natgillin/translations-raw huggingface dataset:
Worth, A.P., Fentem J.H., Balls M., Botham P.A., Curren R.D., Earl L.K., Esdaile D.J., Liebsch M., (1998).
Worth, A.P., Fentem J.H., Balls M., Botham P.A., Curren R.D., Earl L.K., Esdaile D.J., Liebsch M. (1998).
Perform validated and accepted in vitro or ex vivo test for skin irritation Irritant response Assume irritancy in vivo. No further testing is needed. ↓ Validated in vitro or ex vivo testing methods for skin irritation are not yet available or substance is not an irritant ↓ 7 Perform initial in vivo rabbit test using one animal Severe damage to skin Considered corrosive. No further testing is needed. ↓ No severe damage ↓ 8 Perform confirmatory test using one or two additional animals Corrosive or irritating Considered corrosive or irritating. No further testing is needed Not corrosive or irritating Considered not corrosive or irritating. No further testing needed (1) can be considered before Steps 2 and 3.
STRATEGIJA PRESKUŠANJA IN VREDNOTENJA ZA DERMALNO DRAŽILNOST/JEDKOST
This method is equivalent to the OECD TG 405 (2002)
Ta metoda ustreza OECD TG 405 (2002).
In the preparation of this updated method special attention was given to possible improvements through the evaluation of all existing information on the test substance in order to avoid unnecessary testing in laboratory animals and thereby address animal welfare concerns.
Pri pripravi te dopolnjene metode je veljala posebna pozornost možnim izboljšavam z vrednotenjem vseh obstoječih informacij o preskusni snovi, da bi se izognili nepotrebnemu preskušanju na laboratorijskih živalih zaradi skrbi za zdravje živali.
This method includes the recommendation that prior to undertaking the described in vivo test for acute eye irritation/corrosion, a weight-of-the-evidence analysis be performed (1) on the existing relevant data.
Ta metoda vključuje priporočilo, da je treba pred začetkom opravljanja opisanega preskusa in vivo za akutno očesno dražilnost/jedkost opraviti analizo tehtnosti dokazov (1) na podlagi ustreznih obstoječih podatkov.
Where insufficient data are available, it is recommended that they be developed through application of sequential testing (2)(3).
Kadar ni na voljo dovolj podatkov, je priporočeno, da se pridobijo z uporabo zaporednega preskušanja (2)(3).
The testing strategy includes the performance of validated and accepted in vitro tests and is provided as an Appendix to the testing method.
Strategija preskušanja vključuje opravljanje validiranih in sprejetih in vitro preskusov in je dana kot dodatek k tej metodi preskušanja.
In addition, the use of an in vivo dermal irritation/corrosion test to predict eye corrosion prior to consideration of an in vivo eye test is recommended.
Poleg tega je priporočena uporaba in vivo preskusa dermalne dražilnosti/jedkosti, da se predvidi očesna jedkost pred upoštevanjem očesnega preskusa in vivo.
In the interest of both sound science and animal welfare, in vivo testing should not be considered until all available data relevant to the potential eye corrosivity/irritation of the substance has been evaluated in a weight-of-the-evidence analysis.
Za znanstveno zanesljivost in zdravje živali je koristno, da se preskušanje in vivo ne začne opravljati, dokler se niso ocenili vsi razpoložljivi podatki, pomembni za možno očesno dražilnost/jedkost snovi z analizo tehtnosti dokazov.
Such data will include evidence from existing studies in humans and/or laboratory animals, evidence of corrosivity/irritation of one or more structurally related substances or mixtures of such substances, data demonstrating high acidity or alkalinity of the substance (4)(5), and results from validated and accepted in vitro or ex vivo tests for skin corrosion and irritation (6)(6a).
Takšni podatki bodo vključevali dokaze iz obstoječih študij na ljudeh in/ali laboratorijskih živalih o dražilnosti/jedkosti ene ali več strukturno sorodnih snovi ali mešanic takšnih snovi, podatke, ki bodo dokazovali močno kislost ali alkalnost snovi (4)(5), in rezultate validiranih in sprejetih in vitro ali ex vivo preskusov za kožno jedkost in dražilnost (6)(6a).
The studies may have been conducted prior to, or as a result of, a weight-of-the-evidence analysis.
Mogoče je, da so se te študije opravile na podlagi analize tehtnosti dokazov ali pa iz nje sledile.
For certain substances, such an analysis may indicate the need for in vivo studies of the ocular corrosion/irritation potential of the substance.
Za nekatere snovi lahko takšna analiza nakaže potrebo po in vivo študijah potenciala očesne jedkosti/dražilnosti snovi.
In all such cases, before considering the use of the in vivo eye test, preferably a study of the in vivo dermal effects of the substance should be conducted first and evaluated in accordance with testing method B.4 (7).
V takšnih primerih bi bilo bolje pred upoštevanjem uporabe očesnega preskusa in vivo najprej opraviti in vivo študijo kožnih učinkih snovi in jih oceniti v skladu z metodo preskušanja B.4 (7).
The application of a weight-of-the-evidence analysis and the sequential testing strategy should decrease the need for in vivo testing for eye corrosivity/irritation of substances for which sufficient evidence already exists from other studies.
Uporaba analize tehtnostnih dokazov in strategija zaporednega preskušanja bi morali zmanjšati potrebo po in vivo preskušanju za očesno jedkost/dražilnost snovi, za katere obstaja že dovolj dokazov iz drugih študij.
If a determination of eye corrosion or irritation potential cannot be made using the sequential testing strategy, even after the performance of an in vivo study of dermal corrosion and irritation, an in vivo eye corrosion/irritation test may be performed.
Če z uporabo strategije zaporednega preskušanja ni mogoče določiti potenciala očesne jedkosti ali dražilnosti niti po opravljeni in vivo študiji dermalne jedkosti in dražilnosti, se lahko opravi invivo preskus očesne jedkosti/dražilnosti.
A preferred sequential testing strategy, which includes the performance of validated in vitro or ex vivo tests for corrosion/irritation, is included in the Appendix to this testing method.
Bolj upoštevana strategija zaporednega preskušanja, ki vključuje opravljanje validiranih invitro ali ex vivo preskusov za jedkost/dražilnost, je vključena v dodatku k tej metodi preskušanja.
The strategy was developed at, and unanimously recommended by the participants of, an OECD workshop (8), and has been adopted as the recommended testing strategy in the Globally Harmonised System for the Classification of Chemical Substances (GHS) (9).
To strategijo so razvili in soglasno priporočili udeleženci OECD delavnice (8) in se je sprejela kot priporočena strategija preskušanja v Globalno usklajenem sistemu za razvrstitev kemijskih snovi (GHS) (9).
For new substances it is the recommended stepwise testing approach for developing scientifically sound data on the corrosivity/irritation of the substance.
Za nove snovi je priporočen postopen način preskušanja za pridobivanje znanstveno zanesljivih podatkov o jedkosti/dražilnosti snovi.
For existing substances with insufficient data on skin and eye corrosion/irritation, the strategy should be used to fill missing data gaps.
Za obstoječe snovi, za katere ni dovolj podatkov o kožni in očesni jedkosti/dražilnosti, je treba uporabiti to strategijo za zapolnitev vrzeli manjkajočih podatkov.
The use of a different testing strategy or procedure, or the decision not to use a stepwise testing approach, should be justified.
Uporabo drugačne strategije preskušanja ali postopka ali odločitev, da se ne bo uporabil način postopni preskušanja, je treba obrazložiti.
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.
Očesna dražilnost: je nastanek sprememb na očesu, ki sledijo aplikaciji preskusne snovi na sprednjo površino očesa in ki so v celoti reverzibilne v 21 dneh aplikacije.
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.
Očesna jedkost: je nastanek poškodbe tkiva v očesu ali resnega fizičnega poslabšanja vida, ki sledi aplikaciji preskusne snovi na sprednjo površino očesa in ki ni v celoti reverzibilna v 21 dneh aplikacije.
The substance to be tested is applied in a single dose to one of the eyes of the experimental animal; the untreated eye serves as the control.
Snov, ki jo je treba preskusiti, se nanese v enkratnem odmerku na eno od očes eksperimentalne živali; netretirano oko služi za kontrolo.
The degree of eye irritation/corrosion is evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals.
Stopnja očesne dražilnosti/jedkosti se oceni s seštevanjem lezij na očesni veznici, roženici in šarenici, v točno določenih intervalih.
Other effects in the eye and adverse systemic effects are also described to provide a complete evaluation of the effects.
Drugi učinki na oko in nasprotni sistemski učinki se prav tako opišejo, da se zagotovi celovito vrednotenje učinkov.
The duration of the study should be sufficient to evaluate the reversibility or irreversibility of the effects.
Študija mora trajati dovolj dolgo, da se oceni reverzibilnost ali ireverzibilnost učinkov.
Criteria for making the decision to humanely kill moribund and severely suffering animals can be found in reference (10).
Kriterije za sprejem odločitve o humani usmrtitvi umirajočih in hudo trpečih živali je mogoče najti v sklicu (10).
Selection of species
Izbira vrst
The albino rabbit is the preferable laboratory animal, and healthy young adult animals are used.
Kunec beličnik je najbolj zaželena laboratorijska žival in uporabljajo se zdrave mlade odrasle živali.
A rationale for using other strains or species should be provided.
Za uporabo drugih sevov ali vrst je potrebna obrazložitev.
Both eyes of each experimental animal provisionally selected for testing should be examined within 24 hours before testing starts.
Obe očesi vsake eksperimentalne živali, do nadaljnjega izbrane za preskušanje, je treba pregledati v 24 urah, preden se preskušanje začne.
Animals showing eye irritation, ocular defects, or pre-existing corneal injury should not be used.
Živali, ki kažejo očesno dražilnost, očesne napake ali že prej nastalo poškodbo roženice, se ne smejo uporabiti.
The test substance should be placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball.
Preskusno snov je treba dati v mešiček veznice enega očesa vsake živali, potem ko se nežno potegne spodnja veka stran od zrkla.
The lids are then gently held together for about one second in order to prevent loss of the material.
Veke se nato nežno držijo skupaj približno 1 sekundo, da se prepreči izguba materiala.
The other eye, which remains untreated, serves as a control.
Drugo oko, ki ostane netretirano, služi za kontrolo.
Irrigation
Izpiranje
The eyes of the test animals should not be washed for at least 24 hours following instillation of the test substance, except for solids (see Section 1.4.2.3.2), and in case of immediate corrosive or irritating effects.
Oči preskusnih živali se ne smejo umivati najmanj 24 ur po vkapanju preskusne snovi, z izjemo trdnih snovi (glej oddelek 1.4.2.3.2) in v primeru takojšnjih jedkih ali dražilnih učinkov.
At 24 hours a washout may be used if considered appropriate.
Po 24 urah se lahko uporabi izpiranje, če se meni, da je to ustrezno.
Use of a satellite group of animals to investigate the influence of washing is not recommended unless it is scientifically justified.
Uporaba satelitske skupine živali za raziskovanje vpliva izpiranja ni priporočena, razen če je znanstveno upravičena.
If a satellite group is needed, two rabbits should be used.
Če je satelitska skupina potrebna, je treba uporabiti dva kunca.
Conditions of washing should be carefully documented, e.g. time of washing; composition and temperature of wash solution; duration, volume, and velocity of application.
Pogoje izpiranja je treba skrbno dokumentirati, npr. čas izpiranja; sestavo in temperaturo raztopine za izpiranje; trajanje, volumen in hitrost aplikacije.
Testing of liquids
Preskušanje tekočih snovi
For testing liquids, a dose of 0,1 ml is used.
Za preskušanje tekočih snovi se uporablja odmerek 0,1 ml.
Pump sprays should not be used for instilling the substance directly into the eye.
Razpršila pod pritiskom se ne smejo uporabljati za vkapanje snovi neposredno v oko.
The liquid spray should be expelled and collected in a container prior to instilling 0,1 ml into the eye.
Tekoče razpršilo je treba iztisniti in zbrati v posodo pred vkapanjem 0,1 ml v oko.
Testing of solids
Preskušanje trdnih snovi
When testing solids, pastes, and particulate substances, the amount used should have a volume of 0,1 ml or a weight of not more than 100 mg.
Pri preskušanju trdnih snovi, kašnatih zmesi in zdrobljenih snovi, mora imeti uporabljena količina volumen 0,1 ml ali težo, ki ni večja kakor 100 mg.
The test material should be ground to a fine dust.
Preskusni material je treba zdrobiti v fin prah.
The volume of solid material should be measured after gently compacting it, e.g. by tapping the measuring container.
Volumen trdnega materiala je treba izmeriti po rahlem zgoščevanju, npr. z rahlim potrkavanjem na merilno posodo.
If the solid test substance has not been removed from the eye of the test animal by physiological mechanisms at the first observation time point of one hour after treatment, the eye may be rinsed with saline or distilled water.
Če fiziološki mehanizmi niso odstranili iz očesa preskusne živali trdno preskusno snov na prvi časovni točki opazovanja eno uro po tretiranju, se lahko oko izplakne z raztopino vode in soli ali destilirano vodo.
Testing of aerosols
Preskušanje razpršil
It is recommended that all pump sprays and aerosols be collected prior to instillation into the eye.
Priporočeno je, da se vsa utekočinjena razpršila in razpršila pod pritiskom zberejo v posodo pred vkapanjem v oko.
The one exception is for substances in pressurised aerosol containers, which cannot be collected due to vaporisation.
Izjema so snovi v posodah za razpršila pod pritiskom, ki jih ni mogoče zbrati zaradi izhlapevanja.
In such cases, the eye should be held open, and the test substance administered to the eye in a simple burst of about one second, from a distance of 10 cm directly in front of the eye.
V takšnih primerih je treba držati oko odprto in nanesti preskusno snov v oko enostavnim z vbrizgom, ki traja približno eno sekundo, z razdalje 10 cm neposredno pred očesom.
This distance may vary depending on the pressure of the spray and its contents.
Ta razdalja se lahko spreminja v odvisnosti od pritiska razpršila in njegove vsebine.
Care should be taken not to damage the eye from the pressure of the spray.
Paziti je treba, da se oko ne poškoduje zaradi pritiska razpršila.
In appropriate cases, there may be a need to evaluate the potential for ‘mechanical’ damage to the eye from the force of the spray.
V ustreznih primerih bo mogoče potrebno oceniti potencial za nastanek „mehanske“ poškodbe očesa zaradi moči razpršila.
An estimate of the dose from an aerosol can be made by simulating the test as follows: the substance is sprayed on to weighing paper through an opening the size of a rabbit eye placed directly before the paper.
Oceno odmerka iz razpršila je mogoče dobiti z naslednjim preskusom: snov se razprši na tehtalni papir skozi odprtino velikosti kunčjega očesa, ki je nameščena neposredno pred papir.
The weight increase of the paper is used to approximate the amount sprayed into the eye.
Porast teže papirja se uporabi za približno določitev količine, razpršene v oko.
For volatile substances, the dose may be estimated by weighing a receiving container before and after removal of the test material.
Za hlapljive snovi je mogoče odmerek oceniti s tehtanjem v zbirni posodi pred in po odstranitvi preskusnega material.
Initial test (in vivo eye irritation/corrosion test using one animal)
Začetni preskus (In vivo preskus očesne dražilnosti/jedkosti z uporabo ene živali)
As articulated in the sequential testing strategy (see Appendix 1), it is strongly recommended that the in vivo test be performed initially using one animal.
Kot je opredeljeno v strategiji zaporednega preskušanja (glej Dodatek 1), je zelo priporočeno, da se preskus in vivo na začetku izvede z uporabo ene živali.
If the results of this test indicate the substance to be corrosive or a severe irritant to the eye using the procedure described, further testing for ocular irritancy should not be performed.
Če rezultati tega preskusa kažejo, da je snov jedka ali resno dražilna za oči z uporabo opisanega postopka, se nadaljnje preskušanje za očesno dražilnost ne opravi..
Local anaesthetics may be used on a case-by-case basis.
Lokalni anestetiki se uporabljajo v odvisnosti od primera.
If the weight-of-the-evidence analysis indicates that the substance has the potential to cause pain, or initial testing shows that a painful reaction will occur, a local anaesthetic may be used prior to instillation of the test substance.
Če analiza tehtnosti dokazov kaže, da snov lahko povzroči bolečino, ali če začetno preskušanje pokaže, da bo nastala boleča reakcija, se lokalni anestetik lahko uporabi pred vkapanjem preskusne snovi.
The type, concentration, and dose of the local anaesthetic should be carefully selected to ensure that differences in reaction to the test substance will not result from its use.
Vrsto, koncentracijo in odmerek lokalnega anestetika je treba skrbno izbrati, da se zagotovi, da razlike pri reagiranju na preskusno snov ne bodo posledica njegove uporabe.
The control eye should be similarly anaesthetised.
Na podoben način je treba anestezirati kontrolno oko.
Confirmatory test (in vivo eye irritation test with additional animals)
Potrditveni preskus (In vivo preskus dražilnosti z dodatnimi živalmi)
If a corrosive effect is not observed in the initial test, the irritant or negative response should be confirmed using up to two additional animals.
Če se jedek učinek ne opazi v začetnem preskusu, je treba dražilni ali negativni odziv potrditi z uporabo do dveh dodatnih živali.
If a severe irritant effect is observed in the initial test indicating a possible strong (irreversible) effect in the confirmatory testing, it is recommended that the confirmatory test be conducted in a sequential manner in one animal at a time, rather than exposing the two additional animals simultaneously.
Če se v začetnem preskusu opazi resen dražilen učinek, ki kaže, da je možen močan (ireverzibilen) učinek pri potrditvenem preskušanju, je priporočeno, da se potrditveni preskus izvede na zaporeden način na eni živali namesto s sočasno izpostavitvijo dveh dodatnih živali.
If the second animal reveals corrosive or severe irritant effects, the test is not continued.
Če druga žival razkrije jedke ali resne dražilne učinke, se preskus ne nadaljuje.
Additional animals may be needed to confirm weak or moderate irritant responses.
Mogoče bodo potrebne dodatne živali za potrditev šibkih ali zmernih dražilnih odzivov.
The duration of the observation period should be sufficient to evaluate fully the magnitude and reversibility of the effects observed.
Trajanje obdobja opazovanja mora biti dovolj dolgo, da se lahko v celoti ovrednoti obseg in reverzibilnost opaženih učinkov.
However, the experiment should be terminated at any time that the animal shows continuing signs of severe pain or distress (9).
Preskus je treba zaključiti ob katerem koli času, kadar kaže žival trajajoče znake hude bolečine ali trpljenja (9).
To determine reversibility of effects, the animals should be observed normally for 21 days post administration of the test substance.
Za določitev reverzibilnosti učinkov je običajno treba živali opazovati 21 dni po nanašanju preskusne snovi.
If reversibility is seen before 21 days, the experiment should be terminated at that time.
Če se opazi reverzibilnost pred 21 dnem, je treba takrat preskus zaključiti.
Clinical observations and grading of eye reactions
Klinična opazovanja in uvrstitev očesnih reakcij v stopnje
The eyes should be examined at one, 24, 48, and 72 hours after test substance application.
Oči je treba pregledati po 1, 24, 48 in 72 urah po aplikaciji preskusne snovi.
Animals should be kept on test no longer than necessary once definitive information has been obtained.
Živali se lahko preskušajo le toliko časa, kolikor je potrebno za pridobitev dokončnih informacij.
Animals showing continuing severe pain or distress should be humanely killed without delay, and the substance assessed accordingly.
Živali, ki trajno kažejo hude bolečine in trpljenje, je treba nemudoma humano usmrtiti in v skladu s tem oceniti snov.
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.
Usmrtiti je treba živali z naslednjimi očesnimi lezijami po vkapanju: perforacija roženice ali značilno gnojenje roženice vključno s stafilomom; kri v sprednjem delu očesa; stopnja 4 motnosti roženice, ki ne popusti 48 ur; odsotnost svetlobnega refleksa (odziv šarenice stopnje 2), ki traja 72 ur; gnojenje veznične vrečke; nekroza veznične membrane ali žmurke; ali odstopanje.
This is because such lesions generally are not reversible
To pa zaradi tega, ker te lezije na splošno niso reverzibilne.
Animals that do not develop ocular lesions may be terminated not earlier than three days post instillation.
Živali, pri katerih se ne razvijejo očesne lezije, se lahko usmrti ne prej kot 3 dni po instilaciji.
Animals with mild to moderate lesions should be observed until the lesions clear, or for 21 days, at which time the study is terminated.
Živali z blagimi do zmernimi lezijami je treba opazovati dokler lezije ne izginejo ali 21 dni, ko se raziskava zaključi.
Observations should be performed at seven, 14, and 21 days in order to determine the status of the lesions, and their reversibility or irreversibility.
Opazovanja se izvajajo po 7, 14 in 21 dneh, da se določi stanje lezij ter njihova reverzibilnost ali ireverzibilnost.
The grades of ocular reaction (conjunctivae, cornea and iris) should be recorded at each examination (Table I).
Pri vsaki preiskavi je treba zabeležiti stopnjo očesne reakcije (veznice, roženice in šarenice) (tabela 1).
Any other lesions in the eye (e.g. pannus, staining) or adverse systemic effects should also be reported.
Navesti je treba tudi katere koli druge poškodbe očesa (npr. površinski keratitis/panus, obarvanost) ali neželene sistemske učinke.
Examination of reactions can be facilitated by use of a binocular loupe, hand slit-lamp, biomicroscope, or other suitable device.
Za lažji pregled reakcij se lahko uporablja binokularna lupa, ročni oftalmoskop, biomikroskop ali drug ustrezen pripomoček.
After recording the observations at 24 hours, the eyes may be further examined with the aid of fluorescein.
Po evidentiranju rezultatov opazovanja po 24 urah se lahko pregled oči nadaljuje s pomočjo fluoresceina.
The ocular irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility.
Rezultate očesne dražilnosti je treba oceniti v zvezi z vrsto in resnostjo lezij ter njihovo reverzibilnostjo ali pomanjkljivostjo reverzibilnosti.
Instead, individual scores should be viewed as reference values and are only meaningful when supported by a full description and evaluation of all observations.
Namesto tega je treba obravnavati posamezne rezultate kot referenčne vrednosti in so pomembni le, če jih potrjuje popoln opis in vrednotenje vseh opazovanj.