Regulatory safety testing
XCellR8 offers a range of in vitro tests to provide regulatory safety data for raw materials and finished formulations for the cosmetic and chemical industries.
Our turnaround times are typically 6 to 8 weeks and we provide data for human health endpoints including skin and eye irritation, skin corrosion and skin sensitisation. What’s more, we have adapted existing methodologies to 100% animal-product-free conditions and gained regulatory recognition of these adaptations. This means that clients can use XCellR8 tests as part of a vegan testing strategy whilst remaining compliant with OECD Test Guidelines.
We also offer non-regulatory methods yielding animal-free supporting data for regulatory submissions, as part of a weight-of-evidence (WoE) approach. Please get in touch if you’re not sure which method is right for your circumstances. We’ll be happy to advise you.
OUR ANIMAL-FREE REGULATORY TESTS
| TEST GUIDELINE | ENDPOINT | METHOD | |
|---|---|---|---|
| OECD TG 439 | Skin irritation | Human skin model | More info > |
| OECD TG 492 | Eye irritation | Human cornea model | More info > |
| OECD TG 442c | Skin sensitisation | Direct Peptide Reactivity Assay (DPRA) | More info > |
| OECD TG 442d | Skin sensitisation | KeratinoSens™ | More info > |
| OECD TG 442e | Skin sensitisation | Human Cell Line Activation Test (h-CLAT) | More info > |
| OECD TG 431 | Skin corrosion | Human skin model | More info > |
MEET YOUR REGULATORY REQUIREMENTS
XCellR8’s lab is Good Laboratory Practice (GLP) accredited by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency) for in vitro safety testing, so the data we provide can be used at a regulatory level for compliance with a wide range of European and global regulations, including:
- REACH (EC 1907/2006)
- CLP Regulation (EC 1272/2008)
- Biocidal Products Regulation (EC 528/2012)
- Plant Protection Products Regulation (EC 1107/2009)
- Cosmetics Regulation (EC 1223/2009)
Whether you are looking for safety data to form part of a REACH dossier or a Material Safety Data Sheet, or as part of your new product development programme, please ask us for a quote.
Want to learn more?
Because some in vitro methods are still relatively new and not widely understood, we’ve published this essential guide to regulatory in vitro safety testing. It explains how animal-free tests work, how they are more predictive of human safety, which tests can be used in REACH submissions and how the regulators view animal-free testing.
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