natgillin/translations-raw huggingface dataset:
An overview of relevant test conditions specific for validated species:
Tyler (2002), „Utility of a juvenile fathead minnow screening assay for detecting (anti-)estrogenic substances”, Environmental Toxicology and Chemistry 21, pp. 319-326.
Japanese medaka, the three-spined stickleback and zebrafish is provided in Appendix 2.
Wang (2007), „Toxicity of the aromatase inhibitor letrozole to Japanese medaka (Oryzias latipes) eggs, larvae and breeding adults”, Comparative Biochemistry and Physiology C-Toxicology & Pharmacology 145, pp. 533-541.
Results from an acute toxicity test or other short-term toxicity assay [e.g. test method C.14 (34) and OECD TG 210 (1)], preferably performed with the species chosen for this test, should be available.
LeBlanc, and C.V.Sullivan (1999), „Fathead minnow (Pimephales promelas) vitellogenin: purification, characterization and quantitative immunoassay for the detection of estrogenic compounds”, Comparative Biochemistry and Physiology C-Toxicology & Pharmacology 123, pp. 113-125.
This implies that the water solubility and the vapour pressure of the test chemical are known and a reliable analytical method for the quantification of the chemical in the test chambers, with known and reported accuracy and limit of detection, is available.
Porcher (2002), „Development and validation of an enzyme-linked immunosorbent assay to measure vitellogenin in the zebrafish (Danio rerio)”, Environmental Toxicology and Chemistry 21, pp. 1699-1708.
Other useful information includes the structural formula, purity of the chemical, stability in water and light, pKa, Pow and results of a test for ready biodegradability (Test Method C.4) (35).
Hatano, H. Mizukami, M. Yamashita, R. Sakakibara, and E. Tamiya (2002), „Development and application of a monoclonal antibody-based sandwich ELISA for quantification of Japanese medaka (Oryzias latipes) vitellogenin”, Comparative Biochemistry and Physiology C-Toxicology & Pharmacology 132, pp. 161-169.
Test acceptance criteria
Bengtsson (2004), „The juvenile three-spined stickleback (Gasterosteus aculeatus L.) as a model organism for endocrine disruption – II – kidney hypertrophy, vitellogenin and spiggin induction”, Aquatic Toxicology 70, pp. 311-326.
The dissolved oxygen concentration should be at least 60 per cent of the air saturation value (ASV) throughout the test;
Tatarazako, N., M. Koshio, H. Hori, M. Morita, and T. Iguchi (2004), „Validation of an enzyme-linked immunosorbent assay method for vitellogenin in the medaka”, Journal of Health Science 50, pp. 301-308.
The water temperature should not differ by more than ± 1,5 °C between test chambers at any one time during the exposure period and be maintained within the temperature ranges specified for the test species (Appendix 2);
Eidem, J.K., H. Kleivdal, K. Kroll, N. Denslow, R. van Aerle, C. Tyler, G. Panter, T. Hutchinson, and A. Goksoyr (2006), „Development and validation of a direct homologous quantitative sandwich ELISA for fathead minnow (Pimephales promelas) vitellogenin.
A validated method for analysis of the exposure chemical with a detection limit well below the lowest nominal concentration should be available and evidence should be gathered to demonstrate that the concentrations of the test chemical in solution have been satisfactorily maintained within ± 20 % of the mean measured values;
Aquatic Toxicology”, 78, pp. 202-206.
Overall survival of fertilised eggs in the controls and, where relevant, in the solvent controls, should be greater than or equal to the limits defined in Appendix 2;
Ankley (2006), „Evaluation of a commercial kit for measuring vitellogenin in the fathead minnow (Pimephales promelas)”, Ecotoxicology and Environmental Safety 64, pp. 101-105.
Acceptance criteria related to growth and proportions of sex at termination of the test are based on data from the control groups (pooled solvent and water control unless they are significantly different, then solvent only):
Holbech, H., Petersen, G. I., Norman, A., Örn, S, Norrgren, L., and Bjerregaard, P (2001b), „Suitability of zebrafish as test organism for detection of endocrine disrupting chemicals.
Japanese medaka
Comparison of vitellogenin in plasma and whole body homogenate from zebrafish (Danio rerio) and rainbow trout (Oncorhynchus mykiss)”, Nordic Council of Ministers, TemaNord 2001:597, pp. 48-51.
Three-spined stickleback
Porcher, and A. Goksoyr (2004), „Development of quantitative vitellogenin-ELISAs for fish test species used in endocrine disruptor screening”, Analytical and Bioanalytical Chemistry 378, pp. 621-633.
Growth
Orn, S., S. Yamani, and L. Norrgren (2006), „Comparison of vitellogenin induction, sex ratio, and gonad morphology between zebrafish and Japanese medaka after exposure to 17 alpha-ethinylestradiol and 17 beta-trenbolone”, Archives of Environmental Contamination and Toxicology 51, pp. 237-243.
Fish wet weight, blotted dry
Scholz, S. and N. Kluver (2009), „Effects of Endocrine Disrupters on Sexual, Gonadal Development in Fish, Sexual Development” 3, pp. 136-151.
> 75 mg
Fenske, M., G. Maack, C. Schafers, and H. Segner (2005), „An environmentally relevant concentration of estrogen induces arrest of male gonad development in zebrafish, Danio rerio”, Environmental Toxicology and Chemistry 24, pp. 1088-1098.
Length (standard length)
Nagahama (2004), „Two DM domain genes, DMY and DMRT1, involved in testicular differentiation and development in the medaka, Oryzias latipes”, Developmental Dynamics 231, pp. 518-526.
> 20 mm
Shinomiya, A., H. Otake, K. Togashi, S. Hamaguchi, and M. Sakaizumi (2004), „Field survey of sex-reversals in the medaka, Oryzias latipes: genotypic sexing of wild populations”, Zoological Science 21, pp. 613-619.
> 14 mm
Flick (2007), „Collapse of a fish population after exposure to a synthetic estrogen”, Proceedings of the National Academy of Sciences of the United States of America 104, pp. 8897-8901.
Sex ratio (% males or females)
Baron, and K.A. Kidd (2009), „Interspecies differences in biochemical, histopathological, and population responses in four wild fish species exposed to ethynylestradiol added to a whole lake”, Canadian Journal of Fisheries and Aquatic Sciences 66, pp. 1920-1935.
When a solvent is used it should have no statistical significant effect on survival and should not produce any endocrine disrupting effects or other adverse effects on the early-life stages as revealed by a solvent control.
Tyler (2006), „Development of chronic tests for endocrine active chemicals – Part 1.
If a deviation from the test acceptance criteria is observed, the consequences should be considered in relation to the reliability of the test data and these considerations should be included in the reporting.
An extended fish early-life stage test for oestrogenic active chemicals in the fathead minnow (Pimephales promelas)”, Aquatic Toxicology 77, pp. 279-290.
Test chambers
Petersen, P. Jackson, K. Hylland, L. Norrgren, and P. Bjerregaard (2006), „Detection of endocrine disrupters: Evaluation of a Fish Sexual Development Test (FSDT)”, Comparative Biochemistry and Physiology C-Toxicology & Pharmacology 144, pp. 57-66.
Any glass, stainless steel or other chemically inert chambers can be used.
Andersen, L., K. Kinnberg, H. Holbech, B. Korsgaard, and P. Bjerregaard (2004), „Evaluation of a 40 day assay for testing endocrine disrupters: Effects of an anti-estrogen and an aromatase inhibitor on sex ratio and vitellogenin concentrations in juvenile zebrafish (Danio rerio)”, Fish Physiology and Biochemistry 30, pp. 257-266.
The dimensions of the chambers should be large enough to allow compliance with loading rate criteria given below.
Morthorst, J.E., H. Holbech, and P. Bjerregaard (2010), „Trenbolone causes irreversible masculinization of zebrafish at environmentally relevant concentrations”, Aquatic Toxicology 98, pp. 336-343.
It is desirable that test chambers be randomly positioned in the test area.
Metcalf (2003), „Effects of the antiandrogens, vinclozolin and cyproterone acetate on gonadal development in the Japanese medaka (Oryzias latipes)”, Aquatic Toxicology 63, pp. 391-403.
A randomised block design with each concentration being present in each block is preferable to a completely randomised design.
Tyler (2004), „Successful detection of (anti-) androgenic and aromatase inhibitors in pre-spawning adult fathead minnows (Pimephales promelas) using easily measured endpoints of sexual development”, Aquatic Toxicology 70, pp. 11-21.
The test chambers should be shielded from unwanted disturbance.
Petersen, and P. Bjerregaard (2007), „Effects of the fungicide prochloraz on the sexual development of zebrafish (Danio rerio)”, Comparative Biochemistry and Physiology C-Toxicology & Pharmacology 145, pp. 165-170.
Recommended fish species are given in Appendix 2.
Käesoleva lisa peatükk C.14.
The procedures for inclusion of new species are given in paragraph 2.
Noorkalade kasvukatse.
Holding of parental fish
Käesoleva lisa peatükk C.4.
Details on holding the parental fish under satisfactory conditions may be found in OECD TG 210(1).
Kohese biolagunduvuse määramine.
Parental fish should be fed once or twice a day with appropriate food.
Käesoleva lisa peatükk C.37.
Handling of embryos and larvae
äevane katse kaladega – lühiajaline sõelkatse östrogeense ja androgeense toime ning aromataasi inhibeerimise kontrollimiseks.
Initially, embryos and larvae may be exposed within a main chamber in smaller glass or stainless steel chambers, fitted with mesh sides or ends to permit a flow of test chemical through the chamber.
Schäfers, C., Teigeler, M., Wenzel, A., Maack, G., Fenske, M., Segner, H (2007), „Concentration- and time-dependent effects of the synthetic estrogen, 17 alpha-ethinylestradiol, on reproductive capabilities of the zebrafish, Danio rerio” Journal of Toxicology and Environmental Health-Part A, 70, 9-10 pp 768-779.
Non-turbulent flow through these small chambers may be induced by suspending them from an arm arranged to move the chamber up and down but always keeping the organisms submerged.
Lühendid ja mõisted
Where egg containers, grids or meshes have been used to hold eggs within the main test chamber, these restraints should be removed after the larvae hatch, except that meshes should be retained to prevent the escape of the fish.
Apikaalne näitaja
If there is a need to transfer the larvae, they should not be exposed to the air and nets should not be used to release fish from egg containers.
näitaja, mis iseloomustab mõju populatsiooni tasandil
The timing of this transfer varies with the species and transfer may not always be necessary.
õhuga küllastamise väärtus (air saturation value)
Any water in which the test species shows control survival at least as good as in water described in Appendix 3 is suitable as test water.
näitaja, mis iseloomustab mõju üksikisendi tasandil
In order to ensure that the dilution water will not unduly influence the test result (for example by reacting with the test chemical) or adversely affect the performance of the brood stock, samples should be taken at intervals for analysis.
aine või segu
Total organic carbon, conductivity, pH and suspended solids should be measured, for example every three months where dilution water is known to be relatively constant in quality.
päevad pärast koorumist (Days post hatch)
Measurements of heavy metals (e.g. Cu, Pb, Zn, Hg, Cd, Ni), major anions and cations (e.g. Ca2+, Mg2+, Na+, K+, Cl–, SO42–) and pesticides should be done, if water quality is questionable.
Y-spetsiifiline DM-domeeni geen, mis määrab jaapani riisikala arenemise isaskalaks
Details about chemical analysis and water collection can be found in paragraph 34.
ensüümimmuunsorptsioonanalüüs (Enzyme-Linked Immunosorbent Assay)
Flow-through system should be used if practically possible.
Kala mass
For flow-through tests, a system that continually dispenses and dilutes a stock solution of the test chemical (e.g. metering pump, proportional diluter, and saturator system) is necessary to deliver a series of concentrations to the test chambers.
kuivaks pühitud kala märgmass
The flow rates of stock solutions and dilution water should be checked at intervals during the test and should not vary by more than 10 % throughout the test.
kalade seksuaalse arengu katse
A flow rate equivalent to at least five test chamber volumes per 24 hours has been found suitable (1).
hüpotalamuse-ajuripatsi-sugunäärmete telg
Care should be taken to avoid the use of plastic tubing or other materials, some of which may contain biologically active chemicals or may adsorb the test chemical.
Vahesoost kala
The stock solution should preferably be prepared without the use of solvents by simply mixing or agitating the test chemical in the dilution water by using mechanical means (e.g. stirring or ultrasonication).
kala, kellel on enam kui üks munarakk niisas kuue analüüsitud lõike kohta või spermatogeneesi rakud munasarjades (jah/ei)
If the test chemical is difficult to dissolve in water, procedures described in the OECD Guidance Document on aquatic toxicity testing of difficult substances and mixtures should be followed (36).
kalade märgmass vee ruumala kohta
The use of solvents should be avoided but may be necessary in some cases in order to produce a suitably concentrated stock solution.
toimemehhanism (mode of action)
Examples of suitable solvents are given in (36).
pöördtranskriptaasi polümeraasi ahelreaktsioon
Semi-static test conditions should be avoided unless justification is provided on compelling reasons associated with the test chemical (e.g. stability, limited availability, high cost or hazard).
Diferentseerumata kala
For the semi-static technique, two different renewal procedures may be followed.
kala, kelle sugunäärmetes ei ole võimalik eristada sugurakke.
Either new test solutions are prepared in clean chambers and surviving eggs and larvae gently transferred into the new chambers, or the test organisms are retained in the test chambers whilst a proportion (at least two thirds) of the test water is changed daily.
vitellogeniin
Conditions of Exposure
Kalade sugulise arengu katse tingimused (mageveekalade liigid)
Collection of eggs and duration
Jaapani riisikala (Oryzias latipes)
To avoid genetic bias, eggs are collected from a minimum of three breeding pairs or groups, mixed and randomly selected to initiate the test.
Vöötdaanio (Danio rerio)
For the three-spined stickleback, see the description of artificial fertilisation in Appendix 11.
Harilik ogalik (Gasterostreus aculeatus)
The test should start as soon as possible after the eggs have been fertilised, the embryos preferably being immersed in the test solutions before cleavage of the blastodisc commences, or as close as possible after this stage and no later than 12 h post fertilisation.
Läbivooluga või poolstaatiline
The test should continue until sexual differentiation in the control group is completed (60 dph for Japanese medaka, the three-spined stickleback and zebrafish).
Luminofoorlambid (laia spektriga)
Loading
Valguse intensiivsus
The number of fertilised eggs at the start of the test should be at least 120 per concentration divided between a minimum of 4 replicates (square root allocation to control is accepted).
10–20 μE/m2/s, 540–1080 luksi või 50–100 ft-c (labori üldvalgustus)
The eggs should be randomly distributed (by using statistical tables for randomisation) among treatments.
12–16 tundi valgust, 8–12 tundi pimedust
The loading rate (for definition, see Appendix 1) should be low enough in order that a dissolved oxygen concentration of at least 60 % of the ASV can be maintained without direct aeration of the chambers.
Minimaalne kambri suurus
For flow-through tests, a loading rate not exceeding 0,5 g/l per 24 hours, and not exceeding 5 g/l of solution at any time is recommended.
Iga üksikkamber peaks sisaldama vähemalt 7 l vett
No later than 28 days post fertilisation the number of fish per replicate should be redistributed, so that each replicate contains as equal a number of fish as possible.
Katseorganismide vanus kemikaaliga kokkupuute alguses
If exposure related mortality occurs, the number of replicates should be reduced appropriately so that fish density between treatment levels is kept as equal as possible.
Värskelt viljastatud marjaterad (varane blastula staadium)
The photoperiod and water temperature should be appropriate for the test species (see Appendix 2 for experimental conditions for the FSDT).
Värskelt viljastatud marjaterad
Food and feeding are critical, and it is essential that the correct food for each stage is supplied at appropriate time intervals and at a level sufficient to support normal growth.
Marjaterade arv ühe kemikaalikontsentratsiooni kohta
Feeding should be ad libitum whilst minimising the surplus.
Vähemalt 120
To obtain a sufficient growth rate, fish should be fed at least twice daily (accepting once daily on weekends), separated by at least three hours between each feed.
Vähemalt 3 (pluss vajalikud kontrollkatsed)
Surplus food and faeces should be removed, as necessary, to avoid accumulation of waste.
Paralleelkatsete arv ühe kemikaalikontsentratsiooni kohta
As experience is gained, food and feeding regimes are continuously being refined to improve survival and optimise growth.
Vähemalt 4 (välja arvatud ruutjuurjaotustega kontrollkatsete puhul)
Effort should therefore be made to confirm the proposed regime with acknowledged experts.
Elus Artemia, külmutatud täiskasvanud soolase vee hall krevett, helvessööt jne.
Feeding should be withheld 24 hours before ending the test.
Soovitatakse sööta kaks korda päevas.
Examples of appropriate food items are listed in Appendix 2 (see also the OECD Fish Testing Framework (39).
Spetsiaalne kalamaimude kuivtoit, elus Artemia, külmutatud täiskasvanud soolase vee hall krevett, helvessööt jne.
Test chemicals should be spaced as described in Appendix 4.
Soovitatakse sööta kaks korda päevas.
A minimum of three test concentrations in at least four replicates should be used.
Ei ole vajalik, välja arvatud juhul, kui lahustunud hapniku sisaldus langeb alla 60 % küllastuskontsentratsioonist
The curve relating LC50 to period of exposure in the acute studies available should be considered when selecting the range of test concentrations.
Ei ole vajalik, välja arvatud juhul, kui lahustunud hapniku sisaldus langeb alla 70 % küllastuskontsentratsioonist
Five test concentrations are recommended if the data are to be used for risk assessment.
Puhas pinna-, kaevu- või taastatud vesi
Concentrations of the chemical higher than 10 % of the acute adult LC50 or 10 mg/l, whichever is the lower, need not be tested.
Uuritava kemikaaliga kokkupuute kestus
The maximum test concentration should be 10 % of the LC50 on the larval/juvenile life-stage.
Koorumise edukus, ellujäämine, üldine morfoloogia, vitellogeniinsugunäärmete histoloogia, geneetiline sugu sooline jaotumine
Controls
üldine morfoloogia, vitellogeniin sugunäärmete histoloogia, sooline jaotumine
A dilution water control (≥ 4 replicates) and, if relevant, a solvent control (≥ 4 replicates) should be run in addition to the test concentrations.
Katse nõuetekohasuse kriteeriumid kontrollrühmade koondatud paralleelkatsete puhul
Only solvents that have been investigated not to have any statistical significant influence on the test endpoints should be used in the test.
Koorumise edukus > 80 %
Where a solvent is used, its final concentration should not be greater than 0,1 ml/l (36) and it should be the same concentration in all test chambers, except the dilution water control.
Ellujäämine pärast koorumist ≥ 70 %
However, every effort should be made to avoid the use of such solvent or keep solvent's concentrations to a minimum.
Kasv (kuivaks pühitud kala märgmass) > 150 mg
Frequency of Analytical Determinations and Measurements
Kasv (kuivaks pühitud kala märgmass) > 75 mg
Chemical analysis of the test chemical concentration should be performed before initiation of the test to check compliance with the acceptance criteria.
Kasv (kuivaks pühitud kala märgmass) > 120 mg
All replicates should be analysed individually at the beginning and termination of the test.
Pikkus (standardpikkus) > 20 mm
One replicate per test concentration should be analysed at least once per week during the test, changing systematically between replicates (1,2,3,4,1,2…).
Pikkus (standardpikkus > 14 mm)
If samples are stored to be analysed at a later time, the storage method of the samples should be previously validated.
Pikkus (standardpikkus) > 20 mm
Samples should be filtered (e.g. using a 0,45 μm pore size) or centrifuged to ensure that the determinations are made on the chemical in true solution.
Sooline jaotumine (isasloomade või emasloomade %) 30 % – 70 %
During the test, dissolved oxygen, pH, total hardness, conductivity, salinity (if relevant), and temperature should be measured in all test chambers.
Kasutuskõlbliku lahjendusvee keemilised omadused
As a minimum dissolved oxygen, salinity (if relevant), and temperature should be measured weekly, and pH, conductivity and hardness at the beginning and at the end of the test.
KONTSENTRATSIOON
Temperature should preferably be monitored continuously in at least one test chamber.
Tahked osakesed
Results should be based on measured concentrations.
Tabel katsemeetodist c.14: juhend uuritavate kontsentratsioonide valimiseks
However, if the 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.
Veerg (kontsentratsioonide arv 100 ja 10 või 10 ja 1 vahel) [1]
Observations and measurements
Veerust võib valida kolmest (või enamast) järjestikusest kontsentratsioonist koosneva jada.
Stage of embryonic development
Kontsentratsioonidevahelised keskpunktid veerus (x) leitakse veerus (2x + 1).
The exposure should begin as soon as possible after fertilisation and before cleavage of the blastodisc commences and no later than 12 h post fertilisation to ensure exposure during early embryonic development.
Loetletud väärtused võivad esindada kontsentratsioone, mida väljendatakse protsendina mahu või massi kohta (mg/l või μg/l).
Hatching and survival
Väärtusi võib vajaduse korral korrutada või jagada 10 mis tahes astmega.
Extreme care should be taken when removing dead individuals not to knock or physically damage adjacent eggs/larvae, these being extremely delicate and sensitive.
Käesoleva osa eesmärk on kirjeldada vitellogeniini kontsentratsiooni määramise ettevalmistavaid etappe.
Criteria for death vary according to life stage:
Vitellogeniini kontsentratsiooni määramiseks võib kasutada ka muid meetodeid, mis annavad sellega võrreldavaid tulemusi.
for eggs:
Vitellogeniini kontsentratsiooni võib pea/saba homogenaadi asemel määrata ka vereplasmast või maksast.
particularly in the early stages, a marked loss of translucency and change in coloration, caused by coagulation and/or precipitation of protein, leading to a white opaque appearance;
Kala pea ja saba lõigatakse ära kooskõlas katse kooskõlas.
for larvae and juvenile fish:
kõik lõikeriistad ja lõikelaud tuleks loputada ja korralikult puhastada (näiteks 96 % etanooliga) enne iga üksiku kala lõikamist, et hoida ära indutseerimata isaskalade saastamist emaskalade ja indutseeritud isaskalade vitellogeniiniga.
immobility and/or absence of respiratory movement and/or absence of heart-beat and/or white opaque coloration of central nervous system and/or lack of reaction to mechanical stimulus.
Pärast ühtlase massi saavutamist lisatakse koemassiga võrreldes 4–10-kordne kogus jääkülma homogeenimispuhvrit (märkige üles lahjendusaste).
Abnormal appearance
Proovid pannakse jääle kuni tsentrifuugimiseni 4 °C ja 50000 g juures 30 minuti jooksul.
The number of larvae or fish showing abnormality of body form should be recorded, and the appearance and the nature of the abnormality described.
Pipetiga võetakse 20–50 μl (märkige üles kogus) supernatanti ja pannakse vähemalt kahte viaali; pipeti ots viiakse pinnal olevat rasvakihi alla ja tõmmatakse supernatanti sisse nii, et rasva- ja põhjas oleva sademe fraktsioon kaasa ei tuleks.
It should be noted that abnormal embryos and larvae occur naturally and can be of the order of several per cent in the control(s) in some species.
Asetage kasutamise ajaks jääle.