In Vitro Toxicology

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​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.

Many of the in vitro human, animal and 3D tissue alternatives are fully validated, reliable, reproducible and cost-effective tools in determination of various types of toxicity. The experimental design is comparatively easy than in vivo and can be managed with respect to time and higher number of samples to be tested in parallel. The studies are accepted by the authorities mainly in skin irritation, skin corrosion, skin sensitization and phototoxicity. Through an intensive research and global studies, the range of in vitro methods could be numerically but also qualitatively extended enormously in the future years.

In vitro toxicology studies offered by InterBioTox are targeted on the nonclinical tests of cosmetics and pharmaceutical compounds and medical devices as well as in vitro hazard identification (Globally Harmonized System GHS) of chemicals according to the OECD test guidelines. 

A special and well developed part in InterBioTox cluster represents in vitro genetic toxicology with its role to detect potential carcinogens (genotoxic and/or mutagenic effects).

Tests are conducted at GLP certified facilities and comply with the latest versions of the guidelines issued by the OECD, ICH and ISO.

The testing is performed in compliance with Good Laboratory Practice regulations to ensure an acceptance of the results by regulatory authorities worldwide.

We offer a number of in vitro tests on skin and eye for many purposes and products. A choice of the suitable test systems often depends on the test substance as well as the requirements of the regulations.

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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 431Skin 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 439Skin 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 437Serious 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 492Eye 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 432In 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 442CIn Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)
 OECD 442DLuSens - In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method in accordance to the OECD 442D
 OECD 442Eh-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 487In 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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