natgillin/translations-raw huggingface dataset:
0–7
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 (4).
15–55
Surfactant
0–25
Also called surface-active agent, this is a substance, such as a detergent, that can reduce the surface tension of a liquid and thus allow it to foam or penetrate solids; it is also known as a wetting agent.
60–100
Top-Down Approach
10–45
step-wise approach used for a chemical suspected of causing serious eye damage, which starts with the determination of chemicals inducing serious eye damage (positive outcome) from other chemicals (negative outcome).
0–5,5
Test chemical
Médium se poté odstraní a nahradí čerstvým kultivačním médiem (v případě zkoušky KeratinoSensTM je to 150 μl kultivačního média obsahujícího sérum, ale bez geneticinu, do něhož se přidá 50 μl 25násobně rozředěné zkoušené chemické látky a kontrolních látek.
Any substance or mixture tested using this Test Method.
Nejméně jedna jamka na každé destičce by se měla ponechat prázdná (bez buněk a bez expozice), aby bylo možné posoudit hodnoty pozadí.
Tiered testing strategy
A konečně, u chemických látek, jež vyvolávají 1,5násobnou nebo vyšší indukci při nejnižší koncentraci 0,98 μM, se na základě vizuální kontroly křivky dávka-účinek stanoví hodnota EC1,5 < 0,98.
A stepwise testing strategy where all existing information on a test chemical is reviewed, in a specified order, using a weight-of-evidence process at each tier to determine if sufficient information is available for a hazard classification decision, prior to progression to the next tier.
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.
If the irritancy potential of a test chemical can be assigned based on the existing information, no additional testing is required.
Archives of Toxicology 85, 367–485.
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) A system proposing the classification of chemicals (substances and mixtures) according to standardised types and levels of physical, health and environmental hazards, and addressing corresponding communication elements, such as pictograms, signal words, hazard statements, precautionary statements and safety data sheets, so that to convey information on their adverse effects with a view to protect people (including employers, workers, transporters, consumers and emergency responders) and the environment (4).
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UN GHS Category 1 see “Serious damage to eyes” and/or “Irreversible effects on the eye”.
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see “Eye Irritation” and/or “Reversible effects to the eye”.
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UN GHS No Category
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Validated test method A test method for which validation studies have been completed to determine the relevance (including accuracy) and reliability for a specific purpose.
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Generally organic solvents should not exceed 1 % (v/v).
Toxicology and Applied Pharmacology 245, 281–290.
If cytoB is dissolved in DMSO, the total amount of organic solvent used for both the test chemical and cytoB should not exceed 1 % (v/v); otherwise, untreated controls should be used to ensure that the percentage of organic solvent has no adverse effect.
Dinkova-Kostova A.T., Holtzclaw W.D., Kensler T.W.
Aqueous solvents (saline or water) should not exceed 10 % (v/v) in the final treatment medium.
18, 1779–1791.
If other than well-established solvents are used (e.g. ethanol or acetone), their use should be supported by data indicating their compatibility with the test chemical, the test system and their lack of genetic toxicity at the concentration used.
Kansanen E., Kuosmanen S.M., Leinonen H., Levonen A.L.
However, for thorough evaluation, which would be needed to conclude a negative outcome, all three following experimental conditions should be conducted using a short term treatment with and without metabolic activation and long term treatment without metabolic activation (see paragraphs 56, 57 and 58):
1(1), 45–49.
Cells should be exposed to the test chemical without metabolic activation for 3-6 hours, and sampled at a time equivalent to about 1,5 - 2,0 normal cell cycle lengths after the beginning of treatment (19),
Natsch A., Bauch C., Foertsch L., Gerberick F., Normann K., Hilberer A., Inglis H., Landsiedel R., Onken S., Reuter H., Schepky A., Emter R.
Appropriate techniques should be used to control any bias or drift when using an automated scoring system, for instance, flow cytometry, laser scanning cytometry or image analysis.
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Regardless of the automated platform is used to enumerate micronuclei, CBPI, RI, RPD, or RICC should be assessed concurrently.
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Je to měřítko přesnosti zkušební metody, která dává kategorické výsledky, a je důležitým prvkem při hodnocení relevance zkušební metody (8).
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Neošetřený vzorek obsahující všechny složky zkušebního systému, včetně rozpouštědla nebo vehikula, který se zpracovává s exponovanými zkoušenými chemickými látkami a jinými kontrolními vzorky, aby se zjistila základní reakce vzorků zkoušených se zkoušenou chemickou látkou rozpuštěnou ve stejném rozpouštědle nebo vehikulu.
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607/1, pp. 88-124.
Podíl všech negativních/neaktivních chemických látek, které jsou na základě zkušební metody správně zatříděny.
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V kontextu GHS OSN jsou to chemické prvky a jejich sloučeniny v přírodním stavu nebo získané výrobním procesem, včetně všech přídatných látek nezbytných k uchování stability výrobků a veškerých nečistot vznikajících v daném procesu, avšak s výjimkou všech rozpouštědel, která lze oddělit bez ovlivnění stability látky nebo změny jejího složení.
607/1, pp. 125-152.
Strategie postupného zkoušení, kde se všechny existující informace o zkoušené chemické látce přezkoumávají ve stanoveném pořadí s použitím postupu váhy důkazů na každém stupni, aby se zjistilo, zda je k dispozici dost informací pro rozhodnutí o klasifikaci nebezpečnosti, než se postoupí do dalšího stupně.
Albertini, S. et al.
Pokud potenciál dráždivých účinků zkoušené chemické látky lze určit na základě existujících informací, další zkoušení není nutné.
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Jestliže potenciál dráždivých účinků zkoušené látky nelze určit na základě existujících informací, použije se stupňovitý postupný postup zkoušení na zvířatech po krocích, dokud se nestanoví jednoznačná klasifikace.
392/1-2, pp. 187-208.
Zkušební metoda, u níž byly provedeny validační studie k určení její relevantnosti (včetně přesnosti) a spolehlivosti pro konkrétní účel.
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Je nutné poznamenat, že validovaná zkušební metoda nemusí poskytnout postačující výsledek z hlediska přesnosti a spolehlivosti, aby byla shledána přijatelnou pro navržený účel (8).
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Zároveň by měly být shromažďovány údaje vztahující se k jiným tkáním, např. žaludku/dvanáctníku/lačníku, krvi atd. Laboratoř musí prokázat způsobilost ke zkoušení každé jednotlivé tkáně každého druhu, který plánuje zkoušet, a bude muset prokázat, že v této tkáni lze získat přijatelnou pozitivní odezvu na známý mutagen (např. EMS).
392/1-2, pp. 45-59.
Ve většině případů není vhodný odběr vzorků 24 hodin po poslední dávce, který je typický pro studium obecné toxicity.
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Z každého vzorku (na každou tkáň z každého zvířete) by mělo být analyzováno alespoň 150 buněk (s vyloučením „hedgehogs“ – viz odstavec 56), Hodnocení 150 buněk z každého zvířete při nejméně 5 zvířatech na každou dávku (v souběžné pozitivní kontrole méně – viz odstavec 29) poskytuje podle analýzy Smitha et al., 2008 (5) odpovídající statistickou váhu.
410, pp. 81-116.
Užitečné informace o poškození tkání mohou poskytnout i změny v klinických biochemických ukazatelích (např. AST, ALT) a posoudit lze i další ukazatele, jako je aktivace kaspázy, barvivo TUNEL, barvivo Annexin V atd. O použití posledně jmenovaných ukazatelů ve studiích in vivo však existují jen omezené publikované údaje a některé mohou být méně spolehlivé než jiné.
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