natgillin/translations-raw huggingface dataset:
OECD (2000), “Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation”, OECD Environment, Health and Safety Publications (EHS), Series on Testing and Assessment, No. 19, OECD Publishing, Paris.
Kadar se uporablja za ta namen, je v primerjavi s podatki preskusa draženja oči in vivo na kuncih, razvrščenimi glede na sistem za razvrščanje GHS ZN, njena splošna točnost 69-odstotna (135/196), delež lažno pozitivnih rezultatov je 69-odstoten (61/89), delež lažno negativnih rezultatov pa 0-odstoten (0/107) (3) (glej preglednico 2 v Dodatku 2).
Higashikuni, N., S. Sutou (1995), An optimal, generalized sampling time of 30 +/– 6 h after double dosing in the mouse peripheral blood micronucleus test, Mutagenesis, Vol.
Delež dobljenih lažno negativnih rezultatov (kemikalije in vivo, razvrščene kot brez kategorije po GHS ZN, ki povzročajo stopnjo IVIS > 3, glej odstavek 47) je sorazmerno visok, vendar v tem okviru ni ključen, saj se vse preskusne kemikalije, pri katerih se stopnja IVIS giblje v razponu od 3 do 55, naknadno preskusijo z drugimi ustrezno potrjenimi preskusi in vitro ali – kot zadnja možnost – s preskusom na kuncih, in sicer glede na regulativne zahteve, pri čemer se uporabi strategija zaporednega preskušanja s pristopom, ki temelji na zanesljivosti dokazov.
10/4, pp. 313-319.
Pri preskusni metodi BCOP niso vidne nobene posebne pomanjkljivosti za preskušanje alkoholov, ketonov in trdnih snovi, kadar je namenjena opredelitvi kemikalij, ki jih ni treba razvrstiti glede na draženje oči ali hude poškodbe oči (brez kategorije po GHS ZN) (3).
OECD (2014), “Statistical analysis supporting the revision of the genotoxicity Test Guidelines”, OECD Environment, Health and Safety Publications (EHS), Series on Testing and Assessment, No. 198, OECD Publishing, Paris.
Raziskovalci lahko to preskusno metodo uporabijo za vse vrste kemikalij, pri čemer je treba negativni rezultat (stopnja IVIS ≤ 3) sprejeti kot kazalnik za to, da razvrstitev ni potrebna (brez kategorije po GHS ZN).
, “Statistical Analysis of in vivo Cytogenetic Assays”, in Statistical Evaluation of Mutagenicity Test Data.
Ker se lahko s preskusno metodo BCOP pravilno opredeli le 31 % kemikalij, ki jih ni treba razvrstiti glede na draženje oči ali hude poškodbe oči, ta preskusna metoda ne sme biti prva izbira za začetek pristopa od spodaj navzgor (5), če so na voljo druge potrjene in sprejete metode in vitro s podobno visoko občutljivostjo, a večjo specifičnostjo.
UKEMS SubCommittee on Guidelines for Mutagenicity Testing, Report, Part III, Kirkland, D.J.
Zato se lahko ta metoda uporabi za preskušanje snovi in zmesi.
Erythroblast
Preskusna metoda BCOP ni priporočljiva za opredelitev preskusnih kemikalij, ki jih je treba razvrstiti kot dražilne za oči (kategorija 2 ali kategorija 2A po GHS ZN), ali preskusnih kemikalij, ki jih je treba razvrstiti kot zmerno dražilne za oči (kategorija 2B po GHS ZN), saj je precejšnje število kemikalij kategorije 1 po GHS ZN razvrščenih prenizko, in sicer v kategorije 2, 2A ali 2B po GHS ZN, precejšnje število kemikalij brez kategorije po GHS ZN pa je razvrščenih previsoko, in sicer v kategorije 2, 2A ali 2B po GHS ZN (2) (3).
An early stage of erythrocyte development, immediately preceding the immature erythrocyte, where the cell still contains a nucleus.
Zato je morda potrebno nadaljnje preskušanje z drugo ustrezno metodo.
Kinetochore
Pri vseh postopkih na očeh in roženicah goveda je treba upoštevati veljavna pravila in postopke preskusnega laboratorija o ravnanju z živalskim materialom, kamor spadajo med drugim tudi tkiva in tkivne tekočine.
The protein structure that forms on the centromere of eukaryotic cells, which links the chromosome to microtubule polymers from the mitotic spindle during mitosis and meiosis and functions during cell division to pull sister chromatids apart.
Priporočajo se splošni previdnostni ukrepi za laboratorije (11).
Micronuclei
Čeprav se pri preskusni metodi BCOP ne proučujejo poškodbe veznice in šarenice, se obravnavajo učinki na roženico, ki so pomembno gonilo pri razvrščanju in vivo ob upoštevanju razvrščanja po GHS ZN.
Small nuclei, separate from and additional to the main nuclei of cells, produced during telophase of mitosis (meiosis) by lagging chromosome fragments or whole chromosomes.
Popravljivosti poškodb roženice kot take v preskusni metodi BCOP ni mogoče oceniti.
Normochromatic or mature erythrocyte
Na podlagi očesnih študij na kuncih je bilo predlagano, da se za opredelitev nekaterih vrst nepopravljivih učnikov lahko uporabi ocena prvotne globine poškodbe roženice (12).
A fully matured erythrocyte that has lost the residual RNA that remains after enucleation and/or has lost other short-lived cell markers that characteristically disappear after enucleation following the final erythroblast division.
Vendar je potrebno nadaljnje znanstveno znanje, da bi razumeli, kako nastanejo nepopravljivi učinki, ki niso povezani z začetno hudo poškodbo.
Polychromatic or immature erythrocyte
Treba je tudi opozoriti, da s preskusno metodo BCOP ni mogoče oceniti potencialne sistemske toksičnosti, povezane z izpostavljenostjo oči.
A newly formed erythrocyte in an intermediate stage of development, that stains with both the blue and red components of classical blood stains such as Wright's Giemsa because of the presence of residual RNA in the newly-formed cell.
Ta preskusna metoda se bo redno posodabljala ob upoštevanju novih informacij in podatkov.
Such newly formed cells are approximately the same as reticulocytes, which are visualised using a vital stain that causes the residual RNA to clump into a reticulum.
Kadar je potrebna popolnejša opredelitev poškodbe roženice, se je lahko uporabna na primer histopatologija.
Other methods, including monochromatic staining of RNA with fluorescent dyes or labeling of short-lived surface markers such as CD71 with fluorescent antibodies, are now often used to identify the newly formed red blood cell.
Kot je navedeno v Dokumentu s smernicami OECD št. 160 (13), se uporabnikom priporoča, naj roženice shranijo in pripravijo histopatološke vzorce, ki se lahko uporabijo pri ustvarjanju zbirke podatkov in oblikovanju meril za odločanje, s katerimi se lahko nadalje izboljša točnost te preskusne metode.
Polychromatic erythrocytes, reticulocytes, and CD71-positive erythrocytes are all immature erythrocytes, though each has a somewhat different age distribution.
Vsak laboratorij, ki to preskusno metodo izvaja prvič, mora uporabiti kemikalije za preverjanje usposobljenosti iz Dodatka 3.
Reticulocyte
Laboratorij lahko te kemikalije uporabi kot dokaz svoje tehnične usposobljenosti za izvajanje preskusne metode BCOP, preden pošlje podatke o tej metodi za regulativno razvrstitev glede na nevarnosti.
A newly formed erythrocyte stained with a vital stain that causes residual cellular RNA to clump into a characteristic reticulum.
Preskusna metoda BCOP je organotipski model, s katerim se običajna fiziološka in biokemijska funkcija roženice goveda za kratek čas ohrani in vitro.
Reticulocytes and polychromatic erythrocytes have a similar cellular age distribution.
Pri tej preskusni metodi se poškodba, ki jo povzroči preskusna kemikalija, oceni tako, da se spremembe motnjave in prepustnosti roženice merijo kvantitativno z opacitometrom oziroma spektrofotometrom vidne svetlobe.
THE FACTORIAL DESIGN FOR IDENTIFYING SEX DIFFERENCES IN THE IN VIVO MICRONUCLEUS ASSAY
Obe meritvi se uporabita za izračun stopnje IVIS, na podlagi katere je kemikalija razporejena v kategorijo razvrstitve glede na nevarnost draženja in vitro, da se predvidi zmožnost preskusne kemikalije za draženje oči in vivo (glej merila za odločanje, odstavek 48).
These comparisons could be made between the means for the two sexes and between the means for the different concentration levels such as for comparisons with the negative control levels.
Pri preskusni metodi BCOP se uporabljajo izolirane roženice oči sveže zaklanega goveda.
Statisticians who take a modelling approach such as using General Linear Models (GLMs) may approach the analysis in a different but comparable way but will not necessarily derive the traditional ANOVA table, which dates back to algorithmic approaches to calculating the statistics developed in a pre-computer age.
Motnjava roženice se meri kvantitativno in ustreza količini svetlobe, ki prodre skozi roženico.
In Part B, Chapter B.15. is deleted.
Prepustnost se meri kvantitativno in ustreza količini barvila natrijevega fluoresceina, ki prodre skozi celotno debelino roženice in se zazna v mediju v zadnjem delu držala.
In Part B, Chapter B.16. is deleted.
Preskusne kemikalije se dodajo v sprednji del držala za roženico in se tako nanesejo na epitelno površino roženice.
In Part B, Chapter B.18. is deleted.
Dodatek 4 vsebuje opis in sliko držala, ki se uporablja za preskusno metodo BCOP.
In Part B, Chapter B.19. is deleted.
Držala za roženico na trgu ponujajo različna podjetja, laboratoriji pa jih lahko izdelajo tudi sami.
In Part B, Chapter B.20. is deleted.
Izvor in starost oči goveda ter izbor živalskih vrst
In Part B, Chapter B.24. is deleted.
Govedo, ki se zakolje v klavnicah, je običajno namenjeno za človeško prehrano ali druge komercialne uporabe.
In Part B, Chapter B.47. is replaced by the following:
Pri preskusni metodi BCOP se kot vir roženic uporabljajo samo zdrave živali, primerne za vstop v prehransko verigo človeka.
Bovine Corneal Opacity and Permeability Test Method for Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
Ker so goveda glede na pasmo, starost in spol različno težka, ni priporočene teže v trenutku zakola.
This test method is equivalent to OECD test guideline (TG) 437 (2013).
Velikost roženice se lahko pri očeh različno starih živali razlikuje.
The Bovine Corneal Opacity and Permeability (BCOP) test method was evaluated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), in conjunction with the European Centre for the Validation of Alternative Methods (ECVAM) and the Japanese Center for the Validation of Alternative Methods (JaCVAM), in 2006 and 2010 (1)(2).
Roženice z vodoravnim premerom > 30,5 mm in centralno debelino roženice (CCT) ≥ 1100 μm ima običajno govedo, starejše od osem let, roženice z navpičnim premerom < 28,5 mm in CCT < 900 μm, pa govedo, mlajše od pet let (14).
In the first evaluation, the BCOP test method was evaluated for its usefulness to identify chemicals (substances and mixtures) inducing serious eye damage (1).
Zato se oči goveda, starejšega od 60 mesecev, običajno ne uporabljajo.
In the second evaluation, the BCOP test method was evaluated for its usefulness to identify chemicals (substances and mixtures) not classified for eye irritation or serious eye damage (2).
Oči goveda, mlajšega od 12 mesecev, se običajno prav tako ne uporabljajo, saj še niso popolnoma razvite, debelina in premer roženice pa sta bistveno manjša kot pri očeh starejšega goveda.
The BCOP validation database contained 113 substances and 100 mixtures in total (2)(3).
Kljub temu se lahko uporabljajo roženice mladih živali (tj. starih od 6 do 12 mesecev), saj ima njihova uporaba nekatere prednosti, kot so večja razpoložljivost, manjši starostni razpon in manjša nevarnost izpostavljenosti goveji spongiformni encefalopatiji za osebje klavnice (15).
Serious eye damage is the production of tissue damage in the eye, or serious physical decay of vision, following application of a test chemical to the anterior surface of the eye, which is not fully reversible within 21 days of application.
Odvzem in prevoz oči v laboratorij
Test chemicals inducing serious eye damage are classified as UN GHS Category 1.
Oči odvzame osebje klavnice.
Chemicals not classified for eye irritation or serious eye damage are defined as those that do not meet the requirements for classification as UN GHS Category 1 or 2 (2A or 2B), i.e. they are referred to as UN GHS No Category.
Da bi bilo čim manj mehanskih in drugih vrst poškodb oči, jih je treba odvzeti čim prej po zakolu ter jih takoj po odvzemu in med prevozom hraniti na hladnem.
This test method includes the recommended use and limitations of the BCOP test method based on its evaluations.
Da oči ne bi bile izpostavljene potencialno dražilnim kemikalijam, osebje klavnice pri spiranju glav živali ne sme uporabljati detergentov.
The main differences between the original 2009 version and the updated 2013 version of the OECD test guideline concern, but are not limited to: the use of the BCOP test method to identify chemicals not requiring classification according to UN GHS (paragraphs 2 and 7); clarifications on the applicability of the BCOP test method to the testing of alcohols, ketones and solids (paragraphs 6 and 7) and of substances and mixtures (paragraph 8); clarifications on how surfactant substances and surfactant-containing mixtures should be tested (paragraph 28); updates and clarifications regarding the positive controls (paragraphs 39 and 40); an update of the BCOP test method decision criteria (paragraph 47); an update of the study acceptance criteria (paragraph 48); an update to the test report elements (paragraph 49); an update of Appendix 1 on definitions; the addition of Appendix 2 for the predictive capacity of the BCOP test method under various classification systems; an update of Appendix 3 on the list of proficiency chemicals; and an update of Appendix 4 on the BCOP corneal holder (paragraph 1) and on the opacitometer (paragraphs 2 and 3).It is currently generally accepted that, in the foreseeable future, no single in vitro eye irritation test will be able to replace the in vivo Draize eye test to predict across the full range of irritation for different chemical classes.
Oči je treba v dovolj veliki posodi popolnoma potopiti v ohlajeno Hanksovo uravnoteženo raztopino soli (HBSS) in prepeljati v laboratorij tako, da se njihovo stanje čim manj poslabša in/ali da ne pride do bakterijske okužbe.
However, strategic combinations of several alternative test methods within a (tiered) testing strategy may be able to replace the Draize eye test (5).
Ker se oči odvzamejo med zakolom, lahko pridejo v stik s krvjo in drugimi biološkimi snovmi, vključno z bakterijami in drugimi mikroorganizmi.
The Top-Down approach (5) is designed to be used when, based on existing information, a chemical is expected to have high irritancy potential, while the Bottom-Up approach (5) is designed to be used when, based on existing information, a chemical is expected not to cause sufficient eye irritation to require a classification.
Zato je treba zagotoviti, da je tveganje kontaminacije čim manjše (npr. tako da je posoda, v kateri so oči, med odvzemom in prevozom na mokrem ledu ter da se v Hanksovo uravnoteženo raztopino soli, ki se uporablja za shranjevanje oči med prevozom, dodajo antibiotiki [npr. 100 IU/ml penicilina in 100 μg/ml streptomicina]).
The BCOP test method is an in vitro test method that can be used under certain circumstances and with specific limitations for eye hazard classification and labeling of chemicals.
Čas med odvzemom oči in uporabo roženic mora biti pri preskusni metodi BCOP čim krajši (običajno se odvzamejo in uporabijo isti dan) in ne sme vplivati na zanesljivost rezultatov preskusa.
While it is not considered valid as a stand-alone replacement for the in vivo rabbit eye test, the BCOP test method is recommended as an initial step within a testing strategy such as the Top-Down approach suggested by Scott et al.
Ti temeljijo na merilih za izbor oči ter odzivih pozitivnih in negativnih kontrol.
to identify chemicals inducing serious eye damage, i.e. chemicals to be classified as UN GHS Category 1, without further testing (4).
Vse oči, uporabljene v preskusu, morajo pripadati isti skupini oči, odvzeti na določeni dan.
The BCOP test method is also recommended to identify chemicals that do not require classification for eye irritation or serious eye damage, as defined by the UN GHS (UN GHS No Category) (4) within a testing strategy such as the Bottom-up approach (5).
Merila za izbor oči, uporabljenih v preskusni metodi BCOP
However, a chemical that is not predicted as causing serious eye damage or as not classified for eye irritation/serious eye damage with the BCOP test method would require additional testing (in vitro and/or in vivo) to establish a definitive classification.
Po prihodu v laboratorij se skrbno pregleda, ali so oči poškodovane, vključno s povečano motnjavo, praskami in neovaskularizacijo.
The purpose of this test method is to describe the procedures used to evaluate the eye hazard potential of a test chemical as measured by its ability to induce opacity and increased permeability in an isolated bovine cornea.
Uporabljajo se lahko samo roženice nepoškodovanih oči.
Toxic effects to the cornea are measured by: (i) decreased light transmission (opacity), and (ii) increased passage of sodium fluorescein dye (permeability).
Kakovost vsake roženice se oceni tudi v poznejši fazi preskusa.
The opacity and permeability assessments of the cornea following exposure to a test chemical are combined to derive an In Vitro Irritancy Score (IVIS), which is used to classify the irritancy level of the test chemical.
Roženice z motnjavo, večjo od sedmih enot ali enakovredne stopnje v primeru uporabe opacitometra in držala za roženice. se po začetnem enournem umerjanju zavržejo (OPOZORILO: opacitometer je treba umeriti v skladu s standardi za določevanje enot motnjave, glej Dodatek 4).
Definitions are provided in Appendix 1.
Vsaka tretirana skupina (preskusna kemikalija, sočasne negativne in pozitivne kontrole) je sestavljena iz najmanj treh oči.
This test method is based on the ICCVAM BCOP test method protocol (6)(7), which was originally developed from information obtained from the Institute for in vitro Sciences (IIVS) protocol and INVITTOX Protocol 124 (8).
Pri preskusni metodi BCOP je treba za negativno kontrolo uporabiti tri roženice.
The latter represents the protocol used for the European Community-sponsored prevalidation study conducted in 1997-1998.
Ker se roženice odstranijo s celotnega zrkla in pritrdijo v držala za roženice, se lahko zaradi artefaktov, ki nastanejo zaradi prijemanja, vrednosti motnjave in prepustnosti v posameznih primerih spremenijo (vključno z negativno kontrolo).
Both of these protocols were based on the BCOP test method first reported by Gautheron et al.
Poleg tega se vrednosti motnjave in prepustnosti roženic iz roženic za negativno kontrolo uporabljajo za popravljanje vrednosti motnjave in prepustnosti roženic, tretiranih s preskusno kemikalijo, in za pozitivno kontrolo pri izračunih stopenj IVIS.
The BCOP test method can be used to identify chemicals inducing serious eye damage as defined by UN GHS, i.e. chemicals to be classified as UN GHS Category 1 (4).
Priprava oči
When used for this purpose, the BCOP test method has an overall accuracy of 79 % (150/191), a false positive rate of 25 % (32/126), and a false negative rate of 14 % (9/65), when compared to in vivo rabbit eye test method data classified according to the UN GHS classification system (3) (see Appendix 2, Table 1).
Nepoškodovane roženice se secirajo tako, da se ohrani 2 do 3 mm širok rob beločnice, kar olajša nadaljnje ravnanje, pri čemer je treba paziti, da se epitelij in endotelij roženice ne poškodujeta.
When test chemicals within certain chemical (i.e., alcohols, ketones) or physical (i.e., solids) classes are excluded from the database, the BCOP test method has an overall accuracy of 85 % (111/131), a false positive rate of 20 % (16/81), and a false negative rate of 8 % (4/50) for the UN GHS classification system (3).
Izolirane roženice se pritrdijo v posebej za to izdelana držala, sestavljena iz sprednjega in zadnjega dela, na katera je roženica pripeta z epitelno oziroma endotelno stranjo.
The potential shortcomings of the BCOP test method when used to identify chemicals inducing serious eye damage (UN GHS Category 1) are based on the high false positive rates for alcohols and ketones and the high false negative rate for solids observed in the validation database (1)(2)(3).
Oba dela držala se do roba napolnita z ogretim Eaglovim minimalnim osnovnim medijem (EMEM) brez fenol rdečega (in sicer najprej zadnji del držala), pri čemer je treba paziti, da ne nastajajo mehurčki.
However, since not all alcohols and ketones are over-predicted by the BCOP test method and some are correctly predicted as UN GHS Category 1, these two organic functional groups are not considered to be out of the applicability domain of the test method.
Naprava se nato vsaj eno uro uravnotežuje pri 32 ± 1 °C, kar omogoči, da se roženice uravnotežijo z medijem in da se doseže čim bolj normalna metabolna dejavnost (približna temperatura na površini roženice in vivo je 32 °C).
It is up to the user of this test method to decide if a possible over-prediction of an alcohol or ketone can be accepted or if further testing should be performed in a weight-of-evidence approach.
Po uravnoteženju se v oba dela držala doda svež, ogret medij EMEM brez fenol rdečega, za vsako roženico pa se zabeležijo odčitki izhodiščne vrednosti motnjave.
Regarding the false negative rates for solids, it should be noted that solids may lead to variable and extreme exposure conditions in the in vivo Draize eye irritation test, which may result in irrelevant predictions of their true irritation potential (10).
Roženice z makroskopskimi poškodbami tkiva (npr. praskami, pigmentacijo, neovaskularizacijo) ali motnjavo, večjo od sedmih enot ali enakovredne stopnje v primeru uporabe opacitometra in držala za roženice, se zavržejo.
It should also be noted that none of the false negatives identified in the ICCVAM validation database (2)(3), in the context of identifying chemicals inducing serious eye damage (UN GHS Category 1), resulted in IVIS ≤ 3, which is the criterion used to identify a test chemical as a UN GHS No Category.
Vsaj tri roženice se izberejo kot roženice za negativno kontrolo (ali kontrolo s topilom).
Moreover, BCOP false negatives in this context are not critical since all test chemicals that produce an 3 < IVIS ≤ 55 would be subsequently tested with other adequately validated in vitro tests, or as a last option in rabbits, depending on regulatory requirements, using a sequential testing strategy in a weight-of-evidence approach.
Preostale roženice se nato razdelijo v tretirano skupino in skupine za pozitivno kontrolo.
Given the fact that some solid chemicals are correctly predicted by the BCOP test method as UN GHS Category 1, this physical state is also not considered to be out of the applicability domain of the test method.
Ker ima voda večjo toplotno kapaciteto kot zrak, zagotavlja stabilnejše temperaturne pogoje za inkubacijo.
Investigators could consider using this test method for all types of chemicals, whereby an IVIS > 55 should be accepted as indicative of a response inducing serious eye damage that should be classified as UN GHS Category 1 without further testing.
Zato je za ohranjanje držala za roženice in njegove vsebine pri temperaturi 32 ± 1 °C priporočljiva uporaba vodne kopeli.
However, as already mentioned, positive results obtained with alcohols or ketones should be interpreted cautiously due to potential over-prediction.
Lahko se uporabljajo tudi inkubatorji za vzdrževanje temperature zraka, če zagotavljajo stabilno temperaturo (tj. s predogrevanjem držal in medijev).
The BCOP test method can also be used to identify chemicals that do not require classification for eye irritation or serious eye damage under the UN GHS classification system (4).
Uporaba preskusne kemikalije
When used for this purpose, the BCOP test method has an overall accuracy of 69 % (135/196), a false positive rate of 69 % (61/89), and a false negative rate of 0 % (0/107), when compared to in vivo rabbit eye test method data classified according to the UN GHS classification system (3) (see Appendix 2, Table 2).
Uporabljata se dva različna protokola tretiranja, in sicer eden za tekočine in površinsko aktivne snovi (trdne snovi ali tekočine), drugi pa za površinsko neaktivne snovi (trdne snovi).