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Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

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2. Experimental design<br />

• EFSA guidance advocates use of a randomised complete block<br />

design (RCBD) in which males and females are randomised<br />

together.<br />

• However, current toxicology study animal husbandry practices<br />

intenti<strong>on</strong>ally separate males and females (e.g., by assigning<br />

genders to different cage racks).<br />

• There is a c<strong>on</strong>cern that housing opposite genders in adjacent<br />

cages, particularly in paired housing setups, may lead to intra-<br />

MSK2 MSK3<br />

cage aggressi<strong>on</strong> in males.<br />

• EuropaBio Members’ str<strong>on</strong>g recommendati<strong>on</strong> is that the<br />

current practice of gender separati<strong>on</strong> be maintained.<br />

17

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