Follow-up to the ECVAM Prevalidation Study on In Vitro Tests for Acute Skin Irritation

Abstract

The European Centre for the Validation of Alternative Methods (ECVAM) Skin Irritation Task Force was established in 1996, to review the status of the development and validation of alternative tests for skin irritation and corrosion, and to identify appropriate non-animal tests for predicting human skin irritation that were sufficiently well-developed to be prevalidated and validated by ECVAM. The EpiDerm™ method, based on a reconstituted human skin model, was proposed as being sufficiently well advanced to enter a prevalidation (PV) study. Based on a review of test protocols, prediction models (PMs), and data submitted by test developers on ten specified chemicals, with 20% sodium lauryl sulphate as a reference standard, the task force recommended the inclusion of four other tests: EPISKIN™ and PREDISKIN™, based on reconstituted human epidermis or on human skin; the non-perfused pig-ear test, based on pig skin; and the skin integrity function test (SIFT), with ex vivo mouse skin. The prevalidation study on these methods was funded by ECVAM, and took place during 1999–2000. The outcome of the PV study was that none of the methods was ready to enter a formal validation study, and that the protocols and PMs of the methods had to be improved in order to increase their predictive abilities. Improved protocols and PMs for the EpiDerm and EPISKIN methods, the pig ear test, and the SIFT were presented at an extended Task Force meeting held in May 2001. It was agreed that, in the short term, the performance of the revised and harmonised EpiDerm and EPISKIN methods, as well as the modified SIFT, should be evaluated in a further study with a new set of 20 test chemicals. In addition, it was decided that the SIFT and the pig-ear test would be compared to see if common endpoints (transepidermal water loss, methyl green-pyronine stain) could be identified.

Skin capacitance imaging and corneosurfametry. A comparative assessment of the impact of surfactants on stratum corneum

“…In conclusion, skin capacitance imaging appears to be a reliable tool in the evaluation of the irritative potential of a surfactant solution in non‐exaggerated conditions of use. This method can be added to the list of many in vitro and in vivo predictive methods presently available for rating the potential irritancy of surfactants (4, 9, 10, 16–18, 41, 42). Searching for more sensitive methods remains one of the goals in this field of research.…”

Assessment of skin absorption and irritation potential of arachidonic acid and glyceryl arachidonate using in vitro diffusion cell techniques

“…Specifically noted was the detection of irritation before visual evidence by evaporimetry in vivo (Zuang et al 2000). The main non-invasive test carried over for evaluation in vitro has been evaporimetry (Heylings et al 2001;Zuang et al 2002).…”

In vitro Skin Irritation Test of Honeypolis using Human Skin Model

“…Skin Model methods were conducted under the auspices of ECVAM (Fentem et al, 2001;Faller et al, 2002;Cotovio et al, 2005;Zuang et al, 2002). It was concluded that the modified in vitro EpiDerm TM ‚ Skin Irritation Test (EPI-200-SIT) showed evidence of being a reliable and relevant stand-alone replacement test for in vivo skin irritation testing (EURL-ECVAM, 2008) or a partial replacement test with a testing strategy (OECD, 2014).…”