#2512640
Nochtadh aonair infhéitheach, inpheireatóineach nó fo-chraicneach
Intravenous, intraperitoneal or subcutaneous single exposure
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#2512641
Measfar an tástáil infhéitheach, inpheireatóineach nó fho-chraicneach mar mheasúnacht an-íogair lenar féidir an ionfhabhtaíocht, go háirithe, a dhéanamh amach.
The intravenous, intraperitoneal or subcutaneous test shall be considered a highly sensitive assay to elicit in particular infectivity.
#294068
3.7.2.5.6. Maidir le staidéir a úsáideann bealaí dáilte amhail instealladh infhéitheach nó inpheireatóineach, agus a fhágann go nochtar na horgáin atáirgthe do leibhéil den tsubstaint tástála atá ró-ard ar fad, nó go ndéantar damáiste logánta do na horgáin atáirgthe, lena n-áirítear greannú, caithfear iad a léirmhíniú go han-chúramach agus go hiondúil ní bhíonn staidéir den sórt sin ina mbonn aicmithe leo féin.
3.7.2.5.6. Studies involving routes of administration such as intravenous or intraperitoneal injection, which result in exposure of the reproductive organs to unrealistically high levels of the test substance, or elicit local damage to the reproductive organs, including irritation, must be interpreted with extreme caution and on their own are not normally the basis for classification.
#2512644
Déanfar staidéar in ainmhithe tástála i gcomhréir leis na treoirlínte ábhartha, mura féidir leis an iarratasóir a léiriú nach bhfuil ionfhabhtaíocht agus pataigineacht infhéitheach, inpheireatóineach nó fho-chraicneach ann bunaithe ar chur chuige thromachar na fianaise mar a leagtar amach i bpointe 5.2.
A study in test animals in accordance with the relevant guidelines shall be performed, unless the applicant can demonstrate absence of intravenous, intraperitoneal or subcutaneous infectivity and pathogenicity based on a weight of evidence approach as set out in point 5.2.