natgillin/translations-raw huggingface dataset:
For the test results to be acceptable the following conditions apply:
loomade aklimatiseerimise korra üksikasjad;
the mortality in the water (or solvent) controls should not exceed 10 % at the end of the exposure period;
kalade kehamass kemikaaliga kokkupuute alguses (kalaparvest võetud osaproovi põhjal).
the dissolved oxygen concentration should be at least 60 % of the air saturation value (ASV) throughout the exposure period;
Katsetingimused:
the water temperature should not differ by more than ± 1,5 °C between test vessels at any one time during the exposure period and be maintained within a range of 2 °C within the temperature ranges specified for the test species (Appendix 2);
kasutatud katsemeetod (katse tüüp, laadimisnorm, loomkoormus jne);
evidence should be available to demonstrate that the concentrations of the test chemical in solution have been satisfactorily maintained within ± 20 % of the mean measured values.
põhilahuse valmistamise meetod ja voolukiirus;
Normal laboratory equipment and especially the following:
nominaalsed katsekontsentratsioonid, iga nädal mõõdetud katselahuste kontsentratsioonid ja kasutatud analüüsimeetod, katsenõudes mõõdetud väärtuste keskmised ja nende standardhälbed ning tõendid selle kohta, et need mõõtmised näitavad uuritava kemikaali kontsentratsiooni tegelikus lahuses;
oxygen and pH meters;
lahjendusvee omadused (pH, karedus, leelisus, temperatuur, lahustunud hapniku kontsentratsioon, kloorisisaldus, orgaanilise süsiniku üldsisaldus, hõljuvaine sisaldus ja kõik muud mõõdetud näitajad);
equipment for determination of water hardness and alkalinity;
vee kvaliteet katsenõus:
adequate apparatus for temperature control and preferably continuous monitoring;
pH, karedus, temperatuur ja lahustunud hapniku kontsentratsioon;
tanks made of chemically inert material and of a suitable capacity in relation to the recommended loading and stocking density (see Appendix 2);
üksikasjalik teave söötmise kohta (nt sööda (söötade) tüüp, päritolu, lisatud kogus ja söötmise sagedus ning asjakohaste saasteainete analüüs (nt polüklooritud bifenüülid, polütsüklilised aromaatsed süsivesinikud ja kloororgaanilised pestitsiidid).
spawning substrate for fathead minnow and zebrafish, Appendix 4 gives the necessary details;
tõendid selle kohta, et kontrollkatsed vastasid nõuetekohasuse kriteeriumidele;
suitably accurate balance (i.e. accurate to ± 0,5 mg).
andmed suremuse kohta iga katsekontsentratsiooni rühmades ja kontrollrühmas;
Any water in which the test species shows suitable long-term survival and growth may be used as test water.
kasutatud statistilise analüüsi meetodid, andmete töötlemine ja kasutatud meetodite valimise põhjendus;
It should be of constant quality during the period of the test.
bioloogiliste vaatluste andmed üldiste morfoloogiliste muutuste kohta, sealhulgas teiseste sootunnuste ja vitellogeniini kohta;
The pH of the water should be within the range 6,5 to 8,5, but during a given test it should be within a range of ± 0,5 pH units.
andmete analüüsi tulemused, eelistatavalt tabelite ja graafikute kujul;
In order to ensure that the dilution water will not unduly influence the test result (for example by complexion of test chemical), samples should be taken at intervals for analysis.
kalade ebatavalised reaktsioonid ja nähtavad ilmingud, mida põhjustas uuritav kemikaal.
Measurements of heavy metals (e.g. Cu, Pb, Zn, Hg, Cd, and Ni), major anions and cations (e.g. Ca2+, Mg2+, Na+, K+, Cl-, and SO42-), pesticides (e.g. total organophosphorus and total organochlorine pesticides), total organic carbon and suspended solids should be made, for example, every three months where dilution water is known to be relatively constant in quality.
TULEMUSTE TÕLGENDAMISE JA KATSETULEMUSTE KEHTIVAKS TUNNISTAMISE JUHISED
If water quality has been demonstrated to be constant over at least one year, determinations can be less frequent and intervals extended (e.g. every six months).
Käesolevas osas on esitatud mõningad kaalutlused, mida tuleks arvesse võtta mitmesuguste mõõdetavate näitajate kohta saadud katsetulemuste tõlgendamisel.
Some chemical characteristics of acceptable dilution water are listed in Appendix 3.
Tulemuste tõlgendamisel tuleb olla ettevaatlik, kui uuritav kemikaal põhjustab selgelt mürgitust või mõjutab katseloomade üldist seisundit.
Test solutions of the chosen concentrations are prepared by dilution of a stock solution.
Katsekontsentratsioonide vahemiku valimisel tuleks jälgida, et ei ületataks maksimaalset talutavat kontsentratsiooni, muidu ei saa andmeid mõistlikult tõlgendada.
The stock solution should preferably be prepared by simply mixing or agitating the test chemical in dilution water by using mechanical means (e.g. stirring or ultrasonication).
On oluline, et vähemalt ühe kontsentratsiooni juures ei ilmneks märke mürgisuse kohta.
Saturation columns (solubility columns) can be used for achieving a suitable concentrated stock solution.
Haiguse ja toksilise mõju tundemärke tuleks põhjalikult hinnata ja esitada need katseprotokollis.
The use of a solvent carrier is not recommended.
Näiteks on võimalik, et vitellogeniini sünteesi emaskalades võib mõjutada ka kemikaali üldine mürgisus ja muu kui endokriinse mehhanismi kaudu avalduv mürgisus, näiteks hepatotoksilisus.
However, in case a solvent is necessary, a solvent control should be run in parallel, at the same solvent concentration as the chemical treatments.
Mõju tõlgendamist võivad hõlbustada andmed sellistel kontsentratsioonidel, kus andmeid ei moonuta süsteemne toksilisus.
For difficult test chemicals, a solvent may be technically the best solution;
Katsetulemuste kehtivaks tunnistamisel tuleb arvesse võtta mitut aspekti.
the OECD Guidance Document on aquatic toxicity testing of difficult substances and mixtures should be consulted (22).
Juhinduda tuleb sellest, et vitellogeniini tase kontrollrühmades peaks isas- ja emaskaladel olema erinev; erinevus peaks olema ligikaudu kolm suurusjärku tüseda tömpnina ja vöötdaanio puhul ning umbes üks suurusjärk jaapani riisikala puhul.
The choice of solvent will be determined by the chemical properties of the chemical.
Valideerimisprotokollides (1, 2, 3, 4) on esitatud näited väärtuste kohta, mis määrati kontrollrühmade ja uuritava kemikaaliga rühmade puhul.
The OECD Guidance Document recommends a maximum of 100 μl/l, which should be observed.
Kõrge vitellogeniinitase kontrollrühma isaskaladel võib negatiivselt mõjutada meetodi tundlikkust ja nõrkade östrogeeni agonistide tuvastamise võimet.
However a recent review (23) highlighted additional concerns when using solvents for endocrine activity testing.
Madal vitellogeniinitase kontrollrühma emaskaladel võib negatiivselt mõjutada meetodi tundlikkust ning aromataasi inhibiitorite ja östrogeeni antagonistide tuvastamise võimet.
Therefore it is recommended that the solvent concentration, if necessary, is minimised wherever technically feasible (dependent on the physical-chemical properties of the test chemical).
Valideerimisuuringuid kasutati selliste suuniste väljatöötamiseks.
A flow-through test system will be used.
Kui laboris ei ole asjaomast katset varem tehtud või seal on toimunud olulisi muudatusi (nt on muutunud kalade liin või tarnija), siis on soovitatav teha tehnilise pädevuse uuring.
Such a system continually dispenses and dilutes a stock solution of the test chemical (e.g. metering pump, proportional diluter, saturator system) in order to deliver a series of concentrations to the test chambers.
Soovitatav on kasutada kemikaale, millel on terve rida toimemehhanisme või mis avaldavad mõju mitmele otsitavale näitajale.
The flow rates of stock solutions and dilution water should be checked at intervals, preferably daily, during the test and should not vary by more than 10 % throughout the test.
Praktikas kutsutakse iga laborit üles looma varasemate kontrollrühma andmete põhjal oma andmekogu isas- ja emaskalade näitajate kohta ning tegema positiivse kontrolli katse östrogeense toimega kemikaaliga (nt 17β-östradiool kontsentratsioonis 100 ng/l või mõni teadaolev nõrk agonist), mille mõjul tõuseb vitellogeniini tase isaskalades, positiivse kontrolli katse aromataasi pärssiva kemikaaliga (nt fadrosool või prokloraas kontsentratsioonis 300 μg/l), mille tõttu väheneb emaskalade vitellogeniinisisaldus, ning positiivse kontrolli katse androgeense toimega kemikaaliga (nt 17β-trenboloon kontsentratsioonis 5 μg/l), mis põhjustab emastel tüsedatel tömpninadel ja jaapani riisikaladel isaskalade teiseste sootunnuste ilmumist.
Care should be taken to avoid the use of low-grade plastic tubing or other materials that may contain biologically active chemicals.
Kõiki neid andmeid võib võrrelda kättesaadavate valideerimisuuringute andmetega (1, 2, 3), et kinnitada labori pädevust.
When selecting the material for the flow-through system, possible adsorption of the test chemical to this material should be considered.
Üldiselt tuleks vitellogeniini mõõtmised lugeda positiivseks, kui tuvastatakse vitellogeniinitaseme statistiliselt oluline (p < 0,05) tõus isaskalades või statistiliselt oluline (p < 0,05) langus emaskalades vähemalt suurimal katses kasutatud kontsentratsioonil kontrollrühmaga võrreldes, kui samas ei ilmne üldise mürgisuse märke.
Holding of fish
Positiivset tulemust toetab täiendavalt bioloogiliselt usutava kontsentratsiooni ja toime vahelise sõltuvuse tuvastamine.
Test fish should be selected from a laboratory population, preferably from a single stock, which has been acclimated for at least two weeks prior to the test under conditions of water quality and illumination similar to those used in the test.
Screening and testing for endocrine disruption in fish-biomarkers as „signposts,” not „traffic lights,” in risk assessment.
It is important that the loading rate and stocking density (for definitions, see Appendix 1) be appropriate for the test species used (see Appendix 2).
Effects of waterborne exposure to 17B-estradiol on secondary sex characteristics and gonads of the fathead minnow (Pimephales promelas).
Following a 48-hour settling-in period, mortalities are recorded and the following criteria applied:
Villeneuve ja G.T.
mortalities of greater than 10 % of population in seven days:
Lühendid ja mõisted
reject the entire batch;
Keemiline aine:
mortalities of between 5 % and 10 % of population:
aine või segu.
acclimation for seven additional days;
variatsioonikordaja.
if more than 5 % mortality during second seven days, reject the entire batch;
ensüümimmuunsorptsioonanalüüs.
mortalities of less than 5 % of population in seven days:
Laadimisnorm
accept the batch
kalade märgmass vee ruumalaühiku kohta.
Fish should not receive treatment for disease during the acclimation period, in the pre-exposure period, or during the exposure period.
Loomkoormus
Pre-exposure and selection of fish
kalade arv vee ruumalaühiku kohta.
A one-week pre-exposure period is recommended, with animals placed in vessels similar to the actual test.
VTG (vitellogeniin)
Fish should be fed ad libitum throughout the holding period and during the exposure phase.
fosfolipoglükoproteiin, mis on munakollases esineva valgu eelkäija ja mida tavaliselt leidub kõikides munemise teel paljunevate liikide seksuaalselt aktiivsetes emasloomades.
The exposure phase is started with sexually dimorphic adult fish from a laboratory supply of reproductively mature animals (e.g. with clear secondary sexual characteristics visible as far as fathead minnow and medaka are concerned), and actively spawning.
HAS-telg
For general guidance only (and not to be considered in isolation from observing the actual reproductive status of a given batch of fish), fathead minnows should be approximately 20 (± 2) weeks of age, assuming they have been cultured at 25 ± 2 °C throughout their lifespan.
hüpotalamuse-ajuripatsi-sugunäärmete telg.
Japanese medaka should be approximately 16 (± 2) weeks of age, assuming they have been cultured at 25 ± 2 °C throughout their lifespan.
maksimaalne talutav kontsentratsioon, mis on ligikaudu 10 % LC50 väärtusest.
Zebrafish should be approximately 16 (± 2) weeks of age, assuming they have been cultured at 26 ± 2 °C throughout their lifespan.
Kalade endokriinsüsteemi mõjutavate kemikaalide sõeluuringu katse tingimused
TEST DESIGN
Soovitatav liik
Three concentrations of the test chemical, one control (water) and, if needed, one solvent control are used.
Tüse tömpnina
The data may be analysed in order to determine statistically significant differences between treatment and control responses.
Vöötdaanio
These analyses will inform whether further longer term testing for adverse effects (namely, survival, development, growth and reproduction) is required for the chemical, rather than for use in risk assessment (24).
Analüüsi tüüp
For zebrafish and medaka, on day 21 of the experiment, males and females from each treatment level (5 males and 5 females in each of the two replicates) and from the control(s) are sampled for the measurement of vitellogenin and secondary sex characteristics, where applicable.
Läbivooluga
For fathead minnow, on day 21 of exposure, males and females (2 males and 4 females in each of the four replicates) and from the control(s) are sampled for the measurement of vitellogenin and secondary sex characteristics.
Vee temperatuur
For the purposes of this test, the highest test concentration should be set by the maximum tolerated concentration (MTC) determined from a range finder or from other toxicity data, or 10 mg/l, or the maximum solubility in water, whichever is lowest.
Valgustuse kvaliteet
The MTC is defined as the highest test concentration of the chemical which results in less than 10 % mortality.
Luminofoorlambid (laia spektriga)
Using this approach assumes that there are existing empirical acute toxicity data or other toxicity data from which the MTC can be estimated.
10–20 μE/m2/s, 540–1000 luksi (labori üldvalgustus)
Estimating the MTC can be inexact and typically requires some professional judgment.
Valgustusperiood (koidu/hämariku üleminekuid võib korraldada, kuid neid ei peeta tingimata vajalikuks)
Three test concentrations, spaced by a constant factor not exceeding 10, and a dilution-water control (and solvent control if necessary) are required.
16 tundi valgust, 8 tundi pimedust
A range of spacing factors between 3,2 and 10 is recommended.
12–16 tundi valgust, 12–8 tundi pimedust
Selection and weighing of test fish
< 5 g/l
It is important to minimise variation in weight of the fish at the beginning of the assay.
Katsekambri suurus
Suitable size ranges for the different species recommended for use in this test are given in Appendix 2.
10 l (miinimum)
For the whole batch of fish used in the test, the range in individual weights for male and female fish at the start of the test should be kept, if possible, within ± 20 % of the arithmetic mean weight of the same sex.
2 l (miinimum)
It is recommended to weigh a subsample of the fish stock before the test in order to estimate the mean weight.
5 l (miinimum)
Conditions of exposure
Katselahuse maht
The test duration is 21 days, following a pre-exposure period.
8 l (miinimum)
The recommended pre-exposure period is one week.
1,5 l (miinimum)
Fish should be fed ad libitum with an appropriate food (Appendix 2) at a sufficient rate to maintain body condition.
4 l (miinimum)
Care should be taken to avoid microbial growth and water turbidity.
Uuritava lahuse kogu ruumala asendamine
As a general guidance, the daily ration may be divided into two or three equal portions for multiple feeds per day, separated by at least three hours between each feed.
Vähemalt 6 korda päevas
A single larger ration is acceptable particularly for weekends.
Vähemalt 5 korda päevas
Food should be withheld from the fish for 12 hours prior to sampling/necropsy.
Vt punkt 20
Fish food should be evaluated for the presence of contaminants such as organochlorine pesticides, polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs).
Isased:
Food with an elevated level of phytoestrogens that would compromise the response of the assay to known oestrogen agonist (e.g. 17-beta estradiol) should be avoided.
Emased:
Uneaten food and faecal material should be removed from the test vessels at least twice weekly, e.g. by carefully cleaning the bottom of each tank using a siphon.
Kalade arv katsenõu kohta
The photoperiod and water temperature should be appropriate for the test species (see Appendix 2).
6 (2 isaskala ja 4 emaskala)
Frequency of analytical determinations and measurements
10 (5 isaskala ja 5 emaskala)
Prior to initiation of the exposure period, proper function of the chemical delivery system should be ensured.
Kontsentratsioonide arv
All analytical methods needed should be established, including sufficient knowledge on the chemical stability in the test system.
= 3 (pluss vajalikud kontrollkatsed)
During the test, the concentrations of the test chemical are determined at regular intervals, as follows:
Nõude arv ühe kemikaalikontsentratsiooni kohta
the flow rates of diluent and toxicant stock solution should be checked preferably daily but as a minimum twice per week, and should not vary by more than 10 % throughout the test.
Vähemalt 4
It is recommended that the actual test chemical concentrations be measured in all vessels at the start of the test and at weekly intervals thereafter.
Vähemalt 2
It is recommended that results be based on measured concentrations.
Kalade arv ühe katses kasutatud kontsentratsiooni kohta
However, if concentration of the test chemical in solution has been satisfactorily maintained within ± 20 % of the nominal concentration throughout the test, then the results can either be based on nominal or measured values.
16 täiskasvanud emaslooma ja 8 isaslooma (4 emaslooma ja 2 isaslooma igas paralleelkatsenõus)
Samples may need to be filtered (e.g., using a 0,45 μm pore size) or centrifuged.
10 täiskasvanud emaslooma ja 10 isaslooma (5 emaslooma ja 5 isaslooma igas paralleelkatsenõus)
If needed, then centrifugation is the recommended procedure.
Söötmisrežiim
However, if the test material does not adsorb to filters, filtration may also be acceptable.
Elus või külmutatud soolase vee krevettide täiskasvanud või noorjärgus isendid 2–3 korda päevas (ad libitum), müügil olev kalasööt või nende kombinatsioon
During the test, dissolved oxygen, temperature, and pH should be measured in all test vessels at least once per week.
Soolase vee krevettide noorjärgus isendid 2–3 korda päevas (ad libitum), müügil olev kalasööt või nende kombinatsioon
Total hardness and alkalinity should be measured in the controls and one vessel at the highest concentration at least once per week.
Üksnes siis, kui lahustunud hapnikku on alla 60 % küllastuskontsentratsioonist
Temperature should preferably be monitored continuously in at least one test vessel.
Puhas pinnavesi, kaevuvesi, taastatud vesi või deklooritud kraanivesi
A number of general (e.g. survival) and core biological responses (e.g. vitellogenin levels) are assessed over the course of the assay or at termination of the assay.
Kokkupuute-eelne periood
Measurement and evaluation of these endpoints and their utility are described below.
Soovitatavalt 7 päeva
Survival
Kemikaaliga kokkupuute kestus
Fish should be examined daily during the test period and any mortality should be recorded and the dead fish removed as soon as possible.
Bioloogilised näitajad
Dead fish should not be replaced in either the control or treatment vessels.
ellujäämine,
Sex of fish that die during the test should be determined by macroscopic evaluation of the gonads.
käitumine,
Behaviour and appearance
teisesed sootunnused,
Any abnormal behaviour (relative to controls) should be noted;
vitellogeniin
this might include signs of general toxicity including hyperventilation, uncoordinated swimming, loss of equilibrium, and atypical quiescence or feeding.
Katse nõuetekohasus
Additionally external abnormalities (such as haemorrhage, discoloration) should be noted.
Lahustunud hapnikku > 60 % küllastuskontsentratsioonist;
Such signs of toxicity should be considered carefully during data interpretation since they may indicate concentrations at which biomarkers of endocrine activity are not reliable.
keskmine temperatuur 25 ± 2 °C;
Such behavioural observations may also provide useful qualitative information to inform potential future fish testing requirements.
kontrollrühma(de)s jäi ellu 90 % kaladest;
For example, territorial aggressiveness in normal males or masculinised females has been observed in fathead minnows under androgenic exposure;
katse ajal mõõdetud kontsentratsioonid vahemikus ± 20 % mõõdetud väärtuste keskväärtusest igal kontsentratsioonil
in zebrafish, the characteristic mating and spawning behaviour after the dawn onset of light is reduced or hindered by oestrogenic or anti-androgenic exposure.
keskmine temperatuur 24 ± 2 °C;
Because some aspects of appearance (primarily colour) can change quickly with handling, it is important that qualitative observations be made prior to removal of animals from the test system.
keskmine temperatuur 26 ± 2 °C;
Experience to date with fathead minnows suggests that some endocrine active chemicals may initially induce changes in the following external characteristics:
Mõned lahjendusvee nõutavad keemilised omadused
body colour (light or dark), coloration patterns (presence of vertical bands), and body shape (head and pectoral region).
< 20 mg/l
Therefore observations of physical appearance of the fish should be made over the course of the test, and at conclusion of the study
< 2 mg/l
Humane killing of fish
Fosfororgaaniliste pestitsiidide üldsisaldus
At day 21, i.e. at termination of the exposure, the fish should be euthanized with appropriate amounts of Tricaine (Tricaine methane sulfonate, Metacain, MS-222 (CAS 886-86-2), 100-500 mg/l buffered with 300 mg/l NaHCO3 (sodium bicarbonate, CAS 144-55-8) to reduce mucous membrane irritation; blood or tissue is then sampled for vitellogenin determination, as explained in the Vitellogenin section.
A liide
Observation of secondary sex characteristics
Vöötdaanio kudemissubstraat
Some endocrine active chemicals may induce changes in specialised secondary sex characteristics (number of nuptial tubercles in male fathead minnow, papillary processes in male medaka).
Kudemisalus
Notably, chemicals with certain modes of action may cause abnormal occurrence of secondary sex characteristic in animals of the opposite sex;
üleni klaasist instrumendinõu, näiteks 22 × 15 × 5,5 cm (pikkus × laius × sügavus), kaetud eemaldatava roostevabast terastraadist võrega (võresilma suurus 2 mm).
for example, androgen receptor agonists, such as trenbolone, methyltestosterone and dihydrotestosterone, can cause female fathead minnows to develop pronounced nuptial tubercles or female medaka to develop papillary processes (11, 20, 21).
Võre peaks katma instrumendinõu valendiku allpool nõu äärt.
It also has been reported that oestrogen receptor agonists can decrease nuptial tubercle numbers and size of the dorsal nape pad in adult males (25, 26).
Võre peale tuleks kinnitada kudemissubstraat.
Such gross morphological observations may provide useful qualitative and quantitative information to inform potential future fish testing requirements.
See peaks moodustama struktuuri, millesse kalad saavad siseneda.
The number and size of nuptial tubercles in fathead minnow and papillary processes in medaka can be quantified directly or more practically in preserved specimens.
Sobivad näiteks rohelisest plastikmaterjalist kunstlikud akvaariumitaimed (NB! tuleb arvestada uuritava kemikaali võimaliku adsorbeerumisega plastikmaterjalile).
Recommended procedures for the evaluation of secondary sex characteristics in fathead minnow and medaka are available from Appendix 5A and Appendix 5B, respectively.
Plastikmaterjali tuleb leostada piisava koguse sooja veega piisavalt kaua, et hoida ära kemikaalide leostumine vette katse ajal.
Vitellogenin (VTG)
Klaasmaterjali kasutamisel tuleks tagada, et kalad ei saaks vigastusi ega peaks oma aktiivse tegevuse käigus taluma ruumikitsikust.
Blood is collected from the caudal artery/vein with a heparinised microhematocrit capillary tubule, or alternatively by cardiac puncture with a syringe.
Vahemaa aluse ja kambri klaasseinte vahel peaks olema vähemalt 3 cm, et kudemine toimuks kindlalt vaagnale.