natgillin/translations-raw huggingface dataset:
The protocol is based on information obtained from published protocols, as well as the current protocol used by TNO (10) (11) (12) (13) (14).
Po potrebi se lahko dodatno spere po 10-sekundnem učinkovanju in v poznejših časovnih točkah (npr. v primeru odkritja ostankov preskusne kemikalije na roženici).
A wide range of chemicals has been tested in the validation underlying this test method and the empirical database of the validation study amounted to 152 chemicals including 72 substances and 80 mixtures (5).
V splošnem dodatno uporabljena količina fiziološke raztopine ni ključnega pomena, pač pa je pomembno to, ali se opazi oprijemanje kemikalije na roženico.
The test method is applicable to solids, liquids, emulsions and gels.
V vsak poskus je treba vključiti sočasno negativno kontrolo ali kontrolo s topilom/vehiklom ter pozitivne kontrole.
The liquids may be aqueous or non-aqueous; solids may be soluble or insoluble in water.
Pri preskušanju 100-odstotnih tekočin ali trdnih snovi se kot primerjalna negativna kontrola pri preskusni metodi ICE uporablja fiziološka raztopina, da se odkrijejo nespecifične spremembe preskusnega sistema in da preskusni pogoji ne povzročajo neustreznih dražilnih reakcij.
Gases and aerosols have not been assessed yet in a validation study.
Pri preskušanju razredčenih tekočin se v preskusno metodo vključi sočasna kontrolna skupina s topilom/vehiklom, da se odkrijejo nespecifične spremembe preskusnega sistema in da preskusni pogoji ne povzročajo neustreznih dražilnih reakcij.
The ICE test method can be used to identify chemicals inducing serious eye damage, i.e., chemicals to be classified as UN GHS Category 1 (4).
Kot je navedeno v odstavku 31, se lahko uporablja samo topilo/vehikel, za katerega je dokazano, da na preskusni sistem nima škodljivih učinkov.
When used for this purpose, the identified limitations for the ICE test method are based on the high false positive rates for alcohols and the high false negative rates for solids and surfactants (1) (3) (9).
V vsak poskus se kot sočasna pozitivna kontrola vključi znana dražilna snov za oči, da se preveri, ali se sproži želena reakcija.
However, false negative rates in this context (UN GHS Category 1 identified as not being UN GHS Category 1) are not critical since all test chemicals that come out negative would be subsequently tested with other adequately validated in vitro test(s), or as a last option in rabbits, depending on regulatory requirements, using a sequential testing strategy in a weight-of-evidence approach.
Ker se preskus ICE pri tej preskusni metodi uporablja za opredelitev jedkih ali zelo dražilnih snovi, je treba za pozitivno kontrolo uporabiti tako referenčno kemikalijo, ki pri tej preskusni metodi povzroči močno reakcijo.
Investigators could consider using this test method for all types of chemicals, whereby a positive result should be accepted as indicative of serious eye damage, i.e., UN GHS Category 1 classification without further testing.
Za pozitivno kontrolo je treba pridobiti dovolj podatkov in vitro, da se lahko izračuna statistično opredeljeno sprejemljivo območje pozitivne kontrole.
However, positive results obtained with alcohols should be interpreted cautiously due to risk of over-prediction.
Če za določeno pozitivno kontrolo ni na voljo ustreznih podatkov o preskusni metodi ICE iz preteklih preskusov, je treba opraviti študije, v katerih se bodo ti podatki zbrali.
When used to identify chemicals inducing serious eye damage (UN GHS Category 1), the ICE test method has an overall accuracy of 86 % (120/140), a false positive rate of 6 % (7/113) and a false negative rate of 48 % (13/27) when compared to in vivo rabbit eye test method data classified according to the UN GHS classification system (4) (5).
Primera pozitivnih kontrol za tekoče preskusne kemikalije sta 10-odstotna ocetna kislina ali 5-odstoten benzalkonijev klorid, primera pozitivnih kontrol za trdne preskusne kemikalije pa natrijev hidroksid in imidazol.
The ICE 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).
Tretirane roženice se ocenijo pred tretiranjem in nato 30, 75, 120, 180 in 240 minut (± 5 minut) po spiranju, opravljenem po tretiranju.
The appropriate regulatory authorities should be consulted before using the ICE in a bottom up approach under other classification schemes.
S temi časovnimi točkami se omogoči ustrezno število meritev med štiriurnim tretiranjem in hkrati zagotovi dovolj časa, da se oči med posameznimi meritvami ustrezno pregledajo.
This test method can be used for all types of chemicals, whereby a negative result could be accepted for not classifying a chemical for eye irritation and serious eye damage.
Končne točke, ki se ocenijo, so motnjava in nabreklost roženice, zadrževanje fluoresceina in morfološki učinki (tj. luknjičavost ali odstopanje epitelija).
However, on the basis of one result from the validation database, anti-fouling organic solvent-containing paints may be under-predicted (5).
Vse končne točke razen zadrževanja fluoresceina (ki se oceni samo pred tretiranjem in 30 minut po izpostavljenosti preskusni kemikaliji) se ocenijo pri vsaki od navedenih časovnih točk.
When used to identify chemicals that do not require classification for eye irritation and serious eye damage, the ICE test method has an overall accuracy of 82 % (125/152), a false positive rate of 33 % (26/79), and a false negative rate of 1 % (1/73), when compared to in vivo rabbit eye test method data classified according to the UN GHS (4) (5).
Priporoča se, da se motnjava roženice, zadrževanje fluoresceina, morfološki učinki in morebitni histopatološki izvidi dokumentirajo.
When test chemicals within certain classes (i.e., anti-fouling organic solvent containing paints) are excluded from the database, the accuracy of the ICE test method is 83 % (123/149), the false positive rate 33 % (26/78), and the false negative rate of 0 % (0/71) for the UN GHS classification system (4) (5).
Po tem ko se po štirih urah opravi končni pregled, se uporabnikom priporoča, naj oči shranijo v ustrezni fiksirni raztopini (tj. v nevtralnem formalinskem pufru), da se lahko po potrebi opravi histopatološki pregled (za podrobnosti glej odstavek 14 in vir (8)).
The ICE test method is not recommended for the identification of test chemicals that should be classified as irritating to eyes (i.e., UN GHS Category 2 or Category 2A) or test chemicals that should be classified as mildly irritating to eyes (UN GHS Category 2B) due to the considerable number of UN GHS Category 1 chemicals underclassified as UN GHS Category 2, 2A or 2B and UN GHS No Category chemicals overclassifed as UN GHS Category 2, 2A or 2B.
Nabreklost roženice se določi na podlagi meritev debeline roženice, opravljenih z optičnim pahimetrom na biomikroskopu s špranjsko svetilko.
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.
Izrazi se v odstotkih in izračuna iz meritev debeline roženice z naslednjo formulo:
Universal laboratory precautions are recommended (16).
debelina roženice v času t
Whilst the ICE test method does not consider conjunctival and iridal injuries as evaluated in the rabbit ocular irritancy test method, it addresses corneal effects which are the major driver of classification in vivo when considering the UN GHS Classification.
debelina roženice v času
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 may be used to identify some types of irreversible effects (17).
roženice v času
In particular, further scientific knowledge is required to understand how irreversible effects not linked with initial high level injury occur.
Srednja odstotna vrednost nabreklosti roženice vseh preskusnih oči se izračuna za vse časovne točke opazovanja.
Finally, the ICE test method does not allow for an assessment of the potential for systemic toxicity associated with ocular exposure.
Na podlagi najvišje srednje vrednosti nabreklosti roženice, kot je bila opažena v kateri koli časovni točki, se za vsako preskusno kemikalijo določi skupna vrednost za posamezno kategorijo (glej odstavek 51).
To evaluate this possibility, users are encouraged to preserve eyes and prepare histopathology specimens that can be used to develop a database and decision criteria that may further improve the accuracy of this test method.
Pri oceni motnjave roženice se upošteva predel roženice, ki je pri beleženju rezultatov najbolj moten (glej preglednico 1).
The OECD has developed a Guidance Document on the use of in vitro ocular toxicity test methods, which includes detailed procedures on the collection of histopathology specimens and information on where to submit specimens and/or histopathology data (8).
Za vse časovne točke opazovanja se izračuna srednja vrednost motnjave roženice vseh preskusnih oči.
For any laboratory initially establishing this assay, the proficiency chemicals provided in Appendix 2 should be used.
Na podlagi najvišje srednje vrednosti motnjave roženice, kot je bila opažena v kateri koli časovni točki, se za vsako preskusno kemikalijo določi skupna vrednost za posamezno kategorijo (glej odstavek 51).
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.
Vrednosti motnjave roženice
The ICE test method is an organotypic model that provides short-term maintenance of the chicken eye in vitro.
Vrednost
In this test method, damage by the test chemical is assessed by determination of corneal swelling, opacity, and fluorescein retention.
Opažanje
While the latter two parameters involve a qualitative assessment, analysis of corneal swelling provides for a quantitative assessment.
0roženica ni motna
Each measurement is either converted into a quantitative score used to calculate an overall Irritation Index, or assigned a qualitative categorisation that is used to assign an in vitro ocular hazard classification, either as UN GHS Category 1 or as UN GHS non-classified.
roženica zelo malo motna
Either of these outcomes can then be used to predict the potential in vivo serious eye damage or no requirement for eye hazard classification of a test chemical (see Decision Criteria).
posamična ali razpršena območja motnjave; podrobnosti šarenice jasno vidne
However, no classification can be given for chemicals not predicted as causing serious eye damage or as not classified with the ICE test method (see paragraph 11).
lahko razločljivo prosojno območje; podrobnosti šarenice rahlo zabrisane
Source and Age of Chicken Eyes
zelo motna roženica; podrobnosti šarenice niso vidne; velikost zenice komaj razpoznavna
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.
popolnoma motna roženica; šarenica ni vidna
Only the eyes of healthy animals considered suitable for entry into the human food chain are used.
Zadrževanje fluoresceina se oceni samo v časovni točki opazovanja po 30 minutah, kot je prikazano v preglednici 2.
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).
Nato se izračuna srednja vrednost zadržanega fluoresceina vseh preskusnih oči za časovno točko opazovanja po 30 minutah, ki se pri vsaki preskusni kemikaliji uporabi kot skupna vrednost za posamezno kategorijo (glej odstavek 51).
Heads should be removed immediately after sedation of the chickens, usually by electric shock, and incision of the neck for bleeding.
Vrednost zadržanega fluoresceina
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 minimise deterioration and/or bacterial contamination.
zadržanega fluoresceina
The time interval between collection of the chicken heads and placing the eyes in the superfusion chamber following enucleation should be minimised (typically within two hours) to assure meeting assay acceptance criteria.
zelo malo zadržanega fluoresceina v posameznih celicah
Because eyes are dissected in the laboratory, the intact heads are transported from the slaughterhouse at ambient temperature (typically between 18 °C and 25 °C) in plastic boxes humidified with tissues moistened with isotonic saline.
posamezne celice z nekaj fluoresceina, razpršene po tretiranem predelu roženice
Selection Criteria and Number of Eyes Used in the ICE
točkaste ali zlite celice z veliko fluoresceina
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.
velika zlita področja roženice, v katerih se zadržuje fluorescein
Each treatment group and concurrent positive control consists of at least three eyes.
Morfološki učinki vključujejo „luknjičaste“ epitelne celice roženice, epitelij, ki odstopa, „grobo“ roženično površino in „prilepljenost“ preskusne kemikalije na roženico.
The negative control group or the solvent control (if using a solvent other than saline) consists of at least one eye.
Te ugotovitve so lahko različno resne in se lahko pojavijo istočasno.
In the case of solid materials leading to a GHS NC outcome, a second run of three eyes is recommended to confirm or discard the negative outcome.
Razvrščanje teh ugotovitev poteka subjektivno v skladu z razlago raziskovalca.
The eyelids are carefully excised, taking care not to damage the cornea.
Rezultate za motnjavo in nabreklost roženice ter zadrževanje fluoresceina je treba oceniti ločeno, da se ustvari razred ICE za vsako končno točko.
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.
Razredi ICE za vsako končno točko se nato združijo, da se vsaka preskusna kemikalija lahko razvrsti v razred dražilnosti.
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).
Po oceni vsake končne točke se na podlagi vnaprej določenega območja določijo razredi ICE.
If undamaged, the eye is further dissected from the skull, taking care not to damage the cornea.
, kar ustreza 0,095 mm.
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.
Uporabniki se morajo zavedati, da se lahko z biomikroskopi pri različnih širinah špranje pridobijo različne vrednosti meritev debeline roženice.
It is important to avoid causing corneal damage due to excessive pressure (i.e., compression artifacts).
Preglednica 3
When the eye is removed from the orbit, a visible portion of the optic nerve should be left attached.
Merila ICE za razvrstitev glede na nabreklost roženice
Once removed from the orbit, the eye is placed on an absorbent pad and the nictitating membrane and other connective tissue are cut away.
Srednja nabreklost roženice (v %) [8]
The enucleated eye is mounted in a stainless steel clamp with the cornea positioned vertically.
Razred ICE
The clamp is then transferred to a chamber of the superfusion apparatus (18).
0 do 5
The clamps should be positioned in the superfusion apparatus such that the entire cornea is supplied with the isotonic saline drip (3-4 drops per minute or 0,1 to 0,15 ml/min).
> 5 do 12
The chambers of the superfusion apparatus should be temperature controlled at 32 ± 1,5 °C.
> 12 do 18 (> 75 min po tretiranju)
Appendix 3 provides a diagram of a typical superfusion apparatus and the eye clamps, which can be obtained commercially or constructed.
> 12 to 18 (≤ 75 min po tretiranju)
The apparatus can be modified to meet the needs of an individual laboratory (e.g. to accommodate a different number of eyes).
> 18 do 26
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.
> 26 do 32 (> 75 min po tretiranju)
Corneal thickness should also be measured at this time at the corneal apex using the depth measuring device on the slit-lamp microscope.
> 26 to 32 (≤ 75 min po tretiranju)
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.
Preglednica 4
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.
Merila ICE za razvrstitev motnjave roženice
Users should be aware that slit-lamp microscopes could yield different corneal thickness measurements if the slit-width setting is different.
Najvišja srednja vrednost motnjave [9]
The slit-width should be set at 0,095 mm.
Preglednica 5
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.
Merila ICE za razvrstitev glede na srednjo vrednost zadržanega fluoresceina
Following the equilibration period, a zero reference measurement is recorded for corneal thickness and opacity to serve as a baseline (i.e., time = 0).
Srednja vrednost zadržanega fluoresceina 30 minut po tretiranju [10]
The fluorescein score determined at dissection is used as the baseline measurement for that endpoint.
Razvrstitev preskusne kemikalije in vitro se oceni na podlagi razvrstitve po GHS ZN, ki ustreza kombinaciji kategorij, pridobljenih za nabreklost in motnjavo roženice ter zadrževanje fluoresceina, kot je navedeno v preglednici 6.
Immediately following the zero reference measurements, the eye (in its holder) is removed from the superfusion apparatus, placed in a horizontal position, and the test chemical is applied to the cornea.
Preglednica 6
Liquid test chemicals are typically tested undiluted, but may be diluted if deemed necessary (e.g. as part of the study design).
Splošne razvrstitve in vitro
The preferred solvent for diluted test chemicals is physiological saline.
Razvrstitev po GHS ZN
However, alternative solvents may also be used under controlled conditions, but the appropriateness of solvents other than physiological saline should be demonstrated.
Kombinacije treh končnih točk
Liquid test chemicals are applied to the cornea such that the entire surface of the cornea is evenly covered with the test chemical; the standard volume is 0,03 ml.
druge kombinacije
If possible, solid test chemicals should be ground as finely as possible in a mortar and pestle, or comparable grinding tool.
2 × IV, 1 × II [11]2 × IV, 1 × I [11]motnjava roženice ≥ 3 po 30 min (pri vsaj dveh očeh)
The powder is applied to the cornea such that the surface is uniformly covered with the test chemical; the standard amount is 0,03 g.
motnjava roženice = 4 pri kateri koli časovni točki (pri vsaj dveh očeh)
The test chemical (liquid or solid) is applied for 10 seconds and then rinsed from the eye with isotonic saline (approximately 20 ml) at ambient temperature.
epitelij močno odstopa (pri vsaj enem očesu)
The eye (in its holder) is subsequently returned to the superfusion apparatus in the original upright position.
Preskus se šteje za sprejemljivega, če so sočasne negativne kontrole ali kontrole z vehiklom/topilom opredeljene kot brez kategorije po GHS ZN, sočasne pozitivne kontrole pa kot kategorija 1 po GHS ZN.
In case of need, additional rinsing may be used after the 10-sec application and at subsequent time points (e.g. upon discovery of residues of test chemical on the cornea).
Preskusna kemikalija in kontrolne kemikalije:
In general the amount of saline additionally used for rinsing is not critical, but the observation of adherence of chemical to the cornea is important.
kemijska imena, na primer strukturno ime, ki ga uporablja Služba za izmenjavo kemijskih izvlečkov (CAS), ki jim sledijo druga imena, če so znana;
Concurrent negative or solvent/vehicle controls and positive controls should be included in each experiment.
registrska številka CAS (RN), če je znana;
When testing liquids at 100 % or solids, physiological saline is used as the concurrent negative control in the ICE test method to detect non-specific changes in the test system, and to ensure that the assay conditions do not inappropriately result in an irritant response.
čistost in sestava preskusne/kontrolne kemikalije (v masnih odstotkih), če so ti podatki na voljo;
When testing diluted liquids, a concurrent solvent/vehicle control group is included in the test method to detect non-specific changes in the test system, and to ensure that the assay conditions do not inappropriately result in an irritant response.
fizikalno-kemijske lastnosti, pomembne za izvedbo študije, npr. agregatno stanje, vrednost pH, stabilnost, kemijski razred, topnost v vodi;
As stated in paragraph 31, only a solvent/vehicle that has been demonstrated to have no adverse effects on the test system can be used.
obdelava preskusnih/kontrolnih kemikalij pred preskušanjem, če je ustrezno (npr. segrevanje, drobljenje);
A known ocular irritant is included as a concurrent positive control in each experiment to verify that an appropriate response is induced.
stabilnost, če je znana.
As the ICE assay is being used in this test method to identify corrosive or severe irritants, the positive control should be a reference chemical that induces a severe response in this test method.
ime in naslov naročnika, preskuševalnega laboratorija in vodje študije;
However, to ensure that variability in the positive control response across time can be assessed, the magnitude of the severe response should not be excessive.
podatki o viru oči (npr. obrat, v katerem so bile odvzete).
Sufficient in vitro data for the positive control should be generated such that a statistically defined acceptable range for the positive control can be calculated.
opis uporabljenega preskusnega sistema;
If adequate historical ICE test method data are not available for a particular positive control, studies may need to be conducted to provide this information.
uporabljeni biomikroskop s špranjsko svetilko (npr. model) in nastavitve tega uporabljenega instrumenta;
Examples of positive controls for liquid test chemicals are 10 % acetic acid or 5 % benzalkonium chloride, while examples of positive controls for solid test chemicals are sodium hydroxide or imidazole.
sklic na rezultate negativnih in pozitivnih kontrol iz preteklih preskusov in, če je ustrezno, podatki iz preteklih preskusov, ki dokazujejo sprejemljiva območja sočasne primerjalne kontrole;
Treated corneas are evaluated prior to treatment and at 30, 75, 120, 180, and 240 minutes (± 5 minutes) after the post-treatment rinse.
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).
These time points provide an adequate number of measurements over the four-hour treatment period, while leaving sufficient time between measurements for the requisite observations to be made for all eyes.
teža in starost živali darovalke in druge posebne značilnosti živali, od katerih so bile pridobljene oči (npr. spol, sev), če so na voljo;
The endpoints evaluated are corneal opacity, swelling, fluorescein retention, and morphological effects (e.g. pitting or loosening of the epithelium).
pogoji hranjenja in prevoza oči (npr. datum in čas odvzema oči, čas od odvzema glav piščancev do vstavitve odvzetih oči v komoro naprave za superfuzijo);