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The experimental test groups chosen and the minimum number of animals per group to be used are shown in the following table:

Group

% of daily dietary intake (w/w)

No. of animals

Isogenic non-
GM (NK603)

NK603

NK603 +
Roundup

Males

Females

1

33

0

0

16

16

2

22

11

0

16

16

3

0

33

0

16

16

4

22

0

11

16

16

5

0

0

33

16

16

Total

 

80

80

 

The number of animals per group has been chosen based on the OECD Test Guideline 408 and as recommended by the EFSA Guidance (2011).

 

A statistical analysis will be performed prior to the beginning of the feeding trial to determine whether the number of animals per group chosen is adequate, and, if necessary, it will be adjusted. The data to be obtained will be compared with background data on variations in endpoint values for Wistar Han Rcc rats fed a standard lab chow from Harlan Inc. present in the public domain (http://webapps.harlan.com/wistarhannover).

 

A statistical analysis of the data obtained will be performed by WP4 by taking into account, among other documents, the EFSA Guidance (2011) and will be accompanied by an analysis report. A specific chapter on assumptions and uncertainties will be included in the study report.

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