| European CommissionJRCIHCPTSAR |
| Skin irritation and Corrosion |
| Artificial Skin Model (EPIDERM) for Skin Irritation (with MTT reduction and IL-a release ) |
| 3 Rs Category | : | Partial Replacement |
| Type of Method | : | In vitro |
| Validation Statement | : | 1) Scientific validity of test method (ESAC): 27/04/2007. Following this first statement, the method has been modified and validated as a full replacement in the context of an "Update Validation Study", c.f. TSAR entry on "Modified EpiDerm". 2) Performance Standards for in vitro skin irritation testing (ESAC): 08/07/2009. The Performance Standards (updated according to GHS) were published on 24/08/2009. |
| Comment | : | The original EpiDerm has the capacity to partially replace the skin irritation Draize test since it allows to reliably identify irritant substances. The modified EpiDerm has been validated as a full replacement method (c.f. TSAR entry on "Modified EpiDerm"). |
| Status of adoption in EU | : | Adopted in 2009. |
| 1st Published in EC Regulations/ Updates | : | Directive 761/2009/EC (Official Journal L 220 2009). |
| Text of EU method | : | B.46 |
| Corresponding OECD TG | : | Parallel work in the OECD TG Programme: On-going development of a TG, led by the EC (ECVAM). Expert meetings took place in October 2008 and June 2009. Additional data and revised performance standards provided by the EC (ECVAM). Adoption foreseen end 2009 or early 2010. |
| Status of adoption by OECD | : | OECD |