natgillin/translations-raw huggingface dataset:
Matsushima, T., Hayashi, M., Matsuoka, A., Ishidate, M. Jr., Miura, K.F., Shimizu, H., Suzuki, Y., Morimoto, K., Ogura, H., Mure, K., Koshi, K. and Sofuni, T. (1999), Validation study of the in vitro micronucleus test in a Chinese hamster lung cell line (CHL/IU), Mutagenesis, 14, 569-580.
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Elhajouji, A., and Lorge, E. (2006), Special Issue: SFTG International collaborative study on in vitro micronucleus test, Mutation Res., 607, 1-152.
Elhajouji, A., och Lorge, E. (2006), Special Issue: SFTG International collaborative study on in vitro micronucleus test, Mutation Res., 607, 1–152.
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Zhang, L.S., Honma, M., Hayashi, M., Suzuki, T., Matsuoka, A. och Sofuni, T. (1995), A comparative study of TK6 human lymphoblastoid and L5178Y mouse lymphoma cell lines in the in vitro micronucleus test, Mutation Res., 347, 105–115.
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Pincu, M., Bass, D. and Norman, A. (1984), An improved micronuclear assay in lymphocytes, Mutation Res., 139, 61-65.
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Food Chem, Toxicol., 34, 999-1002.
Food Chem, Toxicol., 34, 999–1002.
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)).
Dessutom kan det för kemiska klasser eller ämnen som har funktionella grupper som påvisats agera som potentiella störfaktorer (15) vara nödvändigt att använda test på marsvin (dvs. B.6; OECD:s testriktlinje 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).
Det rekommenderas att de begränsningar som anges för LLNA (1 och kapitel B.42 i denna bilaga) även ska gälla för LLNA: BrdU-ELISA (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.
Utöver sådana identifierade begränsningar bör LLNA: BrdU-ELISA gå att använda för testning av alla kemikalier, utom om en kemikalie förknippas med egenskaper som kan påverka LLNA: BrdU-ELISA-metodens exakthet.
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).
Dessutom bör överväganden göras rörande möjligheten till positiva gränsresultat, när man erhåller värden för stimulationsindex mellan 1,6 och 1,9 (se punkterna 31–32).
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).
Detta grundar sig på valideringsdatabasen med 43 ämnen och användning av SI ≥ 1,6 (se punkt 6) för vilka LLNA: BrdU-ELISA ger korrekt identifiering av alla 32 sensibiliserande ämnen enligt LLNA men felaktig identifiering av 2 av 11 icke-sensibiliserande ämnen enligt LLNA med SI-värden mellan 1,6 och 1,9 (dvs. på gränsen till positivt) (10).
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.
Reproducerbarheten mellan laboratorier fastställs under förvalideringen och valideringen och den indikerar i hur stor utsträckning ett test framgångsrikt kan överföras mellan laboratorier (33).
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).
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).
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.
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.
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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).
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).
The Reduced Murine Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products, NIH Publication Number 09-6439, Research Triangle Park, NC: National Institute of Environmental Health Sciences.
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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, p. 1.
Europaparlamentets och rådets förordning (EG) nr 1272/2008 av den 16 december 2008 om klassificering, märkning och förpackning av ämnen och blandningar, ändring och upphävande av direktiven 67/548/EEG och 1999/45/EG samt ändring av förordning (EG) nr 1907/2006 (EUT L 353, 31.12.2008, s. 1).
NIH Publication No: 99-4494.
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