FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: 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).
Slovak: 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.
Maltese: Barra minn hekk, il-klassijiet ta’ sustanzi kimiċi jew sustanzi li fihom gruppi funzjonali li ntwerew li jaġixxu bħala konfondituri potenzjali (21) jistgħu jeħtieġu l-użu ta’ testijiet fuq il-fniek tal-Indi (jiġifieri B.6; Linja Gwida 406 tal-OECD għall-Ittestjar (13). Barra minn hekk, skont il-bażi tad-dejta ta’ validazzjoni limitata, li kienet tikkonsisti prinċipalment minn formulazzjonijiet ta’ pestiċidi, l-LLNA aktarx li tagħti aktar riżultat pożittiv mit-test fuq il-fniek tal-Indi għal dawn it-tipi ta’ sustanzi tat-test (22). Madankollu, meta wieħed jeżamina l-formulazzjonijiet, jista' jikkunsidra li jinkludi sustanzi simili b'riżultati magħrufa bħala sustanzi ta’ referenza sabiex juri li l-LLNA qiegħda taħdem kif suppost (ara l-paragrafu 16). Minbarra dawn il-limitazzjonijiet identifikati, l-LLNA għandha tkun applikabbli għall-ittestjar ta’ kwalunkwe sustanza diment li ma jkunx hemm karatteristiċi assoċjati ma’ dawn is-sustanzi li jistgħu jinterferixxu mal-eżattezza tal-LLNA.
English: 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
Slovak: PRINCÍP TESTU
Maltese: IL-PRINĊIPJU TAT-TEST
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. The purpose of the pre-screen test is to provide guidance for selecting the maximum dose level to use in the main LLNA 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. The maximum dose level tested should be 100 % of the test substance for liquids or the maximum possible concentration for solids or suspensions.
Maltese: Fin-nuqqas ta’ informazzjoni sabiex tkun iddeterminata l-ogħla doża li għandha tiġi ttestjata (ara l-paragrafu (18), għandu jsir test ta’ qabel l-iskrinjar sabiex jiġi ddefinit il-livell ta’ doża xierqa li għandha tkun ittestjata fl-LLNA. L-iskop tat-test ta’ qabel l-iskrinjar huwa li jipprovdi gwida għall-għażla tal-livell massimu ta’ doża li għandu jintuża fl-istudju ewlieni tal-LLNA, meta l-informazzjoni dwar il-konċentrazzjoni li tikkawża tossiċità sistemika (ara l-paragrafu 24) u/jew irritazzjoni lokali eċċessiva tal-ġilda (ara l-paragrafu 23) ma tkunx disponibbli. Il-livell massimu tad-doża ttestjata għandu jkun 100 % tas-sustanza tat-test għal-likwidi jew il-konċentrazzjoni massima possibbli għas-solidi jew għas-sospensjonijiet.
English: Such a test method would be a candidate for catch-up validation. Interchangeably used with similar test method (9).
Maltese: Outlier Outlier hija osservazzjoni li hija mmarkata differenti minn valuri oħra f’kampjun aleatorju minn popolazzjoni.
English: Relevance Description of relationship of the test to the effect of interest and whether it is meaningful and useful for a particular purpose. It is the extent to which the test correctly measures or predicts the biological effect of interest.
Maltese: Dawn is-sustanzi kimiċi għandhom ikunu rappreżentanti tal-klassijiet ta’ sustanzi kimiċi li għalihom huwa mistenni jintuża l-metodu ta’ ttestjar, u dawn għandhom jirrappreżentaw il-firxa sħiħa ta’ reazzjonijiet li jistgħu jkunu mistennija mis-sustanzi kimiċi li għalihom huwa mistenni li jintuża dan il-metodu ta’ ttestjar, minn qawwija, għal dgħajfa, sa negattivi.
English: It is a measure of accuracy for a test method that produces categorical results, and is an important consideration in assessing the relevance of a test method (9). Skin irritation The production of reversible damage to the skin following the application of a test chemical for up to 4 hours.
Maltese: Sensitizzazzjoni tal-ġilda Proċess immunoloġiku li jitfaċċa meta individwu suxxettibbli jkun espost b’mod topiku għal allerġen kimiku induttur, li jipprovoka rispons immuni fil-ġilda li jista’ jwassal għall-iżvilupp ta’ sensitizzazzjoni mal-kuntatt.
English: Skin irritation is a locally arising, non-immunogenic reaction, which appears shortly after stimulation (29). Its main characteristic is its reversible nature involving inflammatory reactions and most of the clinical characteristic signs of irritation (erythema, oedema, itching and pain) related to an inflammatory process.
Portuguese: Constitui uma medida da exatidão de um método de ensaio cujos resultados sejam estabelecidos em função de categorias e é um aspeto importante a ter em conta na avaliação da adequação do método de ensaio (9).
Maltese: Indiċi ta’ Stimolazzjoni (SI) Valur ikkalkolat sabiex jeżamina l-potenzjal ta’ sensitizzazzjoni tal-ġilda ta’ sustanza tat-test li huwa l-proporzjon tal-proliferazzjoni fil-gruppi ttrattati għal dik fil-grupp ta’ kontroll ta’ mezz simultanju.
English: Tiered testing strategy Testing which uses test methods in a sequential manner; the test methods selected in each succeeding level are decided based on the results in the previous level of testing (9). Test chemical (also referred to as test substance) Any substance or mixture tested using this TM.
Maltese: Huwa importanti li jiġi osservat li metodu ta’ ttestjar validat jista’ ma jkollux prestazzjoni suffiċjenti f’termini ta’ preċiżjoni u affidabbiltà sabiex jitqies aċċettabbli għall-iskop propost (14).
English: The 20 recommended Reference Chemicals listed in Table 1 include chemicals representing different chemical classes (i.e. chemical categories based on functional groups), and are representative of the full range of Draize irritancy scores (from non-irritant to strong irritant). The chemicals included in this list comprise 10 UN GHS/EU CLP Category 2 chemicals and 10 non-categorised chemicals, of which 3 are optional UN GHS Category 3 chemicals.
Maltese: L-20 Sustanza Kimika ta’ Referenza rrakkomandati elenkati fit-Tabella 1 jinkludu sustanzi kimiċi li jirrappreżentaw klassijiet differenti ta’ sustanzi kimiċi (jiġifieri kategoriji ta’ sustanzi kimiċi bbażati fuq gruppi funzjonali), u jirrappreżentaw il-firxa sħiħa ta’ punteġġi ta’ irritazzjoni Draize (minn xejn irritanti għal ferm irritanti) Is-sustanzi kimiċi inklużi fil-lista jinkludu għaxar (10) sustanzi kimiċi tal-Kategorija 2 tal-UN GHS/EU CLP u għaxar (10) sustanzi kimiċi mhux kategorizzati, li minnhom tlieta huma sustanzi kimiċi fakultattivi tal-Kategorija 3 tal-UN GHS.
English: The treatment medium is removed and replaced with fresh medium containing cytoB, and the cells are harvested 1,5-2,0 normal cell cycles later. 42. If both initial tests of the short (3-6 hrs) treatment are negative or equivocal, a subsequent, extended exposure treatment without S9 is used. Two treatment options are available and are equally acceptable.
Maltese: Għal-limfoċiti, l-aktar approċċ effiċjenti huwa li l-esponiment għas-sustanza tat-test jinbeda f'44-48 siegħa wara l-istimulazzjoni tal-PHA, meta tkun telqet is-sinkronizzazzjoni taċ-ċiklu (5).
English: Primary cells and cell lines should be treated in a similar manner to lymphocytes except that it is not necessary to stimulate them with PHA for 44-48 hrs. Cells other than lymphocytes should be exposed such that at the time of study termination, the cells are still in log-phase growth. Cell lines without cytoB 44. Cells should be treated for 3-6 hrs in the presence and absence of S9.
Maltese: Il-mezz tat-trattament jitneħħa u jiġi sostitwit b'mezz frisk, u ċ-ċelloli jittieħdu wara 1,5–2,0 ċikli taċ-ċelloli normali addizzjonali.
English: Inclusion of a concurrent PC is recommended because it demonstrates competency of the laboratory to successfully conduct each assay and allows for an assessment of intra- and inter-laboratory reproducibility and comparability. Some regulatory authorities also require a PC for each study and therefore users are encouraged to consult the relevant authorities prior to conducting the LLNA: BrdU-ELISA.
Maltese: L-inklużjoni ta’ PC simultanju hija rrakkomandata għaliex dan juri l-kompetenza tal-laboratorju biex iwettaq b'suċċess kull analiżi u tippermetti l-valutazzjoni u t-tqabbil tar-riproduċibbiltà fil-laboratorju u bejn il-laboratorji.
English: The following clinical observations may indicate systemic toxicity (30) when used as part of an integrated assessment and therefore may indicate the maximum dose level to use in the main LLNA: BrdU-ELISA: changes in nervous system function (e.g. pilo-erection, ataxia, tremors, and convulsions); changes in behaviour (e.g. aggressiveness, change in grooming activity, marked change in activity level); changes in respiratory patterns (i.e. changes in frequency and intensity of breathing such as dyspnea, gasping, and rales), and changes in food and water consumption. In addition, signs of lethargy and/or unresponsiveness and any clinical signs of more than slight or momentary pain and distress, or a > 5 % reduction in body weight from Day 1 to Day 6 and mortality should be considered in the evaluation.
Maltese: L-osservazzjonijiet kliniċi li ġejjin jistgħu jindikaw tossiċità sistemika (30) meta jintużaw bħala parti minn valutazzjoni integrata u għalhekk jistgħu jindikaw il-livell massimu tad-doża li għandha tintuża fl-LLNA: BrdU-ELISA ewlenija: bidliet fil-funzjoni tas-sistema nervuża (eż. pil wieqaf, atassja, rogħda, u konvulżjonijiet); bidliet fl-imġiba (eż. aggressività, bidla fl-attività tal-indafa, bidla sinifikanti fil-livell ta’ attività); bidliet fit-tendenzi respiratorji (jiġifieri bidliet fil-frekwenza u fl-intensità tan-nifs bħal dispneja, nifs maqtugħ, u ħsejjes mill-pulmun (rales), u bidliet fil-konsum tal-ikel u tal-ilma. Barra minn hekk, sinjali ta’ letarġija u/jew nuqqas ta’ reazzjoni u kull sinjal kliniku ieħor ta’ aktar minn uġigħ jew tbatija żgħira jew momentanja, jew tnaqqis ta’ > 5 % fil-piż tal-ġisem minn Jum 1 sa Jum 6 u mortalità, għandhom jiġu kkunsidrati fl-evalwazzjoni. Annimali moribondi jew annimali li juru sinjali ta’ uġigħ jew dieqa severa għandhom jinqatlu b'mod uman (31).
English: Moribund animals or animals showing signs of severe pain and distress should be humanely killed (31). Main study experimental schedule
Maltese: Skeda ta’ sperimentazzjoni tal-istudju ewlieni
English: Dose and vehicle selection should be based on the recommendations given in references (3) and (5). Consecutive doses are normally selected from an appropriate concentration series such as 100 %, 50 %, 25 %, 10 %, 5 %, 2,5 %, 1 %, 0,5 %, etc. Adequate scientific rationale should accompany the selection of the concentration series used.
Dutch: De keuze van de doses en het medium wordt gebaseerd op de aanbevelingen in de referenties (3) en (5), Opeenvolgende doses worden doorgaans gekozen uit een geschikte concentratiereeks, zoals 100 %, 50 %, 25 %, 10 %, 5 %, 2,5 %, 1 %, 0,5 % enz. Aan de keuze van de gebruikte concentratiereeks moet een toereikende wetenschappelijke motivering ten grondslag liggen.
English: An assessment of between-laboratory reproducibility is not essential if the proposed method is to be used in a single laboratory only. For methods to be transferred between laboratories, the concordance of classifications (UN GHS/EU CLP Category 2 and No Category) obtained in different, independent test runs of the 20 Reference Chemicals between preferentially a minimum of three laboratories should be equal or higher (≥) than 80 %.
Dutch: Het is niet nodig de interlaboratoriumreproduceerbaarheid te beoordelen als de voorgestelde methode in slechts één laboratorium zal worden gebruikt; Voor methoden die tussen laboratoria moeten worden overgedragen, moet de concordantie van classificaties van de 20 referentiestoffen (VN GHS/EU CLP categorie 2 en geen categorie) die tot stand zijn gekomen in verschillende, onafhankelijke experimenten in bij voorkeur minimaal drie laboratoria, ten minste (≥) 80 % zijn.
English: Equivocal results may be clarified by analysis of another 1000 cells from all the cultures to avoid loss of blinding. If this approach does not resolve the result, further testing should be performed.
Dutch: Onduidelijke resultaten kunnen worden opgehelderd door de analyse van nogmaals 1000 cellen uit alle culturen om verlies van blindering te voorkomen. indien deze aanpak geen oplossing biedt voor het resultaat, moeten verdere testen worden verricht.
English: Clare, G., Lorenzon, G., Akhurst, L.C., Marzin, D., van Delft, J., Montero, R., Botta, A., Bertens, A., Cinelli, S., Thybaud, V. and Lorge, E. (2006), SFTG International collaborative study on the in vitro micronucleus test. II.
Dutch: Clare, G., Lorenzon, G., Akhurst, L.C., Marzin, D., van Delft, J., Montero, R., Botta, A., Bertens, A., Cinelli, S., Thybaud, V. and Lorge, E. (2006), SFTG International collaborative study on the in vitro micronucleus test.
English: , A protocol for the in vitro micronucleus test. II.
Dutch: , A protocol for the in vitro micronucleus test.
English: This does not necessarily imply that in all instances the LLNA should be used in place of guinea pig tests (i.e. B.6; OECD Test Guideline 406) (13), but rather that the assay is of equal merit and may be employed as an alternative in which positive and negative results generally no longer require further confirmation. The testing laboratory should consider all available information on the test substance prior to conducting the study.
Polish: Nie oznacza to, że należy koniecznie we wszystkich przypadkach stosować LLNA zamiast testu na świnkach morskich (tj. B.6; wytyczna OECD nr 406 dotycząca badań) (13), a tylko, że badanie to ma tę samą wartość merytoryczną i może zostać zastosowane jako badanie alternatywne, którego pozytywne lub negatywne wyniki nie wymagają już dalszego potwierdzenia Laboratorium badawcze powinno uwzględnić wszystkie dostępne informacje na temat badanej substancji przed rozpoczęciem badań.
English: The assessment of skin irritation has typically involved the use of laboratory animals (OECD Test Guideline 404; Chapter B.4 in this Annex) (4). In relation to animal welfare concerns, B.4 was revised in 2004 allowing for the determination of skin corrosion/irritation by applying a tiered testing strategy, using validated in vitro or ex vivo test methods, thus avoiding pain and suffering of animals. Three validated in vitro test methods have been adopted as OECD Test Guidelines 430, 431 and 435 (5) (6) (7) and two of them as Chapters B.40 and B.40a of this Annex, to be used for the corrosivity part of the tiered testing strategy of B.4 or OECD Test Guideline 404 (4).
Polish: Ocena działania drażniącego na skórę obejmowała na ogół wykorzystanie zwierząt laboratoryjnych (zob. wytyczna OECD nr 404 dotycząca badań; rozdział B.4 w niniejszym załączniku] (4). Z uwagi na konieczność zapewnienia dobrostanu zwierząt zmodyfikowano w 2004 r. metodę B.4, umożliwiając ustalenie działania żrącego/drażniącego na skórę dzięki zastosowaniu strategii badań wielopoziomowych, przy użyciu zwalidowanych metod badania in vitro i ex vivo, co z kolei pozwoliło na uniknięcie zadawania bólu zwierzętom i powodowania ich cierpienia. Trzy zwalidowane metody badania in vitro zostały przyjęte w wytycznych OECD nr 430, 431 i 435 dotyczących badań (5) (6) (7) i dwóch z nich jako rozdziały B.40 i B.40bis niniejszego załącznika, które mają być stosowane do części dotyczącej badań działania żrącego w ramach strategii badań wielopoziomowych B.4 lub wytycznej OECD nr 404 dotyczącej badań (4).
English: Mc Graw-Hill, New York.
Portuguese: Mc Graw-Hill, Nova Iorque.
Polish: Mc Graw-Hill, Nowy Jork.
English: details of food and water quality (including diet type/source, water source); details of treatment and sampling schedules;
Polish: szczegóły dotyczące poddania działaniu substancji oraz harmonogramów pobierania próbek,
English: Furthermore, the LLNA does not require the use of an adjuvant, as is the case for the guinea pig maximisation test (13). Thus, the LLNA reduces animal pain and distress.
Portuguese: Também não implica a utilização de nenhum adjuvante, ao contrário do que sucede no ensaio de maximização na cobaia (13), reduzindo assim a dor e sofrimento causados aos animais.
English: Can be estimated by determination of the concentration at which a marker chemical reduces the viability of the tissues by 50 % (IC50) after a fixed exposure time, see also ET50. Infinite dose Amount of test chemical applied to the epidermis exceeding the amount required to completely and uniformly cover the epidermis surface.
Portuguese: Pode ser estimada determinando a concentração à qual um produto químico marcador reduz a viabilidade dos tecidos em 50 % (CI50), após um tempo de exposição fixo; ver também TE50.
English: Included are; (i) essential test method components; (ii) a minimum list of Reference Chemicals selected from among the chemicals used to demonstrate the acceptable performance of the validated test method; and (iii) the comparable levels of accuracy and reliability, based on what was obtained for the validated test method, that the proposed test method should demonstrate when evaluated using the minimum list of Reference Chemicals (9). Reference chemicals Chemicals selected for use in the validation process, for which responses in the in vitro or in vivo reference test system or the species of interest are already known.
Portuguese: O termo é sinónimo de “método de ensaio similar” (9).
English: Replacement test A test which is designed to substitute for a test that is in routine use and accepted for hazard identification and/or risk assessment, and which has been determined to provide equivalent or improved protection of human or animal health or the environment, as applicable, compared to the accepted test, for all possible testing situations and chemicals (9). Sensitivity The proportion of all positive/active test chemicals that are correctly classified by the test.
Portuguese: A fiabilidade é avaliada com base nos valores calculados das reprodutibilidades intralaboratorial e interlaboratorial (9).
English: Individual culture data should be provided. Additionally, all data should be summarised in tabular form.
Portuguese: Os dados devem ser fornecidos por cultura e resumidos em quadros.
English: Furthermore, the LLNA: BrdU-ELISA does not require the use of an adjuvant, as is the case for the guinea pig maximisation test (Chapter B.6 of this Annex, 13). Thus, the LLNA: BrdU-ELISA reduces animal distress.
Portuguese: Também não implica a utilização de nenhum adjuvante, ao contrário do que sucede no ensaio de maximização na cobaia (capítulo B.6 do presente anexo, 13), reduzindo a dor e o sofrimento causados aos animais.
English: J. Toxicol.
Portuguese: J. Toxicol. Environ.
English: (Optional Cat. 3) [4] 1-decanol [3]
Romanian: ecanol [3]
English: 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.
Romanian: Acest fapt se bazează pe baza de date de validare de 44 de substanțe prezentând un IS ≥ 1,8 (a se vedea punctul (6) pentru care LLNA: DA a identificat corect toți cei 32 de agenți de sensibilizare LLNA, dar a identificat incorect trei dintre cei 12 agenți de non-sensibilizare LLNA prezentând un IS cuprins între 1,8 și 2,5 (și anume rezultate pozitive de limită) (10). Cu toate acestea, deoarece același set de date a fost utilizat pentru stabilirea valorilor IS și pentru calcularea proprietăților estimative ale testului, rezultatele indicate ar putea supraestima proprietățile estimative reale.
English: Kimber, I. and Basketter, D.A. (1992), The murine local lymph node assay; collaborative studies and new directions: A commentary, Food Chem. Toxicol., 30, 165-169.
Slovak: Kimber, I. and Basketter, D. A. (1992), The murine local lymph node assay; collaborative studies and new directions: A commentary, Food Chem. Toxicol., 30, 165 – 169.
English: Kimber, I., Dearman, R.J., Scholes, E.W. and Basketter, D.A. (1994), The local lymph node assay: developments and applications, Toxicol., 93, 13-31.
Slovak: Kimber, I., Dearman, R. J., Scholes, E. W. and Basketter, D. A. (1994), The local lymph node assay: developments and applications, Toxicol., 93, 13 – 31.
English: Kimber, I., Hilton, J., Dearman, R.J., Gerberick, G.F., Ryan, C.A., Basketter, D.A., Lea, L., House, R.V., Ladies, G.S., Loveless, S.E. and Hastings, K.L. (1998), Assessment of the skin sensitisation potential of topical medicaments using the local lymph node assay: An interlaboratory exercise, J. Toxicol.
Slovak: Kimber, I., Hilton, J., Dearman, R. J., Gerberick, G. F., Ryan, C. A., Basketter, D. A., Lea, L., House, R. V., Ladies, G. S., Loveless, S. E. and Hastings, K. L. (1998), Assessment of the skin sensitisation potential of topical medicaments using the local lymph node assay: An interlaboratory exercise, J. Toxicol.
English: Chamberlain, M. and Basketter, D.A. (1996), The local lymph node assay: status of validation, Food Chem. Toxicol., 34, 999-1002.
Slovak: Chamberlain, M. and Basketter, D. A. (1996), The local lymph node assay: status of validation, Food Chem. Toxicol., 34, 999 – 1002.
English: Basketter, D.A., Gerberick, G.F., Kimber, I. and Loveless, S.E. (1996), The local lymph node assay: A viable alternative to currently accepted skin sensitisation tests, Food Chem. Toxicol., 34, 985-997.
Slovak: Basketter, D. A., Gerberick, G. F., Kimber, I. and Loveless, S. E. (1996), The local lymph node assay: A viable alternative to currently accepted skin sensitisation tests, Food Chem. Toxicol., 34, 985 – 997.
English: Kimber, I., Dearman, R.J., Betts, C.J., Gerberick, G.F., Ryan, C.A., Kern, P.S., Patlewicz, G.Y. and Basketter, D.A. (2006), The local lymph node assay and skin sensitisation: a cut-down screen to reduce animal requirements?
Slovak: Kimber, I., Dearman, R. J., Betts, C. J., Gerberick, G. F., Ryan, C. A., Kern, P. S., Patlewicz, G. Y. and Basketter, D. A. (2006), The local lymph node assay and skin sensitisation: a cut-down screen to reduce animal requirements?
English: McGarry, H.F. (2007), The murine local lymph node assay: regulatory and potency considerations under REACH, Toxicol., 238, 71-89.
Slovak: McGarry, H. F. (2007), The murine local lymph node assay: regulatory and potency considerations under REACH, Toxicol., 238, 71 – 89.