natgillin/translations-raw huggingface dataset:
ICE-forsøgsmetoden er en organotypisk model, som kortvarigt opretholder kyllingeøjets funktion in vitro.
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 mLl, and each of the inner chambers is 1,5 cm in diameter and 2,2 cm in depth.
Ved denne forsøgsmetode vurderes testkemikaliets beskadigende virkning ved bestemmelse af corneaopsvulmning, -uklarhed og -fluoresceinretention.
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.
Mens de to sidstnævnte parametre indebærer en kvalitativ vurdering, medfører analyse af corneaopsvulmning, at der skal foretages en kvantitativ vurdering.
This is necessary to assure that permeability values are correctly determined for the calculation of the IVIS by the proposed formula
Hver måling konverteres enten til en kvantitativ score, som anvendes til beregning af et samlet irritationsindeks (Irritation Index), eller tildeles en kvalitativ kategorisering, som anvendes til at tildele en in vitro-fareklassificering enten som UN GHS-kategori 1 eller som UN GHS uden for kategori.
Appendix 5
Disse resultater kan derefter anvendes til at forudsige potentiel alvorlig øjenskade in vivo eller fraværet af kravet om klassificering af risikoen for øjenskade for et testkemikalie (jf. Beslutningskriterier).
THE OPACITOMETER
Der kan imidlertid ikke gives nogen klassificering for kemikalier, som ikke forudsiges at medføre alvorlig øjenskade, eller som ikke er klassificeret med ICE-forsøgsmetoden (jf. punkt 11).
The opacitometer is a light transmission measuring device.
Kilde til kyllingeøjne og deres alder
For example, for the OP-KIT equipment from Electro Design (Riom, France) used in the validation of the BCOP test method, 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.
Historisk set er der til dette assay anvendt øjne indsamlet fra kyllinger på et slagteri, hvor de aflives med henblik på anvendelse til konsum, hvilket eliminerer behovet for forsøgsdyr.
The opacity units are established.
Kun øjnene fra raske dyr, som anses for egnede til at indgå i menneskets fødekæde, anvendes.
Other types of opacitometers with a different setup (e.g., not requiring the parallel measurements of the control and experimental compartments) may be used if proven to give similar results to the validated equipment.
Selv om der ikke er gennemført en kontrolleret undersøgelse til vurdering af den optimale kyllingealder, har de ved denne forsøgsmetode anvendte kyllinger historisk set haft samme alder og vægt som de på et fjerkræslagteri traditionelt behandlede vårkyllinger (dvs. ca. syv uger gamle kyllinger med en vægt på 1,5-2 kg).
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).
Tidsintervallet mellem indsamling af kyllingehovederne og placering af øjnene i superfusionsapparatets kammer efter enukleering bør minimeres (typisk inden for to timer) for at sikre, at assayets acceptkriterier overholdes.
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.
Eftersom øjnene fridissekeres i laboratoriet, transporteres de intakte hoveder fra slagteriet ved omgivende temperatur (typisk mellem 18 °C og 25 °C) i plastkasser befugtet med klude, som er vædet med isotonisk saltvand.
Reference values and initial set point depend on the type of equipment used.
Udvælgelseskriterier for og antal øjne, der anvendes i ICE-testen
Linearity of opacity measurements should be ensured by appropriate (instrument specific) procedures.
Øjne med et højt niveau af basislinjefluoresceinfarvning (dvs. > 0,5) eller en høj cornea-uklarhedsscore (dvs. > 0,5) efter enukleering kasseres.
For example, for the OP-KIT equipment from Electro Design (Riom, France), the opacitometer is first calibrated to 0 opacity units using the calibration chamber without a calibrator.
Hver behandlingsgruppe og en samtidig positiv kontrol består af mindst tre øjne.
Three different calibrators are then placed into the calibration chamber one by one and the opacities are measured.
Den negative kontrolgruppe eller opløsningsmiddelkontrollen (hvis der anvendes et andet opløsningsmiddel end saltvand) består af mindst et øje.
Calibrators 1, 2 and 3 should result in opacity readings equal to their set values of 75, 150, and 225 opacity units, respectively, ± 5 %.
I tilfælde af faste materialer, der resulterer i UN GHS uden for kategori, anbefales det at foretage endnu en test af tre øjne for at be- eller afkræfte det negative resultat.
In Part B, Chapter B.48 is replaced by the following:
Øjenlågene bortskæres forsigtigt og uden at beskadige cornea.
Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
Der foretages en hurtig vurdering af cornea-integriteten ved at påføre en dråbe 2 % (vægt/volumen) natriumfluorescein på cornea-overfladen i nogle få sekunder, hvorefter der skylles med isotonisk saltvand.
This test method is equivalent to OECD test guideline (TG) 438 (2013).
De fluoresceinbehandlede øjne undersøges derefter med et spaltelampemikroskop for at sikre, at cornea er ubeskadiget (dvs. har scorer for fluoresceinretention og cornea-uklarhed ≤ 0,5).
The Isolated Chicken Eye (ICE) 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 Centre for the Validation of Alternative Methods (JaCVAM), in 2006 and 2010 (1) (2) (3).
Er cornea ubeskadiget, fridissekeres øjet helt fra kraniet uden at beskadige cornea.
In the first evaluation, the ICE was endorsed as a scientifically valid test method for use as a screening test to identify chemicals (substances and mixtures) inducing serious eye damage (Category 1) as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (1) (2) (4) and Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP) [7].
Øjeæblet trækkes ud af øjenhulen ved et fast tag i blinkhinden med en kirurgisk tang, og øjenmusklerne skæres over med en bøjet, stumpendet saks.
In the second evaluation, the ICE test method was evaluated for use as a screening test to identify chemicals not classified for eye irritation or serious eye damage as defined by UN GHS (3) (4).
Det er vigtigt at undgå skader på cornea som følge af overdrevent tryk (dvs. komprimeringsartefakter).
The results from the validation study and the peer review panel recommendations maintained the original recommendation for using the ICE for classification of chemicals inducing serious eye damage (UN GHS Category 1), as the available database remained unchanged since the original ICCVAM validation.
Når øjet fjernes fra øjenhulen, skal der medfølge en synlig vedhængende del af synsnerven.
At that stage, no further recommendations for an expansion of the ICE applicability domain to also include other categories were suggested.
Efter fjernelsen fra øjenhulen anbringes øjet på et absorberende underlag, hvorefter blinkhinden og andet bindevæv skæres væk.
A re-evaluation of the in vitro and in vivo dataset used in the validation study was made with the focus of evaluating the usefulness of the ICE to identify chemicals not requiring classification for eye irritation or serious eye damage (5).
Det enukleerede øje anbringes i en rustfri stålholder med cornea i lodret position.
This re-evaluation concluded that the ICE test method can also be used to identify chemicals not requiring classification for eye irritation and serious eye damage as defined by the UN GHS (4) (5).
Derefter indsættes holderen i et kammer i superfusionsapparatet (18).
This test method includes the recommended uses and limitations of the ICE test method based on these evaluations.
Holderne bør anbringes sådan i superfusionsapparatet, at det isotoniske saltvand drypper ned over hele cornea (3-4 dråber pr. minut eller 0,1 til 0,15 ml/min).
The main differences between the original 2009 version and the updated 2013 version of the OECD test guideline include, but are not limited to, the use of the ICE test method to identify chemicals not requiring classification according to the UN GHS Classification System, an update to the test report elements, an update of Appendix 1 on definitions, and an update to Appendix 2 on the proficiency chemicals.
Temperaturen i superfusionsapparatets kamre bør være reguleret til 32 ± 1,5 °C.
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.
Tillæg 3 indeholder et diagram over et typisk superfusionsapparat og øjenholderne, som kan købes i handelen eller konstrueres.
However, strategic combinations of several alternative test methods within a (tiered) testing strategy may be able to replace the Draize eye test (6).
Apparatet kan modificeres, så det opfylder det enkelte laboratoriums behov (f.eks. så det kan rumme et andet antal øjne).
The Top-Down approach (7) is designed to be used when, based on existing information, a chemical is expected to have high irritancy potential, while the Bottom-Up approach (7) is designed to be used when, based on existing information, a chemical is expected not to cause sufficient eye irritation to require a classification.
Efter anbringelsen i superfusionsapparatet undersøges øjnene igen med et spaltelampemikroskop for at sikre, at de ikke er blevet beskadiget under dissektionsproceduren.
The ICE test method is an in vitro test method that can be used, under certain circumstances and with specific limitations as described in paragraphs 8 to 10 for eye hazard classification and labelling of chemicals.
På dette tidspunkt måles også corneatykkelsen.
While it is not considered valid as a stand-alone replacement for the in vivo rabbit eye test, the ICE test method is recommended as an initial step within a testing strategy such as the Top-Down approach suggested by Scott et al.
Den måles ved corneas toppunkt ved anvendelse af dybdemålingsanordningen på spaltelampemikroskopet.
to identify chemicals inducing serious eye damage, i.e., chemicals to be classified as UN GHS Category 1 without further testing (4).
Øjne med i) en fluoresceinretentionsscore på > 0,5, ii) en cornea-uklarhed på > 0,5 eller iii) eventuelle andre tegn på beskadigelse bør udskiftes.
The ICE 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 (No Category, NC) (4), and may therefore be used as an initial step within a Bottom-Up testing strategy approach (7).
Af de øjne, der ikke kasseres ud fra nogen af ovennævnte kriterier, kasseres øjne med en corneatykkelse, som afviger mere end 10 % fra gennemsnitsværdien for alle øjne.
However, a chemical that is not predicted as causing serious eye damage or as not classified for eye irritation/serious eye damage with the ICE test method would require additional testing (in vitro and/or in vivo) to establish a definitive classification.
Brugerne skal være opmærksomme på, at spaltelampemikroskoper kan give forskellige corneatykkelsesmålinger alt efter indstillingen af spaltebredden.
Furthermore, the appropriate regulatory authorities should be consulted before using the ICE in a bottom up approach under other classification schemes than the UN GHS.
Spaltebredden bør indstilles til 0,095 mm.
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 or not toxicity in an enucleated chicken eye.
Når alle øjnene er undersøgt og godkendt, inkuberes de i ca. 45 til 60 minutter for at bringe dem i ligevægt med testsystemet inden dosering.
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.
Efter ligevægtsindstillingsperioden foretages en nulpunktsreferencemåling af corneatykkelse og -uklarhed, der skal fungere som basislinje (dvs. tid = 0).
The corneal opacity, swelling, and damage assessments following exposure to a test chemical are assessed individually and then combined to derive an Eye Irritancy Classification.
Den ved fridissekering bestemte fluoresceinscore anvendes som basislinjemåling for det endepunkt.
This test method is based on the protocol suggested in the OECD Guidance Document 160 (8), which was developed following the ICCVAM international validation study (1) (3) (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).
Umiddelbart efter nulpunktsreferencemålingerne fjernes øjet (i sin holder) fra superfusionsapparatet og anbringes i vandret position, hvorefter testkemikaliet påføres på cornea.
The protocol is based on information obtained from published protocols, as well as the current protocol used by TNO (10) (11) (12) (13) (14).
Flydende testkemikalier testes typisk ufortyndede, men kan fortyndes, hvis det anses for nødvendigt (f.eks. som del af undersøgelsens design).
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).
Det foretrukne opløsningsmiddel til fortyndede testkemikalier er fysiologisk saltvand.
The test method is applicable to solids, liquids, emulsions and gels.
Der kan imidlertid også anvendes alternative opløsningsmidler under kontrollerede betingelser, men egnetheden af andre opløsningsmidler end fysiologisk saltvand bør påvises.
The liquids may be aqueous or non-aqueous; solids may be soluble or insoluble in water.
Flydende testkemikalier påføres på cornea således, at hele overfladen af cornea dækkes jævnt med testkemikaliet.
Gases and aerosols have not been assessed yet in a validation study.
Standardvolumenet er 0,03 ml. Om muligt bør faste testkemikalier formales så fint som muligt med morter og støder eller et tilsvarende formalingsværktøj.
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).
Pulveret påføres på cornea således, at overfladen dækkes jævnt med testkemikaliet.
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).
Standardmængden er 0,03 g.
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.
Øjet (i sin holder) sættes derefter tilbage i superfusionsapparatet i sin oprindelige opretstående position.
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.
Hvis der er behov for yderligere skylning, kan dette ske 10 sekunder efter påførelsen og på efterfølgende tidspunkter (f.eks. ved fund af rester af testkemikaliet på cornea).
However, positive results obtained with alcohols should be interpreted cautiously due to risk of over-prediction.
Generelt er det ikke afgørende, hvilken mængde saltvand der bruges til yderligere skylning, men det er vigtigt at observere, om kemikaliet klæber fast til cornea.
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).
Der bør indgå samtidige negative kontroller eller opløsningsmiddel/bærestof-kontroller og positive kontroller i hvert forsøg.
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).
Ved test af væsker i en koncentration på 100 % eller faste stoffer anvendes fysiologisk saltvand som den samtidige negative kontrol ved ICE-forsøgsmetoden, således at ikke-specifikke ændringer i testsystemet kan påvises, og det kan sikres, at assaybetingelserne ikke fejlagtigt resulterer i en irritationsrespons.
The appropriate regulatory authorities should be consulted before using the ICE in a bottom up approach under other classification schemes.
Ved test af fortyndede væsker medtages en samtidig opløsningsmiddel/bærestof-kontrolgruppe ved forsøgsmetoden, således at ikke-specifikke ændringer i testsystemet kan påvises, og det kan sikres, at assaybetingelserne ikke fejlagtigt resulterer i en irritationsrespons.
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.
Som anført i punkt 31 kan der kun anvendes et opløsningsmiddel/bærestof, som påviseligt ikke påvirker testsystemet negativt.
However, on the basis of one result from the validation database, anti-fouling organic solvent-containing paints may be under-predicted (5).
Der medtages et kendt øjenirriterende stof som samtidig positiv kontrol i hvert forsøg for at verificere, at der induceres en passende respons.
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).
Eftersom ICE-assayet anvendes i denne forsøgsmetode til identifikation af ætsende eller stærkt irriterende stoffer, bør den positive kontrol være et referencekemikalie, som inducerer en svær respons ved denne forsøgsmetode.
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).
For at sikre at det er muligt at vurdere variabiliteten i den positive kontrolrespons over tid, bør den svære respons imidlertid ikke være overdrevent stor.
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.
Der bør genereres tilstrækkelige in vitro-data for den positive kontrol, således at der kan beregnes et statistisk defineret acceptabelt interval for den positive kontrol.
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.
Hvis der ikke er tilstrækkelige historiske ICE-forsøgsmetodedata tilgængelige for en bestemt positiv kontrol, kan det være nødvendigt at gennemføre undersøgelser for at tilvejebringe disse oplysninger.
Universal laboratory precautions are recommended (16).
Eksempler på positive kontroller for flydende testkemikalier er 10 % eddikesyre eller 5 % benzalkoniumchlorid, mens eksempler på positive kontroller for faste testkemikalier er natriumhydroxid eller imidazol.
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.
Behandlede corneae vurderes inden behandlingen og ved 30, 75, 120, 180 og 240 minutter (± 5 minutter) efter skylningen efter behandlingen.
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).
Med disse tidspunkter opnås et passende antal målinger over behandlingsperioden på fire timer, samtidig med at der er tilstrækkelig tid mellem målingerne til at foretage de fornødne observationer for alle øjnene.
In particular, further scientific knowledge is required to understand how irreversible effects not linked with initial high level injury occur.
De vurderede endepunkter er cornea-uklarhed, -opsvulmning og -fluoresceinretention samt morfologiske virkninger på cornea (f.eks. erosion eller løsning af epitelet).
Finally, the ICE test method does not allow for an assessment of the potential for systemic toxicity associated with ocular exposure.
Alle endepunkterne med undtagelse af fluoresceinretention (som kun bestemmes inden behandlingen og 30 minutter efter eksponering med testkemikaliet) bestemmes på hvert af de ovennævnte tidspunkter.
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.
Det tilrådes at tage fotografier for at dokumentere cornea-uklarhed og -fluoresceinretention, morfologiske virkninger på cornea og, hvis det udføres, histopatologi.
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).
Efter den afsluttende undersøgelse efter fire timer opfordres brugerne til at konservere øjnene i et egnet fikseringsmiddel (f.eks. neutralbufret formalin) med henblik på eventuel histopatologisk undersøgelse (jf. punkt 14 og henvisning (8) for nærmere oplysninger).
For any laboratory initially establishing this assay, the proficiency chemicals provided in Appendix 2 should be used.
Cornea-opsvulmning bestemmes ud fra corneatykkelsesmålinger foretaget med et optisk pachymeter på et spaltelampemikroskop.
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.
Den udtrykkes i procent og beregnes ud fra corneatykkelsesmålinger ved hjælp af følgende formel:
The ICE test method is an organotypic model that provides short-term maintenance of the chicken eye in vitro.