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Statisticky významný pokles hmotností dvou nebo více cílových orgánů ve skupinách, jimž byla podávána zkoušená chemická látka spolu s TP, v porovnání s kontrolní skupinou, které byl podáván pouze TP, ukazuje, že zkoušená chemická látka je z hlediska potenciální antiandrogenní aktivity pozitivní (viz odstavec 61).
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)).
Zváží se pět tkání závislých na androgenech (ventrální prostata (VP), semenné váčky (SV), svaly m. ligator ani a m. bulbocavernosus (LABC), Cowperovy žlázy (COW), žalud penisu GP)), Tyto tkáně se vyříznou, opatrně zbaví nadbytečných ulpělých tkání a tuku a stanoví se jejich hmotnost v čerstvém (nefixovaném) stavu.
Additional TK data, such as metabolite profiles, concentration-time courses, etc. should also be considered, if they are available.
Předkládané údaje by měly zahrnovat přinejmenším údaje o hmotnostech ventrální prostaty, semenných váčků, svalů m. levator ani a m. bulbocavernosus, Cowperových žláz, žaludu penisu, jater a o tělesné hmotnosti a změně tělesné hmotnosti od začátku podávání dávek až do pitvy.
Supplemental TK data may also be collected during the main study, provided that it does not interfere with the collection and interpretation of the main study endpoints.
Validací se rozumí vědecký proces, který má charakterizovat operační požadavky a omezení zkušební metody a prokázat její spolehlivost a vhodnost pro konkrétní účel.
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;
Report of the First Meeting of the OECD Endocrine Disrupter Testing and Assessment (EDTA) Task Force, 10.–11. března 1998, ENV/MC/CHEM/RA(98)5.
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.
Dorfman RI (1962).
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.
Gray LE Jr, Furr J and Ostby JS (2005).
The pre-mating treatment should be sufficiently long to achieve steady-state exposure conditions in P males and females.
Current Protocols in Toxicology 16.9.1–16.9.15.
An auditory startle test should be performed on PND 24 (± 1 day) using animals in cohort 2A.
Owens, W, Zeiger E, Walker M, Ashby J, Onyon L, Gray, Jr, LE (2006).
The day of testing should be counterbalanced across treated and control groups.
Use of a potent agonist and a potent antagonist to test the standardized protocol.
Males and females of the same dose group should be cohabited (avoiding the pairing of siblings) for up to two weeks, beginning on or after PND 90, but not exceeding PND 120.
114:1265–1269.
Procedures should be similar to those for the P animals.
Owens W, Gray LE, Zeiger E, Walker M, Yamasaki K, Ashby J, Jacob E (2007).
Systemic effects should be monitored in P animals.
115(5):671–8.
Fasted blood samples from a defined site are taken from 10 randomly-selected P males and females per dose group at termination, stored under appropriate conditions and subjected to partial or full-scale haematology, clinical biochemistry, assay of T4 and TSH or other examinations suggested by the known effect profile of the test chemical (see OECD Guidance Document 151(40)).
Korenchevsky V (1932).
Full histopathology of the organs listed in paragraphs 62 and 63 is performed for all high-dose and control P animals.
Biochem J26:413–422.
Organs demonstrating treatment-related changes should also be examined in all animals at the lower dose groups to aid in determining a NOAEL.
Korenchevsky V, Dennison M, Schalit R (1932).
Cooper, R.L., J.C. Lamb, S.M.
Biochem J26:1306–1314.
Thigpen, J.E., K.D.R.
Eisenberg E, Gordan GS (1950).
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.
J Pharmacol Exp Therap 99:38–44.
Conolly, R.B., B.D.