natgillin/translations-raw huggingface dataset:
In diet or drinking water studies, the pups will additionally receive test substance directly when they commence eating for themselves during the last week of the lactation period.
Pri študijah s prehrano ali pitno vodo dobijo mladiči dodatno preskusno snov neposredno, ko začnejo v zadnjem tednu laktacijskega obdobja sami jesti.
For substances administered via the diet or drinking water, it is important to ensure that the quantities of the test substance involved do not interfere with normal nutrition or water balance.
Pri snoveh, ki se dajejo s hrano ali pitno vodo, je treba zagotoviti, da količine uporabljene preskusne snovi ne vplivajo na običajno raven vnosa hrane ali porabe vode.
When the test substance is administered in the diet either a constant dietary concentration (ppm) or a constant dose level in terms of the body weight of the animal may be used; the alternative used must be specified.
Kadar se preskusna snov daje s hrano, se lahko uporabi bodisi konstantna koncentracija v hrani (ppm) bodisi konstantna velikost odmerka glede na telesno maso živali; treba je navesti uporabljeni način.
For a substance administered by gavage, the dose should be given at similar times each day, and adjusted at least weekly to maintain a constant dose level in terms of animal body weight.
Če dajemo snov z gavažo, je treba odmerke dati vsak dan približno ob istem času in jih najmanj enkrat tedensko prilagoditi, da se vzdržuje konstantna velikost odmerka glede na telesno maso živali.
Information regarding placental distribution should be considered when adjusting the gavage dose based on weight.
Pri prilagajanju odmerka gavaže, ki temelji na masi, je treba upoštevati informacije o porazdelitvi posteljice.
Daily dosing of the parental (P) males and females shall begin when they are five to nine weeks old.
Dnevno dajanje odmerkov starševskim (P) samcem in samicam se začne, ko so stari 5 do 9 tednov.
Daily dosing of the F1 males and females shall begin at weaning; it should be kept in mind that in cases of test substance administration via diet or drinking water, direct exposure of the F1 pups to the test substance may already occur during the lactation period.
Dnevno dajanje odmerkov samcem in samicam F1 se začne ob odstavitvi; treba pa je upoštevati, da se lahko v primeru dajanja preskusne snovi s hrano ali pitno vodo začne neposredna izpostavljenost mladičev F1 preskusni snovi že v laktacijskem obdobju.
For both sexes (P and F1), dosing shall be continued for at least 10 weeks before the mating period.
Pri obeh spolih (P in F1) se odmerjanje nadaljuje najmanj 10 tednov pred obdobjem parjenja.
Dosing is continued in both sexes during the two week mating period.
Odmerjanje se nadaljuje pri obeh spolih še 2 tedna v obdobju parjenja.
Males should be humanely killed and examined when they are no longer needed for assessment of reproductive effects.
Samce je treba humano usmrtiti in preučiti, ko niso več potrebni za ocenjevanje reproduktivnih učinkov.
For parental (P) females, dosing should continue throughout pregnancy and up to the weaning of the F1 offspring.
Pri starševskih (P) samicah se mora odmerjanje nadaljevati skozi ves čas brej osti in do odstavljanja potomcev F1.
Consideration should be given to modifications in the dosing schedule based on available information on the test substance, including existing toxicity data, induction of metabolism or bioaccumulation.
Upoštevati je treba spremembe načrta odmerjanja, ki temeljijo na razpoložljivih informacijah o preskusni snovi, vključno z obstoječimi podatki o toksičnosti, nastajanju presnove ali bioakumulaciji.
The dose to each animal should normally be based on the most recent individual body weight determination.
Odmerek za vsako žival navadno temelji na zadnji posamični določitvi telesne mase.
Treatment of the P and F1 males and females shall continue until termination.
Tretiranje samcev in samic P in F1 se nadaljuje do konca.
All P and F1 adult males and females should be humanely killed when they are no longer needed for assessment of reproductive effects.
Vse odrasle samce in samice P in F1 je treba humano usmrtiti, ko niso več potrebni za ocenjevanje reproduktivnih učinkov.
offspring not selected for mating and all F2 offspring should be humanely killed after weaning.
Potomci F1, ki niso izbrani za parjenje, in vsi potomci F2 se humano usmrtijo po odstavitvi.
Parental (P) mating
Parjenje staršev (P)
For each mating, each female shall be placed with a single male from the same dose level (1:1 mating) until copulation occurs or twq weeks have elapsed.
Pri vsakem parjenju se vsaka samica da skupaj z enim samcem z enako velikostjo odmerka (parjenje 1: 1), dokler ne pride do kopulacije ali dokler ne mineta 2 tedna.
Each day, the females shall be examined for presence of sperm or vaginal plugs.
Samice se vsak dan pregledajo glede navzočnosti semena ali vaginalnega čepa.
Day 0 of pregnancy is defined as the day a vaginal plug or sperm are found.
Dan brej osti 0 je opredeljen kot dan, ko je najden vaginalni čep ali seme.
In case pairing is unsuccessful, re-mating of females with proven males of the same group could be considered.
V primeru, da parjenje ni uspešno, se lahko razmisli o ponovnem parjenju samic z dokazanimi samci iste skupine.
Mating pairs should be clearly identified in the data.
Sparjeni pari morajo biti jasno navedeni v podatkih.
Mating of siblings should be avoided.
Parjenju sorojencev se je treba izogibati.
mating
Parjenje F1
For mating the F1 offspring, at least one male and one female should be selected at weaning from each litter for mating with other pups of the same dose level but different litter, to produce the F2 generation.
Pri parjenju potomcev F1, je treba iz vsakega zaroda po odstavitvi izbrati najmanj enega samca in eno samico za parjenje z drugimi mladiči z enako velikostjo odmerka, vendar iz drugega zaroda, za ustvarjenje generacije F2.
Selection of pups from each litter should be random when no significant differences are observed in body weight or appearance between the litter mates.
Izbira mladičev iz vsakega zaroda mora biti naključna, brez značilnih opaznih razlik v telesni masi ali videzu med vrstniki iz zaroda.
In case these differences are observed, the best representatives of each litter should be selected.
V primeru, da so opažene te razlike, je treba izbrati najboljše predstavnike iz vsakega zaroda.
Pragmatically, this is best done on a body weight basis but it may be more appropriate on the basis of appearance.
Praktično je to najbolje storiti glede na telesno maso, lahko pa je primernejše na podlagi videza.
The F1 offspring should not be mated until they have attained full sexual maturity.
Potomci F1 se ne bi smeli pariti, dokler ne dosežejo polne spolne zrelosti.
Pairs without progeny should be evaluated to determine the apparent cause of the infertility.
Pari brez potomcev se morajo ovrednotiti, da se določi pravi vzrok neplodnosti.
This may involve such procedures as additional opportunities to mate with other proven sires or dams, microscopic examination of the reproductive organs, and examination of the oestrous cycles or spermatogenesis.
To lahko vključuje postopke, kot so dodatne možnosti za parjenje z drugimi dokazanimi očeti ali materami, mikroskopski pregled reproduktivnih organov in pregled ciklov estrusa ali spermatogeneze.
Second mating
Drugo parjenje
In certain instances, such as treatment-related alterations in litter size or the observation of an equivocal effect in the first mating, it is recommended that the P or F1 adults be remated to produce a second litter.
V nekaterih primerih, na primer pri spremembah velikosti zaroda, povezanih s tretiranjem, ali pri opaženem dvoumnem učinku pri prvem parjenju, je priporočljivo, da se odrasli P ali F1 ponovno parijo, da bi ustvarili drugi zarod.
It is recommended to remate females or males, which have not produced a litter with proven breeders of the opposite sex.
Priporočeno je, da se ponovno parijo samice ali samci, ki niso ustvarili zaroda z dokazanimi plemenskimi živalmi nasprotnega spola.
If production of a second litter is deemed necessary in either generation, animals should be remated approximately one week after weaning of the last litter.
Če se zdi, da je pri kateri koli generaciji potrebno ustvariti drugi zarod, je treba živali ponovno pariti približno en teden po odstavitvi zadnjega zaroda.
Litter size
Velikost zaroda
Animals shall be allowed to litter normally and rear their offspring to weaning.
Živalim se dovoli, da normalno skotijo in redijo svoje potomce do odstavitve.
Standardisation of litter sizes is optional.
Standardizacija velikosti zaroda ni obvezna.
When standardisation is done, the method used should be described in detail.
Kadar se standardizacija opravi, se metoda podrobno opiše.
Clinical observations
Klinična opazovanja
A general clinical observation should be made each day and, and in the case of gavage dosing its timing should take into account the anticipated peak period of effects after dosing.
Splošno klinično opazovanje je treba opraviti vsak dan in v primeru dajanja odmerkov z gavažo je treba upoštevati vrhunec pričakovanih učinkov po odmerjanju.
Behavioural changes, signs of difficult or prolonged parturition and all signs of toxicity should be recorded.
Zabeležiti je treba vedenjske spremembe, znake težke ali podaljšane kotitve in vse znake toksičnosti.
An additional, more detailed examination of each animal should be conducted on at least a weekly basis and could conveniently be performed on an occasion when the animal is weighed.
Dodatni, podrobnejši pregled vsake živali se izvede najmanj enkrat tedensko in se lahko primerno opravi takrat, ko se žival tehta.
Twice daily, during the weekend once daily when appropriate, all animals should be observed for morbidity and mortality.
Dvakrat dnevno, ob koncu tedna pa enkrat dnevno, je treba vse živali opazovati glede obolevnosti in smrtnosti.
Body weight and food/water consumption of parent animals
Telesna masa in poraba hrane/vode pri starših
Parental animals (P and Fl) shall be weighed on the first day of dosing and at least weekly thereafter.
Starši (P in F1) se stehtajo prvi dan dajanja odmerkov in potem najmanj enkrat tedensko.
Parental females (P and F1) shall be weighed at a minimum on gestation days 0, 7, 14, and 20 or 21, and during lactation on the same days as the weighing of litters and on the day the animals are killed.
Starševske samice (P in F1) se med brejostjo stehtajo najmanj na 0., 7., 14. in 20. ali 21. dan ter med laktacijo na iste dneve, kot je tehtanje zaroda, in na dan, ko so živali usmrčene.
During the premating and gestation periods food consumption shall be measured weekly at a minimum.
Med obdobjem pred parjenjem in med brejostjo se poraba hrane meri najmanj tedensko.
Water consumption shall be measured weekly at a minimum if the test substance is administered in the water.
Poraba vode se meri najmanj tedensko, če se preskusna snov daje z vodo.
Oestrus cycle
Cikel estrusa
Estrous cycle length and normality are evaluated in P and F1 females by vaginal smears prior to mating, and optionally during mating, until evidence of mating is found.
Dolžina in normalnost cikla estrusa se pri samicah P in F1 ovrednotita z vaginalnim brisom pred parjenjem in po izbiri med parjenjem, dokler ni najden dokaz o parjenju.
When obtaining vaginal/cervical cells, care should be taken to avoid disturbance of mucosa and subsequently, the induction of pseudopregnancy (1).
Med jemanjem vaginalnih/vratnih celic je treba paziti, da ne pride do poškodb sluznice in pozneje do nastanka psevdogravidnosti (1).
Sperm parameters
Parametri semena
For all P and F1 males at termination, testis and epididymis weight shall be recorded and one of each organ reserved for histopathological examination (see Section 1.5.7, 1.5.8.1).
Pri vseh samcih P in F1 se na koncu zabeleži teža moda in obmodka in po en organ od vsakega shrani za histopatološki pregled (glej oddelek 1.5.7, 1.5.8.1).
Of a subset of at least 10 males of each group of P and F1 males, the remaining testes and epididymides should be used for enumeration of homogenisation-resistant spermatids and cauda epididymal sperm reserves, respectively.
Za podskupino najmanj desetih samcev iz vsake skupine samcev P in F1 je treba preostala moda in obmodke uporabiti za štetje semenčic, odpornih na homogenizacijo, ali zalog semena v repu obmodka.
For this same subset of males, sperm from the cauda epididymides or vas deferens should be collected for evaluation of sperm motility and sperm morphology.
Pri tej isti podskupini samcev je treba zbrati seme iz repov obmodkov ali semenovodov za ovrednotenje gibljivosti in morfologije semena.
If treatment-related effects are observed or when there is evidence from other studies of possible effects on spermatogenesis, sperm evaluation should be conducted in all males in each dose group; otherwise enumeration may be restricted to control and high-dose P and F1 males.
Če se opazujejo učinki, povezani s tretiranjem, ali kadar je v drugih študijah dokaz za možne učinke na spermatogenezo, se ovrednotenje semena izvede pri vseh samcih v vsaki skupini odmerka; drugače se lahko štetje omeji na kontrolne samce in samce P in F1 z velikim odmerkom.
The total number of homogenisation-resistant testicular spermatids and cauda epididymal sperm should be enumerated (2)(3).
Prešteti je treba tudi celotno število semenčic iz moda, ki so odporne na homogenizacijo, in seme iz repa obmodka (2) (3).
Cauda sperm reserves can be derived from the concentration and volume of sperm in the suspension used to complete the qualitative evaluations, and the number of sperm recovered by subsequent mincing and/or homogenising of the remaining cauda tissue.
Na zaloge semena v repu se lahko sklepa po koncentraciji in količini semena v suspenziji, ki se uporabi za dokončanje kakovostnih vrednotenj, in števila semena, dobljenega z naknadnim mletjem in/ali homogeniziranjem preostalega tkiva repa obmodka.
If no treatment-related effects (e.g. effects on sperm count, motility, or morphology) are seen the other dose groups need not be analysed.
Če niso vidni nobeni učinki, povezani s tretiranjem (npr. učinki na število semenčic, gibljivost ali morfologijo), drugih skupin odmerkov ni treba analizirati.
When treatment-related effects are noted in the high-dose group, then the lower dose groups should also be evaluated.
Kadar se učinki, povezani s tretiranjem, opazijo v skupini z velikim odmerkom, je treba ovrednotiti tudi skupine z manjšim odmerkom.
Epididymal (or ductus deferens) sperm motility should be evaluated or video taped immediately after sacrifice.
Gibljivost semena v obmodku (ali semenovodu) je treba ovrednotiti ali posneti na video takoj po usmrtitvi.
Sperm should be recovered while minimising damage, and diluted for motility analysis using acceptable methods (4).
Seme je treba ohraniti s čim manjšimi poškodbami in razredčiti za analizo gibljivosti s sprejemljivimi metodami (4).
The percentage of progressively motile sperm should be determined either subjectively of objectively.
Odstotek progresivno gibljivega semena je treba določiti bodisi subjektivno ali objektivno.
When computer-assisted motion analysis is performed (5)(6)(7)(8)(9)(10) the derivation of progressive motility relies on user-defined thresholds for average path velocity and straightness or linear index.
Kadar se opravi analiza gibanja s pomočjo računalnika (5) (6) (7) (8) (9) (10), izpeljava progresivne gibljivosti temelji na uporabniško določenih pragovih za povprečno hitrost ali na linearnem indeksu.
If samples are videotaped (11) or the images are otherwise recorded at the time of necropsy, subsequent analysis of only control and high-dose P and F1 males may be performed unless treatment-related effects are observed; in that case, the lower dose groups should also be evaluated.
Če se v času obdukcije vzorci posnamejo na videotrak (11) ali se drugače zabeležijo slike, se lahko pozneje analizirajo le samci P in F1 iz kontrolne skupine in skupine z velikim odmerkom, razen če so opazni učinki, povezani s tretiranjem, v tem primeru je treba ovrednotiti tudi skupine z manjšim odmerkom.
In the absence of a video or digital image, all samples in all treatment groups should be analysed at necropsy.
Če ni video ali digitalne slike, se morajo ob obdukciji analizirati vsi vzorci iz vseh tretiranih skupin.
A morphological evaluation of an epididymal (or vas deferens) sperm sample should be performed.
Treba je opraviti morfološko ovrednotenje semena iz obmodka (ali semenovoda).
Sperm (at least 200 per sample) should be examined as fixed, wet preparations (12) and classified as either normal or abnormal.
Seme (najmanj 200 na vzorec) je treba preučiti kot fiksirane, mokre preparate (12) in ga razvrstiti bodisi v normalno ali nenormalno.
Examples of morphologic sperm abnormalities would include fusion, isolated heads, and misshapen heads and/or tails.
Primeri morfoloških anomalij semena vključujejo spojitev, ločene glavice ter glavice in/ali repke nepravilnih oblik.
Evaluation should be performed on the selected subset of males of all dose groups either immediately after killing the animals, or, based on the video or digital recordings, at a later time.
Ovrednotenje je treba izvesti na izbrani podskupini samcev v vseh skupinah odmerkov bodisi takoj po usmrtitvi živali ali pozneje na podlagi video ali digitalnih posnetkov.
Smears, once fixed, can also be read at a later time.
Tudi brisi se, potem ko so fiksirani, lahko preučujejo pozneje.
In these instances, the controls and high dose group may be analysed first.
V teh primerih se lahko najprej analizirajo kontrole in skupina z velikim odmerkom.
If no treatment-related effects (e.g. effects on sperm morphology) are seen the other dose groups need not be analysed.
Če niso vidni nobeni učinki (npr. učinki na morfologijo semena), drugih skupin odmerkov ni treba analizirati.
If any of the above sperm evaluation parameters have already been examined as part of a systemic toxicity study of at least 90 days, they need not necessarily be repeated in the two-generation study.
Če so bili zgornji parametri za ovrednotenje semena že preučeni v študiji sistemske toksičnosti, ki je trajala vsaj 90 dni, jih ni treba ponoviti v dvogeneracijski študiji.
It is recommended, however, that samples or digital recordings of sperm of the P generation are saved, to enable later evaluation, if necessary.
Vsekakor pa je priporočljivo, da se shranijo vzorci ali digitalni posnetki semena generacije P, da se omogoči poznejše vrednotenje, če bi bilo potrebno.
Each litter should be examined as soon as possible after delivery (lactation day 0) to establish the number and sex of pups, stillbirths, live births, and the presence of gross anomalies.
Vsak zarod je treba preučiti čim prej po skotitvi (laktacijski dan 0) in ugotoviti število in spol mladičev, mrtvorojenih, živorojenih, in navzočnost večjih nepravilnosti.
Pups found dead on day 0, if not macerated, should preferably be examined for possible defects and cause of death and preserved.
Mladiče, ki so mrtvi na dan 0, je najbolje, če se ne macerirajo, preučiti glede možnih napak in vzroka smrti in konzervirati.
Live pups should be counted and weighed individually at birth (lactation day 0) or on day 1, and on regular weigh days thereafter, e.g. on days 4, 7, 14, and 21 of lactation.
Žive mladiče je treba prešteti in posamično stehtati ob skotitvi (laktacijski dan 0) ali na dan 1 in pozneje na dneve rednega tehtanja, npr. na 4., 7., 14. in 21. dan laktacije.
Physical development of the offspring should be recorded mainly by body weight gain.
Telesni razvoj potomcev je treba zabeležiti v glavnem po prirastu telesne mase.
Other physical parameters (e.g. ear and eye opening, tooth eruption, hair growth) may give supplementary information, but these data should preferably be evaluated in the context of data on sexual maturation (e.g. age and body weight at vaginal opening or balano-preputial separation) (13).
Drugi telesni parametri (npr. očesne in ušesne odprtine, izbijanje zob, rast las) lahko dajo dodatne informacije, a ti podatki se raje ovrednotijo v kontekstu podatkov o spolni zrelosti (npr. starost in telesna masa ob vaginalni odprtini ali ločitvi prepucija na glavici penisa) (13).
Functional investigations (e.g. motor activity, sensory function, reflex ontogeny) of the F1 offspring before and/or after weaning, particularly those related to sexual maturation, are recommended if such investigations are not included in separate studies.
Funkcionalne preiskave (npr. motorične dejavnosti, senzorne funkcije, refleksna ontogenija) potomcev F1 pred in/ali po odstavitvi, zlasti tiste, ki se nanašajo na spolno zrelost, so priporočljive, če take preiskave niso vključene v posebne študije.
The age of vaginal opening and preputial separation should be determined for F1 weanlings selected for mating.
Starost vaginalne odprtine in ločitve prepucija je treba določiti pri odstavljenih mladičih F1, izbranih za parjenje.
Anogenital distance should be measured at postnatal day 0 in F2 pups if triggered by alterations in F1 sex ratio or timing of sexual maturation.
Zadnjično-genitalno razdaljo pri mladičih F2 je treba izmeriti na poporodni dan 0, če jo sprožijo spremembe v razmerju spolov pri F1 ali časovna uskladitev spolne zrelosti.
Functional observations may be omitted in groups that otherwise reveal clear signs of adverse effects (e.g. significant decrease in weight gain, etc.).
Funkcionalna opazovanja se lahko opustijo pri skupinah, ki sicer jasno kažejo znake škodljivih učinkov (npr. znatno zmanjšanje pridobivanja telesne mase itd.).
If functional investigations are made, they should not be done on pups selected for mating.
Če se opravljajo funkcionalne preiskave, naj se ne delajo na mladičih, ki so izbrani za parjenje.
At the time of termination or death during the study, all parental animals (P and F1), all pups with external abnormalities or clinical signs, as well as one randomly selected pup/sex/litter from both the F1 and F2 generation, shall be examined macroscopically for any structural abnormalities or pathological changes.
Na koncu študije ali ob smrti med študijo se makroskopsko pregledajo vsi starši (P in F1), vsi mladiči z zunanjimi anomalijami ali kliničnimi znaki, pa tudi po en naključno izbran mladič vsakega spola in zaroda iz obeh generacij F1 in F2 glede kakršnih koli strukturnih anomalij ali patoloških sprememb.
Special attention should be paid to the organs of the reproductive system.
Posebno pozornost je treba posvetiti organom reproduktivnega sistema.
Pups that are humanely killed in a moribund condition and dead pups, when not macerated, should be examined for possible defects and/or cause of death and preserved.
Mladiče, ki so humano usmrčeni v razmerah poginjanja, in mrtve mladiče je treba, če se ne macerirajo, preučiti glede možnih napak in/ali vzroka smrti in konzervirati.
The uteri of all primiparous females should be examined, in a manner which does not compromise histopathological evaluation, for the presence and number of implantation sites.
Maternice vseh samic, ki so prvič kotile, se pregledajo na način, ki ne škoduje histopatološkemu ovrednotenju, glede navzočnosti in števila vgnezditev.
Organ weights
Masa organov
At the time of termination, body weight and the weight of the following organs of all P and F1 parental animals shall be determined (paired organs should be weighed individually):
Na koncu se določi telesna masa in masa naslednjih organov vseh staršev P in F1 (parni organi se stehtajo posamično):
uterus, ovaries,
maternice, jajčnikov,
testes, epididymides (total and cauda),
mod, obmodkov (v celoti in repa),
seminal vesicles with coagulating glands and their fluids and prostate (as one unit),
semenskih mešičkov s koagulacijskimi žlezami in njihovimi tekočinami ter prostato (kot ena enota),
brain, liver, kidneys, spleen, pituitary, thyroid and adrenal glands and known target organs.
možganov, jeter, ledvic, vranice, hipofize, ščitnice in nadledvičnih žlez ter znanih ciljnih organov.
Terminal body weights should be determined for F1 and F2 pups that are selected for necropsy.
Končno telesno maso je treba določiti za mladiče F1 in F2, ki so izbrani za obdukcijo.