natgillin/translations-raw huggingface dataset:
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);
pogoji za hrambo in prevoz oči (tj. dan in čas odvzema oči, čas pred prvim testiranjem, prevozna sredstva in temperaturni pogoji, morebitno uporabljeni antibiotiki);
If available, specific characteristics of the animals from which the eyes were collected (e.g., age, sex, weight of the donor animal).
posebne lastnosti živali, katerim so bili odvzete oči, če so znane (tj. starost, spol, teža živali donatorke).
Justification of the Test Method and Protocol Used
utemeljitev testne metode in uporabljenega protokola
Test Method Integrity
celovitost testne metode
The procedure used to ensure the integrity (i.e., accuracy and reliability) of the test method over time (e.g., periodic testing of proficiency substances, use of historical negative and positive control data).
postopek za zagotavljanje celovitosti (tj. natančnosti in zanesljivosti) testne metode v daljšem časovnem obdobju (npr. redno testiranje snovi za ugotavljanje sposobnosti, uporaba podatkov o negativni in pozitivni kontroli iz preteklih testov).
Criteria for an Acceptable Test
merila za sprejemljivost testa
Acceptable concurrent positive and negative control ranges based on historical data;
sprejemljiva primerjalna pozitivna in negativna kontrola na podlagi podatkov iz preteklih testov;
If applicable, acceptable concurrent benchmark control ranges based on historical data.
sprejemljiva primerjalna pozitivna in negativna kontrola na podlagi podatkov iz preteklih testov.
Test Conditions
testni pogoji
Description of test system used;
opis uporabljenega testnega sistema;
Type of corneal holder used;
vrsta uporabljenega držala za roženico;
Calibration information for devices used for measuring opacity and permeability (e.g., opacitometer and spectrophotometer);
podatki o kalibriranju naprav za merjenje motnjave in prepustnosti (npr. opacitometer in spektrofotometer);
Information on the bovine corneas used, including statements regarding their quality;
podatki o uporabljenih roženicah goveda, vključno z izjavami o njihovi kakovosti;
Details of test procedure used;
podrobnosti o uporabljenem testnem postopku;
Test substance concentration(s) used;
uporabljene koncentracije testne snovi;
Description of any modifications of the test procedure;
opis vseh sprememb testnega postopka;
Reference to historical data of the model (e.g., negative and positive controls, proficiency substances, benchmark substances);
sklic na podatke o modelu iz preteklih testov (tj. negativna in pozitivna kontrola, snovi za preverjanje sposobnosti; ugotavljanje sposobnosti, primerjalne snovi);
Description of evaluation criteria used.
opis uporabljenih meril za ocenjevanje.
Results
rezultati
Tabulation of data from individual test samples (e.g., opacity and OD490 values and calculated IVIS for the test substance 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);
tabele s podatki iz posameznih testnih vzorcev (npr. vrednosti motnjave in OD490 ter izračunane vrednosti IVIS za testno snov ter pozitivne, negativne in primerjalne kontrole [če so bile upoštevane], vključno s podatki iz ponovitev poskusa v dvojniku, če so bile opravljene, ter povprečne vrednosti ± standardni odklon pri vsakem poskusu);
Description of other effects observed.
opis drugih opaženih učinkov;
Discussion of the Results
razprava o rezultatih
Conclusion
sklepne ugotovitve
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006.
OJ L 353, 31.12.2008, p. 1.
OJ L 353, 31.12.2008, 1.
Second revised edition, New York & Geneva: United Nations Publications, 2007. Available:
Second revised edition, New York & Geneva: United Nations Publications, 2007.Available:
Available:
Na voljo:
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’.
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 in pomenita delež ustreznih rezultatov testne metode.
Benchmark substance A substance used as a standard for comparison to a test substance.
Primerjalna snov snov, ki se uporablja kot standard za primerjavo s testno snovjo.
A benchmark substance should have the following properties; (i) a consistent and reliable source(s); (ii) structural and functional similarity to the class of substances being tested; (iii) known physical/chemical characteristics; (iv) supporting data on known effects, and (v) known potency in the range of the desired response.
Primerjalna snov mora imeti naslednje lastnosti: (i) trajen in zanesljiv vir; (ii) strukturno in funkcijsko podobnost z razredom testiranih snovi; (ii) znane fizikalne/kemijske lastnosti; (iv) spremni podatki o znanih učinkih in (v) znana potenca v razponu želene reakcije.
Cornea The transparent part of the front of the eyeball that covers the iris and pupil and admits light to the interior.
Roženica prozoren sprednji del zrkla, ki pokriva šarenico in zenico ter skozi katerega vstopa svetloba.
Corneal opacity Measurement of the extent of opaqueness of the cornea following exposure to a test substance.
Motnjava roženice merjenje stopnje motnjave roženice po izpostavljenosti testni snovi.
Increased corneal opacity is indicative of damage to the cornea.
Povečana motnjava roženice pomeni, da je roženica poškodovana.
Opacity can be evaluated subjectively as done in the Draize rabbit eye test, or objectively with an instrument such as an ‘opacitometer’.
Motnjava se lahko ocenjuje subjektivno kot pri Dreizovem testu na očeh zajcev ali objektivno z inštrumentom, kot je „opacitometer“.
Corneal permeability Quantitative measurement of damage to the corneal epithelium by a determination of the amount of sodium fluorescein dye that passes through all corneal cell layers.
Prepustnost roženice kvantitativna vrednost poškodovanega epitelija roženice, izmerjena z določanjem količine barvila natrijevega fluoresceina, ki prodre skozi vse celične plasti roženice.
EPA Category 1 Corrosive (irreversible destruction of ocular tissue) or corneal involvement or irritation persisting for more than 21 days (1).
EPA kategorija 1 jedka snov (ireverzibilno uničenje očesnega tkiva), ki prizadene ali draži roženico več kot 21 dni (1).
EU Category R41 Production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application (2).
EU kategorija R41 poškodba očesnega tkiva ali resno fizično poslabšanje vida po aplikaciji testne snovi na sprednjo površino očesa, ki po 21 dneh aplikacije ni popolnoma reverzibilna (2).
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 prikaže kot lažno negativne.
False positive rate The proportion of all negative substances that are falsely identified by a test method as positive.
Delež lažno pozitivnih rezultatov delež vseh negativnih snovi, ki jih testna metoda prikaže kot lažno pozitivne.
GHS (Globally Harmonized System of Classification and Labelling of Chemicals) A system proposing the classification of chemicals (substances and mixtures) according to standardized 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 (3).
GHS (Globalno usklajeni sistem za razvrščanje in označevanje kemikalij) sistem za razvrščanje kemikalij (snovi in zmesi) s pomočjo standardiziranih vrst in stopenj fizikalnih, zdravstvenih in okoljskih nevarnosti ter za označevanje z npr. piktogrami, opozorilnimi besedami, izjavami o nevarnosti, varnostnimi izjavami in varnostnimi listi z namenom razširjanja informacij o škodljivih učinkih kemikalij ter s tem zaščite ljudi (vključno z delodajalci, delavci, prevozniki, potrošniki in reševalci) in okolja (3).
GHS Category 1 Production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application (3).
GHS kategorija 1 poškodba očesnega tkiva ali resno fizično poslabšanje vida po aplikaciji testne snovi na sprednjo površino očesa, ki po 21 dneh aplikacije ni popolnoma reverzibilna (3).
Hazard Inherent property of an agent or situation having the potential to cause adverse effects when an organism, system or (sub) population is exposed to that agent.
Nevarnost neločljiva lastnost snovi ali stanja, ki lahko ob izpostavljenosti tej snovi škodljivo učinkuje na organizem, sistem ali (pod)populacijo.
In Vitro Irritancy Score (IVIS)
Vrednost draženja in vitro (IVIS)
An empirically-derived formula used in the BCOP assay whereby the mean opacity and mean permeability values for each treatment group are combined into a single in vitro score for each treatment group.
empirično izpeljana formula, ki se uporablja pri testu BCOP, pri kateri se povprečne vrednosti motnjave in prepustnosti za vsako testno skupino združijo v eno samo vrednost in vitro za vsako testno skupino.
The IVIS = mean opacity value + (15 × mean permeability value).
IVIS = povprečna vrednost motnjave + (15 x povprečna vrednost prepustnosti).
Negative control An untreated replicate containing all components of a test system.
Negativna kontrola netestirani dvojnik, ki vsebuje vse komponente testnega sistema.
This sample is processed with test substance-treated samples and other control samples to determine whether the solvent interacts with the test system.
Ta vzorec se obdela z vzorci, testiranimi s testno snovjo, ali drugimi kontrolnimi vzorci, da se ugotovi, ali topilo reagira s testnim sistemom.
Non-irritant Substances that are not classified as EPA Category I, II, or III; EU Category R41 or R36; or GHS Category 1, 2A, or 2B ocular irritants.
Nedražilna snov snovi, ki niso razvrščene v EPA kategorije I, II ali III; EU kategoriji R41 ali R36 ali GHS kategorije 1, 2A ali 2B dražilnih snovi za oči.
Ocular corrosive (a) A substance that causes irreversible tissue damage to the eye; (b) Substances that are classified as GHS Category 1, EPA Category I, or EU Category R41 ocular irritants (1) (2) (3).
Jedka snovi za oči (a) snov, ki povzroča ireverzibilno poškodbo očesnega tkiva; (b) snovi, ki so razvrščene v GHS kategorijo 1, EPA kategorijo I ali EU kategorijo R41 dražilnih snovi za oči (1) (2) (3).
Ocular irritant (a) A substance that produces a reversible change in the eye following application to the anterior surface of the eye; (b) Substances that are classified as EPA Category II or III, EU Category R36, or GHS Category 2A or 2B ocular irritants (1) (2) (3).
Dražilna snov za oči (a) snov, ki po aplikaciji na sprednjo površino očesa povzroči reverzibilno poškodbo očesa; (b) snovi, ki so razvrščene v EPA kategoriji II ali III, EU kategorijo R36 ali GHS kategoriji 2A ali 2B dražilnih snovi za oči (1) (2) (3).
Ocular severe irritant (a) A substance that causes tissue damage in the eye following application to the anterior surface of the eye that does not resolve within 21 days of application or causes serious physical decay of vision; (b) Substances that are classified as GHS Category 1, EPA Category I, or EU Category R41 ocular irritants (1) (2) (3).
Zelo dražilna snov za oči (a) snov, ki po aplikaciji na sprednjo površino očesa povzroči poškodbo tkiva, ki po 21 dneh po aplikaciji ne izgine oziroma resno fizično poslabša vid; (b) snovi, ki so razvrščene v GHS kategorijo 1, EPA kategorijo I ali EU kategorijo R41 dražilnih snovi za oči (1) (2) (3).
Opacitometer An instrument used to measure ‘corneal opacity’ by quantitatively evaluating light transmission through the cornea.
Opacitometer inštrument za merjenje motnjave roženice, ki kvantitativno ocenjuje prenos svetlobe skozi roženico.
The typical instrument has two compartments, each with its own light source and photocell.
Navadno ima dva dela, ki imata vsak svoj vir svetlobe in fotocelico.
One compartment is used for the treated cornea, while the other is used to calibrate and zero the instrument.
En del se uporablja za testirano roženico, drugi za kalibriranje in nastavitev inštrumenta na vrednost nič.
Light from a halogen lamp is sent through a control compartment (empty chamber without windows or liquid) to a photocell and compared to the light sent through the experimental compartment, which houses the chamber containing the cornea, to a photocell.
Svetloba halogene svetilke se skozi kontrolni del (prazen del brez okenc ali tekočine) usmeri v fotocelico in primerja s svetlobo, usmerjeno v fotocelico skozi testni del, v katerem je del z roženico.
The difference in light transmission from the photocells is compared and a numeric opacity value is presented on a digital display.
Nato se primerja razlika v svetlobi, ki se prenese iz fotocelic, na digitalnem ekranu pa se prikaže numerična vrednost motnjave.
Positive control A replicate containing all components of a test system and treated with a substance known to induce a positive response.
Pozitivna kontrola dvojnik, ki vsebuje vse komponente testnega sistema in se testira s snovjo, za katero je znano, da reagira pozitivno.
To ensure that variability in the positive control response across time can be assessed, the magnitude of the severe response should not be excessive.
Da se zagotovi, da se odkloni pri reakciji pozitivne kontrole ocenjujejo v daljšem časovnem obdobju, stopnja močne reakcije ne sme biti prevelika.
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 stopnja reproduktivnosti testne metode v laboratorijih in med njimi v določenem časovnem obdobju pri uporabi istega protokola.
It is assessed by calculating intra- and inter-laboratory reproducibility and intra-laboratory repeatability.
Oceni se z izračunom laboratorijske in medlaboratorijske reproduktivnosti in ponovljivosti.
Solvent/vehicle control An untreated sample containing all components of a test system, including the solvent or vehicle that is processed with the test substance-treated and other control samples to establish the baseline response for the samples treated with the test substance dissolved in the same solvent or vehicle.
Kontrola s topilom/vehiklom netestirani vzorec, ki vsebuje vse komponente testnega sistema, vključno s topilom ali vehiklom, ki se obdela s kontrolnimi vzorci, testiranimi s testno snovjo, in drugimi kontrolnimi vzorci, da se določi izhodiščna reakcija za vzorce, testirane s testno snovjo in raztopljene v istem topilu ali vehiklu.
When tested with a concurrent negative control, this sample also demonstrates whether the solvent or vehicle interacts with the test system.
Pri testiranju s primerjalno negativno kontrolo ta vzorec tudi pokaže, ali topilo oziroma vehikel reagira s testnim sistemom.
Tiered testing A stepwise testing strategy where all existing information on a test substance is reviewed, in a specified order, using a weight of evidence process at each tier to determine if sufficient information is available for a hazard classification decision, prior to progression to the next tier.
Stopenjsko testiranje stopenjska testna strategija, pri kateri se v posebnem vrstnem redu pregledajo vse informacije o testni snovi, pri čemer se na vsaki stopnji uporabi teža dokazov, da se določi, ali je na voljo dovolj informacij za razvrstitev snovi med nevarne snovi, preden se preide na naslednjo stopnjo.
If the irritancy potential of a test substance can be assigned based on the existing information, no additional testing is required.
Če se lahko na podlagi razpoložljivih informacij določi potencialno draženje snovi, dodatno testiranje ni potrebno.
If the irritancy potential of a test substance cannot be assigned based on the existing information, a step-wise sequential animal testing procedure is performed until an unequivocal classification can be made.
Če na podlagi razpoložljivih informacij potencialnega draženja testne snovi ni mogoče določiti, se opravi postopno sekvenčno testiranje na živalih, dokler ni mogoča jasna razvrstitev.
Validated test method A test method for which validation studies have been completed to determine the relevance (including accuracy) and reliability for a specific purpose.
Validirana testna metoda testna metoda, za katero sta bili na podlagi validacijskih študij določeni primernost (vključno z natančnostjo) in zanesljivost za določen namen.
It is important to note that a validated test method may not have sufficient performance in terms of accuracy and reliability to be found acceptable for the proposed purpose.
Treba je opozoriti, da natančnost in zanesljivost validirane testne metode nista nujno zadostni, da bi bili sprejemljivi za predlagani namen.
Weight-of-evidence The process of considering the strengths and weaknesses of various pieces of information in reaching and supporting a conclusion concerning the hazard potential of a substance.
Teža dokazov proces preučevanja prednosti in slabosti različnih informacij z namenom sprejetja zaključka o potencialni nevarnosti snovi in njegovi utemeljitvi.
Proficiency substances for the BCOP test method
Snovi za preverjanje usposobljenosti za testno metodo BCOP
Prior to routine use of a test method that adheres to this test method, laboratories may wish to demonstrate technical proficiency by correctly identifying the ocular corrosivity classification of the 10 substances recommended in Table 1.
Preden lahko začnejo laboratoriji redno uporabljati testno metodo, ki izpolnjuje zahteve te testne metode, morajo dokazati tehnično usposobljenost tako, da deset priporočenih snovi iz tabele 1 pravilno razvrstijo glede na njihov dražilni učinek na oči.
These substances were selected to represent the range of responses for local eye irritation/corrosion, which is based on results in the in vivo rabbit eye test (TG 405) (i.e., Categories 1, 2A, 2B, or Not Classified and Labelled according to the UN GHS (3) (7).
Te snovi so bile izbrane, ker predstavljajo razpon reakcij lokalnega draženja/razjedanja očesa, ki temelji na rezultatih testa in vivo na očeh zajcev (TG 405) (tj. kategorije 1, 2A, 2B ali snovi, ki niso razvrščene in označene v skladu z UN GHS (3) (7)).
However, considering the validated usefulness of these assays (i.e., to identify ocular corrosives/severe irritants only), there are only two test outcomes for classification purposes (corrosive/severe irritant or non-corrosive/non-severe irritant) to demonstrate proficiency.
Vendar se lahko zaradi validirane primernosti teh poskusov (tj. izključno za določevanje jedkih in zelo dražilnih snovi za oči) usposobljenost dokaže samo z dvema testnima rezultatoma, na podlagi katerih je mogoča razvrstitev (jedka/zelo dražilna snov ali nejedka/nedražilna snov).
Other selection criteria were that substances are commercially available, there are high quality in vivo reference data available, and there are high quality data from the two in vitro methods for which Test Guidelines are being developed.
Druga merila za izbor snovi so bila, da so te dostopne na trgu, da so na voljo visokokakovostni referenčni podatki in vivo in visokokakovostni podatki, pridobljeni z dvema metodama in vitro, za kateri se pripravljajo smernice.
For this reason, irritant substances were selected from the ICCVAM recommended list of 122 reference substances for the validation of in vitro ocular toxicity test methods (see Appendix H: ICCVAM Recommended Reference Substances) (5).
Zaradi tega so bile dražilne snovi izbrane iz priporočenega seznama ICCVAM, ki vsebuje 122 referenčnih snovi za validacijo testnih metod in vitro za ugotavljanje toksičnosti za oči (glej dodatek H: ICCVAM - Priporočene referenčne snovi) (5).
Reference data are available in the ICCVAM Background Review Documents for BCOP and Isolated Chicken Eye (ICE) test method (17) (18).
Referenčni podatki so zbrani v dokumentih ICCVAM o pregledu ozadja testne metode BCOP in testne metode ICE na izoliranih očeh piščancev (17) (18).
Recommended substances for demonstrating technical proficiency with BCOP
Priporočene snovi za ugotavljanje tehnične usposobljenosti za BCOP
Abbreviations: CASRN = Chemical Abstracts Service Registry Number
Kratice: št. CAS = registrska številka Službe za izmenjavo kemijskih izvlečkov (CAS).
Physical Form
Fizikalna oblika
In Vivo Classification [2]
Razvrstitev in vivo [2]
In Vitro Classification [3]
Razvrstitev in vitro [3]
Benzalkonium chloride (5 %)
benzalkonijev klorid (5 %)
Onium compound
onijska spojina
Liquid
tekoča
Corrosive/Severe Irritant
jedka/zelo dražilna snov
Chlorhexidine
klorheksidin
Amine, Amidine
amin, amidin
Solid
trdna
Dibenzoyl-L-tartaric acid
dibenzoil-L-vinska kislina
Carboxylic acid, Ester
karboksilna kislina, ester
Imidazole
imidazol
Heterocyclic
heterociklična spojina
Trichloroacetic acid (30 %)
trikloroocetna kislina (30 %)
Carboxylic Acid
karboksilna kislina
2,6-Dichlorobenz-oyl chloride
2,6-diklorobenzoil klorid
Acyl halide
kislinski halid
Category 2A
kategorija 2A
Non corrosive/Non severe irritant
nejedka/lažje dražilna snov
Ethyl-2-methylaceto-acetate
etil-2-metil acetoacetat
Ketone, Ester
keton, ester
Category 2B
kategorija 2B
Ammonium nitrate
amonijev nitrat
Inorganic salt
anorganska sol
Not Labelled
ni oznake
Hydrocarbon
ogljikovodik
(acyclic)
(acikličen)
Not Labeled
ni oznake
Noncorrosive/Non severe irritant
nejedka/lažje dražilna snov
Chemical classes were assigned to each test substance using a standard classification scheme, based on the National Library of Medicine Medical Subject Headings (MeSH) classification system (available at http://www.nlm.nih.gov/mesh).
Kemijski razredi so bili dodeljeni za vsako testno snov s standardnim sistemom za razvrščanje, ki temelji na sistemu MeSH (na voljo na http//www.nlm.nih.gov/mesh).
Based on results from the in vivo rabbit eye test (OECD TG 405) and using the UN GHS (3)(7).
Na podlagi rezultatov, pridobljenih s testom in vivo na očeh zajcev (OECD TG 405), in ob upoštevanju UN GHS (3)(7).
Based on results in BCOP and ICE.
Na podlagi rezultatov BCOP in ICE.
THE BCOP CORNEAL HOLDER
DRŽALO ZA ROŽENICO ZA DOLOČANJE BCOP
The BCOP corneal holders are made of an inert material (e.g., polypropylene).
Držala za roženico za BCOP so narejena iz intertnega materiala (npr. polipropilena).
The holders are comprised of two halves (an anterior and posterior chamber), and have two similar cylindrical internal chambers.
Sestavljena so iz dveh polovic (sprednjega in zadnjega dela) in dveh podobnih cilindričnih notranjih posodic.
Each chamber holds a volume of 5 mL and terminates in a glass window, through which opacity measurements are recorded.
Prostornina vsake posodice je 5 mL in se konča s steklenim okencem, skozi katerega se beležijo vrednosti motnjave.
Each of the inner chambers is 1,7 cm in diameter and 2,2 cm in depth [1].
Premer notranjih posodic je 1,7 cm, globina pa 2,2 cm [1].