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 In Vitro Compatibility Testing
Institut Dr. Schrader
Ancopharm
After animal testing of cosmetic finished products had been prohibited in the European Union as stipulated by the Animal Protection Law, the 7th Amendment to the EU Cosmetics Directive adopted on 12 February 2003 requires a stepwise limitation and from the year 2013 a complete ban of animal testing for cosmetic ingredients. As soon as a scientifically based and experimentally proven animal testing-free alternative method becomes available for a test method, this alternative method must be used to test new substances. The in vitro test assays described below are routinely used to ensure the safety of new finished products and to select raw materials.
Potential irritancy can be detected reliably in the RBC, NRU and HET/CAM tests or by tests in replicated skin cultures. In studies with the NRU cytotoxicity test with a defined ultraviolet exposure possible phototoxic reactions can also be detected. Determination of the percutaneous absorption in isolated mammalian skin allows risk assessment of the systemic exposure. Proof that none of the active ingredients or only small ineffective amounts penetrate the skin makes further toxicological testing for systemic effects unnecessary. Our range of services includes the following tests:
In vitro determination of the irritation potential:
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Assessment of the acute dermal irritation/corrosion potential of finished products, raw materials and chemicals, e.g. corrosivity test in the human skin model according to OECD TG 431
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EpiDerm™ test system for classification of skin irritancy
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EpiOcular™ test system for estimation of ocular irritancy
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Chorioallantoic membrane test in incubated hen's eggs (HET/CAM-Test) for evaluation of eye irritancy of finished products and raw materials (INVITTOX Protocol #
47/96)
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Test of hemolysis in the red blood cell test (RBC test) for rating of the irritation potential of surfactants and surfactant-containing products (INVITTOX Protocol # 37)
Other test methods upon request.
Tests in Standardized Cell Cultures:
- Cytotoxicity test (neutral red test) according to USP XXIII and ISO 10993 for assessment of toxic potential and dermal irritancy of active substances and raw materials in fibroblasts
- Risk assessment of contact sensitizing properties in Sandwich ELISA assays (e.g. IL -1ß) in cell cultures (Langerhans cells) and human skin models
In vitro photoxicity studies:
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3T3 NRU phototoxicity test in standardized fibroblasts according to OECD TG 432 for assessment of the phototoxic potential of water-soluble test substances
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EpiDerm™ phototoxicity test with a three-dimensional skin model for classification of the phototoxic potential of cosmetic and pharmaceutical finished products (ECVAM SOP)
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Photohemolysis test; a primary test method to estimate the influence of light on the toxic effect of test substances (INVITTOX Protocol #81)
Other test methods such as the linoleic acid test, OxyDNA assay and histidine photo-oxidation test; information on these upon request
Percutaneous absorption:
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