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Feeding of MON 810 resulted in 11/15 significant effects in females (Table , crude means with SEM; Annex Table ), which again highlights sex-differential effects. The sex-dependency for the measured parameters in liver and kidney is observed for all rats (Annex Fig. & Fig. ). The significant GM-maize linked effects are generally detected either after 14 weeks of consumption or at a high GM feed dose in the diet. Parameters affected relate to: blood cells, adrenal gland and kidney weights, an increase in blood urea nitrogen and higher spleen weight. Significantly disturbed parameters in males are concentrated in liver function at the 33% GM-maize feeding level in the diet, with a slight diminution in general serum albumin production. All disturbances are <20% and p-values are significant but >1% (Table , starred values). However, p-values adjusted for FDR are not significant.

Table 2 

Differences between MON 810-fed rats and controls. For details, see legend Table .

3.3. MON 863

We have already described our evaluation of the MON 863 rat feeding studies []. Sex-dependency is well marked in this case also for the spreading of all parameters in liver and kidney (Annex Fig. & Fig. ). The 34 significant GM-linked effects are equally distributed among males (16) and females (18). This contrasts with what is observed with NK 603 and MON 810. Nevertheless, 9/16 (56%) of males show statistically significant differences in kidney compared to 4/18 females. However, although kidney parameters represent only 37.5% of all measurements, these data show a male-specific effect in kidney function. This trend is somewhat opposite to what is seen in liver parameters where males showed significant effects in 5/16 cases whereas the rate is 9/18 in females. Male rats also appear more sensitive to kidney disturbances at the higher GM feeding dose (11 effects at 33% versus 5 at 11%).

Additional statistically significant differences include (i) a serum glucose and triglyceride increase (up to 40%) in females versus controls, together with a higher liver (7%) and overall body (3.7%) weight, (ii) elevated creatinine, blood urea nitrogen and urine chloride excretion in females, but greater variation in male kidney function (creatinine, and in urine sodium, potassium and phosphorus), (iii) up to a significant kidney weight decrease (7%) with a noticeable chronic nephropathy in males [], (iv) a decrease (3.3%) in male body weights and (v) some liver function differences in males (albumin, globulin, as in females, plus alanine aminotransferase), although none of the FDR-adjusted p-values are significant.

Furthermore, we have also measured in this study for the first time the differences between time-related variations (at weeks 5 and 14) for this GM maize variety, at each feeding dose versus controls. We have represented these variations for each rat for all parameters. Among these, the significant variations corresponding to disturbed parameters are illustrated (Figs. -). Our analysis clearly shows that female rat triglyceride levels vary between 5 and 14 weeks of feeding (Fig. ; p=0.025). Triglyceride levels increase over time within the GM maize feeding group and whilst decreasing in the case of controls. Again in females, the increase in creatinine caused by MON 863 is more evident with longer feeding periods at an 11% level (Fig. ; p=0.022). Another significant difference (p=0.011), which we observe is a reciprocal variation in female urine chloride excretion (Fig. ). In the males, only urine potassium decreases over time with the consumption of GM feed but increases in controls (Fig. , p=0.011).

In summary, the tendency for physiological disturbance is characteristic of almost all rats of all GM-fed treatment groups, and physio-pathological profiles differ according to dose or sex.

Fig 3 

Kinetic plot for urine creatinine clearance in male rats fed NK 603.