INVITRO-CONNECT GMBH

Microbiological examinations / Microbiological tests against viruses, bacteriophages, bacteria, yeast, molds, mycobacteria and bacterial spores for disinfectants, medical devices, pharmaceutical products and cosmetics Our team of experts supports manufacturers of biocidal and medical products as well as cosmetics and pharmaceuticals scientifically in the context of approval projects. For example, we create safety assessments for cosmetics and biocompatibility assessments for medical devices. Here we focus in particular on infection prevention and wound treatment products. For more information please contact INVITRO-CONNECT GmbH for assistance in developing specialized protocols for your test materials. INVITRO-CONNECT GmbH: Fast Project Execution: personal - competent - reliable --> contact@invitro-connect.com

- in vitro gene mutation study in bacteria: Ames Test OECD 471 - in vitro gene mutation study in mammalian cells: Mouse Lymphoma Assay (MLTK Assay) OECD 490 - in vitro gene mutation study in mammalian cells: HPRT test / OECD 476 - Micronucleus Assay in vitro (Human Lymphocytes or V79 cells) / OECD 487 - Chromosomal aberration Assay in vitro (Human Lymphocytes or V79 cells) / OECD 473 - Hen’s Egg Test – Induction of Micronuclei (HET-MN) - COMET Assay in different cell types - Cell Transformation Assay in Bhas Cells / OECD 231 (draft) - Mammalian Erythrocyte Micronucleus Test / OECD 474 / ISO 10993-3 - Combined Mammalian Erythrocyte Micronucleus Test with concurrent Alkaline Comet Assay in vivo OECD 474 & 489 - In vivo Mammalian Alkaline Comet Assay / OECD 489 - Unscheduled DNA synthesis (UDS) Test with Mammalian Liver Cells in vivo / OECD 486 - Mammalian Spermatogonial Chromosomal Aberration test / OECD 483 - Mammalian Bone Marrow Chromosomal Aberration test / OECD 475

Determination of skin sensitization potential is a critical endpoint in the safety assessment of raw materials, chemicals, mixtures and formulations. Although the Guinea Pig Maximization Test (GPMT) and Local Lymph node assay (LLNA) have historically been used to address this adverse effect, in vitro assays have been developed and validated in order to replace these resource-intensive animal tests. INVITRO-CONNECT GmbH offers various test strategies without animal testing for examining skin sensitization: - Direct Peptide Reactivity Activation Assay (DPRA, OECD 442C) - ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D) -Human Cell Line Activation Test (h-CLAT, OECD 442E) -Kinetic Direct Peptide Reactivity Assay (kDPRA) -Myeloid U937 Skin Sensitization Test (MUSST / U-SENS) -and more Fast Project Execution: personal - competent - reliable --> contact@invitro-connect. - More than 80 Test Laboratories - Product Safety - Regulatory Service -

INVITRO-CONNECT GmbH offers various test strategies without animal testing for examining Eye Irritation / Eye damage hazard assessment. From standard regulatory hazard assessments to providing information on the degree of ocular irritation, to discriminating among extremely mild eye area products, INVITRO-CONNECT’ Study Monitors take the time to understand your specific goals and apply the most relevant, cost-effective strategies to achieve them. Tests for Eye Irritation / Eye damage hazard assessment in vitro: HET-CAM Assay BCOP: OECD 437 Isolated Chicken Eye Test: OECD 438 STE / Short Time Exposure (STE, OECD 491): Ocular Irritection EpiOcular & SkinEthic HCE Reconstructed human Cornea-like Epithelium (RhCE): OECD 492 For more information please contact INVITRO-CONNECT GmbH for assistance in developing specialized protocols for your test materials. INVITRO-CONNECT GmbH: Fast Project Execution: personal - competent - reliable --> contact@invitro-connect.com

INVITRO-CONNECT GmbH offers various test strategies without animal testing for examining skin Corrosion: - OECD 435 - Skin Corrosion : "In Vitro Membrane Barrier Test Method for Skin Corrosion" (Corrositex): The Corrositex® assay is a standardized and quantitative in vitro test developed as a replacement for the dermal corrosivity rabbit test. The Corrositex® assay is presently the only in vitro assay approved by the U.S. Department of Transportation for testing potential corrosive materials and assigning packing group categories. For more information please contact INVITRO-CONNECT GmbH for assistance in developing specialized protocols for your test materials. INVITRO-CONNECT GmbH: Fast Project Execution: personal - competent - reliable --> contact@invitro-connect.com More than 80 test laboratories - Product safety - Regulatory service - In vitro tests - All OECD tests for pharmaceuticals, chemicals, medical devices and cosmetics - Study monitoring, MSDS etc.

- OECD 439 / Skin Irritation Test (SIT) in a Reconstructed Human Epidermis (RhE) Model - Skin Irritation in the regulatory hazard classification and labeling context is defined as the production of reversible damage to skin following a defined chemical exposure. The Skin Irritation Test (SIT) is an in vitro, non-animal test designed to identify those chemicals and mixtures capable of inducing moderate skin irritation (UN GHS Category 2 Skin Irritants1), and to discriminate UN GHS Category 2 Skin Irritants from UN GHS 3 Mild Skin Irritants as well as those not requiring classification for skin irritation potential. INVITRO-CONNECT GmbH has extensive expertise with a wide variety of reconstructed skin-based protocols. For more information please contact INVITRO-CONNECT GmbH for assistance in developing specialized protocols for your test materials. INVITRO-CONNECT GmbH: Fast Project Execution: personal - competent - reliable --> contact@invitro-connect.com

Medical Device Services / Medical Device Laboratory Testing INVITRO-CONNECT GmbH offers you: - General regulatory advice for medical devices - All regulatory examinations and tests under GLP - Project management and study monitoring - Medical Device Regulatory Service - Product testing for contained SVHC substances INVITRO-CONNECT offers you a complete service for the approval of medical devices according (EU) 2017/745 (Medical Device Regulation - MDR) / ISO 10993. From the development of an ideal test strategy to laboratory and project coordination, study monitoring, toxicological expertise and GLP inspections in the cooperation laboratories. We deliver the finalized test reports including the registration dossier - digitally and on paper, worldwide. Benefit from our diverse know-how, our experienced cooperation partners and an international, very well-organized network. Questions? -> contact@invitro-connect.com

INVITRO-CONNECT GmbH: - Regulatory advice - All OECD laboratory tests - Phys-Chem / Tox / in vitro tests / Genotox / Ecotox, E-fate etc. - Personal project management - in-house toxicologists - Study monitoring - Study Summaries, IUCLID 6 - Dossier creation - MSDS etc. Benefit from an international, very well organized network: carefully selected experts, in-house toxicologists and more than 80 accredited test laboratories and service providers with over 20 years of experience in the industry. We are your competent partner for regulatory and toxicological issues, expert services, reports and all OECD laboratory tests We are also happy to be your reliable partner for your laboratory services and regulatory projects. Questions? -> contact@invitro-connect.com Your Mrs. Dr. Ute Hassmann and Your Mr. Pascal Piller