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In addition, chemical classes or substances containing functional groups shown to act as potential confounders (21) may necessitate the use of guinea pig tests (i.e. B.6; OECD Test Guideline 406) (13). Further, based on the limited validation database, which consisted primarily of pesticide formulations, the LLNA is more likely than the guinea pig test to yield a positive result for these types of test substances (22).
Okrem toho chemické skupiny alebo látky, ktoré obsahujú potenciálne zmätočné funkčné skupiny (21), si tiež môžu vyžadovať použitie testov s morčatami (t. j. B.6; usmernenie OECD na vykonávanie testov 406 (13). Ďalej na základe obmedzenej validačnej databázy, ktorá sa skladá predovšetkým z prípravkov na ochranu rastlín, pri LLNA je pravdepodobnejšie, že pri týchto druhoch testovacích látok sa dosiahne pozitívny výsledok ako pri teste s morčatami (22). Pri testovaní prípravkov by sa však malo vziať do úvahy zahrnutie podobných látok so známymi výsledkami ako referenčných látok na preukázanie toho, že LLNA riadne funguje (pozri odsek 16). Okrem takto identifikovaných obmedzení by sa LLNA mala uplatňovať pri testovaní všetkých látok okrem prípadov, keď tieto látky majú vlastnosti, ktoré by mohli narúšať presnosť LLNA.
However, when testing formulations, one could consider including similar substances with known results as benchmark substances to demonstrate that the LLNA is functioning properly (see paragraph 16). Other than such identified limitations, the LLNA should be applicable for testing any substances unless there are properties associated with these substances that may interfere with the accuracy of the LLNA. PRINCIPLE OF THE TEST
PRINCÍP TESTU
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The purpose of Performance Standards (PS) is to communicate the basis by which new test methods, both proprietary (i.e. copyrighted, trademarked, registered) and non-proprietary can be determined to have sufficient accuracy and reliability for specific testing purposes. These PS, based on validated and accepted test methods, can be used to evaluate the reliability and accuracy of other similar methods (colloquially referred to as “me-too” tests) that are based on similar scientific principles and measure or predict the same biological or toxic effect (14). 2. Prior to adoption of modified methods (i.e. proposed potential improvements to an approved test method), there should be an evaluation to determine the effect of the proposed changes on the test’s performance and the extent to which such changes affect the information available for the other components of the validation process.
Cieľom noriem výkonnosti (PS) je oznámiť základ, na ktorom možno určiť, že nové testovacie metódy, či už chránené (t. j. chránené autorským právom, obchodnou značkou, registrované), alebo nechránené, sú dostatočne presné a spoľahlivé na konkrétne účely testovania.
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