FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: 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.
Danish: En reduceret version af LLNA (rLLNA), hvor der anvendes op til 40 % færre dyr, er også beskrevet som en mulighed i denne TM (16) (17) (18). rLLNA kan anvendes, når det er lovgivningsmæssigt nødvendigt at bekræfte en negativ forudsigelse af et potentielt hudsensibiliserende stof, forudsat at alle andre LLNA-protokolspecifikationer overholdes som beskrevet i denne TM.
Finnish: 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.
Slovenian: Pristop omejene LLNA (rLLNA), pri katerem bi se lahko uporabilo do 40 % manj živali, je prav tako opisan kot možnost v tej preskusni metodi (16) (17) (18). rLLNA se lahko uporabi, kadar obstaja zakonodajna potreba po potrditvi negativne napovedi o morebitni preobčutljivosti kože, če so izpolnjene vse druge specifikacije protokola LLNA, kot je opisano v tej preskusni metodi.
Romanian: Prezenta metodă de testare descrie, de asemenea, o metodă simplificată a LLNA (rLLNA) opțională, care ar putea utiliza cu până la 40 % mai puține animale (16) (17) (18). rLLNA poate fi utilizată atunci când există o necesitate de reglementare pentru a confirma o estimare negativă a potențialului de sensibilizare dermică, cu condiția să se respecte toate celelalte specificații de protocol LLNA, astfel cum sunt descrise în prezenta MT.
Latvian: Kā viena no iespējamām pieejām šajā TM aprakstīta reducētā LLNA (rLLNA), kura ļauj maksimāli par 40 % samazināt izmantoto dzīvnieku skaitu (16) (17) (18). rLLNA var izmantot, ja ir regulatīva vajadzība apstiprināt negatīvu ādas sensibilizācijas potenciāla prognozi un ar nosacījumu, ka tiek ievērotas visas pārējās šajā TM aprakstītās LLNA protokola specifikācijas.
Lithuanian: Šiame BM kaip vienas iš variantų aprašytas ir sumažintojo LLNA (rLLNA) metodas, kurį taikant galima būtų naudoti iki 40 % mažiau gyvūnų (16) (17) (18). rLLNA gali būti taikomas, kai reguliavimo reikmėms būtina patvirtinti odos jautrinimo potencialo neigiamą prognozę, jei laikomasi visų kitų LLNA protokolo specifikacijų, aprašytų šiame BM.
English: Prediction of a negative outcome should be made based on all available information as described in paragraph 4. Before applying the rLLNA approach, clear justifications and scientific rationale for its use should be provided.
Danish: En forudsigelse af et negativt resultat bør være baseret på alle foreliggende oplysninger som beskrevet i punkt 4.
Slovenian: Napoved negativnega rezultata bi morala temeljiti na vseh razpoložljivih informacijah, kot je opisano v odstavku 4.
Romanian: Estimarea unui rezultat negativ se bazează pe toate informațiile disponibile descrise la punctul 4.
Latvian: Negatīvai ādas sensibilizācijas potenciāla prognozei būtu jābalstās uz visu pieejamo informāciju, kā aprakstīts 4. punktā.
Lithuanian: Neigiamo rezultato prognozė turi būti grindžiama visa turima informacija, kaip aprašyta 4 skirsnyje.
English: The reduction in number of dose groups is the only difference between the LLNA and the rLLNA test method protocols and for this reason the rLLNA does not provide dose-response information. Therefore, the rLLNA should not be used when dose-response information is needed.
Danish: Det reducerede antal dosisgrupper er den eneste forskel mellem LLNA- og rLLNA-testprotokollerne, og rLLNA tilvejebringer derfor ikke oplysninger om dosis-responsforholdet. rLLNA bør derfor ikke anvendes, når der er behov for oplysninger om dosis-responsforholdet.
English: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
French: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT).
Italian: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for:In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Portuguese: EpiDermTM SOP, Version 7.0 (revisto em março de 2009). Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), for use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Dutch: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation's reconstructed human epidermal model EpiDerm (EPI-200).
Danish: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation's reconstructed human epidermal model EpiDerm (EPI-200).
Swedish: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation's reconstructed human epidermal model EpiDerm (EPI-200).
Finnish: EpiDermTM SOP, Version 7.0 (tarkistettu versio, maaliskuu 2009). Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation's reconstructed human epidermal model EpiDerm (EPI-200).
Slovak: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for:In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Polish: EpiDermTM SOP, Version 7.0 (poddany przeglądowi w marcu 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Slovenian: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Estonian: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Latvian: EpiDermTM SOP, Version 7.0 (Revised March 2009), Protocol for: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm (EPI-200).
Maltese: EpiDermTM SOP, Verżjoni 7.0 (Riveduta Marzu 2009), Protokoll għal: In vitro EpiDermTM skin irritation test (EPI-200-SIT), For use with MatTek Corporation's reconstructed human epidermal model EpiDerm (EPI-200).
English: The term is used interchangeably with accuracy, and is defined as the proportion of all chemicals tested that are correctly classified as positive or negative.
German: Der Begriff wird gleichbedeutend mit Genauigkeit verwendet und wird als Anteil aller geprüften Chemikalien definiert, die korrekt als positiv oder negativ eingestuft werden.
Spanish: Este término y el de “exactitud” se pueden usar indistintamente, y se define como la proporción de todas las sustancias estudiadas que se clasifican correctamente como positivas o negativas (9).
Italian: Il termine è usato in modo intercambiabile con “accuratezza” ed è definito come la proporzione di tutte le sostanze di prova che sono correttamente classificate come positive o negative.
Danish: Udtrykket benyttes som synonym for »nøjagtighed« og defineres som andelen af alle kemikalier, der klassificeres korrekt som positive eller negative.
Polish: Określenie jest stosowane wymiennie z określeniem »dokładność«; definiuje się jako odsetek wszystkich badanych substancji chemicznych, które są prawidłowo sklasyfikowane jako pozytywne lub negatywne.
Slovenian: Izraz se izmenično uporablja z natančnostjo in je opredeljen kot delež vseh preskušanih kemikalij, ki so pravilno razvrščene kot pozitivne ali negativne.
Romanian: Termenul este adesea utilizat în paralel cu termenul «acuratețe» și este definit ca proporție a tuturor substanțelor chimice testate și clasificate corect ca fiind pozitive sau negative.
English: 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.
Danish: Der indgår ikkeklassificerede og klassificerede (FN GHS/EU CLP »Ingen kategori«) og klassificerede (kategori 2 ifølge FN GHS/EU CLP) (1) kemikalier, således at pålideligheden og nøjagtigheden med hensyn til følsomhed, specificitet og generel nøjagtighed af den foreslåede testmetode kan sammenlignes med VRM. Inden metoden tages i brug til test af nye kemikalier, skal det fastslås, om den er pålidelig og — afhængigt af lovgivningsrammerne, inden for hvilke dataene genereres — om den kan identificere hudirriterende kemikalier i kategori 2 ifølge FN GHS/EU CLP »Ingen kategori« korrekt.
Swedish: Kemikalier i kategorin ’inte klassificerad’ (’ingen kategori’ enligt FN:s GHS eller CLP-förordningen) och kategorin ’klassificerad’ (kategori 2 enligt FN:s GHS eller CLP-förordningen) (1) som representerar olika kemiska klasser ingår, så att den föreslagna metodens tillförlitlighet och exakthet (känslighet, specificitet och totala exakthet) kan jämföras med motsvarande värden för den validerade referensmetoden. Metodens tillförlitlighet, såväl som metodens förmåga att korrekt identifiera irriterande kemikalier i kategori 2 enligt FN:s GHS eller CLP-förordningen och, beroende på den rättsliga ram som gäller för de uppgifter som tas fram, även metodens förmåga att korrekt identifiera ’ingen kategori’-kemikalier enligt FN:s GHS eller CLP-förordningen, bör bestämmas innan metoden används för testning av nya kemikalier.
Finnish: 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.
English: Due to the adoption of the UN GHS system for classification and labelling in EU (EU CLP) (3), which took place between the finalisation of the validation study and the completion of this TM, the PS have been updated (8). This update concerns mainly changes (i), in the set of the PS Reference Chemicals; and (ii), the defined reliability and accuracy values (2) (23).
Danish: Som følge af vedtagelsen af FN's GHS-system for klassificering og mærkning i EU ((EU CLP) (3), der skete i perioden mellem afslutningen af valideringsundersøgelsen og færdiggørelsen af denne TM, er ydeevnestandarderne blevet opdateret (8). Denne opdatering vedrører navnlig ændringer af i) PS-referencekemikalierne og ii) de fastlagte nøjagtigheds- og pålidelighedsværdier (2) (23).
English: However, a further specific restriction applies to the sensitivity of the proposed in vitro method inasmuch as only two in vivo Category 2 chemicals, 1-decanol and di-n-propyl disulphide, may be misclassified as No Category by more than one participating laboratory. The specificity should be equal or higher (≥) than 70 % (2) (8) (23). There is no further restriction with regard to the specificity of the proposed in vitro method, i.e. any participating laboratory may misclassify any in vivo No Category chemical as long as the final specificity of the test method is within the acceptable range. The overall accuracy should be equal or higher (≥) than 75 % (2) (8) (23). Although the sensitivity of the VRM calculated for the 20 Reference Chemicals listed in Table 1 is equal to 90 %, the defined minimum sensitivity value required for any similar or modified method to be considered valid is set at 80 % since both 1-decanol (a borderline chemical) and di-n-propyl disulphide (a false negative of the VRM) are known to be non-irritant in humans (31) (32) (33), although being identified as irritants in the rabbit test. Since RhE models are based on cells of human origin, they may predict these chemicals as non-irritant (UN GHS/EU CLP No Category).
Danish: Der er imidlertid en yderligere særlig begrænsning for følsomheden af den foreslåede in vitro-metode, da kun to in vivo-kemikalier i kategori 2, 1-decanol og di-n-propyldisulfid, må fejlklassificeres som ikkeklassificerede (»Ingen kategori«) af mere end et deltagende laboratorium. Specificiteten skal være 70 % eller derover (2) (8) (23). Der er ingen yderligere begrænsning med hensyn til specificiteten af den foreslåede in vitro-metode, dvs. at de deltagende laboratorier kan fejlklassificere ethvert ikkeklassificeret in vivo-kemikalie, så længe testmetodens endelige specificitet ligger inden for det acceptable interval. Den generelle nøjagtighed skal være 75 % eller derover (2) (8) (23). Selv om den beregnede følsomhed af VRM for de 20 referencekemikalier i tabel 1 er 90 %, skal den definerede minimumsfølsomhedsværdi for en lignende eller modificeret metode være 80 % for at kunne blive betragtet som gyldig, da både 1-decanol (et borderline-kemikalie) og di-n-propyl propyldisulfid (et falsk negativ af VRM) vides at være ikkeirriterende for mennesker (31) (32) (33), selv om de er identificeret som lokalirriterende stoffer i kanintesten. Eftersom RhE-modeller er baseret på celler af menneskelig oprindelse, kan de anvendes til at identificere disse kemikalier som ikkeirriterende (FN GHS/EU CLP »Ingen kategori«).
English: There are extensive data to support the validity of the MNvit assay using various rodent cell lines (CHO, V79, CHL/IU, and L5178Y) and human lymphocytes (18) (19) (20) (21) (22) (23) (24) (25) (26) (27) (28) (29) (30) (31). These include, in particular, the international validation studies coordinated by the Société Française de Toxicologie Génétique (SFTG) (18) (19) (20) (21) (22) and the reports of the International Workshop on Genotoxicity Testing (4) (16).
Danish: Der findes omfattende data, der påviser gyldigheden af MNvit-assayet, hvor der anvendes forskellige cellelinjer fra gnavere (CHO, V79, CHL/IU ogL5178Y) og humane lymfocytter (18) (19) (20) (21) (22) (23) (24) (25) (26) (27) (28) (29) (30) (31), herunder navnlig de internationale valideringsundersøgelser koordineret af Société Française de Toxicologie Génétique (SFTG) (18) (19) (20) (21) (22) og rapporterne fra den internationale workshop vedrørende testning for genotoksicitet (4) (16).
English: (eds), Genotoxic Effects of Airborne Agents.
French: In: Tice, R.R., Costa, D.L. and Schaich, K.M.
German: (eds), Genotoxic Effects of Airborne Agents. New York, Plenum, pp.
Spanish: (eds), Genotoxic Effects of Airborne Agents. New York, Plenum, pp.
Portuguese: In Tice, R.R., Costa, D.L., Schaich, K.M. (eds.), Genotoxic Effects of Airborne Agents.
Danish: (eds), Genotoxic Effects of Airborne Agents. New York, Plenum, pp.
Greek: Tice, R.R., Costa, D.L. and Schaich, K.M. (eds), Genotoxic Effects of Airborne Agents. New York, Plenum, pp.
Hungarian: (eds), Genotoxic Effects of Airborne Agents. New York, Plenum, pp.
Romanian: (eds), Genotoxic Effects of Airborne Agents. New York, Plenum, pp.
English: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition.
French: Hoffman, W.P., Garriott, M.L. et Lee, C. (2003), In vitro micronucleus test.
German: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition. S. Chow (ed.), Marcel Dekker, Inc. New York, NY, pp.
Spanish: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition. S. Chow (ed.), Marcel Dekker, Inc. New York, NY, pp.
Portuguese: Hoffman, W.P., Garriott, M.L., Lee, C. (2003). In vitro micronucleus test. In Encyclopedia of Biopharmaceutical Statistics, second edition.
Danish: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition. S. Chow (ed.), Marcel Dekker, Inc. New York, NY, pp.
Swedish: Hoffman, W.P., Garriott, M.L. och Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition.
Finnish: Hoffman, W. P., Garriott, M. L. ja Lee, C. (2003).
Greek: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition. S. Chow (ed.), Marcel Dekker, Inc. New York, NY, pp.
Slovak: Hoffman, W. P., Garriott, M. L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition.
Slovenian: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, v: Encyclopedia of Biopharmaceutical Statistics, Second edition.
Romanian: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition. S. Chow (ed.), Marcel Dekker, Inc. New York, NY, pp.
Estonian: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition.
Latvian: Hoffman, W.P., Garriott, M.L. and Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition.
Maltese: Hoffman, W.P., Garriott, M.L. u Lee, C. (2003), In vitro micronucleus test, In: Encyclopedia of Biopharmaceutical Statistics, Second edition.
English: Other than such identified limitations, the LLNA: DA should be applicable for testing any substances unless there are properties associated with these substances that may interfere with the accuracy of the LLNA: DA. In addition, consideration should be given to the possibility of borderline positive results when Stimulation Index (SI) values between 1,8 and 2,5 are obtained (see paragraphs 31-32). This is based on the validation database of 44 substances using an SI ≥ 1,8 (see paragraph 6) for which the LLNA: DA correctly identified all 32 LLNA sensitisers, but incorrectly identified three of 12 LLNA non-sensitisers with SI values between 1,8 and 2,5 (i.e. borderline positive) (10). However, as the same dataset was used for setting the SI-values and calculating the predictive properties of the test, the stated results may be an over-estimation of the real predictive properties. PRINCIPLE OF THE TEST METHOD
Dutch: PRINCIPE VAN DE TESTMETHODE
Danish: TESTMETODENS PRINCIP
English: In the absence of information to determine the highest dose to be tested (see paragraph 18), a pre-screen test should be performed in order to define the appropriate dose level to test in the LLNA: DA. The purpose of the pre-screen test is to provide guidance for selecting the maximum dose level to use in the main LLNA: DA study, where information on the concentration that induces systemic toxicity (see paragraph 24) and/or excessive local skin irritation (see paragraph 23) is not available.
Danish: Hvis der ikke foreligger tilstrækkelige oplysninger til at bestemme højeste dosis, der skal testes (se punkt 18), foretages en prescreening for at definere det passende dosisniveau, der skal testes i LLNA: DA. Formålet med prescreeningen er at få hjælp til at vælge det maksimale dosisniveau, der skal anvendes i LLNA: DA-hovedundersøgelsen, hvis der ikke foreligger oplysninger om den koncentration, der inducerer systemisk toksicitet (se punkt 24) og/eller for stærk lokal hudirritation (se punkt 23).
English: Hazard The potential for an adverse health or ecological effect. The adverse effect is manifested only if there is an exposure of sufficient level.
French: Indice de stimulation (IS) paramètre d’évaluation du pouvoir de sensibilisation cutanée d’une substance d’essai, calculé comme le quotient de la prolifération mesurée dans les groupes traités sur celle du groupe témoin concurrent recevant le véhicule.
Portuguese: Perigo Potencial de efeitos adversos na saúde ou no ambiente, que só se manifestam se o grau de exposição for suficiente.
Danish: Reproducerbarhed mellem laboratorier Mål for, i hvilken grad forskellige kvalificerede laboratorier kan opnå de samme resultater kvalitativt og kvantitativt, når de anvender samme protokol og tester de samme teststoffer.
English: The LLNA PS are based on the variability of results from tests of HCA and 2,4-dinitrochlorobenzene (DNCB) in different laboratories. ECt values should be derived independently from a single study conducted in at least three separate laboratories. To demonstrate acceptable inter-laboratory reproducibility, each laboratory should obtain ECt values of 5 % to 20 % for HCA and 0,025 % to 0,1 % for DNCB, which represents the range of 0,5-2,0 times the mean EC3 concentrations specified for HCA (10 %) and DNCB (0,05 %), respectively, in the LLNA (see Table 1).
French: La reproductibilité interlaboratoires est jugée acceptable lorsque chaque laboratoire obtient des CEm situées entre 5 % et 20 % pour chaque essai avec l’HCA et entre 0,025 % et 0,1 % pour le DNCB, ce qui correspond à 0,5-2,0 fois la CE3 moyenne spécifiée respectivement pour l’HCA (10 %) et le DCNB (0,05 %) dans l’ELGL (voir tableau 1).
German: Zum Nachweis einer akzeptablen Inner-Labor-Reproduzierbarkeit sollte jedes Labor ECt-Werte zwischen 5 % und 20 % für HCA und 0,025 % bis 0,1 % für DNCB erzielen, was einer Bandbreite von jeweils 0,5-2,0 mal den mittleren spezifizierten EC3-Konzentrationen für HCA (10 %) und DBCB (0,05 %) im LLNA entspricht (siehe Tabelle 1).
Swedish: Reproducerbarheten mellan laboratorier anses vara godtagbar om varje laboratorium får ECt-värden som är 5–20 % för hexylkanelaldehyd och 0,025–0,1 % för 2,4-dinitroklorbensen, vilket representerar skalan 0,5–2,0 gånger det EC3-medelvärde som specificeras för hexylkanelaldehyd (10 %) och 2,4-dinitroklorbensen (0,05 %) i LLNA (se tabell 1).
English: False negative A test substance incorrectly identified as negative or non-active by a test method, when in fact it is positive or active. False positive A test substance incorrectly identified as positive or active by a test, when in fact it is negative or non-active.
German: Diese Chemikalien sollten repräsentativ für die Chemikalienklassen sein, für die die Prüfmethode voraussichtlich verwendet werden soll; ferner sollten sie die ganze Bandbreite an Reaktionen abdecken, die von den Zielchemikalien erwartet werden kann — von stark über schwach bis negativ.