natgillin/translations-raw huggingface dataset:
, adrenals [6] These organs, from 10 animals per sex per group for rodents and all non-rodents, plus thyroid (with parathyroids) for all non-rodents, should be weighed.
, nadledvične žleze [6] Navedene organe, odvzete na desetih živalih po spolu na skupino v primeru glodalcev ter na vseh neglodalcih, skupaj s ščitnico (in obščitnicami), je treba stehtati.
, oesophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, uterus, urinary bladder, lymph nodes, pancreas, gonads [6] These organs, from 10 animals per sex per group for rodents and all non-rodents, plus thyroid (with parathyroids) for all non-rodents, should be weighed.
, požiralnik, želodec, dvanajsternik, zgornje tanko črevo, spodnje tanko črevo, slepo črevo, debelo črevo, danko, maternico, sečni mehur, limfne vozle, trebušno slinavko, spolne žleze [6] Navedene organe, odvzete na desetih živalih po spolu na skupino v primeru glodalcev ter na vseh neglodalcih, skupaj s ščitnico (in obščitnicami), je treba stehtati.
, accessory genital organs, female mammary gland, skin, musculature, peripheral, nerve, spinal cord (cervical, thoracic, lumbar), sternum with bone marrow and femur (including joint) and eyes.
, pomožne spolne organe, mlečno žlezo samic, kožo, mišičevje, periferni živec, hrbtenjača (vratni, prsni in ledveni del), prsnica s kostnim mozgom ter stegnenica (vključno s sklepom) in oči.
Inflation of lungs and urinary bladder with a fixative is the optimal way to preserve these tissues; inflation of the lungs in inhalation studies is essential for appropriate histopathological examination.
Vpihovanje pljuč in sečnega mehurja s fiksativom je najboljši način za ohranitev teh tkiv; vpihovanje pljuč pri inhalacijskih študijah je nujno za ustrezno histopatološko preiskavo.
In special studies such as inhalation studies, the entire respiratory tract should be studied, including nose, pharynx and larynx.
V posebnih študijah, kot so inhalacijske študije, je treba proučiti celotna dihala, vključno z nosom, žrelom in grlom.
If other clinical examinations are carried out, the information obtained from these procedures should be available before microscopic examination, because it may give significant guidance to the pathologist.
Če so opravljeni drugi klinični pregledi, morajo biti podatki, pridobljeni v teh postopkih, na voljo pred mikroskopskim pregledom, saj lahko to daje patologu pomembne smernice.
All visible changes, particularly tumours and other lesions occurring in any organ should be examined microscopically.
Vse vidne spremembe, zlasti tumorje in kemije. Lezije, ki nastanejo na katerem koli organu, je treba mikroskopsko pregledati.
In addition, the following procedures are recommended:
Poleg tega so priporočeni še naslednji postopki:
microscopic examination of all preserved organs and tissues with complete description of all lesions found in:
Mikroskopski pregled vseh ohranjenih organov in tkiv s popolnim opisom vseh lezij, odkritih pri:
all animals that died or were killed during the study;
vseh živalih, ki so umrle ali bile žrtvovane med študijo;
all of the high-dose group and controls;
vseh skupinah z visokimi odmerki gama-glutamil-transpeptidaza, kontrolnih skupinah;
organs or tissues showing abnormalities caused, or possibly caused, by the test substance are also examined in the lower-dose groups;
Organi ali tkiva, ki kažejo abnormalnosti, ki je povzročila ali verjetno povzročila preskusna snov se pregledajo tudi pri skupini z nizkim odmerkom;
where the result of the test gives evidence of substantial reduction of the animals' normal lifespan or the induction of effects that might affect a toxic response, the next-lower dose level should be examined as described above;
Kadar rezultat preskusa kaže na znatno zmanjšanje normalne življenjske dobe živali ali na sprožitev učinkov, ki lahko vplivajo na odziv strupenosti, je treba pregledati naslednjo skupino z nizkim odmerkom, kot je opisano zgoraj;
information on the incidence of lesions normally occurring in the strain of animals used, under the same laboratory conditions, i.e. historical control data, is indispensable for correctly assessing the significance of changes observed in treated animals.
Podatki o pojavu lezij, ki so običajne pri sevu uporabljenih živali pod enakimi laboratorijskimi pogoji, npr. pretekli kontrolni podatki, so nepogrešljivi za pravilno oceno pomembnosti sprememb, opaženih na korelacijo živalih.
Data should be summarised in tabular form, showing for each test group the number of animals at the start of the test, the number of animals showing lesions and the percentage of animals displaying each type of lesion.
Podatki se povzamejo v obliki tabele, iz katere so razvidni število živali za vsako preskusno skupino na začetku preskusa, število živali, pri katerih so opažene lezije, in odstotek živali, ki kažejo določen tip lezije.
Description of exposure apparatus:
Opis opreme za izpostavljenost:
Including design, type, dimensions, source of air, system for generating particulates and aerosols, method of conditioning air, treatment of exhaust air and the method of housing animals in a test chamber when this is used.
vključno z obliko, tipom, dimenzijami, virom zraka, sistemom za sproščanje delcev in aerosolov, metodo klimatiziranja, obdelavo izpušnega zraka in metodo nastanitve živali v preskusne komore, kadar so te uporabljene.
The equipment for measuring temperature, humidity and, where appropriate, stability of aerosol concentration or particle size, should be described.
Opisati je treba opremo za merjenje temperature, vlažnosti in, kadar je ustrezno, stabilnosti koncentracij aerosola ali velikosti delcev.
These should be tabulated and presented with mean values and a measure of variability (e.g. standard deviation) and should include:
zbrati jih je treba v tabeli in prikazati s srednjimi vrednostmi ter meritvami nihanj (npr. standardno odstopanje), zajemati pa morajo:
description of toxic and other effects,
opis strupenih ali drugih učinkov,
This method is a replicate of OECD TG 414 (2001).
Ta metoda ustreza metodi OECD TG 414 (2001).
This method for developmental toxicity testing is designed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism in utero; this may include assessment of maternal effects as well as death, structural abnormalities, or altered growth in the foetus.
Metoda za preskušanje strupenosti za razvoj je namenjena zagotavljanju splošnih informacij o učinkih predrojstvene izpostavljenosti breje preskusne živali in razvijajočih se organizmov v maternici; to lahko vključuje oceno vplivov matere, pa tudi smrti, strukturnih anomalij ali spremenjene rasti zarodka.
Functional deficits, although an important part of development, are not an integral part of this test method.
Funkcionalne pomanjkljivosti, čeprav pomemben del razvoja, niso sestavni del te preskusne metode.
They may be tested for in a separate study or as an adjunct to this study using the test method for developmental neurotoxicity.
Lahko se preizkusijo v posebni študiji ali kot dodatek k tej študiji z uporabo preskusne metode za razvojno nevrotoksičnost.
For information on testing for functional deficiencies and other postnatal effects the test method for the two-generation reproductive toxicity study and the developmental neurotoxicity study should be consulted as appropriate.
Za informacije o preskušanju funkcionalnih pomanjkljivosti in drugih poporodnih učinkov preskusne metode se lahko na primeren način uporabi študija dvogeneracijske reproduktivne strupenosti ali študija razvojne nevrotoksičnosti.
This test method may require specific adaptation in individual cases on the basis of specific knowledge on e.g. physicochemical or toxicological properties of the test substance.
Pri tej preskusni metodi je lahko v posameznih primerih potrebna posebna prilagoditev na podlagi posebnega poznavanja npr. fizikalno-kemijskih ali toksikoloških lastnosti preskusne snovi.
Such adaptation is acceptable, when convincing scientific evidence suggests that the adaptation will lead to a more informative test.
Taka prilagoditev je sprejemljiva, kadar prepričljivi znanstveni podatki kažejo, da bo prilagoditev omogočila bolj informativen preskus.
In such a case, this scientific evidence should be carefully documented in the study report.
V takem primeru je treba znanstvene podatke natančno dokumentirati v poročilu o študiji.
Developmental toxicology: the study of adverse effects on the developing organism that may result from exposure prior to conception, during prenatal development, or postnatally to the time of sexual maturation.
Razvojna toksikologija: preučevanje škodljivih učinkov na razvoj organizma, ki so lahko posledica izpostavljenosti pred spočetjem, med razvojem pred rojstvom ali po rojstvu do spolne zrelosti.
The major manifestations of developmental toxicity include 1) death of the organism, 2) structural abnormality, 3) altered growth, and 4) functional deficiency.
Glavne pojavne oblike strupenosti za razvoj vključujejo 1. smrt organizma, 2. strukturno anomalijo, 3. spremenjeno rast in 4. funkcionalno pomanjkljivost.
Developmental toxicology was formerly often referred to as teratology.
Razvojno toksikologijo so v preteklosti pogosto imenovali teratologija.
Adverse effect: any treatment-related alteration from baseline that diminishes an organism's ability to survive, reproduce or adapt to the environment.
Škodljivi učinek: vsako odstopanje od normalnega, povezano s tretiranjem, ki zmanjšuje sposobnost organizma za preživetje, razmnoževanje ali prilagoditev okolju.
Concerning developmental toxicology, taken in its widest sense it includes any effect which interferes with normal development of the conceptus, both before and after birth.
V razvojni toksikologiji v njenem najširšem pomenu vključuje vsak učinek, ki moti normalen razvoj zarodka pred rojstvom in po njem.
Altered growth: an alteration in offspring organ or body weight or size.
Spremenjena rast: sprememba mase ali velikosti organa ali telesa potomca.
Alterations (anomalies): structural alterations in development that include both malformations and variations (28).
Spremembe (nepravilnosti): strukturne spremembe v razvoju, ki vključujejo deformnosti in odstopanja (28).
Malformation/Major abnormality: structural change considered detrimental to the animal (may also be lethal) and is usually rare.
Deformnost/večja anomalija: strukturna sprememba, ki naj bi bila za žival škodljiva (lahko tudi smrtna) in je navadno redka.
Variation/Minor abnormality: structural change considered to have little or no detrimental effect on the animal; may be transient and may occur relatively frequently in the control population.
Odstopanje/manjša anomalija: strukturna sprememba, ki naj bi imela malo ali nič škodljivega učinka na žival; lahko je prehodna in lahko se razmeroma pogosto pojavlja v kontrolni populaciji.
Conceptus: the sum of derivatives of a fertilised ovum at any stage of development from fertilisation until birth including the extra-embryonic membranes as well as the embryo or foetus.
Zarodek: vsota izpeljank oplojenega jajčeca v kateri koli stopnji razvoja od oploditve do rojstva, vključno z embrionalnimi membranami ter embriom ali fetusom.
Implantation (nidation): attachment of the blastocyst to the epithelial lining of the uterus, including its penetration through the uterine epithelium, and its embedding in the endometrium.
Vgnezditev (nidacija): pritrditev blastociste v epitelno maternično sluznico, vključno s prediranjem skozi maternični epitelij in vsaditvijo v endometrij.
Embryo: the early or developing stage of any organism, especially the developing product of fertilisation of an egg after the long axis appears and until all major structures are present.
Embrio: zgodnja ali razvojna stopnja katerega koli organizma, zlasti razvojni produkt oplojenega jajčeca od takrat, ko se pojavi vzdolžna os, do takrat, ko nastanejo vse glavne strukture.
Embryotoxicity: detrimental to the normal structure, development, growth, and/or viability of an embryo.
Embriotoksičnost: škodljivo za normalno strukturo, razvoj, rast in/ali sposobnost za preživetje embria.
Foetus: the unborn offspring in the post-embryonic period.
Fetus: nerojeni potomec v postembrionalnem obdobju.
Foetotoxicity: detrimental to the normal structure, development, growth, and/or viability of a foetus.
Fetalna toksičnost: škodljivo za normalno strukturo, razvoj, rast in/ali preživetje fetusa.
Abortion: the premature expulsion from the uterus of the products of conception: of the embryo or of a nonviable foetus.
Splav: predčasna izločitev produktov spočetja iz maternice: embria ali fetusa, nezmožnega preživetja.
Resorption: a conceptus which, having implanted in the uterus, subsequently died and is being, or has been resorbed.
Resorpcija: zarodek, ki naknadno po vgnezditvi v maternici odmre in se resorbira. Zgodnja resorpcija: dokaz o vgnezditvi brez prepoznavnega embria/fetusa.
Early resorption: evidence of implantation without recognisable embryo/foetus
Pozna resorpcija: mrtvi embrio ali fetus z zunanjimi degenerativnimi spremembami.
Normally, the test substance is administered to pregnant animals at least from implantation to one day prior to the day of scheduled kill, which should be as close as possible to the normal day of delivery without risking loss of data resulting from early delivery.
Navadno se preskusna snov daje brejim živalim najmanj od vgnezditve do enega dne pred dnevom predvidene usmrtitve, ki naj bo čim bliže normalnemu dnevu kotitve brez tveganja izgube podatkov, ki izhajajo iz predčasne kotitve.
The test method is not intended to examine solely the period of organogenesis, (e.g. days 5-15 in the rodent, and days 6-18 in the rabbit) but also effects from preimplantation, when appropriate, through the entire period of gestation to the day before caesarean section.
Preskusna metoda ni namenjena samo preučevanju obdobja organogeneze (npr. od 5 do 15 dne pri glodalcu in od 6 do 18 dne pri kuncu), temveč tudi učinkov pred vgnezditvijo, kadar je primerno, v vsem obdobju brej osti do dneva pred carskim rezom.
Shortly before caesarean section, the females are killed, the uterine contents are examined, and the foetuses are evaluated for externally visible anomalies and for soft tissue and skeletal changes.
Malo pred carskim rezom se samice usmrtijo, preuči se maternična vsebina, fetusi pa se ocenijo glede na zunanje vidne nepravilnosti in spremembe mehkega tkiva in okostja.
It is recommended that testing be performed in the most relevant species, and that laboratory species and strains which are commonly used in prenatal developmental toxicity testing be employed.
Priporoča se, da se preskušanje izvaja na najustreznejših vrstah in da se uporabijo laboratorijske vrste in sevi, ki se navadno uporabljajo pri preskušanju strupenosti za predrojstveni razvoj.
The preferred rodent species is the rat and the preferred non-rodent species is the rabbit.
Priporočena glodalska vrsta je podgana in priporočena neglodalska vrsta je kunec.
Justification should be provided if another species is used.
Če se uporabi druga vrsta, je treba to utemeljiti.
Mating procedures should be carried out in cages suitable for the purpose.
Parjenje naj se izvaja v kletkah, ki so primerne za ta namen.
While individual housing of mated animals is preferred, group housing in small numbers is also acceptable.
Čeprav je priporočljiva individualna namestitev živali, ki se parijo, je sprejemljiva tudi skupinska namestitev v manjšem številu.
The animals of all test groups should, as nearly as practicable, be of uniform weight and age.
Živali v vseh preskusnih skupinah naj bodo čim enotnejše po masi in starosti.
Young adult nulliparous female animals should be used at each dose level.
Za vsako velikost odmerka je treba uporabiti mlade odrasle samice, ki še niso kotile.
The females should be mated with males of the same species and strain, and the mating of siblings should be avoided.
Samice naj se parijo s samci iste vrste in seva, izogibati se je treba parjenju sorojencev.
For rodents day 0 of gestation is the day on which a vaginal plug and/or sperm are observed; for rabbits day 0 is usually the day of coitus or of artificial insemination, if this technique is used.
Pri glodalcih je dan brejosti 0 tisti dan, ko se opazi vaginalni čep in/ali seme; pri kuncih je dan 0 navadno dan koitusa ali umetne osemenitve, če se uporabi ta tehnika.
Mated females should be assigned in an unbiased manner to the control and treatment groups.
Sparjene samice se na nepristranski način dodelijo v kontrolno in tretirano skupino.
Mated females should be assigned in an unbiased manner to the control and treatment groups, and if the females are mated in batches, the animals in each batch should be evenly distributed across the groups.
Sparjene samice se na nepristranski način dodelijo v kontrolno in tretirano skupino in če se samice parijo v serijah, se živali iz vsake serije enakomerno porazdelijo v skupini.
Similarly, females inseminated by the same male should be evenly distributed across the groups.
Podobno se samice, ki jih osemeni isti samec, enakomerno porazdelijo v obe skupini.
Each test and control group should contain a sufficient number of females to result in approximately 20 female animals with implantation sites at necropsy.
Vsaka preskusna in kontrolna skupina naj vključuje zadostno število samic, tako da bo za obdukcijo približno 20 ženskih živali z vgnezditvijo.
Groups with fewer than 16 animals with implantation sites may be inappropriate.
Skupine z manj kakor 16 živali z vgnezditvijo so lahko neustrezne.
Maternal mortality does not necessarily invalidate the study providing it does not exceed approximately 10 %.
Ni nujno, da smrtnost mater ogrozi študijo, pod pogojem, da ni večja od približno 10 %.
If a vehicle or other additive is used to facilitate dosing, consideration should be given to the following characteristics: effects on the absorption, distribution, metabolism, and retention or excretion of the test substance; effects on the chemical properties of the test substance which may alter its toxic characteristics; and effects on the food or water consumption or the nutritional status of the animals.
Če se za olajšanje odmerjanja uporablja nosilec ali drug aditiv, je treba upoštevati naslednje lastnosti: učinke na absorpcijo, distribucijo, presnovo in retencijo ali ekskrecijo preskusne snovi; učinke na kemijske lastnosti preskusne snovi, ki lahko spremenijo njene toksične lastnosti; ter učinke na porabo hrane ali vode ali na prehranjenost živali.
The vehicle should neither be developmentally toxic nor have effects on reproduction.
Nosilec ne sme biti toksičen za razvoj in ne sme učinkovati na reprodukcijo.
Normally, the test substance should be administered daily from implantation (e.g. day 5 post mating) to the day prior to scheduled caesarean section.
Normalno se preskusna snov daje vsak dan od vgnezditve (npr. od 5. dne po parjenju) do dneva pred predvidenim carskim rezom.
If preliminary studies, when available, do not indicate a high potential for preimplantation loss, treatment may be extended to include the entire period of gestation, from mating to the day prior to scheduled kill.
Če predhodne študije, ki so na voljo, ne navajajo visoke možnosti za izgubo pred vgnezditvijo, se lahko tretiranje podaljša, tako da vključuje celotno obdobje brej osti, od parjenja do dneva pred predvideno usmrtitvijo.
It is well known that inappropriate handling or stress during pregnancy can result in prenatal loss.
Dobro je znano, da se lahko neprimerno ravnanje ali stres med nosečnostjo končata s predrojstveno izgubo.
To guard against prenatal loss from factors which are not treatment related, unnecessary handling of pregnant animals as well as stress from outside factors such as noise should be avoided.
Da bi zavarovali predrojstveno izgubo pred dejavniki, ki niso povezani s tretiranjem, se je treba izogibati nepotrebnemu pretovarjanju brejih živali, pa tudi stresu zaradi zunanjih dejavnikov, na primer hrupa.
At least three dose levels and a concurrent control should be used.
Uporabiti je treba najmanj tri velikosti odmerkov in hkratno kontrolo.
Healthy animals should be assigned in an unbiased manner to the control and treatment groups.
Zdrave živali se na nepristranski način dodelijo v kontrolno in tretirano skupino.
The dose levels should be spaced to produce a gradation of toxic effects.
Velikost odmerkov se razporedi tako, da se toksični učinki stopnjujejo.
Unless limited by the physical/chemical nature or biological properties of the test substance, the highest dose should be chosen with the aim to induce some developmental and/or maternal toxicity (clinical signs or a decrease in body weight) but not death or severe suffering.
Razen kadar to zaradi fizikalno-kemijske narave ali bioloških lastnosti preskusne snovi ni mogoče, je treba najvišjo vrednost odmerka izbrati tako, da povzroči nekaj toksičnosti za razvoj in/ali pri materi (klinični znaki ali zmanjšanje telesne mase), vendar ne smrt ali hudo trpljenje.
At least one intermediate dose level should produce minimal observable toxic effects.
Najmanj ena vmesna velikost odmerka mora povzročiti minimalno opazne toksične učinke.
The lowest dose level should not produce any evidence of either maternal or developmental toxicity.
Najmanjša velikost odmerka ne sme povzročiti nobenega dokaza toksičnosti niti za razvoj niti pri materi.
A descending sequence of dose levels should be selected with a view to demonstrating any dosage-related response and no-observed-adverse-effect level (NOAEL).
Padajoče zaporedje velikosti odmerkov je treba izbrati tako, da se pokažejo vse reakcije, ki so odvisne od odmerka, in vrednost brez opaznih škodljivih učinkov (NOAEL).
Two- to four-fold intervals are frequently optimal for setting the descending dose levels, and the addition of a fourth test group is often preferable to using very large intervals (e.g. more than a factor of 10) between dosages.
Za padajoče zaporedje velikosti odmerkov so pogosto optimalni dvakratni do štirikratni intervali, pogosto pa je bolje dodati še dodatno četrto preskusno skupino, kakor uporabiti zelo velike intervale med odmerki (npr. več kakor faktor 10).
Although establishment of a maternal NOAEL is the goal, studies which do not establish such a level may also be acceptable (1).
Čeprav je cilj ugotoviti vrednost brez opaznih škodljivih učinkov pri materi, so lahko sprejemljive tudi študije, ki ne dokažejo take vrednosti (1).
Dose levels should be selected taking into account any existing toxicity data as well as additional information on metabolism and toxicokinetics of the test substance or related materials.
Vrednosti odmerkov je treba izbirati ob upoštevanju vseh obstoječih podatkov o strupenosti, pa tudi dodatnih informacij o presnovi in toksikokinetiki preskusne snovi ali sorodnih materialov.
This information will also assist in demonstrating the adequacy of the dosing regimen.
Te informacije pomagajo tudi pri dokazovanju ustreznosti režima odmerjanja.
A concurrent control group should be used.
Uporabiti je treba hkratno kontrolno skupino.
This group should be a sham-treated control group or a vehicle-control group if a vehicle is used in administering the test substance.
Ta skupina je kontrolna skupina, tretirana z nepravim nadomestkom ali kontrolna skupina, tretirana le z nosilcem, če je ta uporabljen pri dajanju preskusne snovi.
All groups should be administered the same volume of either test substance or vehicle.
Vsem skupinam se daje enaka količina bodisi preskusne snovi ali nosilca.
Animals in the control group(s) should be handled in an identical manner to test group animals.
Živali v kontrolni (h) skupini(ah) se obravnavajo na enak način kakor živali v preskusni skupini.
Vehicle control groups should receive the vehicle in the highest amount used (as in the lowest treatment group).
Kontrolne skupine, tretirane z nosilcem, morajo prejeti količino nosilca, enako največji uporabljeni količini (kakor v najnižji tretirani skupini).