natgillin/translations-raw huggingface dataset:
accordingly, DNA inserted into a shuttle vector can be tested or manipulated in two different cell types or two different organisms.
Štúdiu vývojovej neurotoxicity možno vykonať ako samostatnú štúdiu, zahrnutú do štúdie reprodukčnej toxicity a/alebo štúdie neurotoxicity u dospelých jedincov (napr. testovacie metódy B.34 (14), B.35 (15), B.43 (16)) alebo ju priložiť k štúdii prenatálnej vývojovej toxicity (napr. testovacia metóda B.31 (17)).
Transgenic
Ak je štúdia vývojovej neurotoxicity zahrnutá do inej štúdie, alebo je k nej priložená, je nevyhnutné zachovať integritu oboch typov štúdií.
of, relating to, or being an organism whose genome has been altered by the transfer of a gene or genes from another species.’
Všetky testy by mali byť v súlade s príslušnými právnymi predpismi alebo vládnymi a inštitucionálnymi usmerneniami pre používanie laboratórnych zvierat vo výskume (napr. 18).
Depending on the sensitivity of cognitive function tests, investigation of a large higher number of animals should be considered e.g. up to 1 male and 1 female per litter (for animal assignments see Appendix 1) (further guidance on sample size is provided in the OECD Guidance Document 43 (8)).
Testovacie laboratórium by malo posúdiť všetky dostupné informácie o testovanej chemikálii pred uskutočnením štúdie.
This table presents the minimum number of times when measurements should be performed.
Tieto informácie zahŕňajú identitu a štruktúru chemikálie, jej fyzikálno-chemické vlastnosti, výsledky všetkých ostatných in vitro alebo in vivo testov toxicity s chemikáliou, toxikologické údaje o štrukturálne príbuzných chemikáliách a predpokladané použitie(-ia) chemikálie.
Depending on the anticipated effects, and the results of the initial measurements, it may be advisable to add additional time points (e.g. aged animals) or to perform the measurements in other developmental stages.
Tieto informácie sú potrebné, aby sa zainteresované strany presvedčili, že test má význam pre ochranu zdravia ľudí a pomôže pri výbere vhodnej počiatočnej dávky.
It is recommended that pups not be tested during the two days after weaning (see paragraph 32).
vplyv na absorpciu, distribúciu, metabolizmus alebo zadržiavanie testovanej chemikálie, účinky na chemické vlastnosti testovanej chemikálie, ktoré môžu zmeniť svoje toxické vlastnosti, vplyv na spotrebu potravy a vody alebo na stav výživy zvierat.
Recommended ages for adolescent testing are:
Spôsob podávania bude vo všeobecnosti orálny (napr. sondou, v krmive, v pitnej vode), ale možno použiť aj iné spôsoby (napr. dermálnou aplikáciou, inhaláciou) v závislosti od vlastností a očakávaných alebo známych spôsobov expozície na ľudí (ďalšie usmernenia sú k dispozícii v usmerňovacom dokumente č. 43 (8)).
learning and memory = PND 25 ± 2;
Výber spôsobu podávania je potrebné odôvodniť.
motor and sensory function = PND 25 ± 2.
Testovaná chemikália sa podáva každý deň približne v rovnakom čase.
Recommended ages for testing young adults is PND 60-70.
OECD (1995).
Body weights should be measured at least twice weekly when directly dosing pups for adjustment of doses at a time of rapid body weight gain.
Kodaň, Dánsko, 13.-14. jún 1995.
Brain weights and neuropathology may be assessed at some earlier time (e.g. PND 11), if appropriate (see paragraph 39).
US EPA (1998).
Other developmental landmarks in addition to the body weight (e.g. eye opening) should be recorded when appropriate (see paragraph 31).
Dostupné na:
See paragraph 35.
Cory-Slechta, D.A., Crofton, K.M., Foran, J.A., Ross, J.F., Sheets, L.P., Weiss, B., Mileson, B. (2001).
The threshold CV for a given tissue was identified from a graph of CV values — arranged from smallest sequentially to largest — for all means from all experiments in the validation exercise using a specific model (agonist or antagonist).
Health Perspect., 109:79 - 91.
The threshold CV was read from the point at which the increments between to the next highest CVs in the series are dramatically larger than the preceding few CVs- the “breakpoint”.
Dorman, D.C., Allen, S.L., Byczkowski, J.Z., Claudio, L., Fisher, J.E.
It should be noted that although this analysis identified relatively reliable “breakpoints” for the antagonist model of the assay, CV curves for the agonist assay showed a more uniform increase making identification of a threshold CV by this method somewhat arbitrary.
Garman, R.H., Fix,A.S., Jortner, B.S., Jensen, K.F., Hardisty, J.F., Claudio, L., Ferenc, S. (2001).
Research has shown the mammary gland, especially in early life mammary gland development, to be a sensitive endpoint for oestrogen action.
Health Perspect., 109:93 - 100.
It is recommended that endpoints involving pup mammary glands of both sexes be included in this test method, when validated.
OECD (2003).
“New batch” refers to a fresh batch of cells received from ATCC.
Washington D.C., US, 23. -25. október 2000.
“Frozen batch” refers to cells that have been previously cultured and then frozen at a laboratory other than ATCC.
OECD (2008).
If extraction is required, three replicate measurements are made for each extract.
Júl 2008 Dostupné na:
Method measurement limits are based on the basal hormone production values provided in Table 5, and are performance based.
Spencer, P.S., Schaumburg, H.H., Ludolph, A.C.
If greater basal hormone production can be achieved the limit can be greater.
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Some T and E2 antibodies may cross-react with androstendione and oestrone, respectively, at a greater percentage.
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In such cases it is not possible to accurately determine effects on 17β-HSD.
Slikker, W.B., Chang, L.W.
However, the data can still provide useful information regarding the effects on oestrogen or androgen production in general.
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These include:
WHO (2001) Neurotoxicity Risk Assessment for Human Health:
cholesterol, pregnenolone, progesterone, 11-deoxycorticosterone, corticosterone, aldosterone, 17α-pregnenolone,17α-progesterone, deoxycortisol, cortisol, DHEA, androstenedione, oestrone.
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Solvent (DMSO) control (0), 1 μl DMSO/well.
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+, positive
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The testing laboratory should consider all available information on the test chemical prior to conducting the study.
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Such information will include the identity and structure of the chemical; its physico-chemical properties;
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the results of any other in vitro or in vivo toxicity tests on the chemical; toxicological data on structurally related chemicals;
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This information is necessary to satisfy all concerned that the test is relevant for the protection of human health, and will help in the selection of an appropriate starting dose.
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The route of administration will generally be oral (e.g.gavage, dietary, via drinking water), but other routes (e.g. dermal, inhalation) may be used depending on the characteristics and anticipated or known human exposure routes (further guidance is provided in the Guidance Document 43(8)).
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The test chemical should be administered at approximately the same time every day.
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