natgillin/translations-raw huggingface dataset:
beskrivelse af eventuelle ændringer i testproceduren
The holder is then incubated in a horizontal position for 90 ± 5 min at 32 ± 1 °C.
beskrivelse af de anvendte beslutningskriterier.
The amount of sodium fluorescein that crosses into the posterior chamber is quantitatively measured with the aid of UV/VIS spectrophotometry.
Resultater
Spectrophotometric measurements evaluated at 490 nm are recorded as optical density (OD490) or absorbance values, which are measured on a continuous scale.
angivelse i tabelform af data fra hver enkelt testprøve (f.eks. uklarheds- og OD490-værdier og beregnet IVIS for testkemikaliet og de positive kontroller, negative kontroller og referencekontrollerne [hvis de er medtaget] rapporteret i tabelform, herunder data fra flergangsbestemmelser/gentagne bestemmelser, hvis det er relevant, og gennemsnit ± standardafvigelsen for hvert forsøg)
The fluorescein permeability values are determined using OD490 values based upon a visible light spectrophotometer using a standard 1 cm path length.
beskrivelse af andre observerede virkninger.
Alternatively, a 96-well microtiter plate reader may be used provided that; (i) the linear range of the plate reader for determining fluorescein OD490 values can be established; and (ii), the correct volume of fluorescein samples are used in the 96-well plate to result in OD490 values equivalent to the standard 1 cm path length (this could require a completely full well [usually 360 μl]).
den afledte in vitro-klassificering ifølge UN GHS, hvor det er relevant.
Data Evaluation
Diskussion af resultaterne
Once the opacity and mean permeability (OD490) values have been corrected for background opacity and the negative control permeability OD490 values, the mean opacity and permeability OD490 values for each treatment group should be combined in an empirically-derived formula to calculate an in vitro irritancy score (IVIS) for each treatment group as follows:
Tilgængelig på: [http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm]
IVIS = mean opacity value + (15 × mean permeability OD490 value)
Tilgængelig på: [http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm]
reported that this formula was derived during in-house and inter-laboratory studies.
Tilgængelig på: http://www.unece.org/trans/danger/publi/ghs/ghs_rev04/04files_e.html.
The data generated for a series of 36 compounds in a multi-laboratory study were subjected to a multivariate analysis to determine the equation of best fit between in vivo and in vitro data.
Tilgængelig på: [http://www.cdc.gov/ncidod/dhqp/pdf].
Scientists at two separate companies performed this analysis and derived nearly identical equations.
Kapitel B.5 i dette bilag, Akut øjenirritation/-ætsning.
The opacity and permeability values should also be evaluated independently to determine whether a test chemical induced corrosivity or severe irritation through only one of the two endpoints (see Decision Criteria).
Tilgængelig på: [http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_brd_bcop.htm].
Decision Criteria
Tilgængelig på: http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_1_1_1,00.html
The IVIS cut-off values for identifying test chemicals as inducing serious eye damage (UN GHS Category 1) and test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given hereafter:
Nøjagtighed
IVIS
Overensstemmelsen mellem forsøgsmetodens resultater og accepterede referenceværdier.
UN GHS
Benchmarkkemikalie
No Category
Et kemikalie, der anvendes som standard til sammenligning med et testkemikalie.
No prediction can be made
Et benchmarkkemikalie skal have følgende egenskaber: i) en eller flere ensartede og pålidelige kilder, ii), strukturel og funktionel lighed med den klasse af kemikalier, der testes, iii) kendte fysisk-kemiske egenskaber, iv) støttedata om kendte virkninger og v) kendt styrke i det ønskede responsområde
Category 1
Bottom-up-tilgang
Study Acceptance Criteria
Trinvis tilgang til et kemikalie mistænkt for ikke at kræve klassificering for øjenirritation eller alvorlig øjenskade, der starter med bestemmelse af kemikalier, som ikke kræver klassifikation (negativt resultat) fra andre kemikalier (positivt resultat).
A test is considered acceptable if the positive control gives an IVIS that falls within two standard deviations of the current historical mean, which is to be updated at least every three months, or each time an acceptable test is conducted in laboratories where tests are conducted infrequently (i.e., less than once a month).
Den transparente del af øjeæblets forside, som dækker øjets iris og pupil, og hvorigennem lys kommer ind i øjets indre.
The negative or solvent/vehicle control responses should result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneas treated with the respective negative or solvent/vehicle control.
Cornea-uklarhed
A single testing run composed of at least three corneas should be sufficient for a test chemical when the resulting classification is unequivocal.
Måling af graden af cornea-uigennemsigtighed efter eksponering for et testkemikalie.
However, in cases of borderline results in the first testing run, a second testing run should be considered (but not necessarily required), as well as a third one in case of discordant mean IVIS results between the first two testing runs.
Øget cornea-uklarhed er indikativt for beskadigelse af cornea.
In this context, a result in the first testing run is considered borderline if the predictions from the 3 corneas were non-concordant, such that:
Uklarhed kan vurderes subjektivt som i Draize-kaninøjentesten eller objektivt med et instrument, såsom et »opacitometer«.
2 of the 3 corneas gave discordant predictions from the mean of all 3 corneas, OR,
Corneapermeabilitet
1 of the 3 corneas gave a discordant prediction from the mean of all 3 corneas, AND the discordant result was > 10 IVIS units from the cut-off threshold of 55.
Kvantitativ måling af beskadigelsen af cornea-epitelet ud fra bestemmelse af mængden af farvestoffet natriumfluorescein, der trænger gennem alle corneacellelag.
If the repeat testing run corroborates the prediction of the initial testing run (based upon the mean IVIS value), then a final decision can be taken without further testing.
Øjenirritation
If the repeat testing run results in a non-concordant prediction from the initial testing run (based upon the mean IVIS value), then a third and final testing run should be conducted to resolve equivocal predictions, and to classify the test chemical.
Frembringelse af forandringer i øjet, som opstår efter påføring af et testkemikalie på øjets anteriore overflade, og som er fuldt reversible inden for 21 dage efter påføring.
It may be permissible to waive further testing for classification and labeling in the event any testing run results in a UN GHS Category 1 prediction.
Udskiftelige med »Reversible virkninger på øjet« og »UN GHS-kategori 2« (4).
The test report should include the following information, if relevant to the conduct of the study:
Falsk negativ-rate
Test and Control Chemicals
Den andel af alle positive kemikalier, som ved en forsøgsmetode fejlagtigt identificeres som negative.
Chemical name(s) such as the structural name used by the Chemical Abstracts Service (CAS), followed by other names, if known; the CAS Registry Number (RN), if known;
Dette er en indikator for forsøgsmetodens ydeevne.
Purity and composition of the test/control chemical (in percentage(s) by weight), to the extent this information is available;
Falsk positiv-rate
Physicochemical properties such as physical state, volatility, pH, stability, chemical class, water solubility relevant to the conduct of the study;
Den andel af alle negative kemikalier, som ved en forsøgsmetode fejlagtigt identificeres som positive.
Treatment of the test/control chemicals prior to testing, if applicable (e.g. warming, grinding);
Fare
Stability, if known.
Den iboende egenskab ved et middel eller en situation, som kan forårsage skade, når en organisme, et system eller en (sub)population eksponeres for det pågældende middel.
Information Concerning the Sponsor and the Test Facility
In vitro-irritationsscore (IVIS)
Name and address of the sponsor, test facility and study director.
En empirisk udledt formel, som anvendes i BCOP-forsøgsmetoden, og hvorved den gennemsnitlige uklarhedsværdi og den gennemsnitlige permeabilitetsværdi for hver behandlingsgruppe kombineres i en enkelt in vitro-score for hver behandlingsgruppe.
Test Method Conditions
IVIS = gennemsnitlig uklarhedsværdi + (15 x gennemsnitlig permeabilitetsværdi).
Opacitometer used (e.g. model and specifications) and instrument settings;
Irreversible virkninger på øjet
Calibration information for devices used for measuring opacity and permeability (e.g. opacitometer and spectrophotometer) to ensure linearity of measurements;
Se »Alvorlig øjenskade«.
Type of corneal holders used (e.g. model and specifications);
Blanding
Description of other equipment used;
En blanding eller opløsning, der er sammensat af to eller flere stoffer, hvori de ikke reagerer (4).
The procedure used to ensure the integrity (i.e., accuracy and reliability) of the test method over time (e.g. periodic testing of proficiency chemicals).
Negativ kontrol
Criteria for an Acceptable Test
Et ubehandlet replikat, som indeholder alle komponenter fra et testsystem.
Acceptable concurrent positive and negative control ranges based on historical data;
Prøven behandles sammen med prøver behandlet med testkemikaliet og andre kontrolprøver for at afgøre, hvorvidt opløsningsmidlet interagerer med testsystemet.
If applicable, acceptable concurrent benchmark control ranges based on historical data.
Kemikalier, der ikke er klassificeret for øjenirritation (UN GHS-kategori 1) eller alvorlig øjenskade (UN GHS-kategori 2).
Identification of the source of the eyes (i.e., the facility from which they were collected);
Udskiftelige med »UN GHS uden for kategori«.
Corneal diameter as a measure of age of the source animal and suitability for the assay;
Et instrument, som anvendes til at måle »cornea-uklarhed« ved kvantitativ vurdering af lystransmission gennem cornea.
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);
Lys fra en halogenlampe sendes gennem et kontrolkammer (et væsketomt kammer uden vinduer) til en fotocelle og sammenlignes med det lys, som er sendt gennem forsøgskammeret, som rummer kammeret med cornea, til en fotocelle.
Number of replicates used;
Forskellen i lystransmission fra fotocellerne sammenlignes, og der vises en numerisk uklarhedsværdi på et digitalt display.
Identity of the negative and positive controls used (if applicable, also the solvent and benchmark controls);
For at sikre at det er muligt at vurdere variabiliteten i den positive kontrolrespons over tid, bør den positive respons ikke være overdrevent stor.
Description of study acceptance criteria used;
Reversible virkninger på øjet
Description of any modifications of the test procedure;
Se »Øjenirritation«.
Description of decision criteria used.
Den bedømmes ved beregning af reproducerbarhed inden for og mellem laboratorier og repeterbarhed inden for laboratorier.
Description of other effects observed;
Alvorlig øjenskade
The derived in vitro UN GHS classification, if applicable.
Frembringelse af vævsbeskadigelse i øjet eller alvorlig fysisk synsnedsættelse, som opstår efter påføring af et testkemikalie på øjets anteriore overflade, og som ikke er fuldt reversibel inden for 21 dage efter påføring.
Discussion of the Results
Udskiftelige med »Irreversible virkninger på øjet« og »UN GHS-kategori 1« (4).
Available: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
Opløsningsmiddel-/bærestofkontrol
Research Triangle Park, NC: National Institute of Environmental Health Sciences.
Ubehandlet prøve, som indeholder alle komponenterne fra et testsystem, herunder opløsningsmidlet eller bærestoffet, og som behandles sammen med de testkemikaliebehandlede prøver og andre kontrolprøver for at fastlægge basisresponsen for de prøver, som er behandlet med testkemikaliet opløst i det samme opløsningsmiddel eller bærestof.
Available: http://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm.
Når denne prøve testes med en samtidig negativ kontrol, viser den også, hvorvidt opløsningsmidlet eller bærestoffet interagerer med testsystemet.
Available: http://www.unece.org/trans/danger/publi/ghs/ghs_rev04/04files_e.html.
Stof
Available: [http://www.cdc.gov/ncidod/dhqp/pdf].
Grundstoffer og forbindelser heraf, naturlige eller industrielt fremstillede, indeholdende sådanne tilsætningsstoffer, som er nødvendige til bevarelse af stoffets stabilitet, og sådanne urenheder, som følger af fremstillingsprocessen, bortset fra opløsningsmidler, som kan udskilles, uden at det påvirker stoffets stabilitet eller ændrer dets sammensætning (4).
Series on Testing and Assessment, No. 160.
Overfladeaktivt stof (surfactant)
Adopted October 25, 2011.
Også kaldet overfladeaktivt stof.
Chapter B.5 of this Annex, Acute eye irritation/corrosion.
Et stof, f.eks. et vaske- og rengøringsmiddel, der kan reducere overfladespændingen i en væske og dermed give den mulighed for at skumme eller trænge gennem faste stoffer.
Available: [http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_brd_bcop.htm].
Kaldes også for befugtningsmiddel.
Series on Good Laboratory Practice and Compliance Monitoring.
Blanding indeholdende overfladeaktivt stof
No. 1: OECD Principles on Good Laboratory Practice (revised in 1997).
I forbindelse med denne forsøgsmetode en blanding, der indeholder et eller flere overfladeaktive stoffer i en endelig koncentration på > 5 %.
Available: at: http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_1_1_1,00.html
Top-down-tilgang
Accuracy
Trinvis tilgang, der anvendes for et kemikalie, som mistænkes for at forårsage alvorlig øjenskade, der starter med bestemmelse af kemikalier, som forårsager alvorlig øjenskade (positivt resultat), i forhold til andre kemikalier (negativt resultat).
The closeness of agreement between test method results and accepted reference values.
Trindelt teststrategi
It is a measure of test method performance and one aspect of “relevance”.
Ved anvendelse af den trinvise teststrategi gennemgås alle eksisterende oplysninger om et testkemikalie i en bestemt rækkefølge ved anvendelse af en weight-of-the-evidence-proces på hvert trin for at fastslå, om der foreligger tilstrækkelige oplysninger til at træffe en fareklassificeringsafgørelse, inden der fortsættes til næste trin.
The term is often used interchangeably with “concordance”, to mean the proportion of correct outcomes of a test method.
De Forenede Nationers globalt harmoniserede system for klassificering og mærkning af kemikalier (United Nations Globally Harmonized System of Classification and Labelling of Chemicals — UN GHS)
Benchmark chemical
Et system til klassificering af kemikalier (stoffer og blandinger) efter standardiserede typer og niveauer af fysisk fare, sundhedsfare og miljøfare med tilhørende kommunikationselementer såsom piktogrammer, signalord, risikosætninger, sikkerhedssætninger og sikkerhedsdatablade, således at oplysninger om kemikaliernes skadelige virkninger kan videreformidles med henblik på at beskytte mennesker (f.eks. arbejdsgivere, arbejdstagere, transportører, forbrugere og redningspersonel) og miljø (4).
A chemical used as a standard for comparison to a test chemical.
UN GHS-kategori 1
A benchmark chemical should have the following properties; (i) a consistent and reliable source(s); (ii) structural and functional similarity to the class of chemicals being tested; (iii) known physical/chemical characteristics; (iv) supporting data on known effects, and (v) known potency in the range of the desired response.
UN GHS-kategori 2
Bottom-Up Approach
UN GHS uden for kategori
step-wise approach used for a chemical suspected of not requiring classification for eye irritation or serious eye damage, which starts with the determination of chemicals not requiring classification (negative outcome) from other chemicals (positive outcome).
Kemikalier, der ikke opfylder kravene med hensyn til klassificering som UN GHS-kategori 1 eller 2 (2A eller 2B).
The transparent part of the front of the eyeball that covers the iris and pupil and admits light to the interior.
Udskiftelig med »Ikke-klassificeret«.
Corneal opacity
Valideret forsøgsmetode
Measurement of the extent of opaqueness of the cornea following exposure to a test chemical.
En forsøgsmetode, for hvilken der er gennemført valideringsundersøgelser for at fastslå relevansen (herunder nøjagtigheden) og pålideligheden til et bestemt formål.
Increased corneal opacity is indicative of damage to the cornea.
Det er vigtigt at være opmærksom på, at en valideret forsøgsmetode måske ikke har tilstrækkelig ydeevne med hensyn til nøjagtighed og pålidelighed til at være acceptabel til det planlagte formål.
Opacity can be evaluated subjectively as done in the Draize rabbit eye test, or objectively with an instrument such as an “opacitometer”.
»Weight-of-the-evidence«
Corneal permeability
En proces, hvor styrkerne og svaghederne ved forskellige oplysninger afvejes for at nå frem til og underbygge en konklusion om et testkemikalies farepotentiale.
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.
BCOP-FORSØGSMETODENS FORUDSIGELSESEVNE
Eye irritation
BCOP's forudsigelsesevne til at identificere kemikalier, der medfører alvorlig øjenskade [UN GHS/EU CLP-kat 1 mod ikke kat 1 (kat 2 + uden for kat); US EPA-kat I mod ikke kat I (kat II + kat III + kat IV)]
Production of changes in the eye following the application of a test chemical to the anterior surface of the eye, which are fully reversible within 21 days of application.
Klassificeringssystem
Interchangeable with “Reversible effects on the eye” and with “UN GHS Category 2” (4).
Følsomhed
False negative rate
Specificitet
It is one indicator of test method performance.
Falsk positiv
False positive rate
Tabel 2
The proportion of all negative chemicals that are falsely identified by a test method as positive.
BCOP's forudsigelsesevne til at identificere kemikalier, der ikke kræver klassificering for øjenirritation eller alvorlig øjenskade (»ikke-øjenirriterende«) [UN GHS/ EU CLP uden for kat mod ikke uden for kat (kat 1 + kat 2); US EPA kat IV mod ikke kat IV (kat I + kat II + kat III)]
Hazard
Tillæg 3
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.
KOMPETENCEKEMIKALIER TIL BCOP-FORSØGSMETODEN
In Vitro Irritancy Score (IVIS)
Inden laboratorier påbegynder rutinemæssig brug af denne forsøgsmetode, bør de godtgøre deres tekniske kompetence ved korrekt identifikation af øjenrisikoklassificeringen for de 13 anbefalede kemikalier i tabel 1.
An empirically-derived formula used in the BCOP test method whereby the mean opacity and mean permeability values for each treatment group are combined into a single in vitro score for each treatment group.
Disse kemikalier er udvalgt således, at de repræsenterer det responsområde for øjenrisiko, der er baseret på resultater fra in vivo-kaninøjentesten (TG 405) (17) og UN GHS-klassificeringssystemet (dvs. UN GHS-kategori 1, 2A, 2B eller uden for kategori) (4).
The IVIS = mean opacity value + (15 × mean permeability value).
Andre udvælgelseskriterier var, at kemikalierne er kommercielt tilgængelige, at der er tilgængelige in vivo-referencedata af høj kvalitet, og at der findes in vitro-data af høj kvalitet for BCOP-forsøgsmetoden.
Irreversible effects on the eye
Referencedata findes i SSD (Streamlined Summary Document) (3) og i ICCVAM Background Review Document for BCOP-forsøgsmetoden (2) (18).
See “Serious eye damage”.
Anbefalede kemikalier til godtgørelse af teknisk kompetence i anvendelse af BCOP-forsøgsmetoden
Mixture
Forkortelser: CASRN = Chemical Abstracts Service Registry Number
A mixture or a solution composed of two or more substances in which they do not react (4)
Kemikaliegruppe [1]
Negative control
Fysisk form
An untreated replicate containing all components of a test system.
In vivo-klassificering [2]
This sample is processed with test chemical-treated samples and other control samples to determine whether the solvent interacts with the test system.
BCOP-klassificering
Not Classified
Benzalkoniumchlorid (5 %)
Chemicals that are not classified for Eye irritation (UN GHS Category 2, 2A, or 2B) or Serious eye damage (UN GHS Category 1).
Oniumforbindelse
Interchangeable with “UN GHS No Category”.
Flydende
Opacitometer
Chlorhexidin
An instrument used to measure “corneal opacity” by quantitatively evaluating light transmission through the cornea.
Amin, amidin
The typical instrument has two compartments, each with its own light source and photocell.
Fast
One compartment is used for the treated cornea, while the other is used to calibrate and zero the instrument.
Dibenzoyl-L-vinsyre
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.
Carboxylsyre, ester
The difference in light transmission from the photocells is compared and a numeric opacity value is presented on a digital display.
Imidazol
Positive control
Heterocyklisk
A replicate containing all components of a test system and treated with a chemical known to induce a positive response.
Trichloreddikesyre (30 %)
To ensure that variability in the positive control response across time can be assessed, the magnitude of the positive response should not be excessive.
Carboxylsyre
Reversible effects on the eye
2,6-dichlorbenzoylchlorid
See “Eye irritation”.
Acylhalogenid
Reliability
Kategori 2A
Measures of the extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol.
Der kan ikke foretages en præcis/pålidelig forudsigelse
It is assessed by calculating intra- and inter-laboratory reproducibility and intra-laboratory repeatability.
Ethyl-2-methylacetoacetat
Serious eye damage
Keton, ester
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.
Kategori 2B
Interchangeable with “Irreversible effects on the eye” and with “UN GHS Category 1” (4).
Ammoniumnitrat
Solvent/vehicle control
Uorganisk salt
An untreated sample containing all components of a test system, including the solvent or vehicle that is processed with the test chemical-treated samples and other control samples to establish the baseline response for the samples treated with the test chemical dissolved in the same solvent or vehicle.
Kategori 2 [3]
When tested with a concurrent negative control, this sample also demonstrates whether the solvent or vehicle interacts with the test system.
EDTA, dikaliumsalt
Substance
Amin, carboxylsyre (salt)
Chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (4).
ercaptopyrimidin
Surfactant
Phenylbutazon
Also called surface-active agent, this is a substance, such as a detergent, that can reduce the surface tension of a liquid and thus allow it to foam or penetrate solids; it is also known as a wetting agent.
Polyoxyethylen-23-laurylether (BRIJ-35) (10 %)
Surfactant-containing mixture
Alkohol
In the context of this test method, it is a mixture containing one or more surfactants at a final concentration of > 5 %.