample types or parameters. All of these models allow the evaluation of raw materials, active ingredients and finished products being either in a solid, liquid, powder, cream or gel form. Depending on what you are looking to test, Krishgen’s team can recommend the right tissue type for you.

Tissues are available for skin, pigmented skin (darker shades), gingival (gums), oral, vaginal and corneal (for eye).

PARAMETERS THAT CAN BE TESTED USING EPISKIN:

Skin Irritation (EVCAM: OECD TG 439): Designed for regulatory classification of products, and for claims on finished products. This test assesses whether your chemical or product is irritable to skin when applied in the recommended dose or expected exposure. If a product is classified as an irritant, the below corrosion test must be conducted to correctly classify the degree of irritation.

Skin Corrosion (EVCAM: OECD TG 431): For products that are classified as irritant, or are expected to be corrosive on skin, certain labeling and classification protocols must be followed. Skin corrosiveness testing is conducted to ensure that chemicals and products are properly labeled to alert consumers and workers to take precautions to prevent chemical burns to the skin and eyes. Correctly classifying the corrosiveness of a product by testing can help the product be classified at a lower regulatory cost, or be less expensive for shipping and corrosion labeling.

Corrosion testing is required for:

• Classification and labelling of chemicals regarding in vitro skin corrosion assessment
• Determination of packaging requirement
• Complementary data to in vitro skin irritation assessment of compound classified as irritant (see OECD Test Guideline 439)

Photo Toxicity and Photo Protection: To assess the degree of chemically induced irritation, or sun sensitivity, as well as test the capabilities of the product to protect and repair irritation damage, these tests are often done for UV exposure related products.

Permeability: The ability of a product to enter into skin layers, and the depth to which the product can go is called permeability. As the EpiSkin models closely resemble the human epidermis, we can accurately predict the permeability of a product, as well as gauge it’s effects on human skin metabolic activities and barrier function. This test is particularly used by manufacturers of hair, skin, and cosmetic products, as well as heavily in the medical field for assessing affects of their raw materials and topical products.

Ocular (Eye) Irritation: Just like skin irritation, this test helps classify products based on their irritation. However, as EpiSkin has a specific tissue that mimics the tissues in human eyes, this test is specific for products that are applied on, or near the eyes. This includes medical grade drops, as well as cosmetic and skin care products that are meant to be applied on the upper or lower eyelids.

Pigmentation / De-pigmentation: Designed specifically for testing the level of pigmentation or de-pigmentation caused by a product. Often used for topical products, this test can be designed to assess effects of the product following repeated daily application.

Cytotoxicity : A simple robust MTT test for evaluating cellular viability (i.e. did the cells die) following application of an irritant/toxic agent. The validated method enables evaluation of the viability of epidermal samples after a set time in contact with the product.

IL-1 alpha release (optional with extra charges): IL1 alpha measurement in culture media increases the sensibility of the test. Products can thus be classified according to EU and OECD norms.

READY TO TEST YOUR PRODUCT? Get a quote.

ADVANTAGES OF IN-VITRO DERMAL AND OCULAR IRRITATION / TESTING:

• An ethical method

           Carried out in vitro, the reconstructed tissues make it possible to evaluate the irritant potential of chemical products, without using animal testing.

• Suitable standardized model

           Compared to in vivo study, reconstructed epidermis allows the use of measurement systems that produce quantitative, reproducible results.

• Validated Method with Regulatory Acceptance

            The ECVAM validation of the method has shown its reproducibility within and between laboratories, and demonstrated that it is rapid and economical.

            Allows for scientific claims on products with data tables, and documentation.

• Time Saving

            Unlike animal testing which can take 2 – 4 weeks, in vitro testing can be completed in as little as a few hours.

KEY FEATURES OF KRISHGEN’S SERVICES:

• Superior technical expertise, trained specially by the EpiSkin team for carrying out testing and training.
• Rapid, reliable and cost effective testing, with ease of robust results.
• Tests carried out as per specific guidelines.
• Advanced data analysis software, data storage and analysis.
• Well-equipped laboratory with fully automated sample testing systems.

PREFER TO RUN THE TEST IN YOUR LAB? Our team can help find the right product for you.