natgillin/translations-raw huggingface dataset:
An o-ring located on the posterior chamber is used to prevent leaks.
Tesnilni obroček na zadnjem delu držala preprečuje uhajanje.
The corneas are placed endothelial side down on the o-ring of the posterior chambers and the anterior chambers are placed on the epithelial side of the corneas.
Roženice se z endotelno stranjo navzdol položijo na tesnilni obroček zadnjega dela držala, sprednji del držala pa se položi na epitelno stran roženice.
The chambers are maintained in place by three stainless screws located on the outer edges of the chamber.
Oba dela držala sta pritrjena s tremi vijaki iz nerjavečega materiala na zunanjih robovih vsakega dela.
The end of each chamber houses a glass window which can be removed for easy access to the cornea.
Na koncu vsakega dela držala je stekleno okence, ki se lahko odstrani za lažji dostop do roženice.
An o-ring is also located between the glass window and the chamber to prevent leaks.
Med steklenim okencem in delom držala je tesnilni obroček, ki preprečuje uhajanje.
Two holes on the top of each chamber permit introduction and removal of medium and test compounds.
Skozi luknjici na vrhu vsakega dela držala se vnašajo in odstranjujejo medij in testne snovi.
They are closed with rubber caps during the treatment and incubation periods.
Med testiranjem in inkubacijo sta oba dela držala zaprta z gumijastimi čepki.
Refill:
Refill odprtina za polnjenje
Hanger:
Hanger povezovalni element
Cap:
Cap čepek
Nut:
Nut varovalni obroček
O-ring:
O-ring tesnilni obroček
Posterior compartment:
Posterior compartment zadnji del držala
Anterior compartment:
Anterior compartment sprednji del držala
Fixing screws:
Fixing screws pritrdilni vijaki
The opacitometer is a light transmission measuring device.
Opacitometer je naprava, ki meri prenos svetlobe.
The opacity units are established.
Enote motnjave so že določene.
The opacitometer should provide a linear response through a range of opacity readings covering the cut-offs used for the different classifications described by the Prediction Model (i.e., up to the cut-off determining corrosiveness/severe irritancy).
Opacitometer naj bi prek izmerjenih vrednosti motnjave zagotovil linearno reakcijo, ki ustreza mejnim vrednostim, ki se uporabljajo v različnih sistemih za razvrščanje, opisanih v modelu za prognosticiranje (tj. do mejne vrednosti, ki določa jedkost/močno dražilnost).
To ensure linear and accurate readings up to 75-80 opacity units, it is necessary to calibrate the opacitometer using a series of calibrators.
Da bodo izmerjene vrednosti do 75–80 enot motnjave linearne in natančne, je treba opacitometer kalibrirati s kalibratorji.
Calibrators (opaque sheets of polyester) are placed into the calibration chamber (a corneal chamber designed to hold the calibrators) and read on the opacitometer.
Kalibratorji (neprepustne poliesterske folije) se namestijo v kalibracijski del (del za roženico, zasnovan posebej za kalibratorje) in beležijo na opacitometru.
The calibration chamber is designed to hold the calibrators at approximately the same distance between the light and photocell that the corneas would be placed during the opacity measurements.
Kalibracijski del je zasnovan tako, da je oddaljenost kalibratorjev med svetlobo in fotocelico približno enaka kot oddaljenost roženic med merjenjem prepustnosti.
The opacitometer is first calibrated to 0 opacity units using the calibration chamber without a calibrator.
Opacitometer se najprej kalibrira na 0 enot motnjave, pri čemer se uporablja kalibracijski del brez kalibratorja.
Three different calibrators are then placed into the calibration chamber one by one and the opacities are measured.
Nato se tri različni kalibratorji en za drugim namestijo v kalibracijski del ter se meri prepustnost.
Calibrators 1, 2 and 3 should result in opacity readings equal to their set values of 75, 150, and 225 opacity units, respectively, ± 5 %.
Kalibratorji 1, 2 in 3 naj bi zagotovili vrednosti prepustnosti, ki ustrezajo vnaprej določenim vrednostim 75, 150 oziroma 225 enot motnjave ± 5 %.
The dimensions provided are based on a corneal holder that is used for cows ranging in age from 12 to 60 months old.
Navedene dimenzije se nanašajo na držala za roženico, ki se uporabljajo pri kravah, starih od 12 do 60 mesecev.
In the event that animals 6 to 12 months are being used, the holder would instead need to be designed such that each chamber holds a volume of 4 mL, and each of the inner chambers is 1,5 cm in diameter and 2,2 cm in depth.
Za uporabo pri živalih, starih od šest do 12 mesecev, bi moralo biti držalo zasnovano tako, da bi bila prostornina vsakega dela 4 mL, premer obeh notranjih delov 1,5 cm in njuna globina 2,2 cm.
With any newly designed corneal holder, it is very important that the ratio of exposed corneal surface area to posterior chamber volume should be the same as the ratio in the traditional corneal holder.
Pri vsakem novo zasnovanem držalu za roženico je pomembno, da je razmerje med izpostavljeno površino roženice in prostornino zadnjega dela enako razmerju pri običajnih držalih za roženico.
This is necessary to assure that permeability values are correctly determined for the calculation of the IVIS by the proposed formula.
Tako se zagotovi, da se pravilno določijo vrednosti prepustnosti za izračun IVIS s predlagano formulo.
ISOLATED CHICKEN EYE TEST METHOD FOR IDENTIFYING OCULAR CORROSIVES AND SEVERE IRRITANTS
48 TESTNA METODA NA IZOLIRANIH OČEH PIŠČANCEV ZA UGOTAVLJANJE JEDKIH IN ZELO DRAŽILNIH SNOVI ZA OČI (ICE)
The Isolated Chicken Eye (ICE) test method is an in vitro test method that can be used, under certain circumstances and with specific limitations, to classify substances and mixtures as ocular corrosives and severe irritants, (1) (2) (3).
Testna metoda na izoliranih očeh piščancev (ICE) je testna metoda in vitro, ki se pod določenimi pogoji in z določenimi omejitvami uporablja za razvrščanje snovi in zmesi med ‚jedke in zelo dražilne za oči‘ (1) (2) (3).
While it is not considered valid as a complete replacement for the in vivo rabbit eye test, the ICE is recommended for use as part of a tiered testing strategy for regulatory classification and labelling within a specific applicability domain (4) (5).
Čeprav testa in vivo na očeh zajcev ne more nadomestiti popolnoma, se test ICE priporoča kot del stopenjske testne strategije za regulativno razvrščanje in označevanje za posebna področja uporabe (4) (5).
Test substances and mixtures (6) that are positive in this assay can be classified as ocular corrosives or severe irritants without further testing in rabbits.
Testne snovi in zmesi (6), ki v tem preskusu dajo pozitiven rezultat, se lahko razvrstijo med jedke ali zelo dražilne snovi za oči, ne da bi bilo potrebno opraviti dodatno testiranje na zajcih.
The purpose of this test method is to describe the procedures used to evaluate the potential ocular corrosivity or severe irritancy of a test substance as measured by its ability to induce toxicity in an enucleated chicken eye.
V tej testni metodi so opisani postopki za oceno potencialne jedkosti in močne dražilnosti testne snovi za oči glede na njeno sposobnost, da v izoliranem očesu piščanca povzroča toksičnost.
Toxic effects to the cornea are measured by (i) a qualitative assessment of opacity, (ii) a qualitative assessment of damage to epithelium based on application of fluorescein to the eye (fluorescein retention), (iii) a quantitative measurement of increased thickness (swelling), and (iv) a qualitative evaluation of macroscopic morphological damage to the surface.
Toksični učinki na roženico se merijo z: (i) kvalitativnim ocenjevanjem motnjave, (ii) kvalitativnim ocenjevanjem poškodbe epitelija po aplikaciji fluoresceina (zadrževanje fluoresceina), (iii) kvantitativnim ocenjevanjem povečane debeline (nabreklosti) in (iv) kvantitativnim ocenjevanjem makroskopske morfološke poškodbe na površini.
The corneal opacity, swelling, and damage assessments following exposure to a test substance are assessed individually and then combined to derive an Eye Irritancy Classification.
Motnjava roženice, nabreklost in ocenjevanje poškodb po izpostavljenosti testni snovi se najprej ocenijo posamično in nato združijo, da se lahko določi stopnja dražilnosti očesa.
Ocular irritants that induce lesions that resolve in less than 21 days and non-irritants have also been tested using the ICE test method.
S testno metodo ICE so bile testirane tudi dražilne snovi, ki povzročajo poškodbe oči, ki izginejo v manj kot 21 dneh, in nedražilne snovi.
However, the accuracy and reliability of the ICE test method for substances in these categories have not been formally evaluated.
Vendar natančnost in zanesljivost testne metode ICE pri snoveh iz teh dveh kategorij nista bili ocenjeni formalno.
This test method is based on the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) ICE test method protocol (8), which was developed following an international validation study (4) (5) (9), with contributions from the European Centre for the Validation of Alternative Methods, the Japanese Center for the Validation of Alternative Methods, and TNO Quality of Life Department of Toxicology and Applied Pharmacology (Netherlands).
Ta testna metoda temelji na protokolu (8) testne metode ICE Medagencijskega usklajevalnega odbora za validacijo alternativnih metod (ICCVAM), ki je bil pripravljen po mednarodni študiji o validaciji (4)(5)(9), pri kateri so sodelovali Evropski center za validacijo alternativnih metod (ECVAM), Japonski center za validacijo alternativnih metod (JaCVAM) ter Oddelek za toksikologijo in uporabno farmakologijo nizozemskega Inštituta za raziskave TNO.
The protocol is based on information obtained from published protocols, as well as the current protocol used by TNO (10) (11) (12) (13) (14).
Protokol temelji na informacijah iz objavljenih protokolov ter protokolu, ki ga uporablja TNO (10) (11) (12) (13) (14).
The identified limitations for this method are based upon the false positive rate for alcohols and the false negative rates for solids and surfactants (see paragraph 47) (4).
Opredeljene omejitve za to testno metodo temeljijo na visokem številu lažno pozitivnih rezultatov za alkohole ter visokem številu lažno negativnih rezultatov za trdne in površinsko aktivne snovi (glej točko 47) (4).
When substances within these chemical and physical classes are excluded from the database, the accuracy of ICE across the EU, EPA, and GHS classification systems is substantially improved (4).
Če se snovi iz teh kemijskih in fizikalnih razredov izključijo iz podatkovne zbirke, se natančnost ICE v sistemih za razvrščanje EU, EPA in GHS bistveno izboljša (4).
However, investigators could consider using this test method for testing all types of material (including mixtures), whereby a positive result could be accepted as indicative of an ocular corrosive or severe irritant response.
Vendar pa bi lahko preskuševalci to testno metodo uporabili pri vseh vrstah testnega materiala (tudi pri zmeseh), pri čemer bi bil pozitiven rezultat sprejemljiv kot indikator za jedko ali zelo dražilno snov za oči.
However, positive results obtained with alcohols should be interpreted cautiously due to risk of over-prediction.
Pozitivne rezultate, pridobljene z uporabo alkoholov, je treba razlagati previdno, saj obstaja tveganje, da so vanje vključeni tudi lažno pozitivni rezultati
All procedures with chicken eyes should follow the test facility’s applicable regulations and procedures for handling of human or animal-derived materials, which include, but are not limited to, tissues and tissue fluids.
Pri vseh postopkih na očesih piščancev je treba upoštevati veljavna pravila in postopke testnega urada o ravnanju s človeškim ali živalskim materialom, kamor spadajo med drugim tudi tkiva in tkivne tekočine.
Universal laboratory precautions are recommended (15).
Priporočajo se splošni previdnostni ukrepi za laboratorije (15).
Also, although the reversibility of corneal lesions cannot be evaluated per se in the ICE test method, it has been proposed, based on rabbit eye studies, that an assessment of the initial depth of corneal injury can be used to distinguish between irreversible and reversible effects (16).
Čeprav tudi same reverzibilnosti poškodb roženice s testom ICE ni mogoče oceniti, je bilo na podlagi študij na očeh zajcev kljub temu predlagano, da se oceni prvotna globina poškodbe roženice ter tako razlikuje med ireverzibilnimi in reverzibilnimi učinki (16).
Finally, the ICE test method does not allow for an assessment of the potential for systemic toxicity associated with ocular exposure.
Treba je tudi opozoriti, da s testno metodo ICE ni mogoče oceniti potencialne sistemske toksičnosti, povezane z izpostavljenostjo oči.
Efforts are ongoing to further characterize the usefulness and limitations of the ICE test method for identifying non-severe irritants and non-irritants (see also paragraph 48).
Trenutno potekajo prizadevanja za nadaljnjo karakterizacijo uporabnosti in omejitev testne metode ICE za ugotavljanje lažje dražilnih in nedražilnih snovi (glej tudi točko 48).
Users are also encouraged to provide specimens and/or data to validation organizations for a formal evaluation of possible future uses of the ICE test method, including for the identification of non-severe ocular irritants and non-irritants.
Uporabnikom se priporoča, da organizacijam za validacijo zagotovijo vzorce in/ali podatke za uradno oceno morebitnih prihodnjih uporab testne metode ICE, vključno za ugotavljanje lažje dražilnih ali nedražilnih snovi za oči.
A laboratory can use these chemicals to demonstrate their technical competence in performing the ICE test method prior to submitting ICE data for regulatory hazard classification purposes.
Te kemikalije uporabijo, da dokažejo, da so tehnično sposobni izvajati testno metodo ICE, preden podatke o testu ICE predložijo za regulativno razvrstitev nevarnosti.
The ICE test method is an organotypic model that provides short-term maintenance of the chicken eye in vitro.
Testna metoda ICE je organotipski model, ki zagotavlja kratkoročno ohranjanje piščančjega očesa v in vitro.
In this test method, damage by the test substance is assessed by determination of corneal swelling, opacity, and fluorescein retention.
Pri tej testni metodi se poškodba, ki jo povzroči testna snov, oceni tako, da se določijo nabreklost roženice, njena prepustnost in zadrževanje fluorosceina.
While the latter two parameters involve a qualitative assessment, analysis of corneal swelling provides for a quantitative assessment.
Medtem ko se zadnja parametra ocenjujeta kvalitativno, je treba nabreklost roženice oceniti kvantitativno.
Each measurement is either converted into a quantitative score used to calculate an overall Irritation Index, or assigned a qualitative categorization that is used to assign an in vitro ocular corrosivity and severe irritancy classification.
Vsaka meritev se pretvori v kvantitativen rezultat, ki se uporabi za izračun splošnega indeksa dražilnosti, ali pa se ji dodeli kvalitativna kategorija, ki se uporablja za razred jedkosti in močne dražilnosti za oči in vitro.
Either of these outcomes can then be used to predict the in vivo ocular corrosivity and severe irritation potential of a test substance (see Decision Criteria).
Oba rezultata se lahko nato uporabita za predvidevanje jedkosti in močne dražilnosti testne snovi za oči in vivo (glej merila za odločanje).
Source and Age of Chicken Eyes
Izvor in starost oči piščancev
Historically, eyes collected from chickens obtained from a slaughterhouse where they are killed for human consumption have been used for this assay, eliminating the need for laboratory animals.
Za ta preskus se običajno uporabljajo oči piščancev, ki so bili zaklani v klavnicah in namenjeni za človeško prehrano, kar pomeni, da poskusne živali niso potrebne.
Only the eyes of healthy animals considered suitable for entry into the human food chain are used.
Uporabljajo se samo oči zdravih živali, primernih za vstop v prehransko verigo
Although a controlled study to evaluate the optimum chicken age has not been conducted, the age and weight of the chickens used historically in this test method are that of spring chickens traditionally processed by a poultry slaughterhouse (i.e., approximately 7 weeks old, 1,5-2,5 kg).
Čeprav kontrolirana študija za ocenjevanje najprimernejše starosti piščancev ni bila opravljena, se pri tej testni metodi uporabljajo mladi piščanci, ki so bili zaklani v klavnicah (tj. piščanci, stari približno sedem tednov in težki od 1,5–2,5 kg).
Heads should be removed immediately after sedation of the chickens, usually by electric shock, and incision of the neck for bleeding.
Glave se odstranijo neposredno po omamljanju piščancev, običajno z električnim šokom, in po izkrvavitvi zaradi prereza vratu.
A local source of chickens close to the laboratory should be located so that their heads can be transferred from the slaughterhouse to the laboratory quickly enough to minimize deterioration and/or bacterial contamination.
Piščanci se morajo nahajati v bližini laboratorija, tako da se njihove glave iz klavnice v laboratorij pripeljejo dovolj hitro, da se njihovo stanje čim manj poslabša in/ali da ne pride do bakterijske okužbe.
The time interval between collection of the chicken heads and use of eyes in the ICE test method should be minimized (typically within two hours) and should be demonstrated to not compromise the assay results.
Čas med odvzemom oči in uporabo glav piščancev mora biti pri testni metodi ICE čim krajši (navadno dve uri) in ne sme vplivati na zanesljivost rezultatov preskusa.
Because eyes are dissected in the laboratory, the intact heads are transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with isotonic saline.
Ker se očesa secirajo v laboratoriju, se intaktne glave iz klavnice v laboratorij prepeljejo na sobni temperaturi v plastičnih posodah in navlažene s krpami, napojenimi z izotonično fiziološko raztopino.
Selection Criteria for Eyes Used in the ICE
Merila za izbor oči za test ICE
Eyes that have high baseline fluorescein staining (i.e., > 0,5) or corneal opacity score (i.e., > 0,5) after they are enucleated are rejected.
Oči z močno izhodiščno obarvanostjo s fluoresceinom (tj. > 0,5) ali motno roženico (tj. > 0,5) po izolaciji se zavržejo.
Each treatment group and concurrent positive control consists of at least three eyes.
Vsaka testna skupina in primerjalna pozitivna kontrola sta sestavljeni iz najmanj treh oči.
The negative control group or the solvent control (if using a solvent other than saline) consists of at least one eye.
Za negativno kontrolo ali kontrolo s topilom (če se namesto fiziološke raztopine uporablja drugo topilo) se uporabi najmanj eno oko.
The eyelids are carefully excised, taking care not to damage the cornea.
Skrbno se odstranijo veke, pri čemer je treba paziti, da se roženica ne poškoduje.
Corneal integrity is quickly assessed with a drop of 2 % (w/v) sodium fluorescein applied to the corneal surface for a few seconds, and then rinsed with isotonic saline.
Celovitost roženice se hitro oceni tako, da se na njeno površino za nekaj sekund aplicira kapljica 2-odstotnega (w/v) natrijevega fluoresceina, površina pa se nato spere z izotonično fiziološko raztopino.
Fluorescein-treated eyes are then examined with a slit-lamp microscope to ensure that the cornea is undamaged (i.e., fluorescein retention and corneal opacity scores ≤ 0,5).
Oči, ki jim je bil dodan fluorescein, se nato osvetlijo s špranjsko svetilko, da se roženica ne bi poškodovala (tj. zadrževanje fluoresceina in motnjava roženice ≤ 0,5).
If undamaged, the eye is further dissected from the skull, taking care not to damage the cornea.
Če je oko nepoškodovano, se izreže iz lobanje, pri čemer je treba paziti, da se roženica ne poškoduje.
The eyeball is pulled from the orbit by holding the nictitating membrane firmly with surgical forceps, and the eye muscles are cut with a bent, blunt-tipped scissor.
Zrklo se potegne iz očesne votline potegne tako, da se žmurka zagrabi s kirurškimi prijemalkami, očesne mišice pa se prerežejo z ukrivljenimi škarjami s topo konico.
It is important to avoid causing corneal damage due to excessive pressure (i.e., compression artifacts).
Tako se prepreči, da bi se roženica zaradi prevelikega tlaka poškodovala (tj. artefakti zaradi stisnjenja).
When the eye is removed from the orbit, a visible portion of the optic nerve should be left attached.
Ko se oko odstrani iz očesne votline, se ga mora še vedno držati viden del vidnega živca.
Once removed from the orbit, the eye is placed on an absorbent pad and the nictitating membrane and other connective tissue are cut away.
Po odstranitvi iz očesne votline se oko položi na vpojno podlago, nato pa se odrežeta žmurka in preostalo vezno tkivo.
The enucleated eye is mounted in a stainless steel clamp with the cornea positioned vertically.
Izolirano oko se pritrdi v prijemalko iz nerjavečega materiala, pri čemer mora biti roženica v vodoravnem položaju.
The clamp is then transferred to a chamber of the superfusion apparatus (16).
Prijemalka se nato prenese v komoro naprave za superfuzijo (16).
The clamps should be positioned in the superfusion apparatus such that the entire cornea is supplied with the isotonic saline drip.
Prijemalke je treba v napravi za superfuzijo namestiti tako, da je celotna roženica pokrita z izotonično fiziološko raztopino.
The chambers of the superfusion apparatus should be temperature controlled at 32 ± 1,5 °C.
Temperatura v komorah naprave za superfuzijo mora znašati 32 ± 1,5 °C.
Appendix 3 provides a diagram of a typical superfusion apparatus and the eye clamps, which can be obtained commercially or constructed.
Dodatek 3 vsebuje diagram običajne naprave za superfuzijo z očesnimi prijemalkami, ki je na voljo na trgu, laboratoriji pa jo lahko izdelajo tudi sami.
The apparatus can be modified to meet the needs of an individual laboratory (e.g., to accommodate a different number of eyes).
Naprava se lahko prilagodi potrebam posameznega laboratorija (tj. za sprejem različnega števila oči).
After being placed in the superfusion apparatus, the eyes are again examined with a slit-lamp microscope to ensure that they have not been damaged during the dissection procedure.
V napravi za superfuzijo se oči še enkrat pregledajo s špranjsko svetilko, da se zagotovi, da se med seciranjem niso poškodovale.
Corneal thickness should also be measured at this time at the corneal apex using the depth measuring device on the slit-lamp microscope.
Pri tem se z nastavkom za merjenje globine na špranjski svetilki na apeksu roženice izmeri tudi debelina roženice.
Eyes with; (i), a fluorescein retention score of > 0,5; (ii) corneal opacity > 0,5; or, (iii), any additional signs of damage should be replaced.
Oči z (i) vrednostjo zadržanega fluoresceina > 0,5; (ii) motnjavo roženice > 0,5; ali (iii) dodatnimi znaki poškodb je treba zamenjati.
For eyes that are not rejected based on any of these criteria, individual eyes with a corneal thickness deviating more than 10 % from the mean value for all eyes are to be rejected.
Za oči, ki se na podlagi teh meril ne zavržejo, velja, da se kljub temu zavržejo, če debelina roženice za več kot 10 % odstopa od povprečne vrednosti vseh oči.
Users should be aware that slit-lamp microscopes could yield different corneal thickness measurements if the slit-width setting is different.
Uporabniki morajo upoštevati, da lahko špranjske svetilke pri različnih širinah špranje za debelino roženice dajo različne merilne vrednosti.
The slit-width should be set at 0,095 mm.
Širino špranje je treba nastaviti na 0,095 mm.
Once all eyes have been examined and approved, the eyes are incubated for approximately 45 to 60 minutes to equilibrate them to the test system prior to dosing.
Po pregledu in izločitvi se oči dajo v inkubator za približno 45 do 60 minut, da se pred doziranjem ekvilibrirajo s testnim sistemom.
Following the equilibration period, a zero reference measurement is recorded for corneal thickness and opacity to serve as a baseline (i.e., time = 0).
Po ekvilibriranju se kot izhodiščna vrednost za debelino in motnjavo roženice zabeleži nična vrednost (tj. čas = 0).