In vitro toxicology testing from SGS – demonstrate the safety profile of new chemical entities, pharmaceutical drugs, cosmetic products, and medical devices.
In vitro toxicology testing helps to ensure consumer safety and accelerate product development. It is often required by regulatory agencies, or implemented as part of a commitment to the 3 Rs (Replacement, Reduction and Refinement) in relation to in vivo testing. We offer cost effective in vitro alternatives to establish the toxicological profiles of bio/pharmaceuticals, medical devices, cosmetics and chemicals.
Why choose in vitro toxicology testing from SGS?
Our quality control laboratories operate according to the highest standards (GMP, ISO 13485:2016, ISO 9001:2015) and have been inspected by the FDA and/or local regulatory authorities. We provide high throughput screening and multiplexing technologies via our in vitro toxicology lab, and we have extensive experience in cell-based assay development.
In vitro testing from a trusted provider
We offer several in vitro toxicology testing methods, most of which can be used either as standalone procedures or as part of testing panels, for performing toxicological risk assessments of your products.
Our comprehensive program of analytical techniques for in vitro toxicity testing includes:
Dermal irritation and corrosion tests assess whether a substance may cause reversible or irreversible damage to the skin. Epiderm tests can be used alone or in combination to distinguish between non-irritants/non-corrosives and irritants/corrosives.
Our in vitro dermal irritation and corrosion tests:
- OECD 439 - EpiDerm™ Skin Irritation Test (Reconstructed human Epidermis (RhE) model)
- OECD 431 - EpiDerm™ Skin Corrosion Test (Reconstructed human Epidermis (RhE) model)
Ocular irritation testing
An ocular irritation test assesses whether a substance may cause reversible or irreversible damage to the eye.
Our in vitro ocular irritation test:
- OECD 492 - EpiOcular™ eye irritation test (Reconstructed human Cornea-like Epidermis (RhCE))
Qualitative and quantitative cytotoxicity testing
Qualitative cytotoxic testing uses a numerical grading system to determine how toxic a medical device and its extracts are for cells.
Our USP <87> biological reactivity tests:
- Direct contact
- Agar diffusion
We also offer quantitative testing, using substances or extracts from the medical device.
Genotoxicity testing determines the potential for a product to cause genetic mutations and chromosomal damage. Testing is performed using bacterial and mammalian systems.
Our in vitro tests for genotoxicity:
- OECD 471 - Ames (gene mutation in bacteria)
- OECD 487 - Micronucleus Assay (chromosomal damage in mammalian cells)
A phototoxicity test predicts whether a toxic response may arise from skin exposure or systemic administration of a substance, followed by subsequent exposure to light.
Our phototoxicity test:
- OECD 432 - 3T3 NRU phototoxicity test (cell viability test)
Permeability testing predicts the intestinal absorption and bioavailability of drugs and is used to determine a drug or substance’s permeability class.
Our in vitro permeability test:
- Caco-2 cell monolayer permeability test
To discuss how our in vitro toxicology testing services can help you, contact us today.