natgillin/translations-raw huggingface dataset:
Ryan, T.
Environmental and Molecular Mutagenesis, Vol.
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52/5, pp. 355–362.
(2000), Statistical Methods for Quality Improvement, John Wiley and Sons, New York 2nd ed.
Shi, J., R. Bezabhie, A. Szkudlinska (2010).
Appendix A of the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (Dodatek A Evropské úmluvy o ochraně obratlovců používaných pro pokusné a jiné vědecké účely) (ETS No.
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25/1, pp. 33-40.
Blakey, D.H., G.R.
Fenech, M. et al.
Douglas (1984), Transient DNA lesions induced by benzo[a]pyrene in Chinese hamster ovary cells, Mutation Research, Vol.
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140/2-3, s. 141–45.
534/1-2, pp. 65-75.
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Elhajouji, A., M. Cunha, M. Kirsch-Volders (1998).
236/1, s. 35–41.
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(2012), Tissue sample preparation for in vivo rodent alkaline Comet assay, Genes and Environment, Vol.
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34/1, s. 50–4.
85/8, pp. 873-99.
, Recommendations for conducting the in vivo alkaline Comet assay, Mutagenesis, Vol.18/1, s.45–51.
Mutation Research/Genetic Toxicology and Environmental Mutagenesis, Vol.723/2, pp. 87-90.
Atlas of Comet Assay Images, Scientist Press Co., Ltd., Tokyo, Japan.
Ryan, T. P. (2000).
Lovell, D.P., G.
Hoffman, W.P., M.L.
Thomas, R.
International Conference on Harmonisation (ICH) Guidance S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended For Human Use.
Dubow (1999), Issues related to the experimental design and subsequent statistical analysis of in vivo and in vitro Comet studies, Teratogenesis Carcinogenesis Mutagenesis, Vol.
and:
19/2, s. 109–19.
The level of reproducibility in predictions that can be expected from the test method is in the order of 85 % within laboratories and 80 % between laboratories (10).
Wiklund, S.J., E.
Results generated in the validation study (18) and published studies (19) overall indicate that the accuracy of the DPRA in discriminating sensitisers (i.e. UN GHS/CLP Cat.
Agurell (2003), Aspects of design and statistical analysis in the Comet assay, Mutagenesis, Vol.
1) from non-sensitisers is 80 % (N=157) with a sensitivity of 80 % (88/109) and specificity of 77 % (37/48) when compared to LLNA results.
18/2, s. 167–75.
On the basis of the overall data available, the DPRA was shown to be applicable to test chemicals covering a variety of organic functional groups, reaction mechanisms, skin sensitisation potency (as determined in in vivo studies) and physico-chemical properties (8) (9) (10) (19).
Bright, J. et al.
Taken together, this information indicates the usefulness of the DPRA to contribute to the identification of skin sensitisation hazard.
, Recommendations on the statistical analysis of the Comet assay, Pharmaceutical Statistics, Vol.
The term “test chemical” is used in this test method to refer to what is being tested and is not related to the applicability of the DPRA to the testing of substances and/or mixtures.
10/6, s. 485–93.
This test method is not applicable for the testing of metal compounds since they are known to react with proteins with mechanisms other than covalent binding.
Lovell, D.P., T.
A test chemical should be soluble in an appropriate solvent at a final concentration of 100 mM (see paragraph 18).
Omori (2008), Statistical issues in the use of the Comet assay, Mutagenesis, Vol.
However, test chemicals that are not soluble at this concentration may still be tested at lower soluble concentrations.
23/3, s. 171–82.
In such a case, a positive result could still be used to support the identification of the test chemical as a skin sensitiser but no firm conclusion on the lack of reactivity should be drawn from a negative result.
Box, G.E.P, Hunter, W.G. and Hunter, J.S.
Appearance of precipitate in the reaction mixture at the end of the incubation time, if observed.
Box G.E.P.
If precipitate was re-solubilised or centrifuged;
Doncaster, C.P.
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FDA (Food and Drug Administration (2001).
101–13.
ECETOC (2003).
mortalita nebo jiné nepříznivé účinky a choroby jak u kontrolních, tak u exponovaných ryb je na konci zkoušky menší než 10 %; jestliže je zkouška prodloužena na několik týdnů nebo měsíců, měl by být úhyn nebo jiné nepříznivé účinky v obou skupinách ryb menší než 5 % za měsíc nebo by neměl překročit celkem 30 %.
Relevance incorporates consideration of the accuracy (concordance) of a test method (21).
Je-li hodnota BCF pro celé ryby vyjádřená celkovou aktivitou reziduí ≥ 500, může být účelné – a pro určité kategorie látek, např. pesticidy, se to důrazně doporučuje – identifikovat a kvantifikovat hlavní metabolity Některé regulační orgány mohou kvantifikaci takových metabolitů vyžadovat.
Reliability
údaje o koncentraci zkoušené látky v rybách (Cf, vztažená k jednotlivým rybám) a ve vodě (Cw) (se středními hodnotami pro zkušební a kontrolní skupiny, standardními odchylkami a případně rozpětím) pro všechny odběry (Cf vyjádřená v mg/kg živé hmotnosti celého těla nebo jeho specifikovaných tkání, např. lipidů, a Cw v mg/l), hodnoty Cw pro kontrolní série (měly by být uvedeny i hodnoty pozadí),
The proportion of all negative/inactive chemicals that are correctly classified by the test method.
Na počátku roku 2004 byl na zasedání pracovní skupiny EU PBT předložen návrh protokolu (38) určeného k měření bioakumulačního potenciálu organických látek špatně rozpustných ve vodě, u kterých nebylo možné použít standardní metodu bioakumulace s expozicí ve vodě, spolu s podpůrným podkladovým dokumentem (39).
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 (21).
Dalším odůvodněním ve prospěch metody bylo, že k potenciální expozici takovým špatně rozpustným látkám (tj. s hodnotou log KOW >5) v životním prostředí může dojít hlavně prostřednictvím potravy (viz (40) (41) (42) (43) (44)).
Determination of instrument performance (e.g. sensitivity) by analysis of a reference standard prior to running the analytical batch (22).
Z tohoto důvodu se v některých zveřejněných nařízeních o chemických látkách odkazuje na zkoušky expozice v potravě [43].
Test chemical
Je však třeba si uvědomit, že zde popsaná metoda se pečlivě vyhýbá expozici ve vodné fázi a že hodnotu BMF z této zkušební metody tedy nelze přímo srovnávat s hodnotou BMF ze studie za reálných podmínek (ve které je možné kombinovat expozici ve vodě i potravě).
The term “test chemical” is used to refer to what is being tested.
Tento oddíl této zkušební metody je založen na tomto protokolu (38) a představuje novou metodu, která se v předchozí verzi zkušební metody C.13 neobjevila.
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS)
Tato alternativní zkouška umožňuje za řízených laboratorních podmínek přímo zkoumat způsob expozice v potravě.
90-100
Tato metoda umožňuje stanovit pro zkušební látku v rybách látkově specifický poločas (t1/2, z rychlostní konstanty vylučování k2), účinnost vstřebání (absorpce ve střevech; a), kinetický potravní bioobohacovací faktor (BMFK), o růst upravený kinetický potravní bioobohacovací faktor (BMFKg) a o lipidy upravený [45] kinetický potravní bioobohacovací faktor (BMF KL) (a/nebo o růst a lipidy upravený kinetický potravní bioobohacovací faktor (BMFKgL).
15-45
Stejně jako v metodě expozice ve vodním prostředí, nárůst hmotnosti ryb během zkoušky povede k ředění zkoušené látky v rostoucích rybách, a hodnota (kinetického) BCF bude tedy podhodnocena, nebude-li upravena o růst (srov. odstavce 162 a 163).
60-80
Jestliže se odhadem stanoví, že ve fázi příjmu bylo dosaženo rovnovážného stavu, je možné rovněž vypočítat orientační hodnotu BMF v rovnovážném stavu.
10-55
Jsou k dispozici postupy, jež umožňují odhadnout hodnotu kinetického bioobohacovacího faktoru (BCFK) z údajů získaných ve studii potravy (např. (44) (45) (46) (47) (48)).
30-60
O silných a slabých stránkách těchto postupů se pojednává v dodatku 8.
0-24
Zkouška byla vyvinuta především pro zkoumání špatně rozpustných nepolárních organických látek, jejichž příjem a vylučování u ryb se přibližně řídí kinetikou prvního řádu.
80-100
Při pravidelném používání referenční látky (srov. odstavec 25) se upřednostňuje měřit koncentrace ve zkušební skupině na konci fáze příjmu a ve všech dobách fáze vylučování stanovených pro danou zkoušenou látku (na celých rybách); v kontrolní skupině je nutné analyzovat koncentrace pouze na konci fáze příjmu (na celých rybách).
0-7
Za určitých okolností (například pokud metody analýzy přítomnosti zkoušené látky a referenční látky nejsou slučitelné, takže by pro dodržení harmonogramu odběru vzorků bylo nutné použít dodatečné ryby, lze použít jiný přístup s cílem minimalizovat požadovaný počet dodatečných ryb, jak je uvedeno dále.
15-55
Koncentrace referenční látky se měří pouze během fáze vylučování, a to v den 1, 3 a ve dvou dalších odběrech zvolených tak, aby bylo možné provést spolehlivé odhady koncentrace v čase nula (C0,d) a hodnoty k2 referenční látky.
0-25
Li A, Doucette W.J.
60-100
Environ Toxicol Chem 12: 2031–2035
10-45
(OECD (1997), OECD Environmental Health and Safety Publications Series on Testing and Assessment Number 7: Guidance Document on Direct Phototransformation of Chemicals in Water OCDE/GD(97)21.
0-5,5
Organisation for Economic Co-operation and Development (OECD), Paris, France.
The medium is then removed and replaced with fresh culture medium (150 μl culture medium containing serum but without Geneticin in the case of KeratinoSensTM) to which 50 μl of the 25 fold diluted test chemical and control substances are added.
Connell D.W.
At least one well per plate should be left empty (no cells and no treatment) to assess background values.
102: 117–156.
Finally, for test chemicals generating a 1,5 fold or higher induction already at the lowest test concentration of 0,98 μM, the EC1,5 value of < 0,98 is set based on visual inspection of the dose-response curve.
Bintein S., Devillers J. and Karcher W.
Acceptance criteria
OECD (2011), QSAR Toolbox 2.1.
Adler S., Basketter D., Creton S., Pelkonen O., van Benthem J., Zuang V., Andersen K.E., Angers-Loustau A., Aptula A., Bal-Price A., Benfenati E., Bernauer U., Bessems J., Bois F.Y., Boobis A., Brandon E., Bremer S., Broschard T., Casati S., Coecke S., Corvi R., Cronin M., Daston G., Dekant W., Felter S., Grignard E., Gundert-Remy U., Heinonen T., Kimber I., Kleinjans J., Komulainen H., Kreiling R., Kreysa J., Leite S.B., Loizou G., Maxwell G., Mazzatorta P., Munn S., Pfuhler S., Phrakonkham P., Piersma A., Poth A., Prieto P., Repetto G., Rogiers V., Schoeters G., Schwarz M., Serafimova R., Tähti H., Testai E., van Delft J., van Loveren H., Vinken M., Worth A., Zaldivar J.M.
Brown R.S., Akhtar P., Åkerman J., Hampel L., Kozin I.S., Villerius L.A. and Klamer H.J.C.
Archives of Toxicology 85, 367-485.
35: 4097–4102.
Natsch A. (2010).
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Toxicological Sciences 113, 284-292.
17: 2058–2062.
Emter R., Ellis G., Natsch A. (2010).
Nichols J.W., Fitzsimmons P.N., Whiteman F.W. and Dawson T.D.
Toxicology and Applied Pharmacology 245, 281-290.
77: 206–218.
Dinkova-Kostova A.T., Holtzclaw W.D., Kensler T.W.
Parkerton T.F., Arnot J.A., Weisbrod A.V., Russom C., Hoke R.A., Woodburn K., Traas T., Bonnell M., Burkhard L.P. and Lampi M.A.
18, 1779-1791.
4: 139–155.
Kansanen E., Kuosmanen S.M., Leinonen H., Levonen A.L.
Verbruggen E.M.J., Beek M., Pijnenburg J. and Traas T.P.
1(1), 45-49.
27: 2436–2448.
Natsch A., Bauch C., Foertsch L., Gerberick F., Normann K., Hilberer A., Inglis H., Landsiedel R., Onken S., Reuter H., Schepky A., Emter R. (2011).
Schlechtriem C., Fliedner A. and Schäfers C.
In Vitro 25, 733-744.
(2012), Determination of lipid content in fish samples from bioaccumulation studies: Contributions to the revision of OECD Test Guideline 305.
Natsch A., Ryan C.A., Foertsch L., Emter R., Jaworska J., Gerberick G.F., Kern P. (2013).
OECD (2000), OECD Environmental Health and Safety Publications Series on Testing and Assessment No.
Journal of Applied Toxicology, 33, 1337-1352.
23: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures ENV/JM/MONO(2000)6.
EURL-ECVAM (2014).
US-EPA (1994), Great Lake water quality initiative technical support document for the procedure to determine bioaccumulation factors 822-R-94-002.
Natsch A., Emter R., Ellis G. (2009).
US-FDA (1999), Pesticide analytical manual (PAM).
107, 106-121.
US-EPA (1974), Section 5, A (1) Analysis of Human or Animal Adipose Tissue, in Analysis of Pesticide Residues in Human and Environmental Samples, Thompson, J.F., Editor.
Ball N., Cagen S., Carrillo J.C., Certa H., Eigler D., Emter R., Faulhammer F., Garcia C., Graham C., Haux C., Kolle S.N., Kreiling R., Natsch A., Mehling A. (2011).
Bligh E.G. and Dyer W.J.
60, 389-400.
37: 911–917.
Bauch C., Kolle S.N., Ramirez T., Eltze T., Fabian E., Mehling A., Teubner W., van Ravenzwaay B., Landsiedel R. (2012).
Gardner W.S., Frez W.A., Cichocki E.A. and Parrish C.C.
63, 489-504.
30: 1099–1105.
Jaworska J., Dancik Y., Kern P., Gerberick F., Natsch A. (2013).
Smedes F.
33, 1353-1364.
(1999), Determination of total lipid using non-chlorinated solvents.
Andres E., Sa-Rocha V.M., Barrichello C., Haupt T., Ellis G., Natsch A. (2013).
124: 1711–1718.
Toxicology In Vitro 27, 1220-1225.
OECD (2006), OECD Environmental Health and Safety Publications Series on Testing and Assessment No.
Fabian E., Vogel D., Blatz V., Ramirez T., Kolle S., Eltze T., van Ravenzwaay B., Oesch F., Landsiedel R. (2013).
54: Current approaches in the statistical analysis of ecotoxicity data: a guidance to application.
87, 1683-1969.
Springer T.A., Guiney P.D., Krueger H.O. and Jaber M.J.
Thorne N., Inglese J., Auld D.S.
27: 2271–2280.
Chemistry and Biology 17, 646-657.
Springer T.A.
Gildea L.A., Ryan C.A., Foertsch L.M., Kennedy J.M., Dearman R.J., Kimber I., Gerberick G.F.
Arnot J.A., Meylan W., Tunkel J., Howard P.H., Mackay D., Bonnell M. and Boethling R.S.
Dermatol., 126, 1813-1822.
28: 1168–1177.
Ryan C.A., Gildea L.A., Hulette B.C., Dearman R.J., Kimber I., Gerberick G.F.
Parkerton T., Letinski D., Febbo E., Davi R., Dzambia C., Connelly M., Christensen K. and Peterson D.
150, 301-316.
(2001), A practical testing approach for assessing bioaccumulation potential of poorly water soluble organic chemicals (presentation). in SETAC Europe 12th Annual Meeting: Madrid, Spain.
Emter R., van der Veen J.W., Adamson G., Ezendam J., van Loveren H., Natsch A. (2013).
Fisk A.T., Cymbalisty C.D., Bergman Ã. and Muir D.C.G.
Toxicol. in vitro 27, 2225-2232.
15: 1775–1782.
OECD (2015).
Anonymous (2004), Fish, dietary bioaccumulation study – Basic protocol, document submitted to the TC-NES WG on PBT.
NAFTA (North American Free Trade Agreement) (2012).
Anonymous (2004), Background document to the fish dietary study protocol, document submitted to the TC-NES WG on PBT.
Technical Working Group on Pesticides — (Quantitative) Structure Activity Relationship ((Q)SAR) Guidance Document.
Bruggeman W.A., Opperhuizen A., Wijbenga A. and Hutzinger O.
Imax
(1984), Bioaccumulation of super-lipophilic chemicals in fish, Toxicol.
The suggested NC chemical is calcium-containing (at a concentration of 1,0-1,8 mM), phenol red-free, HBSS (untreated, blank control).
Muir D.C.G., Marshall W.K. and Webster G.R.B.
A maximum leakage control should also be included in each run to allow for the calculation of FL20 values.
14: 829–833.
(mg/ml)
Thomann R.V.
UN GHS C&L EU CLP C&L
23: 699–707.
U.S. EPA C&L
Nichols J.W., Fitzsimmons P.N. and Whiteman F.W.
UN (2009), United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Third revised edition, New York & Geneva: United Nations Publications.
77: 219–229.
EPA (1996), Label Review Manual: 2nd Edition, EPA737-B-96-001, Washington DC: U.S. Environmental Protection Agency.
Gobas F.A.P.C., de Wolf W., Burkhard L.P., Verbruggen E. and Plotzke K.
EC-ECVAM (2009), Statement on the scientific validity of cytotoxicity/cell-function based in vitro assays for eye irritation testing.
(2009), Revisiting bioaccumulation criteria for POPs and PBT assessments.
Scott, L. et al.
5: 624–637.
In Vitro 24, 1-9
Sijm D.T.H.M. and van der Linde A.
EC-ECVAM (1999), INVITOX Protocol 71: Fluorescein Leakage Test, Ispra, Italy: European Centre for the Validation of Alternative Methods (ECVAM).
(1995), Size-dependent bioconcentration kinetics of hydrophobic organic chemicals in fish based on diffusive mass transfer and allometric relationships.
EC-ECVAM (2008), Fluorescein Leakage Assay Background Review Document as an Alternative Method for Eye Irritation Testing.
29: 2769–2777.
Ocular corrosive (a) A chemical that causes irreversible tissue damage to the eye.
Sijm D.T.H.M., Verberne M.E., de Jonge W.J., Pärt P. and Opperhuizen A.
Chemicals that are classified as UN GHS Category 1; EU CLP Category 1; or U.S.
(1995), Allometry in the uptake of hydrophobic chemicals determined in vivo and in isolated perfused gills.
A chemical that produces a reversible change in the eye following application to the anterior surface of the eye; (b) Chemicals that are classified as UN GHS Categories 2A, or 2B; EU CLP Category 2; or U.S.
131: 130–135.
EPA Categories II or III ocular irritants.
Fisk A.T., Norstrom R.J., Cymbalisty C.D. and Muir D.G.G.
EPA Category I ocular irritants.
17: 951–961.
Positive control
McGrath J.A., Parkerton T.F. and Di Toro D.M.
A replicate containing all components of a test system and treated with a chemical known to induce a positive response.
23: 2503–2517.
To ensure that variability in the positive control response across time can be assessed, the magnitude of the positive response should not be extreme.
Poppendieck D.G.
Proficiency Chemicals A sub-set of the list of Reference Chemicals that can be used by a naïve laboratory to demonstrate proficiency with the validated reference test method.
McCarty L.S. and Mackay D.
Relevance
(1993), Enhancing ecotoxicological modelling and assessment: body residues and modes of toxic action.
It is the extent to which the test correctly measures or predicts the biological effect of interest.
27: 1718–1728.
Relevance incorporates consideration of the accuracy (concordance) of a test method (8).
Part II – Additional Report including comparative analysis of trout and carp results ENV/JM/MONO(2012)20.
Reliability
20–25
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.
(Teleostei, Centrarchidae)
Sensitivity
(Teleostei, Salmonidae)
The proportion of all positive/active chemicals that are correctly classified by the test.
13–17
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 (8).
(Teleostei, Gasterosteidae)
An untreated sample containing all components of a test system, including the solvent or vehicle that is processed with the test chemical-treated and other control samples to establish the baseline response for the samples treated with the test chemical dissolved in the same solvent or vehicle.
Meyer A., Biermann C.H. and Orti G.
When tested with a concurrent negative control, this sample also demonstrates whether the solvent or vehicle interacts with the test system.
(1993), The phylogenetic position of the zebrafish (Danio rerio), a model system in developmental biology: An invitation to the comparative method Proc.
Specificity
B.
The proportion of all negative/inactive chemicals that are correctly classified by the test.
252: 231–236.
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.
HARMONOGRAMY ODBĚRU VZORKŮ PRO ZKOUŠKY EXPOZICE VE VODNÍM PROSTŘEDÍ A V POTRAVĚ
Substance
Odběr vzorků ryb
Used in the context of the UN GHS as chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Počet ryb ve vzorku [1]
Test chemical Any substance or mixture tested using this test method.
Minimální požadovaná četnost (dny) [2]
Tiered testing strategy
Dodatečný odběr vzorků (dny) [2]
If the irritancy potential of a test chemical cannot be assigned based on the existing information, a step-wise sequential animal testing procedure is performed until an unequivocal classification can be made.
4–8 [5]
Validated test method
Přemístění ryb do vody neobsahující zkoušenou látku
A test method for which validation studies have been completed to determine the relevance (including accuracy) and reliability for a specific purpose.
40–72
It is important to note that a validated test method may not have sufficient performance in terms of accuracy and reliability to be found acceptable for the proposed purpose (8).
48 ± 80 [5]
Data from other tissues e.g. stomach/duodenum/jejunum, blood etc. could be collected at the same time.
05–10
The laboratory needs to demonstrate proficiency with each individual tissue in each species they are planning to study, and will need to demonstrate that an acceptable positive response with a known mutagen (e.g. EMS) can be obtained in that tissue.
8 ± 13 [8]
Animals should be given daily treatments over a duration of 2 or more days (i.e. two or more treatments at approximately 24 hour intervals), and samples should be collected once at 2-6 h (or at the Tmax) after the last treatment (12).
5–10
Samples from extended dose regimens (e.g. 28-day daily dosing) are acceptable.
10–15 [10]
Successful combination of the comet and the erythrocyte micronucleus test has been demonstrated (10) (19).
13 ± 18 [11]
However careful consideration should be given to the logistics involved in tissue sampling for comet analysis alongside the requirements of tissue sampling for other types of toxicological assessments.
8 ± 13 [11]
Harvest 24 hours after the last dose, which is typical of a general toxicity study, is not appropriate in most cases (see paragraph 40 on sampling time).
10–15 [10]13 ± 18 [11]
For each sample (per tissue per animal), at least 150 cells (excluding hedgehogs — see paragraph 56) should be analysed.