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Now published in EURL ECVAM DB ALM: protocols for in vitro methods in the area of Skin Irritation, Genotoxicity and Pyrogenicity

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Jul 06, 2012
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Compliant with regulatory requirements and/or under evaluation

In July 2012 DB-ALM, the DataBase service on ALternative Methods to Animal Experimentation of the European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), has published the following protocols for in vitro methods compliant with regulatory requirements and/or under evaluation in the area of Skin Irritation, Genotoxicity and Pyrogenicity:

  • EpiSkin™ Skin Irritation Test 15min - 42 hours (No. 131) 
  • GreenScreen HC TM Genotoxicity Test (No. 132) 
  • Human Whole Blood/(IL)-1 ß In Vitro Pyrogenicity (No. 133) 
  • Human Cryopreserved Whole Blood/(IL)-1 ß In Vitro Pyrogenicity Test (No. 134)  

A fifth protocol will be published in July 2012:

  • SKINETHIC™ Skin Irritation Test-42bis (No. 135)

 

Access to the protocols is available via the DB-ALM web site  (please note that in order to use the search option you must complete a registration procedure).

 

The DB-ALM is indicated by the European Chemicals Agency for REACH (REgistration, Authorisation and restriction of CHemicals, Regulation (EC) 1907/2006) registration purposes as a useful information source on in vitro methods for consideration during information gap analysis or in a weight of evidence approach. DB-ALM includes, among others:

Topic Summaries: Thematic Reviews are made available to provide an overall view about the information content on alternative and advanced methods included in the DB-ALM for an entire topic area (e.g. Percutaneous Absorption or Effects on Reproduction).

Method Summaries: Alternative methods and/or more general non-animal models in use for mainly toxicity testing are described as summary records. The summary descriptions are based on extensive literature reviews including information on the objective and applications, scientific principle and rationale, type of tested materials, modifications introduced and the status of development and/or validation including regulatory acceptance, as appropriate for the subject area concerned. 

INVITTOX Protocols: details are provided, complemented by more general information, that enable the documented methods to be transferred to other laboratories without the need of additional information. In vitro techniques are included that are currently in use and under development, as well as those used in validation studies carried out under auspices of EURL ECVAM. The information is obtained directly from the scientists employing the techniques and the protocols are written up in collaboration with those scientists. The INVITTOX  Protocol collection has originally been established by the Fund for the Replacement of Animals in Medical Experiments (FRAME, UK).