natgillin/translations-raw huggingface dataset:
Non-surfactant solids are typically tested as solutions or suspensions at 20 % w/v concentration in a 0,9 % sodium chloride solution, distilled water, or other solvent that has been demonstrated to have no adverse effects on the test system.
Če se pri ponovitvi preskušanj pojavi neskladna napoved iz prve ponovitve preskušanja (ki temelji na srednji vrednosti stopnje IVIS), je treba izvesti tretjo in končno ponovitev preskušanja za razjasnitev neenakih napovedi in razvrstitev preskusne kemikalije.
In certain circumstances and with proper scientific justification, solids may also be tested neat by direct application onto the corneal surface using the open chamber method (see paragraph 32).
Nadaljnje preskušanje za razvrščanje in označevanje se lahko odpravi, če je pri kateri koli ponovitvi preskusa napovedana kategorija 1 po GHS ZN.
Corneas are exposed to solids for four hours, but as with liquids and surfactants, alternative exposure times may be used with appropriate scientific rationale.
V poročilo o preskusu se vključijo naslednji podatki, če so pomembni za izvedbo študije:
Different treatment methods can be used, depending on the physical nature and chemical characteristics (e.g. solids, liquids, viscous vs. non-viscous liquids) of the test chemical.
Preskusne in kontrolne kemikalije:
The critical factor is ensuring that the test chemical adequately covers the epithelial surface and that it is adequately removed during the rinsing steps.
kemijska imena, na primer strukturno ime, ki ga uporablja Služba za izmenjavo kemijskih izvlečkov (CAS), ki jim sledijo druga imena, če so znana; registrska številka CAS (RN), če je znana;
A closed-chamber method is typically used for non-viscous to slightly viscous liquid test chemicals, while an open-chamber method is typically used for semi-viscous and viscous liquid test chemicals and for neat solids.
čistost in sestava preskusne/kontrolne kemikalije (v masnih odstotkih), če so ti podatki na voljo;
In the closed-chamber method, sufficient test chemical (750 μl) to cover the epithelial side of the cornea is introduced into the anterior chamber through the dosing holes on the top surface of the chamber, and the holes are subsequently sealed with the chamber plugs during the exposure.
fizikalno-kemijske lastnosti, pomembne za izvedbo študije, kot so agregatno stanje, hlapnost, vrednost pH, stabilnost, kemijski razred, topnost v vodi;
It is important to ensure that each cornea is exposed to a test chemical for the appropriate time interval.
obdelava preskusnih/kontrolnih kemikalij pred preskušanjem, če je ustrezno (npr. segrevanje, drobljenje);
In the open-chamber method, the window-locking ring and glass window from the anterior chamber are removed prior to treatment.
stabilnost, če je znana.
The control or test chemical (750 μl, or enough test chemical to completely cover the cornea) is applied directly to the epithelial surface of the cornea using a micro-pipet.
Podatki o naročniku in preskuševalnem laboratoriju:
If a test chemical is difficult to pipet, the test chemical can be pressure-loaded into a positive displacement pipet to aid in dosing.
ime in naslov naročnika, preskuševalnega laboratorija in vodje študije.
The pipet tip of the positive displacement pipet is inserted into the dispensing tip of the syringe so that the material can be loaded into the displacement tip under pressure.
Pogoji preskusne metode:
Simultaneously, the syringe plunger is depressed as the pipet piston is drawn upwards.
uporabljeni opacitometer (npr. model in specifikacije) ter nastavitve instrumenta;
If air bubbles appear in the pipet tip, the test chemical is removed (expelled) and the process repeated until the tip is filled without air bubbles.
podatki o umerjanju za merilno napravo, s katero sta se merili motnjava in prepustnost (npr. opacitometer in spektrofotometer), da se zagotovi linearnost meritev;
If necessary, a normal syringe (without a needle) can be used since it permits measuring an accurate volume of test chemical and an easier application to the epithelial surface of the cornea.
vrsta uporabljenih držal za roženico (npr. model in specifikacije);
After dosing, the glass window is replaced on the anterior chamber to recreate a closed system.
opis ostale uporabljene opreme;
Post-Exposure Incubation
postopek, ki se je uporabil za zagotavljanje celovitosti (tj. točnosti in zanesljivosti) preskusne metode v daljšem časovnem obdobju (npr. redno preskušanje kemikalij za preverjanje usposobljenosti).
After the exposure period, the test chemical, the negative control, or the positive control chemical is removed from the anterior chamber and the epithelium washed at least three times (or until no visual evidence of test chemical can be observed) with EMEM (containing phenol red).
Merila za sprejemljivost preskusa:
Phenol red- containing medium is used for rinsing since a colour change in the phenol red may be monitored to determine the effectiveness of rinsing acidic or alkaline test chemicals.
sprejemljiva sočasna pozitivna in negativna kontrola na podlagi podatkov iz preteklih preskusov;
The corneas are washed more than three times if the phenol red is still discoloured (yellow or purple), or the test chemical is still visible.
po potrebi razpon sprejemljivih referenčnih sočasnih kontrol na podlagi podatkov iz preteklih preskusov.
Once the medium is free of test chemical, the corneas are given a final rinse with EMEM (without phenol red).
Zbiranje in priprava oči:
The EMEM (without phenol red) is used as a final rinse to ensure removal of the phenol red from the anterior chamber prior to the opacity measurement.
podatki o viru oči (tj. obrat, v katerem so bile odvzete);
The anterior chamber is then refilled with fresh EMEM without phenol red.
premer roženice kot merilo za starost živalskega vira in primernost za test;
For liquids or surfactants, after rinsing, the corneas are incubated for an additional two hours at 32 ± 1 °C.
pogoji hranjenja in prevoza oči (npr. datum in čas odvzema oči, čas do začetka preskušanja, transportni medij in temperaturni pogoji, morebitni uporabljeni antibiotiki);
Longer post-exposure time may be useful in certain circumstances and could be considered on a case-by-case basis.
priprava in namestitev roženic govedi, vključno z izjavami glede njihove kakovosti, temperature držal za roženice in merili za izbiro roženic, uporabljenih za preskušanje.
Corneas treated with solids are rinsed thoroughly at the end of the four-hour exposure period, but do not require further incubation.
Preskusni postopek:
These observations could be important as they may be reflected by variations in the opacitometer readings.
uporabljene koncentracije preskusne kemikalije, nanos, čas izpostavljenosti in čas po inkubaciji, ki sledi obdobju izpostavljenosti;
Control Chemicals
opis uporabljenih meril za ocenjevanje in odločitev;
Concurrent negative or solvent/vehicle controls and positive controls are included in each experiment.
opis uporabljenih meril za sprejemljivost študije;
When testing a liquid substance at 100 %, a concurrent negative control (e.g. 0,9 % sodium chloride solution or distilled water) is included in the BCOP test method so that nonspecific changes in the test system can be detected and to provide a baseline for the assay endpoints.
opis vseh prilagoditev preskusnega postopka;
It also ensures that the assay conditions do not inappropriately result in an irritant response.
opis uporabljenih meril za ocenjevanje.
When testing a diluted liquid, surfactant, or solid, a concurrent solvent/vehicle control group is included in the BCOP test method so that nonspecific changes in the test system can be detected and to provide a baseline for the assay endpoints.
Rezultati
Only a solvent/vehicle that has been demonstrated to have no adverse effects on the test system can be used.
preglednice s podatki iz posameznih preskusnih vzorcev (npr. vrednosti motnjave in OD490 ter izračunane stopnje IVIS za preskusno kemikalijo ter pozitivne, negativne in primerjalne kontrole [če so bile vključene], prikazane v obliki preglednice, vključno s podatki iz ponovitev preskusov s ponovljenimi vzorci, če so bili izvedeni, ter srednje vrednosti ± standardni odklon za vsak poskus);
A chemical known to induce a positive response is included as a concurrent positive control in each experiment to verify the integrity of the test system and its correct conduct.
opis drugih opaženih učinkov.
However, to ensure that variability in the positive control response across time can be assessed, the magnitude of irritant response should not be excessive.
izpeljana razvrstitev po GHS ZN in vitro, če je ustrezna.
Examples of positive controls for liquid test chemicals are 100 % ethanol or 100 % dimethylformamide.
Razprava o rezultatih:
An example of a positive control for solid test chemicals is 20 % w/v imidazole in 0,9 % sodium chloride solution.
Na voljo na: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
Benchmark chemicals are useful for evaluating the ocular irritancy potential of unknown chemicals of a specific chemical or product class, or for evaluating the relative irritancy potential of an ocular irritant within a specific range of irritant responses.
Na voljo na: http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm.
Opacity is determined by the amount of light transmission through the cornea.
Na voljo na: [http://www.cdc.gov/ncidod/dhqp/pdf].
Corneal opacity is measured quantitatively with the aid of an opacitometer, resulting in opacity values measured on a continuous scale.
Series on Testing and Assessment, št. 160.
Permeability is determined by the amount of sodium fluorescein dye that penetrates all corneal cell layers (i.e., the epithelium on the outer cornea surface through the endothelium on the inner cornea surface).
Sprejet 25. oktobra 2011.
One ml sodium fluorescein solution (4 or 5 mg/ml when testing liquids and surfactants or non- surfactant solids, respectively) is added to the anterior chamber of the corneal holder, which interfaces with the epithelial side of the cornea, while the posterior chamber, which interfaces with the endothelial side of the cornea, is filled with fresh EMEM.
Poglavje B.5 te priloge: Akutno draženje oči/jedkost za oči.
The holder is then incubated in a horizontal position for 90 ± 5 min at 32 ± 1 °C.
Na voljo na: [http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_brd_bcop.htm].
The amount of sodium fluorescein that crosses into the posterior chamber is quantitatively measured with the aid of UV/VIS spectrophotometry.
Št. 1: OECD Principles on Good Laboratory Practice (rev. 1997).
Spectrophotometric measurements evaluated at 490 nm are recorded as optical density (OD490) or absorbance values, which are measured on a continuous scale.
Na voljo na: http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_1_1_1,00.html.
The fluorescein permeability values are determined using OD490 values based upon a visible light spectrophotometer using a standard 1 cm path length.
Točnost
Alternatively, a 96-well microtiter plate reader may be used provided that; (i) the linear range of the plate reader for determining fluorescein OD490 values can be established; and (ii), the correct volume of fluorescein samples are used in the 96-well plate to result in OD490 values equivalent to the standard 1 cm path length (this could require a completely full well [usually 360 μl]).
stopnja ujemanja rezultatov preskusne metode s sprejetimi referenčnimi vrednostmi.
Data Evaluation
Je merilo učinkovitosti preskusne metode in eden od vidikov „ustreznosti“.
Once the opacity and mean permeability (OD490) values have been corrected for background opacity and the negative control permeability OD490 values, the mean opacity and permeability OD490 values for each treatment group should be combined in an empirically-derived formula to calculate an in vitro irritancy score (IVIS) for each treatment group as follows:
Ta izraz in izraz „skladnost“ se pogosto uporabljata kot sopomenki in pomenita delež pravilnih rezultatov preskusne metode.
IVIS = mean opacity value + (15 × mean permeability OD490 value)
Primerjalna kemikalija
reported that this formula was derived during in-house and inter-laboratory studies.
kemikalija, ki se uporablja kot standard za primerjavo s preskusno kemikalijo.
The data generated for a series of 36 compounds in a multi-laboratory study were subjected to a multivariate analysis to determine the equation of best fit between in vivo and in vitro data.
Primerjalna kemikalija mora imeti naslednje značilnosti: (i) ima trajen in zanesljiv vir, (ii) je strukturno in funkcijsko podobna kemikalijam iz preskušanega razreda, (iii) ima znane fizikalne/kemijske lastnosti, (iv) ima spremne podatke o znanih učinkih in (v) ima znano moč v razponu želenega odziva.
Scientists at two separate companies performed this analysis and derived nearly identical equations.
Pristop od spodaj navzgor
The opacity and permeability values should also be evaluated independently to determine whether a test chemical induced corrosivity or severe irritation through only one of the two endpoints (see Decision Criteria).
stopenjski pristop, ki se uporablja za kemikalijo, za katero se domneva, da ne potrebuje razvrstitve glede na draženje oči ali hude poškodbe oči, pri čemer se najprej določijo kemikalije, ki ne potrebujejo razvrstitve (negativni rezultat), nato pa druge kemikalije (pozitivni rezultat).
Decision Criteria
prozoren sprednji del zrkla, ki pokriva šarenico in zenico ter skozi katerega vstopa svetloba.
The IVIS cut-off values for identifying test chemicals as inducing serious eye damage (UN GHS Category 1) and test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given hereafter:
Motnjava roženice
IVIS
merjenje stopnje motnjave roženice po izpostavljenosti preskusni kemikaliji.
UN GHS
Povečana motnjava roženice pomeni, da je roženica poškodovana.
No Category
Motnjava se lahko ocenjuje subjektivno, na primer z Draizovim testom draženja oči na kuncih, ali objektivno z inštrumentom, kot je „opacitometer“.
No prediction can be made
Prepustnost roženice
Category 1
kvantitativno merjenje poškodb epitelija roženice z določitvijo količine barvila natrijevega fluoresceina, ki prodre skozi vse celične plasti roženice.
Study Acceptance Criteria
Draženje oči
A test is considered acceptable if the positive control gives an IVIS that falls within two standard deviations of the current historical mean, which is to be updated at least every three months, or each time an acceptable test is conducted in laboratories where tests are conducted infrequently (i.e., less than once a month).
je povzročitev sprememb v očesu po nanosu preskusne kemikalije na sprednjo površino očesa, ki so v celoti popravljive v 21 dneh po nanosu.
The negative or solvent/vehicle control responses should result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneas treated with the respective negative or solvent/vehicle control.
Ta pojem je sopomenka za „popravljive učinke na oči“ in „kategorijo 2 po GHS ZN“ (4).
A single testing run composed of at least three corneas should be sufficient for a test chemical when the resulting classification is unequivocal.
Delež lažno negativnih rezultatov
However, in cases of borderline results in the first testing run, a second testing run should be considered (but not necessarily required), as well as a third one in case of discordant mean IVIS results between the first two testing runs.
delež vseh pozitivnih kemikalij, ki jih preskusna metoda zmotno prikaže kot negativne.
In this context, a result in the first testing run is considered borderline if the predictions from the 3 corneas were non-concordant, such that:
To je eden od kazalnikov učinkovitosti preskusne metode.
2 of the 3 corneas gave discordant predictions from the mean of all 3 corneas, OR,
Delež lažno pozitivnih rezultatov
1 of the 3 corneas gave a discordant prediction from the mean of all 3 corneas, AND the discordant result was > 10 IVIS units from the cut-off threshold of 55.
delež vseh negativnih kemikalij, ki jih preskusna metoda zmotno prikaže kot pozitivne.
If the repeat testing run corroborates the prediction of the initial testing run (based upon the mean IVIS value), then a final decision can be taken without further testing.
Nevarnost
If the repeat testing run results in a non-concordant prediction from the initial testing run (based upon the mean IVIS value), then a third and final testing run should be conducted to resolve equivocal predictions, and to classify the test chemical.
neločljiva lastnost sredstva ali stanje, ki ob izpostavljenosti temu sredstvu lahko povzroči neželen učinek na organizem, sistem ali (pod)populacijo.
It may be permissible to waive further testing for classification and labeling in the event any testing run results in a UN GHS Category 1 prediction.
Stopnja draženja in vitro (IVIS)
The test report should include the following information, if relevant to the conduct of the study:
empirično izpeljana formula, ki se uporablja pri preskusni metodi BCOP, pri kateri se srednje vrednosti motnjave in prepustnosti za vsako tretirano skupino združijo v eno samo vrednost in vitro za vsako tretirano skupino.
Test and Control Chemicals
Stopnja IVIS = srednja vrednost motnjave + (15 x srednja vrednost prepustnosti).
Chemical name(s) such as the structural name used by the Chemical Abstracts Service (CAS), followed by other names, if known; the CAS Registry Number (RN), if known;
Nepopravljivi učinki na oči
Purity and composition of the test/control chemical (in percentage(s) by weight), to the extent this information is available;
glej „Huda poškodba oči“.
Physicochemical properties such as physical state, volatility, pH, stability, chemical class, water solubility relevant to the conduct of the study;
Zmes
Treatment of the test/control chemicals prior to testing, if applicable (e.g. warming, grinding);
zmes ali raztopina iz dveh ali več snovi, ki v njej ne reagirajo (4).
Stability, if known.
Negativna kontrola
Information Concerning the Sponsor and the Test Facility
netretiran ponovljen vzorec, ki vsebuje vse komponente preskusnega sistema.
Name and address of the sponsor, test facility and study director.
Ta vzorec se obdela z vzorci, tretiranimi s preskusno kemikalijo, ali drugimi kontrolnimi vzorci, da se ugotovi, ali topilo reagira s preskusnim sistemom.
Test Method Conditions
Brez razvrstitve
Opacitometer used (e.g. model and specifications) and instrument settings;
kemikalije, ki niso razvrščene glede na draženje oči (kategorija 2, 2A ali 2B po GHS ZN) ali hude poškodbe oči (kategorija 1 po GHS ZN).
Calibration information for devices used for measuring opacity and permeability (e.g. opacitometer and spectrophotometer) to ensure linearity of measurements;
Ta pojem je sopomenka za „brez kategorije po GHS ZN“.
Type of corneal holders used (e.g. model and specifications);
instrument za merjenje motnjave roženice, ki kvantitativno ocenjuje prenos svetlobe skozi roženico.
Description of other equipment used;
Običajno je sestavljen iz dveh delov, ki imata vsak svoj vir svetlobe in fotocelico.
The procedure used to ensure the integrity (i.e., accuracy and reliability) of the test method over time (e.g. periodic testing of proficiency chemicals).
En del se uporablja za tretirano roženico, drugi pa za umerjanje in nastavitev instrumenta na vrednost nič.
Criteria for an Acceptable Test
Svetloba halogene svetilke se skozi kontrolni del (prazna komora brez okenc ali tekočine) usmeri v fotocelico in primerja s svetlobo, usmerjeno v fotocelico skozi preskusni del, v katerem je komora z roženico.
Acceptable concurrent positive and negative control ranges based on historical data;
Nato se primerja razlika v svetlobi, prenesene iz fotocelic, in se na digitalnem zaslonu prikaže numerična vrednost motnjave.
If applicable, acceptable concurrent benchmark control ranges based on historical data.
Pozitivna kontrola
Identification of the source of the eyes (i.e., the facility from which they were collected);
Za zagotovitev, da se lahko variabilnost odziva pozitivne kontrole oceni v daljšem časovnem obdobju, pa stopnja pozitivnega odziva ne sme biti prevelika.
Corneal diameter as a measure of age of the source animal and suitability for the assay;
Popravljivi učinki na oči
Storage and transport conditions of eyes (e.g. date and time of eye collection, time interval prior to initiating testing, transport media and temperature conditions, any antibiotics used);
glej „Draženje oči“.
Preparation & mounting of the bovine corneas including statements regarding their quality, temperature of corneal holders, and criteria for selection of corneas used for testing.
Zanesljivost
Test Procedure
stopnja obnovljivosti preskusne metode v enem ali več laboratorijih v daljšem časovnem obdobju ob uporabi istega protokola.
Number of replicates used;
Oceni se z izračunom obnovljivosti v enem ali več laboratorijih in interne laboratorijske ponovljivosti.
Identity of the negative and positive controls used (if applicable, also the solvent and benchmark controls);
Huda poškodba oči
Description of evaluation and decision criteria used;
Ta pojem je sopomenka za „nepopravljive učinke na oči“ in „kategorijo 1 po GHS ZN“ (4).
Description of study acceptance criteria used;
Kontrola s topilom/vehiklom
Description of any modifications of the test procedure;
netretiran vzorec, ki vsebuje vse komponente preskusnega sistema, vključno s topilom ali vehiklom, ki se obdela s vzorci, tretiranimi s preskusno kemikalijo, in drugimi kontrolnimi vzorci, da se določi izhodiščni odziv za vzorce, tretirane s preskusno kemikalijo, raztopljeno v istem topilu ali vehiklu.
Description of decision criteria used.
Pri preskušanju s sočasno negativno kontrolo ta vzorec tudi pokaže, ali topilo ali vehikel reagira s preskusnim sistemom.
Results
Snov
Tabulation of data from individual test samples (e.g. opacity and OD490 values and calculated IVIS for the test chemical and the positive, negative, and benchmark controls [if included], reported in tabular form, including data from replicate repeat experiments as appropriate, and means ± the standard deviation for each experiment);
kemijski elementi in njihove spojine, ki so v naravnem stanju ali pridobljeni s katerim koli proizvodnim postopkom, vključno z vsemi dodatki, potrebnimi za ohranitev stabilnosti produkta, in kakršnimi koli nečistotami, ki so nastale v uporabljenem postopku, vendar brez kakršnega koli topila, ki ga je mogoče ločiti, ne da bi to vplivalo na stabilnost snovi ali spremenilo njeno sestavo (4).
Description of other effects observed;
Površinsko aktivna snov
The derived in vitro UN GHS classification, if applicable.
je snov, kot je detergent, ki lahko zmanjša površinsko napetost tekočine in tako omogoči, da se speni ali prodre v trdne snovi; znana je tudi kot omakalno sredstvo.
Discussion of the Results
Zmes, ki vsebuje površinsko aktivno snov
Available: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
v okviru te preskusne metode je to zmes, ki vsebuje eno ali več površinsko aktivnih snovi, pri čemer je njihova končna koncentracija > 5 %
Research Triangle Park, NC: National Institute of Environmental Health Sciences.
Pristop od zgoraj navzdol
Available: http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm.
stopenjski pristop, ki se uporablja za kemikalijo, za katero se domneva, da povzroča hude poškodbe oči, pri čemer se najprej določijo kemikalije, ki jih je treba razvrstiti (pozitivni rezultat), nato pa še druge kemikalije (negativni rezultat).
Available: http://www.unece.org/trans/danger/publi/ghs/ghs_rev04/04files_e.html.
Večstopenjska strategija preskušanja
Available: [http://www.cdc.gov/ncidod/dhqp/pdf].
stopenjsko preskušanje, pri katerem se v posebnem vrstnem redu pregledajo vsi obstoječi podatki o preskusni kemikaliji, pri čemer se na vsaki stopnji uporabi postopek, ki temelji na zanesljivosti dokazov, da se določi, ali je pred nadaljevanjem na naslednji stopnji na voljo dovolj podatkov za odločitev o razvrstitvi kemikalije glede na nevarnost, ki jo povzroča.
Series on Testing and Assessment, No. 160.
Globalno usklajeni sistem Združenih narodov za razvrščanje in označevanje kemikalij (GHS ZN)