natgillin/translations-raw huggingface dataset:
A careful clinical examination should be made at least once each working day, other observations should be made daily with appropriate actions taken to minimise loss of animals to the study, e.g. necropsy or refrigeration of those animals found dead and isolation or sacrifice of weak or moribund animals.
Najmanj enkrat na vsak delavnik je treba izvesti temeljit klinični pregled, druga opazovanja pa se izvajajo vsak dan, z ustreznimi ukrepi za zmanjševanje izgube živali v študiji, npr. z obdukcijo ali ohladitvijo poginulih živali in osamitvijo ali žrtvovanjem šibkih ali umirajočih živali.
Observations should include changes in fur, treated skin, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern.
Opazovati je treba spremembe na kožuhu, tretirani koži, očeh in sluznici ter tudi v dihalih, obtočilih, avtonomnem in osrednjem živčevju, somatomotorični aktivnosti in vedenjskem vzorcu.
Particular attention should be directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
S posebno pozornostjo je treba opazovati tremor, krče, slinjenje, diarejo, letargijo, spanje in komo.
The time of death must be recorded as precisely as possible.
Čas smrti je treba zapisati kolikor je mogoče natančno.
Animals that die during the test and those surviving at the termination of the test are subjected to necropsy.
Na živalih, ki poginejo med preskušanjem, in tistih, preživelih ob koncu preskusa, se opravi obdukcija.
Assessment of toxicity in the other sex
Ocena strupenosti pri drugem spolu
After completion of the study in one sex, at least one group of five animals of the other sex is dosed to establish that animals of this sex are not markedly more sensitive to the test substance.
Po zaključku študije na enem spolu, se snov odmeri najmanj eni skupini 5 živali drugega spola, da se ugotovi, ali so živali tega spola izrazito občutljivejše za preskusno snov.
The use of fewer animals may be justified in individual circumstances.
V posameznih primerih je upravičena uporaba manjšega števila živali.
Where adequate information is available to demonstrate that animals of the sex tested are markedly more sensitive, testing in animals of the other sex may be dispensed with.
Kadar so na voljo zadovoljive informacije, ki kažejo, da so živali preskušenega spola izrazito občutljivejše, preskušanje živali drugega spola ni potrebno.
Data should be summarised in tabular form, showing for each test group the number of animals at the start of the test, time of death of individual animals, number of animals displaying other signs of toxicity, description of toxic effects and necropsy findings.
Podatke je treba povzeti v tabeli, ki za vsako preskusno skupino prikazuje število živali na začetku preskusa, čas smrti posameznih živali, število živali, ki kažejo druge znake strupenosti, opis strupenih učinkov in izsledke obdukcije.
Individual weights of animals should be determined and recorded shortly before the test substance is applied, weekly thereafter, and at death; changes in weight should be calculated and recorded when survival exceeds one day.
Maso posameznih živali je treba določiti in zapisati tik pred nanašanjem preskusne snovi, vsak teden po tem ter ob smrti; spremembe v masi je treba izračunati in zapisati, kadar preskusna žival preživi več kakor en dan.
Data evaluation should include an evaluation of relationships, if any, between the animal's exposure to the test substance and the incidence and severity of all abnormalities, including behavioural and clinical abnormalities, gross lesions, body weight changes, mortality, and any other toxicological effects.
Vrednotenje podatkov mora vključevati vrednotenje morebitnih razmerij med izpostavljenostjo živali preskusni snovi ter incidenco in resnostjo vseh nepravilnosti, vključno z vedenjskimi in kliničnimi nepravilnostmi, hujšimi poškodbami, spremembami v telesni masi, smrtnostjo in kakršnimi koli drugimi strupenimi učinki.
test conditions (including method of skin cleansing and type of dressing: occlusive or not occlusive),
preskusni pogoji (vključno z metodo čiščenja kože in vrsto povoja: okluzivni ali neokluzivni),
dose levels (with vehicle, if used, and concentrations),
velikost odmerkov (z nosilcem, če se uporablja, in koncentracijami),
sex of animals dosed,
spol živali, ki so prejele preskusno snov,
tabulation of response data by sex and dose level (i.e. number of animals that died or were killed during the test, number of animals showing signs of toxicity, number of animals exposed),
tabelarni prikaz podatkov o odzivu po spolu in velikosti odmerka (tj. število živali, ki so poginile ali so bile usmrčene med preskusom; število živali, ki kažejo znake strupenosti; število izpostavljenih živali),
time of death after dosing, reasons and criteria used for humane killing of animals,
čas smrti po odmerjanju, razlogi in merila za humano usmrtitev živali,
value for the sex subjected to a full study, determined at 14 days with the method of determination specified,
vrednost LD50 za spol, na katerem je bila opravljena popolna študija, določena po 14 dneh z navedeno metodo določanja,
95 % confidence interval for the LD50 (where this can be provided),
95 % interval zaupanja za LD50 (kadar je to mogoče),
dose/mortality curve and slope where permitted by the method of determination,
krivulja odmerek/smrtnost in naklon, kadar to omogoča metoda določanja,
results of any test on the other sex,
rezultati kakršnih koli preskusov na drugem spolu,
discussion of results (particular attention should be given to the effect that humane killing of animals during the test may have on the calculated LD50 value),
razprava o rezultatih (posebno pozornost je treba posvetiti morebitnemu učinku humanih usmrtitev živali med preskusom na izračunano vrednost LD50),
This method is equivalent to the OECD TG 404 (2002).
Ta metoda ustreza OECD TG 404 (2002).
In the preparation of this updated method special attention was given to possible improvements in relation to animal welfare concerns and to the evaluation of all existing information on the test substance in order to avoid unnecessary testing in laboratory animals.
Pri pripravi te dopolnjene metode je veljala posebna pozornost možnim izboljšavam v zvezi s skrbjo za zdravje živali in vrednotenje vseh obstoječih informacij o preskusni snovi, da bi se izognili nepotrebnemu preskušanju na laboratorijskih živalih.
This method includes the recommendation that prior to undertaking the described in vivo test for corrosion/irritation of the substance, a weight-of-the-evidence analysis be performed on the existing relevant data.
Ta metoda vključuje priporočilo, da je treba pred začetkom opravljanja preskusa za dražilnost/jedkost snovi in vivo opraviti analizo tehtnosti dokazov na podlagi pomembnih obstoječih podatkov.
Where insufficient data are available, they can be developed through application of sequential testing (1).
Kadar ni na voljo dovolj podatkov, se lahko pridobijo z uporabo zaporednega preskušanja (1).
The testing strategy includes the performance of validated and accepted in vitro tests and is provided as an Appendix to this method.
Strategija preskušanja vključuje opravljanje validiranih in sprejetih in vitro preskusov in je podana kot dodatek k tej metodi.
In addition, where appropriate, the successive, instead of simultaneous, application of the three test patches to the animal in the initial in vivo test is recommended.
Kjer je to ustrezno, je poleg tega priporočena zaporedna aplikacija treh preskusnih obližev na živali v začetnem preskusu in vivo namesto sočasne.
In the interest of both sound science and animal welfare, in vivo testing should not be undertaken until all available data relevant to the potential dermal corrosivity/irritation of the substance have 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 dermalno 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 strong acidity or alkalinity of the substance (2)(3), and results from validated and accepted in vitro or ex vivo tests (4)(5)(5a).
Takšni podatki bodo vključevali dokaze obstoječih študij na ljudeh in/ali laboratorijskih živalih, dokaze o dražilnosti/jedkosti ene ali več strukturno sorodnih snovi ali mešanic takšnih snovi, podatke, ki bodo dokazovali močno kislost ali alkalnost snovi (2)(3), in rezultate iz validiranih in sprejetih in vitro ali ex vivo preskusov (4)(5)(5a).
This analysis should decrease the need for in vivo testing for dermal corrosivity/irritation of substances for which sufficient evidence already exists from other studies as to those two endpoints.
Ta analiza bi morala zmanjšati potrebo po in vivo preskušanju dermalne jedkosti/dražilnosti snovi, za katere obstaja že dovolj dokazov iz drugih študij glede navedenih dveh končnih točk.
A preferred sequential testing strategy, which includes the performance of validated and accepted in vitro or ex vivo tests for corrosion/irritation, is included as an Appendix to this Method.
Bolj upoštevana strategija zaporednega preskušanja, ki vključuje opravljanje validiranih in sprejetih in vitro ali ex vivo preskusov za jedkost/dražilnost, je vključena kot dodatek k tej metodi.
The strategy was developed at, and unanimously recommended by the participants of, an OECD workshop (6), and has been adopted as the recommended testing strategy in the Globally Harmonised System for the Classification of Chemical Substances (GHS) (7).
To strategijo so razvili in soglasno priporočili udeleženci OECD delavnice (6) in se je sprejela kot priporočena strategija preskušanja v Globalno usklajenem sistemu za razvrstitev kemijskih snovi (GHS) (7).
It is recommended that this testing strategy be followed prior to undertaking in vivo testing.
Priporočeno se je ravnati po tej strategiji preskušanja pred opravljanjem preskušanja in vivo.
For new substances it is the recommended a 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 dermal corrosion/irritation, the strategy should be used to fill missing data gaps.
Za obstoječe snovi, za katere ni dovolj podatkov, je treba uporabiti to strategijo za zapolnitev vrzeli manjkajočih podatkov.
The use of a different testing strategy or procedure, or a 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 preskušanja po korakih, je treba upravičiti.
If a determination of corrosivity or irritation cannot be made using a weight-of-the-evidence analysis, consistent with the sequential testing strategy, an in vivo test should be considered (see Appendix).
Če določitev jedkosti ali dražilnosti ni mogoča na podlagi analize tehtnosti dokazov, skladne s strategijo zaporednega preskušanja, je treba upoštevati preskus in vivo (glej Dodatek).
Dermal irritation: is the production of reversible damage of the skin following the application of a test substance for up to four hours.
Dermalna dražilnost: je nastanek reverzibilne poškodbe kože, ki sledi uporabi preskusne snovi, trajajoči do 4 ure.
Dermal corrosion: is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours.
Dermalna jedkost: je nastanek ireverzibilne poškodbe kože, in sicer vidne nekroze skozi epidermisa in v dermis, ki sledi uporabi preskusne snovi, trajajoči do 4 ure.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discoloration due to blanching of the skin, complete areas of alopecia, and scars.
Za jedke reakcije so značilni čiri, krvavitve, krvave kraste in na koncu štirinajstdnevnih opazovanj sprememba barve zaradi pobledele kože, celi predeli plešavosti in brazgotine.
Histopathology should be considered to evaluate questionable lesions.
Dvomljive lezije je treba preiskati histopatološko.
The substance to be tested is applied in a single dose to the skin of an experimental animal; untreated skin areas of the test animal serve as the control.
Snov, ki jo je treba preskusiti, se nanese na kožo preskusne živali v enkratnem odmerku; netretirane površine kože preskusne živali služijo za kontrolo.
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.
Živali, ki kažejo trajne znake hudega trpljenja in/ali bolečine v kateri koli fazi preskusa, je treba humano usmrtiti in snov skladno s tem oceniti.
Criteria for making the decision to humanely kill moribund and severely suffering animals can be found in reference (8).
Kriterije za sprejem odločitve o humani usmrtitvi umirajočih in hudo trpečih živali je mogoče najti v sklicu (8).
Preparation for the in vivo test
Priprava za preskus in vivo
The albino rabbit is the preferable laboratory animal and healthy young adult rabbits are used.
Kunec beličnik je najbolj zaželena laboratorijska žival in uporabljajo se zdravi mladi odrasli kunci.
A rationale for using other species should be provided.
Za uporabo drugih vrst je potrebna obrazložitev.
Preparation of the animals
Priprava živali
Approximately 24 hours before the test, fur should be removed by closely clipping the dorsal area of the trunk of the animals.
Približno 24 ur pred preskusom je treba odstraniti kožuh s skrbnim striženjem na hrbtnem delu trupa živali.
Care should be taken to avoid abrading the skin, and only animals with healthy, intact skin should be used.
Paziti je treba, da se ne odrgne koža in uporabiti le živali z zdravo, nepoškodovano kožo.
Some strains of rabbit have dense patches of hair that are more prominent at certain times of the year.
Nekateri kunčji sevi imajo goste zaplate dlak, ki so bolj izrazite v nekaterih obdobjih med letom.
Such areas of dense hair growth should not be used as test sites.
Takšni predeli goste rasti dlak se ne smejo uporabiti kot preskusni predeli.
Animals should be individually housed.
Živali je treba namestiti posamično.
For feeding, conventional laboratory diets may be used with an unrestricted supply of drinking water.
Za hranjenje se lahko uporabijo običajne predpisane laboratorijske vrste hrane z neomejeno količino pitne vode.
Application of the test substance
Aplikacija preskusne snovi
The test substance should be applied to a small area (approximately 6 cm2) of skin and covered with a gauze patch, which is held in place with non-irritating tape.
Preskusno snov je treba nanesti na del površine kože (približno 6 cm) in pokriti z obližem iz gaze, ki se pritrdi z nedražilnim trakom.
In cases in which direct application is not possible (e.g. liquids or some pastes), the test substance should first be applied to the gauze patch, which is then applied to the skin.
Kadar neposredna aplikacija ni mogoče (npr. tekoče snovi ali nekatere kašnate zmesi), je treba preskusno snov najprej nanesti na obliž iz gaze, ki se nato uporabi na koži.
The patch should be loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period.
Obliž mora biti v ohlapnem stiku s kožo, pritrjen z ustrezno napol zapiralno obvezo med trajanjem izpostavitve.
If the test substance is applied to the patch, it should be attached to the skin in such a manner that there is good contact and uniform distribution of the substance on the skin.
Če se preskusna snov nanese na obliž, jo je treba pritrditi na kožo na takšen način, da je stik dober in snov enakomerno razporejena po koži.
Access by the animal to the patch and ingestion or inhalation of the test substance should be prevented.
Treba je preprečiti živali dostop do obliža in zaužitje ali vdihavanje preskusne snovi.
When testing solids (which may be pulverised, if considered necessary), the test substance should be moistened with the smallest amount of water (or, where necessary, of another suitable vehicle) sufficient to ensure good skin contact.
Kadar se preskušajo trdne snovi (ki se jih lahko zdrobi, če je to po presoji potrebno), je treba preskusno snov navlažiti z zelo majhno količino vode (ali, kadar je potrebno, z drugim ustreznim nosilcem), ki zadostuje za zagotavljanje dobrega stika s kožo.
When vehicles other than water are used, the potential influence of the vehicle on irritation of the skin by the test substance should be minimal, if any.
Kadar se uporabljajo drugi nosilci in ne voda, mora biti možen vpliv nosilca na dražilnost kože zaradi preskusne snovi minimalen, če sploh kateri.
At the end of the exposure period, which is normally four hours, residual test substance should be removed, where practicable, using water or an appropriate solvent without altering the existing response or the integrity of the epidermis.
Na koncu obdobja izpostavljenosti, ki traja običajno 4 ure, je treba odstraniti preostalo preskusno snov, kjer je to izvedljivo, z uporabo vode ali ustreznega topila, ne da bi se spremenil obstoječi odziv ali integriteta epidermisa.
Dose level
Velikost odmerka
A dose of 0,5 ml. of liquid or 0,5 g of solid or paste is applied to the test site.
Odmerek 0,5 ml tekoče snovi ali 0,5 g trdne snovi ali kašnate zmesi se nanese na preskusni predel.
Initial test (in vivo dermal irritation/corrosion test using one animal)
Začetni preskus (dermalni preskus dražilnosti/jedkosti in vivo z uporabo ene živali)
It is strongly recommended that the in vivo test be performed initially using one animal, especially when the substance is suspected to have corrosion potential.
Močno je priporočeno, da se preskus in vivo na začetku izvede z uporabo ene živali, zlasti kadar se za snov domneva, da je potencialno jedka.
This is in accordance with the sequential testing strategy (see Appendix 1).
To je v skladu s strategijo zaporednega preskušanja (glej Dodatek 1).
When a substance has been judged to be corrosive on the basis of a weight-of-the-evidence analysis, no further animal testing is needed.
Kadar se za snov na podlagi analize tehtnosti dokazov presodi, da je jedka, ni potrebno nadaljnje preskušanje na živalih.
For most substances suspected of being corrosive, further in vivo testing is normally not necessary.
Za večino snovi, za katere se domneva, da so jedke, nadaljnje preskušanje in vivo običajno ni potrebno.
However, in those cases where additional data are felt warranted because of insufficient evidence, limited animal testing may be carried out using the following approach: up to three tests patches are applied sequentially to the animal.
Kadar se kljub temu zdi potrebno zagotoviti dodatne podatke zaradi pomanjkljivih dokazov, se lahko izvede preskušanje na živalih z uporabo naslednjega pristopa: Na žival se zaporedoma nanesejo do trije preskusni obliži.
The first patch is removed after three minutes.
Prvi obliž se odstrani po treh minutah.
If no serious skin reaction is observed, a second patch is applied and removed after one hour.
Če ni opazna nobena resna reakcija kože, se nanese drugi obliž in se odstrani po eni uri.
If the observations at this stage indicate that exposure can humanely be allowed to extend to four hours, a third patch is applied and removed after four hours, and the response is graded.
Če kažejo opazovanja v tej fazi, da se na human način lahko dopusti podaljšanje izpostavljenosti na štiri ure, se nanese tretji obliž in se odstrani po štirih urah, odziv pa se razvrsti po stopnjah.
If a corrosive effect is observed after any of the three sequential exposures, the test is immediately terminated.
Če se opazi jedek učinek po kateri koli izmed teh treh zaporednih izpostavitev, se preskus nemudoma zaključi.
If a corrosive effect is not observed after the last patch is removed, the animal is observed for 14 days, unless corrosion develops at an earlier time point.
Če se jedek učinek ne opazi po tem, ko se odstrani zadnji obliž, se žival opazuje 14 dni, razen kadar se jedkost razvije v zgodnejši časovni točki.
In those cases in which the test substance is not expected to produce corrosion but may be irritating, a single patch should be applied to one animal for four hours.
Kadar se ne pričakuje, da bo preskusna snov povzročila jedkost, a bi lahko bila dražilna, je treba nanesti le en obliž na eno žival za štiri ure.
Confirmatory test (in vivo dermal irritation test with additional animals)
Potrditveni preskus (dermalni preskus dražilnosti in vivo z dodatnimi živalmi)
In the exceptional case, in which the initial test is not conducted, two or three animals may be treated with a single patch, which is removed after four hours.
Izjemoma, ko se začetni preskus ne izvaja, se lahko dve ali tri živali tretira le z enim obližem, ki se odstrani po štirih urah.
When two animals are used, if both exhibit the same response, no further testing is needed.
Kadar se uporabljata dve živali, ni potrebno nadaljnje preskušanje, če obe kažeta enak odziv.
Otherwise, the third animal is also tested.
V nasprotnem primeru se preskusi tudi tretja žival.
Equivocal responses may need to be evaluated using additional animals.
Možno je, da bo treba oceniti dvomljive odzive z uporabo dodatnih živali.
The duration of the observation period should be sufficient to evaluate fully the reversibility of the effects observed.
Obdobje opazovanja mora trajati dovolj dolgo, da se lahko v celoti ovrednoti reverzibilnost opaženih učinkov.
However, the experiment should be terminated at any time that the animal shows continuing signs of severe pain or distress.
Preskus je treba zaključiti ob katerem koli času, kadar kaže žival trajajoče znake hude bolečine ali okvar.
To determine the reversibility of effects, the animals should be observed up to 14 days after removal of the patches.
Za določitev reverzibilnosti učinkov je treba živali opazovati 14 dni po odstranitvi obližev.
If reversibility is seen before 14 days, the experiment should be terminated at that time.
Če se opazi reverzibilnost pred potekom 14 dni, je treba v tistem času preskus zaključiti.
Clinical observations and grading of skin reactions
Klinična opazovanja in razvrstitev reakcij kože v stopnje
All animals should be examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48 and 72 hours after patch removal.
Vse živali je treba pregledati, ali imajo znake rdečine in edemov, ter odzive zabeležiti po 60 minutah in nato po 24, 48 in 72 urah po odstranitvi obliža.
For the initial test in one animal, the test site is also examined immediately after the patch has been removed.
Za začetne preskuse na eni živali se pregleda tudi preskusni predel takoj za tem, ko se obliž odstrani.
Dermal reactions are graded and recorded according to the grades in the Table below.
Dermalne reakcije se razvrstijo v stopnje in zabeležijo v skladu s stopnjami iz tabele spodaj.
If there is damage to skin which cannot be identified as irritation or corrosion at 72 hours, observations may be needed until day 14 to determine the reversibility of the effects.
Če nastane poškodba kože, ki je ni mogoče opredeliti kot dražilnost ali jedkost po 72 urah, bodo morda potrebna opazovanja do štirinajstega dne za opredelitev reverzibilnosti učinkov.
In addition to the observation of irritation, all local toxic effects, such as defatting of the skin, and any systemic adverse effects (e.g. effects on clinical signs of toxicity and body weight), should be fully described and recorded.
Poleg opazovanja dražilnosti je treba v celoti zapisati in zabeležiti vse lokalne toksične učinke, kakor npr. tanjšanje kože in vse sistemske nasprotne učinke (npr. učinke na klinične znake toksičnosti in telesno težo).