In-Vitro Tests

These are conducted in laboratory environments using cell cultures or biological simulation systems, without the involvement of live animals. They represent an indispensable method for evaluating the safety and efficacy of medical devices, cosmetic products, and biocidal formulations.

What is an In Vitro Test?

'In vitro' is Latin for 'in glass'. It refers to tests conducted outside a living organism under controlled laboratory conditions. These methods provide scientific data by analyzing the toxicological, irritant, or mutagenic potential of a product on cells.

For which products is it suitable?

• Medical devices (especially products with short-term contact)
• Cosmetic products and raw materials
• Chemical products, detergents
• Biocidal Products
• Materials that come into contact with food

Key In Vitro Tests Performed

The most important in-vitro tests conducted in our laboratory in accordance with European Union regulations (MDR, REACH, CLP, EC 1223/2009) and ISO standards:

• In-vitro Cytotoxicity Test – TS EN ISO 10993-5, TS EN ISO 10993-12
• Cell Viability Test (MTT Assay): Cytotoxicity is assessed by measuring the viability of cells (ISO 10993-5).
• Skin Irritation Test (Reconstructed Human Epidermis – RHE): The skin irritation potential is determined using artificial skin models (OECD TG 439).
• Eye Irritation Test (HET-CAM, BCOP, EpiOcular): The risk of irritation from products that come into contact with the eyes is measured without animal testing.
• Mutagenicity Tests (Ames Test, Micronucleus Test): It is investigated whether the product causes DNA damage.
• Phototoxicity Test: The product's reactions under solar radiation are measured.
• Barrier Penetration Tests: The extent to which cosmetic or topical medicinal products penetrate the skin is analyzed.

Why should in-vitro tests be preferred?

• Offers an ethical alternative to the use of animals
• Complies with regulations (e.g., EC 1223/2009, MDR 2017/745)
• Provides faster and more cost-effective results
• Provides precise and reproducible results
• Makes a positive contribution to consumer safety and brand image