natgillin/translations-raw huggingface dataset:
Alternatively a single point is placed at the centre of the screen and a continuous scan in one direction across the filter is initiated.
Alternativno je na sredini zaslona postavljena ena sama točka, v eni smeri pa poteka stalno skeniranje filtra.
Each fibre of aspect ratio grater than 3:1 touching or crossing this point has its diameter measured and recorded.
Premer se izmeri in zapiše za vsako vlakno z razmerjem dolžina/širina večjim od 3:1, ki se dotika ali prečka to točko.
Fibre sizing
Določanje velikosti vlakna
It is recommended that a minimum of 300 fibres are measured.
Priporoča se merjenje najmanj 300 vlaken.
Each fibre is measured only once at the point of intersection with the line or point drawn on the image (or close to the point of intersection if the fibre edges are obscured).
Vsako vlakno se meri le enkrat v sečišču s črto ali točko, narisano na sliki (ali blizu sečišča, če je rob vlakna nejasen).
If fibres with non-uniform cross sections are encountered, a measurement representing the average diameter of the fibre should be used.
Pri vlaknih z neenakomernim presekom se uporabi meritev, ki predstavlja povprečje premera vlakna.
Care should be taken in defining the edge and measuring the shortest distance between the fibre edges.
Paziti je treba pri določanju robov in merjenju najkrajše razdalje med robovi vlakna.
Sizing may be done on line, or off-line on stored images or photographs.
Določanje velikosti je možno on-line ali off-line na shranjenih slikah ali fotografijah.
Semi-automated image measurement systems that download data directly into a spreadsheet are recommended, as they save time, eliminate transcription errors and calculations can be automated.
Priporoča se uporaba polavtomatskih sistemov za merjenje na slikah, ki nalagajo podatke neposredno v razpredelnice, ker se tako prihrani čas, zmanjša število napak pri prepisovanju, izračuni pa so lahko avtomatizirani.
The ends of long fibres should be checked at low magnification to ensure that they do not curl back into the measurement field of view and are only measured once.
Konci dolgih vlaken naj se preverijo pri majhnih povečavah, da se zagotovi, da se ne zvijajo nazaj v merilno ali vidno polje in so vlakna izmerjena le enkrat.
Fibre diameters do not usually have a normal distribution.
Premeri vlaken po navadi nimajo normalne porazdelitve.
However, by performing a log transformation it is possible to obtain a distribution that approximates to normal.
Če pa se izvede logaritmična transformacija, je možno dobiti porazdelitev, ki se približuje normalni.
Calculate the arithmetic mean (mean lnD) and the standard deviation (SDlnD) of the log to base e values (lnD) of the n fibre diameters (D).
Izračunajte aritmetično srednjo vrednost (srednji lnD) in standardno deviacijo (SDlnD) logaritma z osnovo e (lnD) za n premerov vlakna (D).
The standard deviation is divided by the square root of the number of measurements (n) to obtain the standard error (SElnD).
Standardna deviacija se deli s kvadratnim korenom števila meritev (n), da dobimo standardno napako (SElnD).
Subtract two times the standard error from the mean and calculate the exponential of this value (mean minus two standard errors) to give the geometric mean minus two geometric standard errors.
Dvakrat odštejte standardno napako od srednje vrednosti in izračunajte njen eksponent (srednja vrednost minus dve standardni napaki) in tako dobite geometrijsko srednjo vrednost minus dve geometrijski standardni napaki.
The test report should include at least the following information:
Poročilo o preskusu naj vsebuje vsaj naslednje informacije:
The value of LWGMD-2SE.
vrednost LWGMD-2SE,
Any deviations and particularly those which may have an effect on the precision or accuracy of the results with appropriate justifications.
kakršna koli odstopanja, še zlasti tista, ki vplivajo na natančnost in točnost rezultatov z ustreznimi obrazložitvami.
This magnification value is indicated for 3 µm fibres, for 6 µm fibres a magnification of × 5000 may be more suitable.
Ta vrednost povečave je določena za vlakna s premerom 3 µm, za vlakna s premerom 6 µm pa je primernejša povečava ×5000.
For 3 μm fibres, see previous note.
Za vlakna s premerom 3 μm glej prejšnjo opombo.
IN VITRO SKIN IRRITATION: RECONSTRUCTED HUMAN EPIDERMIS MODEL TEST
TEST DRAŽENJA KOŽE IN VITRO: TEST Z MODELOM REKONSTRUIRANE ČLOVEŠKE POKOŽNICE
Skin irritation refers to the production of reversible damage to the skin following the application of a test substance for up to 4 hours [as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS)](1).
Draženje kože pomeni nastanek popravljive poškodbe kože po nanosu testne snovi za čas do 4 ur [kot je opredeljeno v Globalnem usklajenem sistemu za razvrščanje in označevanje kemikalij (GHS) Združenih narodov (ZN)](1).
This Test Method provides an in vitro procedure that, depending on information requirements, may allow determining the skin irritancy of substances as a stand-alone replacement test within a testing strategy, in a weight of evidence approach (2).
Ta testna metoda zajema postopek in vitro, ki lahko, odvisno od zahtev po podatkih, kot samostojni nadomestni test v okviru testne strategije in na podlagi pristopa določitve zanesljivosti dokazov (weight of evidence approach) omogoči določitev stopnje razdraženosti kože zaradi snovi (2).
The assessment of skin irritation has typically involved the use of laboratory animals (See Method B.4)(3).
Ocenjevanje razdraženosti kože se običajno izvaja na laboratorijskih živalih (glej metodo B.4)(3).
In relation to animal welfare concerns, method B.4 allows for the determination of skin corrosion/irritation by applying a sequential testing strategy, using validated in vitro and ex vivo methods, thus avoiding pain and suffering of animals.
V skladu s prizadevanji za dobro počutje živali omogoča metoda B.4 določanje jedkosti za kožo/draženja kože z uporabo zaporedne testne strategije, pri čemer se uporabljata validirani metodi in vitro in ex vivo, da se tako preprečijo bolečine in trpljenje živali.
Three validated in vitro Test Methods or Test Guidelines, B.40, B.40bis and TG 435 (4, 5, 6), are useful for the corrosivity part of the sequential testing strategy of B.4.
Za del zaporedne testne strategije B.4, ki zadeva jedkost, je smiselno uporabiti tri validirane testne metode ali smernice za testiranje in vitro, in sicer B.40, B.40a in TG 435 (4, 5, 6).
This Test Method is based on reconstructed human epidermis models, which in their overall design (the use of human derived epidermis keratinocytes as cell source, representative tissue and cytoarchitecture) closely mimic the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
Ta testna metoda temelji na modelih rekonstruirane človeške pokožnice, ki so v svoji zasnovi (uporaba človeških keratinocitov pokožnice kot vira celic, vzorčnega tkiva in citoarhitekture) zelo podobni biološkim in fiziološkim značilnostim zgornjih delov človeške kože, tj. pokožnice.
The procedure described under this Test Method allows the hazard identification of irritant substances in accordance with UN GHS category 2.
Postopek, ki je opisan v okviru te testne metode, omogoča ugotavljanje nevarnosti dražilnih snovi v skladu s kategorijo 2 GHS ZN.
This Test Method also includes a set of performance standards for the assessment of similar and modified reconstructed human epidermis based test methods (7).
Ta testna metoda vključuje tudi skupino standardov učinkovitosti za ocenjevanje podobnih in spremenjenih testnih metod za rekonstruirano človeško pokožnico (7).
Prevalidation, optimisation and validation studies have been completed for two in vitro test methods (8, 9, 10, 11, 12, 13, 14, 15, 16, 17), commercially available as EpiSkin™ and EpiDerm™, using reconstructed human epidermis models.
Predvalidacijske, optimizacijske in validacijske študije so dopolnjene z dvema testnima metodama in vitro (8, 9, 10, 11, 12, 13, 14, 15, 16, 17), ki sta na tržišču na voljo pod imenoma EpiSkin™ in EpiDerm™ ter pri katerih se uporabljajo modeli rekonstruirane človeške pokožnice.
These references were based on R 38.
Te reference so temeljile na R 38.
Certain aspects of recalculation for the purposes of GHS are addressed in reference 25.
Nekateri vidiki ponovnega izračuna za namene GHS so obravnavani v referenci 25.
Methods with a performance equivalent to EpiSkin™ (validated reference method 1) are recommended as a stand alone replacement test method for the rabbit in vivo test for classifying GHS category 2 irritant substances.
Metode, katerih učinkovitost je enakovredna EpiSkin™ (validirana referenčna metoda 1), se priporočajo kot samostojne nadomestne testne metode za testiranje in vivo na kuncu za razvrščanje dražilnih snovi kategorije 2 GHS.
Methods with a performance equivalent to EpiDerm™ (validated reference method 2) are only recommended as a screen test method, or as part of a sequential testing strategy in a weight of evidence approach, for classifying GHS category 2 irritant substances.
Metode, katerih učinkovitost je enaka EpiDerm™ (validirana referenčna metoda 2), se priporočajo le kot dodatne testne metode ali kot del zaporedne testne strategije pri načinu določitve zanesljivosti dokazov za razvrščanje dražilnih snovi kategorije 2 GHS.
Before a proposed in vitro reconstructed human epidermis model test for skin irritation can be used for regulatory purposes, its reliability, relevance (accuracy), and limitations for its proposed use should be determined to ensure that it is comparable to that of the validated reference method 1, in accordance with the performance standards set out in this Test Method (Appendix).
Preden se omogoči uporaba predlaganega testa v zvezi z draženjem kože in vitro z rekonstruirano človeško pokožnico za zakonodajne namene, je treba določiti njegovo zanesljivost, ustreznost (natančnost) in omejitve, kar zadeva predlagano uporabo, da se zagotovi njegova primerljivost z validirano referenčno metodo 1 v skladu s standardi učinkovitosti, ki so določeni v tej testni metodi (Dodatek).
Two other in vitro reconstructed human epidermis test methods, have been validated in accordance with the requirements under this Test Method, and show similar results as the validated reference method 1 (18).
V skladu z zahtevami v okviru te testne metode sta bili validirani še dve testni metodi in vitro z rekonstruirano človeško pokožnico, pri čemer so njuni rezultati podobni rezultatom validirane referenčne metode 1 (18).
These are the modified EpiDerm™ test method (modified reference method 2) and the SkinEthic RHE™ test method (me-too method 1).
To sta spremenjena testna metoda EpiDerm™ (spremenjena referenčna metoda 2) in testna metoda SkinEthic RHE™ (podobna metodi 1).
The following definitions are applied within this Test Method:
V okviru te testne metode se uporabljajo naslednje opredelitve pojmov:
Accuracy: The closeness of agreement between test method results and accepted reference values.
Natančnost: stopnja ujemanja rezultatov testne metode s sprejetimi referenčnimi vrednostmi.
It is a measure of test method performance and one aspect of relevance.
To je merilo učinkovitosti testne metode in eden od vidikov ustreznosti.
The term is often used interchangeably with ‘concordance’ to mean the proportion of correct outcomes of a test method.
Ta izraz in izraz „skladnost“ se pogosto izmenično uporabljata za pomen deleža ustreznih rezultatov testne metode.
Batch control substance: Benchmark substance producing a mid-range cell viability response of the tissue.
Snov kontrolne serije: primerjalna snov, ki na tkivu povzroči srednje močen odziv glede viabilnosti celic.
Cell viability: Parameter measuring total activity of a cell population e.g. as ability of cellular mitochondrial dehydrogenases to reduce the vital dye MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue;), which, depending on the endpoint measured and the test design used, correlates with the total number and/or vitality of living cells.
Viabilnost celic: parameter za merjenje celotne dejavnosti celične populacije, npr. zmožnosti celičnih mitohondrijskih dehidrogenaz za redukcijo vitalnega barvila MTT ([3–(4,5-dimetiltiazol-2-il)-2,5-difeniltetrazolijev bromid, Thiazolyl blue;), ki se glede na izmerjeni končni učinek in uporabljeni načrt testa ujema s skupnim številom in/ali viabilnostjo celic.
The exposure time required to reduce cell viability by 50 % upon application of the marker substance at a specified, fixed concentration, see also IC50.
ET50: čas izpostavljenosti, ki je potreben za zmanjšanje viabilnosti celic za 50 % po nanosu določene stalne koncentracije označevalca, glej tudi IC50.
False negative rate: The proportion of all positive substances falsely identified by a test method as negative.
Delež lažno negativnih rezultatov: delež vseh pozitivnih snovi, ki jih testna metoda lažno prikaže kot negativne.
It is one indicator of test method performance.
To je eden od kazalnikov učinkovitosti testne metode.
False positive rate: The proportion of all negative (non-active) substances that are falsely identified as positive.
Delež lažno pozitivnih rezultatov: delež vseh negativnih (neaktivnih) snovi, ki jih testna metoda lažno prikaže kot pozitivne.
Infinite dose: Amount of test substance applied to the skin exceeding the amount required to completely and uniformly cover the skin surface.
Prevelik odmerek: količina na kožo nanesene testne snovi, ki je večja od količine, potrebne za celotno in enakomerno prekrivanje površine kože.
GHS (Globally Harmonized System of Classification and Labelling of Chemicals): A system proposing the classification of 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 (1) and implemented in the EU in Regulation (EC) No 1272/2008.
GHS (globalno usklajen sistem za razvrščanje in označevanje kemikalij): sistem, v okviru katerega se predlaga razvrščanje snovi in zmesi v skladu s standardiziranimi vrstami in stopnjami fizikalnih nevarnosti, nevarnosti za zdravje in okolje, ter obravnavajo ustrezni elementi obveščanja, kot so piktogrami, opozorilne besede, izjave o nevarnosti, varnostne izjave in varnostni listi, da se sporočijo informacije o negativnih vplivih z namenom zaščite ljudi (vključno z delodajalci, zaposlenimi, prevozniki, potrošniki in reševalci) in okolja (1), je v EU izveden z Uredbo (ES) št. 1272/2008.
The concentration at which a marker substance reduces the viability of the tissues by 50 % (IC50) after a fixed exposure time, see also ET50.
IC50: Koncentracija, pri kateri označevalec po določenem času izpostavljenosti zmanjša viabilnost tkiva za 50 % (IC50), glej tudi ET50.
Performance standards: Standards, based on a validated reference method, that provide a basis for evaluating the comparability of a proposed test method that is mechanistically and functionally similar.
Standardi učinkovitosti: standardi, ki temeljijo na validirani referenčni metodi, na podlagi katere se lahko ocenjuje primerljivost predlagane testne metode, ki je referenčni v mehaničnem in funkcijskem smislu podobna.
Included are (I) essential test method components; (II) a minimum list of reference substances selected from among the substances used to demonstrate the acceptable performance of the validated reference method; and (III) the comparable levels of accuracy and reliability, based on what was obtained for the validated reference method, that the proposed test method should demonstrate when evaluated using the minimum list of reference substances.
Vključeni so I) nujni elementi testne metode, II) minimalni seznam referenčnih snovi, izbranih iz skupine snovi, ki se uporabljajo za dokazovanje sprejemljive učinkovitosti validirane referenčne metode, in III) primerljive stopnje natančnosti in zanesljivosti, ki temeljijo na rezultatu uporabe validirane referenčne metode, kar mora dokazati predlagana testna metoda pri ocenjevanju ob uporabi najkrajšega možnega seznama referenčnih snovi.
Reliability: Measures of the extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol.
Zanesljivost: merila za obseg ponovljivosti opravljanja testne metode v enem ali več laboratorijih v določenem časovnem obdobju, kadar poteka ob upoštevanju istega protokola.
It is assessed by calculating intra- and inter-laboratory reproducibility.
Oceni se z izračunom ponovljivosti v enem ali več laboratorijih.
Sensitivity: The proportion of all positive/active substances that are correctly classified by the test.
Občutljivost: delež vseh pozitivnih/aktivnih snovi, ki se s testom pravilno razvrstijo.
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.
To je merilo natančnosti za testno metodo, s katero se dosežejo kategorični rezultati, in je pomemben dejavnik pri ocenjevanju ustreznosti testne metode.
Specificity: The proportion of all negative/inactive substances that are correctly classified by the test.
Specifičnost: delež vseh negativnih/neaktivnih snovi, ki se pravilno razvrstijo s testom.
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.
To je merilo natančnosti za testno metodo, s katero se dosežejo kategorični rezultati, in je pomemben dejavnik pri ocenjevanju ustreznosti testne metode.
Its main characteristic is its reversible process involving inflammatory reactions and most of the clinical characteristic signs of irritation (erythema, oedema, itching and pain) related to an inflammatory process.
Njena glavna lastnost je popravljiv proces, ki vključuje vnetne reakcije in večino značilnih kliničnih znakov razdraženosti (eritem, edem, srbenje in bolečino), povezanih z vnetnim procesom.
A limitation of the reconstructed human epidermis tests falling under this Test Method is that they only classify substances as skin irritants according to UN GHS category 2.
Omejitev testov z rekonstruirano človeško pokožnico v okviru te testne metode je le razvrščanje snovi kot dražil kože v skladu s kategorijo 2 GHS ZN.
As they do not allow the classification of substances to the optional category 3 as defined in the UN GHS, all remaining substances will not be classified (no category).
Ker razvrščanje snovi v neobvezno kategorijo 3, kot je opredeljeno v GHS ZN, ni dovoljeno, ne bo razvrščena nobena od ostalih snovi (v nobeno od kategorij).
Depending on regulatory needs and possible future inclusion of new endpoints, improvements or development of new me-too tests, this Test Method may have to be revised.
To testno metodo je treba prilagajati glede na zakonodajne potrebe in možno prihodnjo vključitev novih končnih učinkov, izboljšav ali razvoja novih podobnih testov.
This Test method allows the hazard identification of irritant mono-constituent substances (19), but it does not provide adequate information on skin corrosion.
Ta testna metoda omogoča ugotavljanje nevarnosti dražilnih snovi iz ene sestavine (19), vendar ne zagotavlja ustreznih informacij o jedkosti za kožo.
Gases and aerosols cannot be tested, while mixtures have not been assessed yet in a validation study.
Plinov in aerosolov ni mogoče testirati, medtem ko zmesi še niso ocenjene v validacijski študiji.
The test substance is applied topically to a three-dimensional reconstructed human epidermis model, comprised of normal, human-derived epidermal keratinocytes, which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
Testna snov se površinsko nanese na tridimenzionalni model rekonstruirane človeške pokožnice, ki vključuje normalne keratinocite človeške pokožnice, gojene za večplastni, zelo raznolik model človeške pokožnice.
It consists of organised basal, spinous and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Sestavljajo ga organizirane bazalne, spinalne in zrnate plasti ter večplastna rožena plast, ki vključuje medcelične lamelarne maščobne plasti, razporejene v vzorce, ki so podobni strukturi in vivo.
The principle of the reconstructed human epidermis model test is based on the premise that irritant substances are able to penetrate the stratum corneum by diffusion and are cytotoxic to the cells in the underlying layers.
Načelo testa z modelom rekonstruirane človeške pokožnice temelji na predpostavki, da lahko dražilne snovi prodrejo v roženo plast z difuzijo in so citotoksične za spodaj ležeče plasti celic.
Cell viability is measured by dehydrogenase conversion of the vital dye MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; EINECS number 206-069-5, CAS number 298-93-1)], into a blue formazan salt that is quantitatively measured after extraction from tissues (20).
Viabilnost celic se meri s konverzijo dehidrogenaze vitalnega barvila MTT [3–(4,5-dimetiltiazol-2-il)-2,5-difeniltetrazolijev bromid, Thiazolyl blue; številka EINECS 206–069–5, številka CAS 298–93–1] v soli modrega formazana, količina katere se izmeri po ekstrakciji iz tkiv (20).
Irritant substances are identified by their ability to decrease cell viability below defined threshold levels (i.e. ≤ 50 %, for UN GHS category 2 irritants).
Dražilne snovi so prepoznavne po zmožnosti zmanjšanja viabilnosti celic pod opredeljene vrednosti praga (tj. ≤ 50 %, za dražila kategorije 2 GHS ZN).
Substances that produce cell viabilities above the defined threshold level, will not be classified (i.e. > 50 %, no category).
Snovi, zaradi katerih je viabilnost celic večja od opredeljene vrednosti praga, ne bodo razvrščene (tj. > 50 %, v nobeno kategorijo).
The reconstructed human epidermis model systems may be used to test solids, liquids, semi-solids and waxes.
Sistemi modela rekonstruirane človeške pokožnice se lahko uporabljajo za testiranje trdnih snovi, tekočih snovi, poltrdnih snovi in voskov.
The liquids may be aqueous or non-aqueous; solids may be soluble or insoluble in water.
Tekoče snovi so lahko vodne raztopine ali ne, trdne snovi so lahko topne ali netopne v vodi.
Whenever possible, solids should be tested as a fine powder.
Če je mogoče, je treba trdne snovi testirati v obliki finega prahu.
Since 58 carefully selected substances, representing a wide spectrum of chemical classes, were included in the validation of the reconstructed human epidermis model test systems, the methods are expected to be generally applicable across chemical classes (16).
Ker je bilo z validacijo sistemov za test z modelom rekonstruirane človeške pokožnice skrbno izbranih 58 snovi, ki predstavljajo veliko različnih kemijskih razredov, se pričakuje splošna veljavnost teh metod za kemijske razrede (16).
The validation includes 13 GHS Cat. 2 irritants.
Validacija vključuje 13 dražilnih snovi kategorije 2 po GHS.
It should be noted that non-corrosive acids, bases, salts and other inorganic substances were not included in the validation and some known classes of organic irritants such as hydroperoxides, phenols and surfactants were not included or were only included to a limited extent.
Opozoriti je treba, da nejedke kisline, baze, soli in druge anorganske snovi niso bile vključene v validacijo in da nekaj znanih razredov organskih dražilnih snovi, kot na primer hidroperoksidi, fenoli in površinsko aktivne snovi, ni bilo vključenih ali pa so bili vključeni le delno.
DEMONSTRATION OF PROFICIENCY
DOKAZOVANJE STROKOVNOSTI