natgillin/translations-raw huggingface dataset:
Characteristics which indicate that the chemical may be difficult to test in aquatic systems include:
opis preskusne kemikalije:
high octanol water partitioning coefficients (log Kow), high volatility, susceptibility to hydrolysis, and susceptibility to photolysis under ambient laboratory lighting conditions.
informacije in podatke o kemikaliji:
Other factors may also be relevant to determining testability and should be determined on a case by case basis.
Za založne raztopine in preskusne raztopine bodo morda potrebne meritve preskusne kemikalije,
If a successful test is not possible for the chemical using a flow-through test system, a static renewal system may be employed.
topilo (če ni voda):
If neither system is capable of accommodating the test chemical, then the default is to not test it using this protocol.
utemeljitev izbire topila in opis topila (vrsta, uporabljena koncentracija).
Exposure System
operativne evidence:
A flow-through diluter system is preferred, when possible, over a static renewal system.
zajemajo opažanja v zvezi z delovanjem preskusnega sistema ter podpornega okolja in infrastrukture.
If physical and/or chemical properties of any of the test chemicals are not amenable to a flow-through diluter system, then an alternative exposure system (e.g., static-renewal) can be employed.
Običajne evidence vključujejo:
The system components should have water-contact components of glass, stainless steel, and/or Polytetrafluoroethylene.
sobno temperaturo, preskusno temperaturo, obdobje osvetljenosti, stanje kritičnih delov sistema izpostavljenosti (npr. črpalke, števci ciklov, tlaki), pretoke, vodostaj, spremembe standardne steklenice in evidence prehranjevanja.
However, suitable plastics can be utilised if they do not compromise the study.
Parametri splošne kakovosti vode vključujejo:
Exposure tanks should be glass or stainless steel aquaria, equipped with standpipes that result in an approximate tank volume between 4,0 and 10,0 l and minimum water depth of 10 to 15 cm.
pH, raztopljeni kisik, prevodnost, skupni jod, alkalnost in trdoto,
The system should be capable of supporting all exposure concentrations and a control, with four replicates per treatment.
odstopanja od preskusne metode:
The flow rate to each tank should be constant in consideration of both the maintenance of biological conditions and chemical exposure (e.g. 25 ml/min).
te informacije morajo vključevati vse informacije ali pripovedne opise odstopanj od preskusne metode.
The treatment tanks should be randomly assigned to a position in the exposure system in order to reduce potential positional effects, including slight variations in temperature, light intensity, etc.
biološka opažanja in podatki:
Fluorescent lighting should be used to provide a photoperiod of 12 hr light:
ti vključujejo dnevna opažanja smrtnosti, porabe hrane, nenormalnega načina plavanja, letargije, izgube ravnotežja, deformnosti, lezij itd. Opažanja in podatki, zbrani v vnaprej določenih časovnih razmikih, vključujejo:
12 hr dark at an intensity that ranges from 600 to 2000 lux (lumen/m2) at the water surface.
razvojno fazo, dolžino zadnjega kraka, dolžino od ust do zadnjične odprtine in mokro težo,
Water temperature should be maintained at 22° ± 1 °C, pH maintained between 6,5 to 8,5, and the dissolved oxygen (DO) concentration > 3,5 mg/l (> 40 % of the air saturation) in each test tank.
histološki podatki:
As a minimum water temperature, pH and dissolved oxygen should be measured weekly;
ti vključujejo pripovedne opise ter razvrščeno resnost in pogostnost specifičnih opažanj, kot je navedeno v smernici za histopatologijo,
temperature should preferably be measured continuously in at least one test vessel.
ad-hoc opažanja:
Appendix 1 outlines the experimental conditions under which the protocol should be executed.
ta opažanja morajo vključevati pripovedne opise študije, ki jih ni mogoče razvrstiti v zgoraj opisane kategorije.
Any water that is locally available (e.g. springwater or charcoal-filtered tap water) and permits normal growth and development of X. laevis tadpoles could be used.
Navedene so tudi tabele za poročanje, ki so uporabne za sporočanje povzetkov podatkov o končnih točkah.
Because local water quality can differ substantially from one area to another, analysis of water quality should be undertaken, particularly, if historical data on the utility of the water for raising Xenopus is not available.
Tabele za poročanje za histološke ocene so navedene v Dodatku 2.
Iodide Concentration in Test Water
Tabela 4
In order for the thyroid gland to synthesise TH, sufficient iodide needs to be available to the larvae through a combination of aqueous and dietary sources.
Izvedbena merila za AMA
Currently, there are no empirically derived guidelines for minimal iodide concentrations.
Merilo
However, iodide availability may affect the responsiveness of the thyroid system to thyroid active agents and is known to modulate the basal activity of the thyroid gland, an aspect that deserves attention when interpreting the results from thyroid histopathology.
Sprejemljive meje
Therefore, measured aqueous iodide concentrations from the test water should be reported.
Preskusne koncentracije
Based on the available data from the validation studies, the protocol has been demonstrated to work well when test water iodide (I-) concentrations ranged between 0,5 and 10 μg/l.
V 21-dnevnem preskusu se ohranjajo pri ≤ 20 % KV (variabilnost izmerjenih preskusnih koncentracij).
Ideally, the minimum iodide concentration in the test water should be 0,5 μg/l.
Smrtnost v kontrolah
If the test water is reconstituted from deionised water, iodine should be added at a minimum concentration of 0,5 μg/l.
≤ 10 % – smrtnost v nobeni ponovitvi v kontrolah ne sme preseči 2 paglavcev.
Any additional supplementation of the test water with iodine or other salts should be noted in the report.
Najnižja srednja razvojna faza kontrol na koncu preskusa
Holding of animals
Razpon razvojnih stopenj v kontrolni skupini
Adult Care and Breeding
Deseti in 90. centil porazdelitve razvojnih faz se ne smeta razlikovati za več kot 4 faze.
Adult care and breeding is conducted in accordance with standard guidelines and the reader is directed to the standard guide for performing the Frog Embryo Teratogenesis Assay (FETAX) (6) for more detailed information.
Raztopljeni kisik
Such standard guidelines provide an example of appropriate care and breeding methods, but strict adherence is not required.
≥ 40 % nasičenosti z zrakom [8]
To induce breeding, pairs (3-5) of adult females and males are injected with human chorionic gonadotropin (hCG).
pH je treba vzdrževati med 6,5 in 8,5.
Female and male specimens are injected with approximately 800 IU-1000 IU and 600 IU-800 IU, respectively, of hCG dissolved in 0,6-0,9 % saline solution.
Razlike med ponovitvami/tretiranji ne smejo presegati 0,5.
Breeding pairs are held in large tanks, undisturbed and under static conditions in order to promote amplexus.
22 °C ± 1 °C – razlike med ponovitvami/tretiranji ne smejo presegati 0,5 °C.
The bottom of each breeding tank should have a false bottom of stainless steel or plastic mesh which permits the egg masses to fall to the bottom of the tank.
Preskusne koncentracije brez očitne strupenosti
Frogs injected in the late afternoon will usually deposit most of their eggs by mid morning of the next day.
Uspešnost ponovitev
After a sufficient quantity of eggs are released and fertilised, adults should be removed from the breeding tanks.
Ogrozita se lahko ≤ 2 ponovitvi v celotnem preskusu.
Larval Care and Selection
Posebni pogoji za uporabo topila
After the adults are removed from the breeding tanks, the eggs are collected and evaluated for viability using a representative sub-set of the embryos from all breeding tanks.
Če se uporabi topilo kot nosilec, je treba uporabiti kontrolo s topilom in kontrolo s čisto vodo ter poročati o rezultatih.
The best individual spawn(s) (2-3 recommended to evaluate the quality of the spawns) should be retained based upon embryo viability and the presence of an adequate number (minimum of 1500) of embryos.
Statistično značilne razlike med kontrolno skupino s topilom in kontrolno skupino z vodo se obravnavajo posebej.
All the organisms used in a study should originate from a single spawning event (i.e., the spawns should not be co-mixed).
Več informacij je navedenih v nadaljevanju.
The embryos are transferred into a large flat pan or dish and all obvious dead or abnormal eggs (see definition in (5)) are removed using a pipette or eyedropper.
Posebni pogoji za sistem s statičnim obnavljanjem
The sound embryos from each of the three spawns are transferred into three separate hatching tanks.
Poročati je treba o reprezentativnih kemijskih analizah pred obnavljanjem in po njem.
Four days after being placed in the hatching tanks, the best spawn, based on viability and hatching success, is selected and the larvae are transferred into an appropriate number of rearing tanks at 22° ± 1 °C.
Ravni amoniaka je treba izmeriti neposredno pred obnavljanjem.
In addition, some additional larvae are moved into extra tanks for use as replacements in the event that mortalities occur in the rearing tanks during the first week.
Vse parametre kakovosti vode iz tabele 1 iz Dodatka 1 je treba izmeriti neposredno pred obnavljanjem.
This procedure maintains consistent organism density and thereby reduces developmental divergence within the cohort of a single spawn.
Obdobje obnavljanja ne sme biti daljše od 72 ur.
All rearing tanks should be siphoned clean daily.
Ustrezen časovni razpored hranjenja (50 % dnevnega obroka komercialne krme za paglavce)
As a precaution, vinyl or nitrile gloves are preferred to latex gloves.
Veljavnost preskusa
Mortalities should be removed daily and replacement larvae should be added back to maintain the organism density during the first week.
Da se preskus šteje za sprejemljiv/veljaven, morajo biti izpolnjene naslednje zahteve:
Feeding should occur at least twice per day.
veljaven poskus v zvezi z negativnim preskusom za aktivnost ščitnice:
During the pre-exposure phase, tadpoles are acclimated to the conditions of the actual exposure phase, including the type of food, temperature, light-dark cycle and the culture medium.
smrtnost v nobenem tretiranem vzorcu (vključno s kontrolami) ne sme preseči 10 %.
Therefore, it is recommended that the same culture/dilution water be used during the pre-exposure phase and the exposure phase.
Smrtnost pri nobeni ponovitvi ne sme preseči treh paglavcev, sicer se ponovitev šteje za ogroženo;
If a static culture system is used for maintaining tadpoles during the pre-exposure phase, the culture medium should be replaced completely at least twice per week.
za analizo morata biti na voljo vsaj dve stopnji tretiranja, pri čemer so vse štiri ponovitve neogrožene;
Crowding, caused by high larval densities during the pre-exposure period, should be avoided because such effects could markedly affect tadpole development during the subsequent testing phase.
za analizo morata biti na voljo vsaj dve stopnji tretiranja brez očitne strupenosti;
Therefore, the rearing density should not exceed approximately four tadpoles/l culture medium (static exposure system) or 10 tadpoles/l culture medium (with e.g. 50 ml/min flow rate in the pre-exposure or culturing system).
veljaven poskus v zvezi s pozitivnim preskusom za aktivnost ščitnice:
Under these conditions, tadpoles should develop from stages 45/46 to stage 51 within twelve days.
v kontrolni skupini sta lahko največ dva smrtna primera paglavcev na ponovitev.
Representative tadpoles of this stock population should be inspected daily for developmental stage in order to estimate the appropriate time point for initiation of exposure.
Način odločanja za izvedbo AMA
Care should be used to minimise stress and trauma to the tadpoles, especially during movement, cleaning of aquaria, and manipulation of larvae.
Način odločanja za AMA je bil pripravljen za zagotovitev smiselne pomoči pri izvedbi in razlagi rezultatov biološkega preskusa (glej tabelo poteka na sliki 3).
Stressful conditions/activities should be avoided such as loud and/or incessant noise, tapping on aquaria, vibrations in the aquaria, excessive activity in the laboratory, and rapid changes in environmental media (light availability, temperature, pH, DO, water flow rates, etc.)
Način odločanja v bistvu obravnava končne točke v navedenem naprednem razvoju, asinhroni razvoj in histopatologija ščitnice se obravnavata podrobno, zakasneli razvoj, dolžina od ust do zadnjične odprtine, teža mokrega telesa in parametri, na katere bi lahko vplivala splošna strupenost, pa se obravnavajo manj podrobno.
If tadpoles do not develop to stage 51 within 17 days after fertilisation, excessive stress should be considered as a potential culprit.
Napredni razvoj (določen z uporabo razvojne faze, SVL in HLL)
Larval Culture and Feeding
Znano je le, da se napredni razvoj pojavi zaradi učinkov, ki so povezani s ščitničnim hormonom.
Tadpoles are fed with e.g. the commercial tadpole feed used in the validation studies (see also appendix 1) throughout the pre-exposure period (after Nieuwkoop and Faber (NF) stage 45/46 (8)) and during the entire test period of 21 days, or other diet that has demonstrated to allow equal performance of the Amphibian Metamorphosis Assay.
To so lahko učinki perifernega tkiva, kot je neposredna interakcija z receptorjem ščitničnega hormona (kot je s T4) ali učinki, ki spreminjajo ravni kroženja ščitničnega hormona.
The feeding regime during the pre-exposure period should be carefully adjusted to meet the demands of the developing tadpoles.
V vsakem primeru se to šteje za ustrezen dokaz, da je kemikalija povezana z aktivnostjo ščitnice.
That is, small portions of food should be provided to the newly hatched tadpoles several times per day (at least twice).
Napredni razvoj se oceni na enega od dveh načinov.
Excess food should be avoided in order i) to maintain water quality and ii) to prevent the clogging of gill filters with food particles and detritus.
Prvič, splošna faza razvoja se lahko oceni s standardiziranim pristopom, kot sta ga opisala Nieuwkoop in Faber (8).
For the tadpole feed used in the validation studies, the daily food rations should be increased along with tadpole growth to approximately 30 mg/animal/day shortly before test initiation.
Drugič, kvantificirajo se lahko specifične morfološke značilnosti, kot je dolžina zadnjega kraka na 7. in 21. dan, kar je pozitivno povezano z agonističnimi učinki na receptor ščitničnega hormona.
This commercially available feed has been shown in the validation studies to support proper growth and development of X. laevis tadpoles, and is a fine particulate that stays suspended in the water column for a long period of time and is subject to washing out with the flow.
Če se pojavi statistično značilen napredek pri razvoju ali dolžini zadnjega kraka, preskus kaže, da kemikalija vpliva na ščitnico.
Therefore, the total daily amount of food should be divided into smaller portions and fed at least twice daily.
Ocenjevanje prisotnosti pospešenega razvoja pri preskusnih živalih glede na kontrolno populacijo bo temeljilo na rezultatih statističnih analiz, izvedenih za naslednje štiri končne točke:
For this feed the feeding regime is outlined in Table 1.
dolžina zadnjega kraka (normalizirana s SVL) na 7. dan študije,
Feeding rates should be recorded.
dolžina zadnjega kraka (normalizirana s SVL) na 21. dan študije,
It can be fed dry or as a stock solution prepared in dilution water.
razvojna faza na 7. dan študije,
Such a stock solution should be freshly prepared every other day and stored at 4 °C when not in use.
razvojna faza na 21. dan študije.
Feeding regime with commercial tadpole feed used in the validation studies for X. laevis tadpolesduring the in-life portion of the AMA in flow-through conditions
Statistične analize dolžine zadnjega kraka je treba izvesti na podlagi meritev dolžine zadnjega levega kraka.
Study Day
Dolžina zadnjega kraka se normalizira z razmerjem med dolžino zadnjega kraka in dolžino od ust do zadnjične odprtine posameznega osebka.
Food ration (mg feed/animal/day)
Nato se primerja sredina normaliziranih vrednosti posamezne stopnje tretiranja.
Analytical Chemistry
Pospešen razvoj se nato kaže z znatnim povečanjem srednje dolžine zadnjega kraka (normalizirane) v kemično obdelani skupini v primerjavi s kontrolno skupino na 7. dan študije in/ali 21. dan študije (glej Dodatek 3).
Prior to conducting a study, the stability of the test chemical should be evaluated using existing information on its solubility, degradability and volatility.
Statistične analize razvojne faze je treba izvesti na podlagi določitve razvojne faze v skladu z morfološkimi merili, ki sta jih opisala Nieuwkoop in Faber (8).
Test solutions from each replicate tank at each concentration should be sampled for analytical chemistry analyses at test initiation (day 0), and weekly during the test for a minimum of four samples.
Pospešen razvoj se kaže, če se na 7. in/ali 21. dan študije v primerjavi s kontrolno skupino z večkvantno analizo zazna znatno povečanje vrednosti, povezanih z razvojno fazo, v kemično obdelani skupini.
It is also recommended that each test concentration be analysed during system preparation, prior to test initiation, to verify system performance.
Pri preskusni metodi AMA se znaten učinek na katero koli od navedenih štirih končnih točk šteje kot ustrezen za zaznavo pospešenega razvoja.
In addition, it is recommended that stock solutions be analysed when they are changed, especially if the volume of the stock solution does not provide adequate amounts of chemical to span the duration of routine sampling periods.
To pomeni, da znatnih učinkov na dolžino zadnjega kraka ob določeni časovni točki ni treba potrditi z znatnimi učinki na dolžino zadnjega kraka ob drugem času ali z znatnimi učinki na razvojno fazo ob tej določeni časovni točki.
In the case of chemicals which cannot be detected at some or all of the concentrations used in a test, stock solutions should be measured and system flow rates recorded in order to calculate nominal concentrations.
Znatnih učinkov na razvojno fazo ob določeni časovni točki pa ni treba potrditi z znatnimi učinki na razvojno fazo ob drugem času ali z znatnimi učinki na dolžino zadnjega kraka ob tej določeni časovni točki.
Chemical Delivery
Pomen dokazov pospešenega razvoja se bo kljub temu povečal, če bodo znatni učinki zaznani pri več kot eni končni točki.
The method used to introduce the test chemical to the system can vary depending on its physicochemical properties.
Asinhroni razvoj (določen z merili za razvojno fazo)
Water soluble chemicals can be dissolved in aliquots of test water at a concentration which allows delivery at the target test concentration in a flow-through system.
Za asinhroni razvoj je značilna motnja relativnega časa morfogeneze ali razvoja različnih tkiv pri enem paglavcu.
Chemicals which are liquid at room temperature and sparingly soluble in water can be introduced using liquid:liquid saturator methods.
Nezmožnost jasne določitve razvojne faze organizma s skupino morfoloških končnih točk, ki se štejejo kot značilne za katero koli fazo, kaže, da se tkiva pri preobrazbi razvijajo asinhrono.
Chemicals which are solid at room temperature and are sparingly soluble in water can be introduced using glass wool column saturators (7).
Asinhroni razvoj je kazalnik aktivnosti ščitnice.
The preference is to use a carrier-free test system, however different test chemicals will possess varied physicochemical properties that will likely require different approaches for preparation of chemical exposure water.
Edini znani načini delovanja, ki povzročajo asinhroni razvoj, so učinki kemikalij na periferno delovanje ščitničnega hormona in/ali metabolizem ščitničnega hormona pri razvijajočih se tkivih, kot je ugotovljen pri inhibitorjih dejodaze.
It is preferred that effort be made to avoid solvents or carriers because:
Ocenjevanje prisotnosti asinhronega razvoja pri preskusnih živalih glede na kontrolno populacijo bo temeljil na splošni morfološki oceni preskusnih živali na 7. in 21. dan študije.
certain solvents themselves may result in toxicity and/or undesirable or unexpected endocrinological responses, ii) testing chemicals above their water solubility (as can frequently occur through the use of solvents) can result in inaccurate determinations of effective concentrations, and iii) the use of solvents in longer-term tests can result in a significant degree of “biofilming” associated with microbial activity.
Opis normalnega razvoja Xenopus laevis, ki sta ga pripravila Nieuwkoop in Faber (8), zagotavlja okvir za opredelitev zaporedja normalnega preoblikovanja tkiva.
For difficult to test chemicals, a solvent may be employed as a last resort, and the OECD Guidance Document on aquatic toxicity testing of difficult substances and mixtures should be consulted (4) to determine the best method.
Izraz ‚asinhroni razvoj‘ se nanaša izrecno na tista odstopanja v splošnem morfološkem razvoju paglavcev, ki preprečujejo dokončno določitev razvojne faze v skladu z Nieuwkoopovimi in Faberjevimi merili (8), ker ključni morfološki znaki kažejo značilnosti različnih faz.
Solvents which have been found to be effective for aquatic toxicity testing include acetone, ethanol, methanol, dimethyl formamide and triethylene glycol.
Kot nakazuje izraz ‚asinhroni razvoj‘, je treba obravnavati le primere, ki kažejo odstopanja v napredovanju preoblikovanja posebnih tkiv glede na napredovanje preoblikovanja drugih tkiv.
In case a solvent carrier is used, solvent concentrations should be below the chronic No Observed Effect Concentration (NOEC);
Nekateri klasični fenotipi vključujejo zakasnitev ali odsotnost razvoja sprednjega kraka kljub normalnemu ali naprednemu razvoju zadnjih krakov ali repnih tkiv ali zgodnjo resorpcijo škrg glede na fazo morfogeneze zadnjih krakov in resorpcije repa.
the OECD Guidance Document recommends a maximum of 100 μl/l;
Da žival kaže asinhroni razvoj, se zabeleži, če ji ni mogoče dodeliti faze, ker ne izpolnjujejo večine pomembnih razvojnih meril za dano fazo po Nieuwkoopu in Faberju (8) ali če obstaja izjemna zakasnitev ali pospešitev ene ali več ključnih značilnosti (npr. popolna resorpcija repa, ko še ni sprednjih krakov).
a recent review recommends that solvent concentrations as low as 20 μl/l of dilution water be used (12).
Ta ocena se izvede kvalitativno in mora zajemati pregled vseh pomembnih značilnosti, ki sta jih navedla Nieuwkoop in Faber (8).
If solvent carriers are used, appropriate solvent controls should be evaluated in addition to non-solvent controls (clean water).
Pri tem pa ni treba zabeležiti stanja razvoja različnih pomembnih značilnosti opazovanih živali.
If it is not possible to administer a chemical via the water, either because of physicochemical characteristics (low solubility) or limited chemical availability, introducing it via the diet may be considered.
Živalim, pri katerih je zabeleženo, da kažejo asinhroni razvoj, se ne dodeli razvojna faza po Nieuwkoopu in Faberju (8).
Preliminary work has been conducted on dietary exposures;
Zato je glavno merilo, da se primeri nenormalnega morfološkega razvoja označijo kot ‚asinhroni razvoj‘, motnja relativnega časa preoblikovanja tkiva in morfogeneze tkiva, medtem ko morfologija prizadetih tkiv ni očitno nenormalna.
however, this route of exposure is not commonly used.
Primer prikaza razlage splošnih morfoloških nenormalnosti je, da bo zadržana morfogeneza zadnjega kraka glede na razvoj drugih tkiv izpolnila merilo ‚asinhronega razvoja‘, medtem ko se primeri manjkajočih zadnjih krakov, nenormalnih števil (npr. ektrodaktilija in polidaktilija) ali drugih očitnih deformnosti krakov ne smejo šteti za ‚asinhroni razvoj‘.
The choice of method should be documented and analytically verified.
V zvezi s tem morajo pomembni morfološki znaki, katerih usklajen metamorfni napredek je treba oceniti, vključevati morfogenezo zadnjih krakov, morfogenezo sprednjih krakov, pojav sprednjih krakov, fazo resorpcije repa (zlasti resorpcijo repne plavuti) in morfologijo glave (npr. velikost škrg, fazo resorpcije škrg, morfologijo spodnje čeljusti in protruzijo Mecklovega hrustanca).