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Inter-laboratory reproducibility is determined during the pre-validation and validation processes, and indicates the extent to which a test can be successfully transferred between laboratories, also referred to as between-laboratory reproducibility (38). Intra-laboratory reproducibility A determination of the extent that qualified people within the same laboratory can successfully replicate results using a specific protocol at different times.
Laboratorioidenvälinen uusittavuus määritetään esivalidointi- ja validointimenettelyissä, ja se osoittaa, missä määrin testi voidaan onnistuneesti toteuttaa eri laboratorioissa (38).
In addition, chemical classes or substances containing functional groups shown to act as potential confounders (15) may necessitate the use of guinea pig tests (i.e. B.6; OECD Test Guideline 406 (13)).
Häiritseviä (15) funktionaalisia ryhmiä sisältävien kemikaaliluokkien tai aineiden yhteydessä voi olla tarpeen käyttää marsutestejä (B.6 menetelmä; OECD:n testiohje 406 (13)).
Limitations that have been identified for the LLNA (1 and Chapter B.42 in this Annex) have been recommended to apply also to the LLNA: BrdU-ELISA (10).
LLNA-menetelmälle asetettuja rajoituksia (1 ja tämän liitteen B.42 luku) on sovellettava myös LLNA: BrdU-ELISA -menetelmään (10).
Other than such identified limitations, the LLNA: BrdU-ELISA should be applicable for testing any chemicals unless there are properties associated with these chemicals that may interfere with the accuracy of the LLNA: BrdU-ELISA.
Tällaisia tunnistettuja rajoituksia lukuun ottamatta mitä tahansa kemikaaleja pitäisi voida testata LLNA: BrdU-ELISA -menetelmällä, elleivät kyseisten kemikaalien ominaisuudet vaikuta LLNA: BrdU-ELISA -menetelmän tarkkuuteen.
In addition, consideration should be given to the possibility of borderline positive results when Stimulation Index (SI) values between 1,6 and 1,9 are obtained (see paragraphs 31-32).
Myös positiivisten rajatulosten mahdollisuus on otettava huomioon, kun saadaan stimulaatioindeksiksi (SI) 1,6–1,9 (katso 31–32 kohta).
This is based on the validation database of 43 substances using an SI ≥ 1,6 (see paragraph 6) for which the LLNA: BrdU-ELISA correctly identified all 32 LLNA sensitisers, but incorrectly identified two of 11 LLNA non-sensitisers with SI values between 1,6 and 1,9 (i.e. borderline positive) (10).
Tämä perustuu 43 aineen validointitietokantaan, jossa aineiden SI ≥ 1,6 (katso 6 kohta) ja jossa LLNA: BrdU-ELISA -menetelmällä on tunnistettu oikein kaikki 32 herkistystä aiheuttavaa LLNA-ainetta mutta tunnistettu väärin kaksi niistä 11 muusta kuin herkistystä aiheuttavasta LLNA-aineesta, joiden SI-arvo on 1,6–1,9 (positiivinen rajatulos) (10).
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Inter-laboratory reproducibility is determined during the pre-validation and validation processes, and indicates the extent to which a test can be successfully transferred between laboratories, also referred to as between-laboratory reproducibility (33). Intra-laboratory reproducibility A determination of the extent that qualified people within the same laboratory can successfully replicate results using a specific protocol at different times.
Laboratorioidenvälinen uusittavuus määritetään esivalidointi- ja validointimenettelyissä, ja sillä osoitetaan, missä määrin testi voidaan onnistuneesti toteuttaa eri laboratorioissa (33).
A reduced LLNA (rLLNA) approach, which could use up to 40 % fewer animals is also described as an option in this TM (16) (17) (18). The rLLNA may be used when there is a regulatory need to confirm a negative prediction of skin sensitising potential, provided there is adherence to all other LLNA protocol specifications, as described in this TM.
Myös koe-eläinten vähäisempään käyttöön perustuva LLNA-menetelmän muunnos (rLLNA-menetelmä), jossa eläimiä käytetään jopa 40 prosenttia vähemmän, kuvataan vaihtoehtona tässä testimenetelmässä (16) (17) (18). rLLNA-menetelmää voidaan käyttää, jos ihoherkistyspotentiaalin ennakoitu negatiivinen löydös on sääntelysyistä vahvistettava, edellyttäen että kaikkia muita tässä testimenetelmässä kuvattuja LLNA-menettelyn vaatimuksia noudatetaan.
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Non-classified (UN GHS/EU CLP No Category) and classified (UN GHS/EU CLP Category 2) (1) chemicals, representing different chemical classes are included, so that the reliability and accuracy (sensitivity, specificity and overall accuracy) of the proposed method can be compared to that of the VRM. The reliability of the method, as well as its ability to correctly identify UN GHS/EU CLP Category 2 irritant chemicals and, depending on the regulatory framework for which data are produced, also its ability to correctly identify UN GHS/EU CLP No Category chemicals (should be determined prior to its use for testing new test chemicals.
Vertailukemikaaleissa on mukana luokittelemattomia (YK:n GHS-järjestelmän / EU:n CLP-asetuksen ’ei luokitusta’) ja luokiteltuja (YK:n GHS-järjestelmän / EU:n CLP-asetuksen luokka 2) (1), erilaisia kemikaaliluokkia edustavia kemikaaleja, joten ehdotetun menetelmän luotettavuutta ja tarkkuutta (herkkyyttä, spesifisyyttä ja yleistä tarkkuutta) VVM:n luotettavuuteen ja tarkkuuteen voidaan verrata. Menetelmän luotettavuus sekä sen kyky tunnistaa oikein YK:n GHS-järjestelmän / EU:n CLP-asetuksen luokkaan 2 kuuluvat ärsytystä aiheuttavat kemikaalit sekä – riippuen siitä säännöstöstä, jota varten tietoja tuotetaan – myös sen kyky tunnistaa oikein YK:n GHS-järjestelmän / EU:n CLP-asetuksen luokkaan ’ei luokitusta’ kuuluvat kemikaalit olisi määritettävä, ennen kuin menetelmää käytetään uusien testikemikaalien testaamiseen.
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