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
|Skin irritation||ET50||More info>|
|Eye irritation||ET50||More info>|
|Oral irritation||ET50||More info>|
|Gingival irritation||ET50||More info>|
|Vaginal irritation||Human cell based vaginal model||More info>|
|Skin sensitisation||GARD®skin||More info>|
|Genotoxicity||BlueScreen™ Animal-Free||More info>|
|Genotoxicity||Mammalian Micronucleus Test||More info>|
|Acute toxicity||Human cell based screen||More info>|
|Inhalation toxicity||EpiAirway™||More info>|
|Cytotoxicity||Metabolic capacity (MTT) or membrane damage (Neutral Red Uptake - NRU)||More info>|
|ISO 10993-5 cytotoxicity||Metabolic capacity (MTT) or membrane damage (Neutral Red Uptake - NRU)||More info>|
|Phototoxicity||Reconstructed human skin model||More info>|
|Mildness to skin||Reconstructed human skin model||More 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.
Ask us a question