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Acute oral toxicity – up-and-down procedure.
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Testing the statistical certainty of a response to increasing doses of a drug.
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Raffaele, K.C., Fisher, E., Hancock, S., Hazelden, K., and Sobrian, S.K.
Jones, R.C. and Edgren, R.A.
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OECD (1982).
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immature females after weaning and prior to puberty;
J. Agric Food Chem.
The uterine weight response will be compared to established historical data (see reference (5)).
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If this baseline positive control study does not yield the anticipated results the experimental conditions should be examined and modified.
Štatisticky významné zníženie hmotnosti dvoch alebo viacerých cieľových orgánov v skupinách, ktorým sa podala testovaná chemikália a TP, v porovnaní s kontrolnou skupinou, ktorej sa podal iba TP, indikuje pozitívny test testovanej chemikálie na možný antiandrogénny účinok (pozri odsek 61).
Sensitivity is the proportion of all positive/active chemicals that are correctly classified by the test.
Uvedené údaje by mali zahŕňať prinajmenšom hmotnosť ventrálnej prostaty, semenných mechúrikov, zdvíhača konečníka a bulbokavernóznych svalov, Cowperových žliaz, žaluďa, pečene, telesnú hmotnosť a zmenu telesnej hmotnosti od začiatku dávkovania po pitvu.
It is a measure of accuracy for a test method that produces categorical results, and is an important consideration in assessing the relevance of a test method.
Report of the First Meeting of the OECD Endocrine Disrupter Testing and Assessment (EDTA) Task Force, 10. - 11. marec 1998, ENV/MC/CHEM/RA(98)5.
Specificity is the proportion of all negative/inactive chemicals that are correctly classified by the test.
Dorfman RI (1962).
It is a measure of accuracy for a test method that produces categorical results and is an important consideration in assessing the relevance of a test method.
Gray LE Jr, Furr J a Ostby JS (2005).
Test chemical means any substance or mixture tested using this test method.
Current Protocols in Toxicology 16.9.1 - 16.9.15.
Uterotrophic is a term used to describe a positive influence on the growth of uterine tissues.
Owens, W, Zeiger E, Walker M, Ashby J, Onyon L, Gray, Jr, LE (2006).
Validation is a scientific process designed to characterise the operational requirements and limitations of a test method and to demonstrate its reliability and relevance for a particular purpose.
Use of a potent agonist and a potent antagonist to test the standardized protocol.
Owens JW, Ashby J. (2002).
Owens W, Gray LE, Zeiger E, Walker M, Yamasaki K, Ashby J, Jacob E (2007).
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Kanno, J, Onyon L, Haseman J, Fenner-Crisp P, Ashby J, Owens W.
Korenchevsky V, Dennison M, Schalit R (1932).
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Biochem J26:1306 - 1314.
Phase 2 — Testing of Potent and Weak Oestrogen Agonists by Multiple Laboratories.
Eisenberg E, Gordan GS (1950).
Kanno J, Onyon L, Peddada S, Ashby J, Jacob E, Owens W.
J Pharmacol Exp Therap 99:38 - 44.
Phase Two — Dose Response Studies.
Eisenberg E, Gordan GS, Elliott HW (1949).
Health Persp.111:1530-1549
Testosterone and tissue respiration of the castrate male rat with a possible test for mytrophic activity.
Phase Two — Coded Single Dose Studies.
Endocrinology 45:113 - 119.
Phase Two — Dietary phytoestrogen analyses.
Hilgar AG, Vollmer EP (1964).
111:1559-1567.
Dorfman RI (1969).
Ogasawara Y, Okamoto S, Kitamura Y, Matsumoto K. (1983).
(Dorfman RI, ed.)
Endocrinology 113:582-587.
New York:Academic Press, 151 - 220.
Branham WS, Sheehan DM, Zehr DR, Ridlon E, Nelson CJ.
Massaro EJ (2002).
Endocrinology 117:2229-2237.
Humana Press, p.
Schlumpf M, Berger L, Cotton B, Conscience-Egli M, Durrer S, Fleischmann I, Haller V, Maerkel K, Lichtensteiger W.
38.
127:10-15.
Korea Food and Drug Administration.
Zarrow MX, Lazo-Wasem EA, Shoger RL.
OECD (2009).
Estrogenic activity in a commercial animal ration.
A shortterm screening assay for (anti)androgenic properties.
Drane HM, Patterson DSP, Roberts BA, Saba N. (1975).
Môže to zahŕňať spermatogenézu (testikulárnu histopatológiu) u samcov a estrálny cyklus, počty folikulov/dozrievanie oocytov a ovariálnu integritu (histopatológiu) u samíc.
Boettger-Tong H, Murphy L, Chiappetta C, Kirkland JL, Goodwin B, Adlercreutz H, Stancel GM, Makela S. (1998).
vplyv nosiča na absorpciu, distribúciu, metabolizmus alebo retenciu testovanej chemikálie, vplyv na chemické vlastnosti testovanej chemikálie, ktoré môžu zmeniť jej toxické vlastnosti, a vplyv na spotrebu potravy alebo vody alebo nutričný stav zvierat.
Environ.
Samce a samice z tej istej dávkovej skupiny sa pária (zabráni sa páreniu medzi súrodencami) po dobu až dvoch týždňov so začiatkom v 90.
OECD (2007).
PND.
Degen GH, Janning P, Diel P, Bolt HM.
Úplné histopatologické vyšetrenie orgánov uvedených v odsekoch 62 a 63 sa vykoná u všetkých zvierat generácie P s vysokou dávkou a z kontrolnej skupiny.
(2002).
Orgány, ktoré vykazujú zmeny súvisiace s testovaním, sa vyšetria aj u všetkých zvierat v skupinách s nižšou dávkou, čo pomôže pri určovaní hladiny bez pozorovaného nepriaznivého účinku (NOAEL).
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Zoetis, T. and I. Walls (2003), Principles and Practices for Direct Dosing of Pre-Weaning Mammals in Toxicity Testing and Research, ILSI Press, Washington, DC.
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Ulbrich, B. and A.K.
Thigpen JE, Haseman JK, Saunders HE, Setchell KDR, Grant MF, Forsythe D. (2003).
Sakai, T., M. Takahashi, K. Mitsumori, K. Yasuhara, K. Kawashima, H. Mayahara and Y.
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Creasy, D.M.
Ashby J, Tinwell H, Odum J, Kimber I, Brooks AN, Pate I, Boyle CC.
Sadleir, R.M.F.S.
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Korenbrot, C.C., I.T.
Thigpen JE, Lockear J, Haseman J, Saunders HE, Caviness G, Grant MF, Forsythe DB.
Gore, E.R., J. Gower, E. Kurali, J.L.
Thigpen JE, Li L-A, Richter CB, Lebetkin EH, Jameson CW.
Klinefelter, G.R., L.E.
I. A standardized method for conducting the mouse bioassay.
Seed, J., R.E.
Sci.37:596-601.
Chapin, R.E., R.S.
Acute oral toxicity — up-and-down procedure.
Klinefelter, G.R., N.L.
OECD (2000).
Slott, V.L., J.D.
OECD (2001).
Slott, V.L., and S.D.
Bulbring, E., and Burn, J.H.
Toth, G.P., J.A.
85: 320 — 333.
Linder, R.E., L.F.
Dorfman, R.I., Gallagher, T.F. and Koch, F.C (1936).
Thigpen, JE, K.D.R.
Endocrinology 19: 33 — 41.
349 - 381.
Reel, J.R., Lamb IV, J.C. and Neal, B.H.
OECD (2013), Guidance Document supporting TG 443: Extended One Generation Reproductive Toxicity Study, Series on Testing and Assessment, No.
34: 288 — 305.
Áno
Jones, R.C. and Edgren, R.A.
0 [21]; 0,01; 0,03; 0,1; 0,3; 1; 3; 10
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0 [21]; 0,03; 0,1; 1; 3; 10; 30; 100
OECD (1982).
0,1; 1; 3; 10; 30; 100 HCG
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Pokiaľ z predchádzajúcich informácií, ako sú napríklad informácie o limitoch rozpustnosti alebo o cytotoxicite, nevyplýva základ na výber testovacích koncentrácií, odporúča sa, aby testovacie koncentrácie pre prvé vykonanie skúšky boli v intervaloch log10, pričom 10–3 M je maximálna koncentrácia.
Dorfman R.I.
Ak je chemikália rozpustná, nie je cytotoxická pri žiadnej z testovaných koncentrácií a prvý pokus bol negatívny pre všetky koncentrácie, potom sa to potvrdí ďalším vykonaním skúšky za tých istých podmienok, za akých sa vykonal prvý pokus (tabuľka 7).
Thigpen J. E. et al.
Hecker, M., Newsted, J.L., Murphy, M.B., Higley, E.B., Jones, P.D., Wu, R. and Giesy, J.P.
ILAR J 45(4): 401-416.
Pharmacol., 217, 114 - 124.
Gray L.E. and Ostby J. (1998).
Hecker, M., Hollert, H., Cooper, R., Vinggaard, A.-M., Akahori, Y., Murphy, M., Nellemann, C., Higley, E., Newsted, J., Wu, R., Lam, P., Laskey, J., Buckalew, A., Grund, S., Nakai, M., Timm, G., and Giesy, J. P. (2007), The OECD validation program of the H295R steroidgenesis assay for the identification of in vitro inhibitors or inducers of testosterone and estradiol production, Phase 2:
14 (1-2): 159-184.
[http://www.oecd.org/document/30/0,3746,en_2649_34377_1916638_1_1_1_1,00.html].
Booth AN, Bickoff EM and Kohler GO.
Dostupné na:
Science 131:1807-1808.
Battelle (2005), Detailed Review Paper on Steroidogenesis, Dostupné na:
Kato H, Iwata T, Katsu Y, Watanabe H, Ohta Y, Iguchi T (2004).
Hilscherova, K., Jones, P. D., Gracia, T., Newsted, J. L., Zhang, X., Sanderson, J. T., Yu, R. M. K., Wu, R. S. S. and Giesy, J. P. (2004), Assessment of the Effects of Chemicals on the Expression of Ten Steroidogenic Genes in the H295R Cell Line Using Real-Time PCR, Toxicol.
52, 1410-1414.
Sci., 81, 78 - 89.
A statistically significant decrease in two or more target organ weights of the test chemical plus TP groups compared to the TP only control group indicates that the test chemical is positive for potential antiandrogenic activity (See paragraph 61).
Pharmacol., 182, 44 - 54.
DESCRIPTION OF THE METHOD
Breen, M.S., Breen, M., Terasaki, N., Yamazaki, M. and Conolly, R.B.
The five androgen-dependent tissues (VP, SV, LABC, COW, GP) should be weighted.
265 - 272.
These tissues should be excised, carefully trimmed of excess adhering tissue and fat, and their fresh (unfixed) weights determined.
Higley, E.B., Newsted, J.L., Zhang, X., Giesy, J.P. and Hecker, M. (2010), Assessment of chemical effects on aromatase activity using the H295R cell line, Environ.
Data presented should include at least: ventral prostate, seminal vesicle, levator ani plus bulbocavernosus, Cowper's glands, glans penis, liver, and body weights and body weight change from the beginning of dosing until necropsy.
Res., 17:1137 - 1148.
Specificity is the capability of a test method to correctly identify chemicals not having the property that is being tested for.
Gazdar, A. F., Oie, H. K., Shackleton, C. H., Chen, T. R., Triche, T. J., Myers, C. E., Chrousos, G. P., Brennan, M. F., Stein, C. A. and La Rocca, R. V. (1990), Establishment and characterization of a human adrenocortical carcinoma cell line that expresses Multiple pathways of steroid biosynthesis, Cancer Res., 50, 5488 - 5496.
Dorfman RI (1962).
Zhang, X.W., Yu, R.M.K., Jones, P.D., Lam, G.K.W., Newsted, J.L., Gracia, T., Hecker, M., Hilscherova, K., Sanderson, J.T., Wu, R.S.S. and Giesy, J.P.
Gray LE Jr, Furr J and Ostby JS (2005).
Technol., 39:2777 - 2785.
Use of a potent agonist and a potent antagonist to test the standardized protocol.
Metab., 77, 731 - 737.
114:1265-1269.
Shapiro, R., and Page, L.B.
Korenchevsky V (1932).
Mosmann, T. (1983), Rapid colorimetric assay for growth and survival:
Biochem J26:413-422.
Methods., 65, 55 - 63.
Korenchevsky V, Dennison M, Schalit R (1932).
Brock, B.J., Waterman, M.R.
Biochem J26:1306-1314.
38:1598 - 1606.
Eisenberg E, Gordan GS (1950).
Oskarsson, A., Ulleras, E., Plant, K., Hinson, J. Goldfarb, P.S., (2006), Steroidogenic gene expression in H295R cells and the human adrenal gland:
J Pharmacol Exp Therap 99:38-44.
Toxicol., 26:484 - 492.
Eisenberg E, Gordan GS, Elliott HW (1949).
Môžu sa vyskytnúť prípady, keď je opodstatnené testovanie len samičiek, napríklad pri testovaní liekov určených pre ženy alebo pri skúmaní ženského/samičieho metabolizmu.
Testosterone and tissue respiration of the castrate male rat with a possible test for mytrophic activity.
Vhodným kompromisom na meranie frekvencií mutácií v tkanivách s rýchlou a aj pomalou proliferáciou sú denné režimy podávania po dobu 28 po sebe nasledujúcich dní (ako sa uvádza v odseku 26) a odber vzoriek tri dni po záverečnom podaní, hoci maximálna frekvencia mutácií sa v tkanivách s pomalou proliferáciou za týchto podmienok nemusí prejaviť.
Endocrinology 45:113-119.
Adams, W.T. and T.R.
Proc Soc Exp Biol Med 83:175-180.
Bielas, J.H.
Hilgar AG, Vollmer EP (1964).
Boerrigter, M.E., M.E.
Dorfman RI (1969).
657 - 659.
(Dorfman RI, ed.)
Carr, G.J. and N.J.
New York:Academic Press, 151-220.
Dean, S.W., T.M.
Massaro EJ (2002).
Douglas, G.R.,J. Jiao, J.D.
Humana Press, p 38.
7485 - 7489.
Supplemental materials for Owens et al.
Douglas, G.R., J.D.
Korea Food and Drug Administration.
197 - 212.
OECD (2009).
Dunson, D.B. and K.R.
A shortterm screening assay for (anti)androgenic properties.
Gossen, J.A., W.J. de Leeuw, C.H.
For reproductive endpoints, it is envisaged that, as a first step and when available, information from repeat-dose studies (including screening reproductive toxicity studies, e.g. OECD TG 422 (32)), or short term endocrine disrupter screening assays, (e.g. Uterotrophic assay — test method B.54 (36); and Hershberger assay — test method B.55 (37)) is used to detect effects on reproductive organs for males and females.
Erikson, R.P.
This might include spermatogenesis (testicular histopathology) for males and oestrous cycles, follicle counts/oocyte maturation and ovarian integrity (histopathology) for females.
125 - 136.
The Extended One-Generation Reproductive Toxicity Study then serves as a test for reproductive endpoints that require the interaction of males with females, females with conceptus, and females with offspring and the F1 generation until after sexual maturity (see OECD Guidance Document 151 supporting this test method (40)).
96 - 106.
Additional TK data, such as metabolite profiles, concentration-time courses, etc. should also be considered, if they are available.
Fung, K.Y., G.R.
Considerations should be given to the following characteristics if a vehicle or other additive is used to facilitate dosing: effects on the absorption, distribution, metabolism, or retention of the test chemical;
253 - 259.
effects on the chemical properties of the test chemical that may alter its toxic characteristics; and effects on the food or water consumption or the nutritional status of the animals.
Heddle, J.A., H.-J.
The duration of the pre-mating treatment in the Extended One-Generation Reproductive Toxicity Study is therefore aimed at the detection of effects on functional changes that may interfere with mating behaviour and fertilisation.
Jakubczak, J.L., G. Merlino, J.E.
The day of testing should be counterbalanced across treated and control groups.
Anal.
Procedures should be similar to those for the P animals.
Appl., 7(8):
Systemic effects should be monitored in P animals.
Lewis P.D., B. Manshian, M.N.
Organs demonstrating treatment-related changes should also be examined in all animals at the lower dose groups to aid in determining a NOAEL.
Piegorsch, W.W., B.H.
Cooper, R.L., J.C. Lamb, S.M.
Piegorsch, W.W., A.C.
Conolly, R.B., B.D.
Toyoda-Hokaiwado, N., T. Inoue, K. Masumura, H. Hayashi, Y.
Sakai, T., M. Takahashi, K. Mitsumori, K. Yasuhara, K. Kawashima, H. Mayahara and Y.
Thybaud, V., S. Dean, T. Nohmi, J. de Boer, G.R.
Creasy, D.M.
141 -151.
Sadleir, R.M.F.S.
G. Pfeifer (ed.), Technologies for Detection of DNA Damage and Mutations, Part II, Plenum Press, New York, NY, USA, s. 391 - 410.
383-390.
Yauk, C.L., J.D.
Korenbrot, C.C., I.T.
117 -123.
Ladics, G.S.
Hayashi, M., K. Dearfield, P. Kasper, D. Lovell, H.-J.
Gore, E.R., J. Gower, E. Kurali, J.L.
Clermont, Y.
Robb, G.W., R.P.
198 - 236.
Klinefelter, G.R., L.E.
Robaire, B., Hinton, B.T., and Oregbin-Crist, M.-C.
Seed, J., R.E.
Russell, L.B.
Chapin, R.E., R.S.
Hodnotenie pozostáva z pozorovaní s cieľom odhaliť makroskopické neurologické abnormality a poruchy správania vrátane posúdenia fyzického vývinu, behaviorálnej ontogenézy, motorickej aktivity, motorických a zmyslových funkcií, učenia a pamäte, ako aj posúdenia hmotnosti mozgu a neuropatológie počas postnatálneho vývinu a dospelosti.
Klinefelter, G.R., N.L.
Uprednostňovaným druhom zvierat sú potkany, ak je to vhodné, môžu sa použiť aj iné druhy.
Slott, V.L., J.D.
Principles and Approaches, (Environmental Health Criteria 223), World Health Organization Publications, Ženeva.
Slott, V.L., and S.D.
Developmental neurotoxicity following neonatal exposure to 3,3′-iminodipropionitrile in the rat.
Toth, G.P., J.A.
Learning and memory deficits in rats following exposure to 3,3′-iminopropionitrile.
Linder, R.E., L.F.
813 – 831.
Thigpen, JE, K.D.R.
Degen GH, Janning P, Diel P, Bolt HM.
Tyl, R.W., K. Crofton, A. Moretto, V. Moser, L.P.
320 - 333.
349-381.
33 – 41.
Yes
284 – 291.
The solubility of the test chemical, forskolin and prochloraz in the solvent; and
Nielenže androgény vplývajú na pečeň, obličky a nadobličky, tieto orgány zároveň slúžia ako užitočné ukazovatele toxicity systému.
Specifically, chemicals to be tested include the strong inducer forskolin (CAS No 66575-29-9); the strong inhibitor prochloraz (CAS No 67747-09-5); the moderate inducer atrazine (CAS No 1912-24-9); the moderate inhibitor aminoglutethimide (CAS No 125-84-8); the weak inducer (E2 production) and weak inhibitor (T production) bisphenol A (CAS No 80-05-7); and the negative chemical human chorionic gonadotropin (HCG) (CAS No 9002-61-3) as shown in Table 2.
Pozri oddiel II, The dissection guidance provided to the laboratories:
0 [21], 0,01, 0,03, 0,1, 0,3, 1, 3, 10
Pre všetky zvieratá generácie F1 a podľa potreby aj zvieratá generácie F2 sa záznamy s uvedením vrhu, z ktorého pochádzajú, uchovajú počas celého trvania štúdie.
0 [21], 0,03, 0,1, 0,3, 1, 3, 10, 30
[http://www.epa.gov/endo/pubs/edmvs/steroidogenesis_drp_final_3_29_05.pdf].
0 [21], 0,03, 0,1, 1, 3, 10, 30, 100
107 - 112.
HCG
246 - 255.
n/a: not applicable as no changes should occur after exposure to non-cytotoxic concentrations of negative control.
405 - 413.
DMSO [25]1 μl
141 - 151.
Unless prior information such as information on solubility limits or cytotoxicity provides a basis for selecting test concentrations, it is recommended that the test concentrations for the initial run be spaced at log10 intervals with 10–3 M being the maximum concentration.
1411 - 1418.
If the chemical is soluble, and not cytotoxic at any of the tested concentrations, and the first run was negative for all concentrations, then it is to be confirmed in one more run using the same conditions as the first run was conducted (Table 7).
249 - 255.
Sci., 81, 78-89.
Dodatok 2
Sanderson, J. T., Boerma, J., Lansbergen, G. and Van den Berg, M. (2002), Induction and inhibition of aromatase (CYP19) activity by various classes of pesticides in H295R human adrenocortical carcinoma cells, Toxicol.
VMG mamm:
Res., 17:1137-1148.
lacZ plazmidové myši;
Gazdar, A. F., Oie, H. K., Shackleton, C. H., Chen, T. R., Triche, T. J., Myers, C. E., Chrousos, G. P., Brennan, M. F., Stein, C. A. and La Rocca, R. V. (1990), Establishment and characterization of a human adrenocortical carcinoma cell line that expresses Multiple pathways of steroid biosynthesis, Cancer Res., 50, 5488-5496.
Súbežnou kontrolnou skupinou je zdanlivo ošetrovaná kontrolná skupina alebo kontrolná skupina, ktorej sa podáva nosič, ak sa pri podávaní testovanej chemikálie používa nosič.
He, Y.H., Wiseman, S.B., Zhang, X.W., Hecker, M., Jones, P.D., El-Din, M.G., Martin, J.W. and Giesy, J.P.
Vyhnúť sa treba používaniu nosičov s potenciálnou vnútornou toxicitou (napríklad acetón, dimetylsulfoxid – DMSO).
, Ozonation attenuates the steroidogenic disruptive effects of sediment free oil sands process water in the H295R cell line, Chemosphere, 80:578-584.
Environment Directorate, OECD, Paríž.