Non-regulatory safety testing

XCellR8 offers a range of animal-free safety tests that can be used in new product development or to provide supplementary data in regulatory submissions as part of a weight­-of­-evidence (WoE) approach.

Clients in the cosmetic and chemical industries use our tests to provide safety data for a range of important human health endpoints including acute toxicity and genotoxicity. We test both raw ingredients in liquid or solid forms, and finished formulations such as moisturisers, shower gels, shampoos and household cleaning products.

We have eliminated the use of animals and animal products from all the tests in our laboratory, meaning you can use safety data that is both ethically sound and scientifically more human-relevant. Whilst our regulatory tests often provide a binary answer such as ‘is the product a sensitiser or not’, our non-regulatory tests can be used to establish the relative likelihood of a test item to elicit a reaction or to benchmark them against industry best sellers.

NON-REGULATORY SAFETY TESTING SERVICES

ENDPOINTMETHOD
Skin irritationET50More info>
Eye irritationET50More info>
Oral irritationET50More info>
Gingival irritationET50More info>
Vaginal irritationHuman cell based vaginal modelMore info>
Skin sensitisationGARD®skinMore info>
GenotoxicityBlueScreen™ Animal-FreeMore info>
GenotoxicityMammalian Micronucleus TestMore info>
Acute toxicityHuman cell based screenMore info>
Inhalation toxicityEpiAirway™More info>
CytotoxicityMetabolic capacity (MTT) or membrane damage (Neutral Red Uptake - NRU)More info>
ISO 10993-5 cytotoxicityMetabolic capacity (MTT) or membrane damage (Neutral Red Uptake - NRU)More info>
PhototoxicityReconstructed human skin modelMore info>
Mildness to skinReconstructed human skin modelMore info>

Our turnaround times are usually within 6 to 8 weeks, and can help you make fast decisions about whether to progress with an ingredient before employing more expensive human volunteer trials. Please get in touch today to ask for a quote.

DEVELOPING A REGULATORY TEST FOR ACUTE TOXICITY

The animal-free testing industry is growing rapidly and innovating constantly to reduce reliance on historic animal data that has been shown to be less accurate in predicting human health outcomes.

Currently, acute systemic toxicity is the only human health endpoint in Annex VII of REACH that has no animal-free test available. There are currently no new in vitro methods in validation, but we aim to change that.

We took the first steps in 2016 by developing a non-regulatory screen for human acute toxicity, using human cells in animal product-free culture. The screen was internally validated for cosmetic ingredients and is already used by our clients a part of a weight-of-evidence approach in REACH submissions, to avoid the widely discredited LD50-related animal tests.

Now with support from the European Horizon 2020 programme, we are further developing the test to expand its applicability across a range of chemical sectors.

To learn more, read our comment piece or download our poster.

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