In Vitro Toxicology
In vitro toxicology provides scientific evaluation of toxic effect not directly on living organisms (like in vivo toxicology) but rather on cells cultivated from bacteria or mammalian species (i.e. mammalian cell lines or bacterial cell lines).
Studies to be performed in vitro are results of a pressure over last years to refine, replace and reduce in vivo animal testing, where for example in vivo studies in the cosmetics industry are completely prohibited since 2013, and are replaced by in vitro alternatives. This is completely in line with the Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes... Read more...
In vitro Skin Tests
In vitro Skin Tests are performed to estimate a presence of reversible damage or impact to the skin upon the application of a test substance within its safety evaluation. The InterBioTox laboratories perform skin irritation and corrosion studies within Top-down and Bottom-up approaches.
|OECD 431||Skin Corrosion: "In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method"|
|OECD 435||Skin Corrosion : "In Vitro Membrane Barrier Test Method for Skin Corrosion" (Corrositex)|
|OECD 439||Skin Irritation: "In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method"|
In vitro Eye Tests
In vitro Eye Tests serve as a very sophisticated replacement of the Draize in vivo test system to estimate the irritant effects of various substances and mixtures to eyes. InterBioTox laboratories offer two types of in vitro eye irritation.
|OECD 437||Serious Eye Damage: "Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage" (BCOP)|
|OECD 492||Eye Irritation: EpiOcularTM Irritation (Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage)|
In vitro Phototoxicity Test
According to OECD Guideline 432 phototoxicity is defined as a toxic response elicited by topically or systemically administered photoreactive chemicals after the exposure of the body to environmental light. The in vitro 3T3 NRU phototoxicity test is based on a comparison of the cytotoxicity of a chemical when tested in the presence and in the absence of exposure to a non-cytotoxic dose of simulated solar light. The InterBioTox laboratories offer the phototoxicity testing to find the phototoxicity potential following topical exposure of many types of substances and products.
|OECD 432||In Vitro 3T3 NRU Phototoxicity Test|
In vitro Skin Sensitization Tests
Skin sensitization studies in vitro cover specific key events within the skin sensitisation adverse outcome pathway (AOP) occurs, which is a sequence of events from the molecular initiating event(s) to the adverse outcome(s) in the whole organism (OECD, 2012). InterBioTox offers three non-animal methods according to OECD TG 442 (DPRA, LuSens and, h-CLAT) and it is recommended to be used in suitable combinations within so called Turnkey testing strategy. The tests results should be integrated, normally under a weight-of-evidence approach.
|OECD 442C||In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)|
|OECD 442D||LuSens - In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method in accordance to the OECD 442D|
|OECD 442E||h-CLAT (human Cell Line Activation Test)|
In vitro Genetic Toxicology
Genotoxicity refers to the ability of harmful substances to damage genetic information in cells. Testing of genotoxic and/or mutagenic effects is an important test category for many product groups and is therefore of high relevance. The studies are performed on bacteria and mammalian cells or human lymphocytes. The InterBioTox laboratories perform the genotoxic studies in a tiered approach, since a single test is not capable to detect all relevant genotoxic/mutagenic agents. It means the usual approach is to conduct a battery of tests of different focuses, starting with a gene mutations on bacteria (AMES test), and proceeding with the conduct of mammalian cell studies and finally in vivo assays (as a last resort):
Therefore the tests are separated in three different categories:
- Testing of gene mutations on bacteria according OECD 471 (AMES)
- Testing of numerical and/or structural chromosome aberrations (aneugenic and clastogenic effects) on mammalian cells/human lymphocytes according OECD 473 or OECD 487
- Testing of gene mutations on mammalian cells according OECD 476
A correct selection is the test system battery is important and depends on the test substance the regulatory requirements as well.
|OECD 471|| Bacterial Reverse Mutation Test – AMES Test|
Ames Screening – MPF Test
|ASTM E1687||LuSens - In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method in accordance to the OECD 442D|
|OECD 473||In Vitro Mammalian Chromosome Aberration Test|
|OECD 487||In Vitro Mammalian Cell Micronucleus Test|
|OECD 490||In Vitro Mammalian Cell Gene Mutation Test: Mouse Lymphoma Test|
|OECD 476||Hypoxanthine-guanine phosphoribosyl transferase Test: HPRT Test|
|ICH Q3A (R2)||Impurities in new drug substances (OECD 471 and OECD 473 are recommended for determination of Genotoxic Impurities of Pharmaceuticals)|
|ICH M7 (R1)||Guideline - Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.|
In vitro Biocompatibility Testing of Medical Devices
Although the safety testing on extracts of medical devices (prepared acc. to ISO 10993-12) is still focused on small animals testing, we observe growing efforts to advance the replacement, reduction, and refinement of the use of animals within testing of safety for medical devices. InterBioTox performs in vitro cytotoxicity and test for irritation potential in vitro using a reconstructed human epidermis (RhE) as a model.
|ISO 10993-3||Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (specific tests)|
|ISO 10993-5||Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (specific tests)|
|ISO 10993-23||Biological evaluation of medical devices - Part 23: Tests for irritation (specific tests)|
In vitro Study for Endocrine Properties
These in vitro studies have been developed in order to detect estrogenic (YES) and androgenic (YAS) activities of natural and synthetic compounds, mixtures and environmental samples.
|YES/YAS Assay||Estrogen- and Androgen Receptor Binding Affinity|
In vitro Cosmetic and Pharmaceutical Formulations Testing
Since the testing on animals for purposes of the cosmetics industry was completely banned since 2013, InterBiotox Cluster offers a complete replacement of the testing like in vitro alternatives.
- Skin tolerance testing: Skin tolerance testing of final formulations, raw materials and mixtures using 3D reconstructed human epidermis model.
- Ocular tolerance testing: Ocular tolerance testing of final formulations, cosmetic raw materials and mixtures using 3D reconstructed human cornea model.
- Mucosa tissue irritation/ inflammation testing: Mucosa tissue (Oral, Gingival, Vaginal) tolerance testing of final formulations, cosmetic raw materials and mixtures using 3D reconstructed human mucosa models.
- Phototoxicity testing: Phototoxicity testing on 2D and/or 3D tissue model (skin/eye) to assess phototoxicity and/ or photo-protection of formulations, raw materials and mixtures
- Markers of inflammation and sensitisation: Screening of inflammatory mediators release (e.g. IL-1a, IL-18) for screening of inflammatory potential of formulations, raw materials and mixtures
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