natgillin/translations-raw huggingface dataset:
For eksisterende stoffer, som ikke er tilstrækkelig undersøgt for øjenætsning/irritation, bør man følge denne strategi for at supplere de mangelfulde data, Anvendes en anden testningsstrategi eller -metode, eller beslutter man sig for ikke at følge den trinvise testningsstrategi, bør dette begrundes.
For existing substances with insufficient data on skin and eye corrosion/irritation, the strategy should be used to fill missing data gaps. The use of a different testing strategy or procedure, or the decision not to use a stepwise testing approach, should be justified.
Ætsning af øjet er frembringelse af vævsbeskadigelse i øjet eller alvorlig fysisk synsnedsættelse, som opstår efter påføring af et teststof på øjets anteriore overflade, og som ikke er fuldt reversibel inden for 21 dage efter påføring.
Eye irritation: is the production of changes in the eye following the application of a test substance to the anterior surface of the eye, which are fully reversible within 21 days of application. Eye corrosion: is the 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.
Graden af øjenirritation/ætsning vurderes ved tildeling af score-værdier til læsionerne af conjunctiva, cornea og iris med bestemte intervaller, Andre virkninger på øjet og systemiske negative virkninger beskrives ligeledes, således at man har en fuldstændig bedømmelse af virkningerne.
The degree of eye irritation/corrosion is evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals. Other effects in the eye and adverse systemic effects are also described to provide a complete evaluation of the effects.
Undersøgelsen skal strække sig over tilstrækkelig lang tid til, at virkningernes reversibilitet eller irreversibilitet kan vurderes.
The duration of the study should be sufficient to evaluate the reversibility or irreversibility of the effects. Animals showing continuing signs of severe distress and/or pain at any stage of the test should be humanely killed, and the substance assessed accordingly.
Anvendelse af en satellitgruppe af dyr til undersøgelse af virkningen af skylningen kan ikke anbefales, medmindre det er videnskabeligt begrundet, Er en satellitgruppe nødvendig, skal den bestå af to kaniner.
Use of a satellite group of animals to investigate the influence of washing is not recommended unless it is scientifically justified. If a satellite group is needed, two rabbits should be used.
Ved undersøgelse af flydende stoffer anvendes 0,1 ml. Der må ikke anvendes pumpespray til direkte instillation af stoffet i øjet.
For testing liquids, a dose of 0,1 ml is used. Pump sprays should not be used for instilling the substance directly into the eye.
Iagttages reversibilitet inden 21 dage, afsluttes forsøget på dette tidspunkt.
To determine reversibility of effects, the animals should be observed normally for 21 days post administration of the test substance. If reversibility is seen before 21 days, the experiment should be terminated at that time.
Øjnene undersøges 1, 24, 48 og 72 timer efter påføring af teststoffet.
The eyes should be examined at one, 24, 48, and 72 hours after test substance application. Animals should be kept on test no longer than necessary once definitive information has been obtained.
Dyr, som viser tegn på stærk lidelse og/eller smerte i nogen del af forsøget, skal omgående aflives humant, og teststoffet vurderes tilsvarende, Når følgende øjenlæsioner optræder efter instillation af teststoffet, skal dyret aflives humant: perforation af cornea eller nævneværdig ulceration af cornea, herunder staphylom; blod i forreste øjenkammer; uklarhed af cornea af grad 4, persisterende i 48 timer; manglende reaktion på lys (irisrespons grad 2), persisterende i 72 timer; ulceration af conjunctivaslimhinden; nekrose af conjunctivae eller blinkhinde; rynker i cornea.
Animals with the following eye lesions post-instillation should be humanely killed: corneal perforation or significant corneal ulceration including staphyloma; blood in the anterior chamber of the eye; grade 4 corneal opacity which persists for 48 hours; absence of a light reflex (iridial response grade 2) which persists for 72 hours; ulceration of the conjunctival membrane; necrosis of the conjuctivae or nictitating membrane; or sloughing. This is because such lesions generally are not reversible
For dyr, som ikke udvikler øjenlæsioner, kan forsøget afsluttes tidligst 3 dage efter instillation, Dyr med lette til moderate læsioner observeres, indtil læsionerne forsvinder, eller i 21 dage, på hvilket tidspunkt forsøget afsluttes, På dag 7, 14 og 21 foretages observation til bestemmelse af læsionernes status og reversibilitet eller irreversibilitet.
Animals with mild to moderate lesions should be observed until the lesions clear, or for 21 days, at which time the study is terminated. Observations should be performed at seven, 14, and 21 days in order to determine the status of the lesions, and their reversibility or irreversibility.
Klassificeringen af øjenrespons er nødvendigvis subjektiv.
The grading of ocular responses is necessarily subjective.
For at give en mere ensartet klassificering af øjenresponset og for at bistå prøvningslaboratorieme og dem, som foretager og fortolker iagttagelserne, må iagttagelserne foretages af personer, som er tilstrækkeligt fortrolige med det anvendte score-system. Klassificeringen af øjenrespons foretages blindt.
To promote harmonisation of grading of ocular response and to assist testing laboratories and those involved in making and interpreting the observations, the personnel performing the observations need to be adequately trained in the scoring system used.
Score-værdierne for øjenirritation vurderes i tilknytning til læsionernes art, sværhedsgrad og reversibilitet eller manglende reversibilitet, De enkelte score-værdier repræsenterer ikke en absolut standard for et stofs irritationsfremkaldende egenskaber, da de også omfatter andre virkninger af teststoffet.
The ocular irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility. The individual scores do not represent an absolute standard for the irritant properties of a material, as other effects of the test material are also evaluated.
Skønt denne sekventielle testning ikke indgår som en del af testmetode B.5, er det den anbefalede strategi til bestemmelse af øjenirritation/ætsning.
Although this testing strategy is not an integrated part of testing method B.5, it expresses the recommended approach for the determination of eye irritation/corrosion properties. This approach represents both best practice and an ethical benchmark for in vivo testing for eye irritation/corrosion.
Strategien repræsenterer både bedste praksis og en etisk standard for in vivo-testning af øjenirritation/ætsning.
The testing method provides guidance for the conduct of the in vivo test and summarises the factors that should be addressed before considering such a test. The sequential testing strategy provides a weight-of-the-evidence approach for the evaluation of existing data on the eye irritation/corrosion properties of substances and a tiered approach for the generation of relevant data on substances for which additional studies are needed or for which no studies have been performed.
Testmetoden giver vejledning i udførelse af in vivo-forsøg og sammenfatter de faktorer, som bør tages i betragtning, før et sådant forsøg påbegyndes, Strategien tilvejebringer en metode til evaluering af foreliggende oplysninger om teststoffets øjenirriterende og ætsende egenskaber og en trinvis fremgangsmåde til at generere relevante data om stoffer, som har behov for yderligere undersøgelse eller ikke er blevet undersøgt, Strategien indebærer, at der først udføres validerede og anerkendte in vivo- eller ex vivo-test, og derefter forsøgsmetode B.4, hudirritation/ætsning, alt efter omstændighederne (3)(4).
The strategy includes the performance first of validated and accepted in vitro or ex vivo tests and then of testing method B.4 skin irritation/corrosion studies under specific circumstances (3)(4). DESCRIPTION OF THE STEPWISE TESTING STRATEGY
Skønt vurdering af enkeltparametre (f.eks. ekstremt pH) i sig selv kan tænkes at give væsentlige oplysninger, må alle de foreliggende oplysninger betragtes under ét, Som grundlag for en afgørelse baseret på weight-of-the-evidence må alle relevante oplysninger om virkningerne af det pågældende stof og af analoge stoffer evalueres, og et rationale for afgørelsen fremlægges.
Although significant information might be gained from the evaluation of single parameters (e.g., extreme pH), the totality of existing information should be assessed. All relevant data on the effects of the substance in question, and its structural analogues, should be evaluated in making a weight-of-the-evidence decision, and a rationale for the decision should be presented.
Resultater fra eventuelle undersøgelser af strukturelt beslægtede stoffer skal tages i betragtning, Når der for strukturelt beslægtede stoffer eller blandinger af sådanne stoffer foreligger tilstrækkelige data fra mennesker og/eller dyr til at bestemme deres potentiale for ætsning/irritation af øjnene, kan teststoffet antages at ville frembringe samme responser.
The results of testing of structurally related chemicals should be considered, if available. When sufficient human and/or animal data are available on structurally related substances or mixtures of such substances to indicate their eye corrrosion/irritancy potential, it can be presumed that the test substance will produce the same responses.
Stoffer, som har udvist ætsende eller stærkt irriterende egenskaber i en in vitro- eller ex vivo-undersøgelse (7)(8), som er valideret og anerkendt specielt til vurdering af ætsende/irriterende virkning på øjne eller hud, behøver ikke testes i dyreforsøg.
Substances that have demonstrated corrosive or severe irritant properties in an in vitro or ex vivo test (7)(8) that has been validated and accepted for the assessment specifically of eye or skin corrosivity/irritation, need not be tested in animals.
Foreligger der ikke validerede og anerkendte in vitro- og/eller ex vivo-test, springes trin 5 og 6 over og fortsættes direkte med trin 7.
If validated and accepted in vitro/ex vivo tests are not available, one should bypass Steps 5 and 6 and proceed directly to Step 7.
Vurdering af stoffets hudirriterende eller ætsende virkning in vivo (trin 7).
Assessment of in vivo dermal irritancy or corrosivity of the substance (Step 7).
Toxicol.
Toxicol. Cut.
Cut.
Ocular Toxicol.
Ingen testning nødvendig.
No testing is needed. ↓
Oplysninger foreligger ikke eller er inkonklusive
no information available, or available information is not conclusive ↓
Der kan ikke angives nogen forventninger, eller forventningerne er inkonklusive eller negative
No predictions can be made, or predictions are not conclusive or negative ↓
2 < pH < 11,5, eller pH ≤ 2,0 eller ≥ 11,5 med ringe eller ingen bufferkapacitet, hvis det er relevant
2< pH < 11.5, or pH ≤ 2.0 or ≥ 11.5 with low/no buffering capacity, if relevant ↓
Oplysninger herom foreligger ikke, eller stoffet er ikke ret toksisk
Such information is not available, or substance is not very toxic ↓
5 Der udføres en valideret og anerkendt in vitro- eller ex vivo-test for ætsende virkning på øjnene Ætsningsrespons Bør anses for at virke ætsende på øjnene.
5 Perform validated and accepted in vitro or ex vivo test for eye corrosion Corrosive response
Ingen yderligere testning nødvendig.
Assume corrosivity to eyes. No further testing is needed.
6 Der udføres en valideret og anerkendt in vitro- eller ex vivo-test for øjenirritation Irritationsrespons Bør anses for øjenirriterende.
6 Perform validated and accepted in vitro or ex vivo test for eye irritation Irritant response
Ingen yderligere testning nødvendig.
Assume irritancy to eyes. No further testing is needed.
7 Potentialet for in vivo-hudirritation/ætsning bestemmes eksperimentelt (se forsøgsmetode B.4 og tilhørende bilag) Ætsnings- eller svær irritationsrespons Bør anses for at virke ætsende på øjnene.
7 Experimentally assess in vivo skin irritation/corrosion potential (see Testing method B.4 including its Annex)
Ingen yderligere testning nødvendig.
Corrosive or severe irritant response Assume corrosivity to eyes.
8 Der udføres en indledende in vivo-kaninøjentest i ét dyr Svære øjenskader Bør anses for at virke ætsende på øjnene, Ingen yderligere testning nødvendig.
8 Perform initial in vivo rabbit eye test using one animal
Ingen svær skade, eller ingen respons
Consider corrosive to eyes. No further testing is needed. ↓
9 Der udføres en verifikationstest i yderligere ét eller to dyr Ætsende eller irriterende Bør anses for ætsende eller irriterende for øjnene.
9 Perform confirmatory test using one or two additional animals Corrosive or irritating
Ingen yderligere testning nødvendig Ikke ætsende eller irriterende Bør anses for ikke irriterende og ikke ætsende for øjnene.
Consider corrosive or irritating to eyes. No further testing is needed Not corrosive or irritating
Ingen yderligere testning nødvendig.
Consider non-irritating and non-corrosive to eyes. No further testing is needed.
Testlappesystemet skal være gennemvædet med teststoffet i et egnet vehikel (valg af vehikel skal begrundes; væsker kan eventuelt anvendes direkte).
The test patch system should be fully loaded with test substance in a suitable vehicle (the choice of the vehicle should be justified; liquid test substances can be applied undiluted, if appropriate).
Testlappesystemet anbringes på testområdet og fastholdes i kontakt med huden med en okklusiv lap eller kapsel og en passende forbinding i seks timer.
The test patch system is applied to the test area and held in contact with the skin by an occlusive patch or chamber and a suitable dressing for six hours.
Testlappesystemet skal være okklusivt.
The test patch system must be occlusive.
ca. 21 timer efter at lappen er fjernet, befries provokationsområdet for hår
approximately 21 hours after removing the patch the challenge area is cleared of hair, approximately three hours later (approximately 30 hours after application of the challenge patch) the skin reactions are observed and recorded according to the grades shown in the Appendix,
Teststoffet indgives med mavesonde, i foderet eller i drikkevandet, afhængigt af formålet med forsøget og stoffets fysisk-kemiske egenskaber.
The test substance is administered by gavage or via the diet or drinking water. The method of oral administration is dependent on the purpose of the study, and the physical/chemical properties of the substance.
Der anvendes generelt mindst tre forsøgsgrupper og en kontrolgruppe.
Generally, at least three test groups and a control group should be used.
Flere grupper af forsøgsdyr udsættes i 28 dage dagligt i en angivet periode for teststoffet i graduerede koncentrationer, idet hver gruppe eksponeres for en bestemt koncentration.Anvendes der et vehikel til at frembringe en passende koncentration af teststoffet i luften, bør der i forsøget indgå en kontrolgruppe, der udsættes for vehiklet alene.
Several groups of experimental animals are exposed daily for a defined period to the test substance in graduated concentrations, one concentration being used per group, for a period of 28 days. Where a vehicle is used to help generate an appropriate concentration of the test substance in the atmosphere, a vehicle control group should be used.
Hvis der foreligger en anvendelig vurdering af menneskers eksponering for stoffet, skal den laveste koncentration overskride denne eksponering, Middelkoncentrationen skal helst frembringe så svage observerbare toksiske virkninger som muligt.
Where there is a usable estimation of human exposure, the lowest concentration should exceed this. Ideally, the intermediate concentration should produce minimal observable toxic effects.
Postmitokondriefraktionen anvendes normalt i en koncentration på 1-10 % (v/v) i det færdige testsubstrat.
The post-mitochondrial fraction is usually used at concentrations in the range from 1-10 % v/v in the final test medium.
Et metabolismeaktiveringssystems beskaffenhed kan afhænge af, hvilken kemisk klasse teststoffet tilhører.
The condition of a metabolic activation system may depend upon the class of chemical being tested.
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De fleste kemiske mutagener forårsager ændringer af kromosomtypen, men også ændringer af kromatidtypen forekommer.
With the majority of chemical mutagens, induced aberrations are of the chromatid-type, but chromosome-type aberrations also occur.
Denne test for kromosomaberrationer er særlig relevant for en vurdering af risikoen for mutationsfremkaldelse, da den giver mulighed for at tage sådanne faktorer som in vivo-metabolisme, farmakokinetik og DNA-reparationsprocesser i betragtning, selv om de kan variere fra art til art og fra væv til væv.
Other species and target tissues are not the subject of this method. This chromosome aberration test is especially relevant to assessing mutagenic hazard in that it allows consideration of factors of in vivo metabolism, pharmacokinetics and DNA-repair processes although these may vary among species and among tissues.
Ved den efterfølgende prøveudtagning behøves kun den højeste dosis benyttet, Den højeste dosis defineres som den dosis, der fremkalder sådanne tegn på toksicitet, at højere dosis med samme indgiftsmønster må forventes at medføre død.
At the later sampling time only the highest dose needs to be used. The highest dose is defined as the dose producing signs of toxicity such that higher dose levels, based on the same dosing regimen, would be expected to produce lethality.
Et positivt resultat af en in vivo-test for kromosomaberrationer viser, at teststoffet fremkalder kromosomaberrationer i knoglemarven hos den undersøgte art. At negativt resultat viser, at teststoffet under testbetingelserne ikke fremkalder kromosomaberrationer i knoglemarven hos den undersøgte art.
Positive results from the in vivo chromosome aberration test indicate that a substance induces chromosome aberrations in the bone marrow of the species tested. Negative results indicate that, under the test conditions, the test substance does not induce chromosome aberrations in the bone marrow of the species tested.
Preston.
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Kirkland (Ed.) Basic Mutagenicity Tests, UKEMS Recommended Procedures.
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Report. Part I revised.
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Måling af umodne (polykromatiske) erythrocytter med mikrokeme i det perifere blod kan også accepteres i andre arter, hvor det er vist, at milten ikke kan fjerne erythrocytter med mikrokerner, eller at deres følsomhed over for stoffer, der forårsager strukturelle eller antalsmæssige kromosomaberrationer, er tilstrækkelig.
The measurement of micronucleated immature (polychromatic) erythrocytes in peripheral blood is equally acceptable in any species in which the inability of the spleen to remove micronucleated erythrocytes has been demonstrated, or which has shown an adequate sensitivity to detect agents that cause structural or numerical chromosome aberrations. Micronuclei can be distinguished by a number of criteria.
Benyttes der to eller flere daglige behandlinger (f.eks. to eller flere behandlinger med 24 timers mellemrum) udtages der for knoglemarvs vedkommende prøver én gang mellem 18 og 24 timer efter den sidste behandling, og for perifert blods vedkommende én gang mellem 36 og 48 timer efter den sidste behandling (12).
Samples of bone marrow are taken at least twice, starting not earlier than 24 hours after treatment, but not extending beyond 48 hours after treatment with appropriate intervals between samples. The use of sampling times earlier than 24 hours after treatment should be justified.