The European Centre for the Validation of Alternative Methods' (ECVAM) Scientific Advisory Committee (ESAC) has endorsed the scientific validity of the harmonized ECVAM performance standards for the Local Lymph Node Assay (LLNA).
ECVAM developed performance standards for the LLNA in compliance with the criteria described in the OECD GD 34. These set out three main elements of performance standards including: the essential test method components, a minimum list of reference chemicals and accuracy and reliability values.
The original ECVAM performance standards for the LLNA underwent a series of revisions in the framework of an extensive ECVAM-ICCVAM collaboration aiming at the harmonization of the performance standards for the LLNA developed independently by ECVAM and the Interagency Coordinating Committee on the Validation on Alternative Methods (ICCVAM). The performance standards for ECVAM and ICCVAM are now harmonized, with ESAC advising the following:
1) The essential test method components are adequate and sufficiently detailed to allow the assessment of the similarity of the proposed test methods with respect to the validated LLNA.
1) The minimum list of reference chemicals contains an adequate number of reference substances and the selection of the substances took into consideration all the relevant criteria (range of responses in the validated test, physical state, availability of reference LLNA, Guinea Pig and human data, etc."
3) The performance criteria set for establishing the reliability and accuracy of the proposed test method when challenged with the reference chemicals are appropriate and adequate.
The LLNA is a scientifically validated and regulatory accepted method for assessing the skin sensitization potential of chemicals. The group reminds the industry that any test method submitted to or validated by ECVAM must be reviewed and endorsed by ESAC before it can be used within the regulatory framework.