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Table 4 Adverse events/effects—reproductive toxicity

From: Evaluation of adverse effects/events of genetically modified food consumption: a systematic review of animal and human studies

Study ID Participant (T/C/R) a Sample size (male/female) Intervention/exposure Dosage Duration Generation Outcome Result
Carman JA 2013 [26] Yorkshire-cross piglets (isowean pig) T:84 T: GM corn containing 90% DK 42–88 RR YG PL (a triple stack of NK603, MON863 and MON810 genes) with the remainder being equal quantities of Pannar 5E-900RR (containing NK603), Pannar 4E-705RR/Bt (a double stack of NK603 and MON810) and Producers 5152 Roundup-Ready™ (containing NK603) Libitum 22.7 weeks 1 Uterus weight The medians of the non-GM-fed (now N = 33) and GM-fed (N = 37) groups after removing one extreme outlier:
C: 0.084% of the body weight,
T: 0.105% of the body weight
(p = 0.025)
   C:84 C: non-GM varieties of soy and corn      
Cisterna B 2008 [31] Swiss mice T:10 A standard diet containing 14% GM soybean obtained by the insertion of a bacterial gene conferring tolerance to glyphosate, the active ingredient of the herbicide Roundup Ad libitum Not reported 2 Labelling density over nucleoplasm and prenucleolar bodies in 2-cell and 4–8-cell embryos The labelling was significantly lower in embryos from GM-fed mice than in controls in anti-polymerase II, anti-BrU and anti-hnRNP only at the 2-cell stage, and it was significantly lower in anti-CstF, anti-CFIm68 and polyadenylated RNA at both the 2-cell stage and the 4–8-cell stage
GM soybean-containing diet does not affect mouse fertility, parturition time or litter health
   C:10 Identical diet but containing non-GM soybean    
Cyran N 2008 c [32]** T1: F0 mice 48 (24 pairs) 33.0% of the transgenic corn (NK603 × MON810) (formulated in accordance with basal diet, similarly hereinafter) Ad libitum 20 weeks 2 1. The number of pairs who delivered in the F0 generation/group 1. T2:23, T3: 23, T4: 22, T5: 20
(P = 0.05);
C2: 24, C3: 24, C4: 24, C5: 24
  C1: F0 mice 48 (24 pairs) 33.0% isoline     2. Average number of pups at birth/pair 2. T4: 9.68 ± 0.688 (P = 0.011),
T5: 8.21 ± 1.077 (P = 0.010);
C4: 11.92 ± 0.496,
C5: 11.38 ± 0.462
  T2: 1st litter of T1 189 33.0% of the transgenic corn (NK603 × MON810) after weaning    
  C2: 1st litter of C1 216 33.0% isoline after weaning     3. Sum of pups at birth/group 3. T2 + T3 + T4 + T5 (GM group): 844; C2 + C3 + C4 + C5 (ISO group): 1035
  T3: 2nd litter of T1 245 33.0% of the transgenic corn (NK603 × MON810) after weaning    
  C3: 2nd litter of C1 260 33.0% isoline after weaning     4. Sum of pups at weaning/group 4. T5: 173 (7.21 ± 0.985), C5: 235 (9.79 ± 0.525)
  T4: 3rd litter of T1 213 33.0% of the transgenic corn (NK603 × MON810) after weaning    
  C4: 3rd litter of C1 286 33.0% isoline after weaning     5. Sum of pup losses/group (birth to weaning) 5. T2: 2 (0.09 ± 0.060),
T3: 19 (0.83 ± 0.375),
T4: 2 (0.12 ± 0.081) * (p = 0.025),
T5: 24 (1.00 ± 0.376)
C2: 16 (0.67 ± 0.305),
C3: 19 (0.79 ± 0.289),
C4: 32 (1.33 ± 0.433),
C5: 38 (1.58 ± 0.371)
  T5: 4th litter of T1 197 33.0% of the transgenic corn (NK603 × MON810) after weaning    
  C5: 4th litter of C1 273 33.0% isoline after weaning     
        6. Litter weights 6. The third litters: the average litter weights were statistically significantly lower in the GM group (T4) at birth and on the second day (at birth p = 0.026; 2d p = 0.040) as well as at weaning (p = 0.031);
the fourth litter the average litter weight was significantly lower in the GM group (T4) (p = 0.05)
Cyran N 2008 a [32] T1: F0 mice 36 33.0% of the transgenic corn (NK603 x MON810) (formulated in accordance with basal diet, similarly hereinafter) Ad libitum The duration of the F0 generation was not known
For pups, the duration was 7 weeks(3 weeks suckling to the dam + 4 weeks consuming the test diet)
5 1. Litter size 1. More litters with n > 8 were seen in the control groups compared to the GM
groups
  C1: F0 mice 36 33.0% isoline    2. Sum of pups at birth/group (number of pups
at birth/pair)
2. There were no statistically significant differences between groups:
T1: 184 (10.22 ± 0.629),
C1: 185 (10.28 ± 0.980),
T2: 189 (7.88 ± 0.779),
C2: 198 (8.25 ± 0.778),
T3: 208 (8.92 ± 0.875),
C3: 202 (8.42 ± 1.025),
T4: 125 (5.68 ± 1.10),
C4: 145 (6.59 ± 1.046),
  R1: F0 mice 36 33.0% GM-free Austrian corn   
  T2: F1 mice 184 33.0% of the transgenic corn (NK603 × MON810) after weaning   
  C2: F1 mice 185 33.0% isoline after weaning   
  R2: F1 mice 138 33.0% GM-free Austrian corn after weaning    3.Sum of pup losses from birth to weaning/group (pup losses/pair) 3. There were no statistically significant differences between groups:
T1: 46 (2.61 ± 0.837),
T2: 22 (1.00 ± 0.510),
T3: 25 (2.95 ± 0.631),
T4: 10 (0.71 ± 0.322)
C1: 34 (2.06 ± 0.683),
C2: 6 (0.26 ± 0.157),
C3: 11 (0.58 ± 0.289),
C4: 3 (0.19 ± 0.136)
R1: 17 (1.06 ± 0.322),
R2: 18 (0.78 ± 0.281),
R3: 21 (0.91 ± 0.266),
R4: 10 (0.50 ± 0.212)
  T3: F2 mice 189 33.0% of the transgenic corn (NK603 × MON810) after weaning   
  C3: F2 mice 198 33.0% isoline after weaning    
  R3: F2 mice 194 33.0% GM-free Austrian corn after weaning   
  T4: F3 mice 208 33.0% of the transgenic corn (NK603 × MON810) after weaning   
  C4: F3 mice 202 33.0% isoline after weaning    
  R4: F3 mice 230 33.0% GM-free Austrian corn after weaning     
  T5: F4 mice 125 33.0% of the transgenic corn (NK603 × MON810) after weaning     
  C5: F4 mouse 145 33.0% isoline after weaning     
  R5: F4 mouse 199 33.0% GM-free Austrian corn after weaning     
Ermakova I 2005 [37]** T1: F0 Wistar rats 6 T1: Roundup-Ready soya (40.3.2 line) (formulated in accordance with standard laboratory feed, similarly hereinafter) T1/C1: before mating: 20 g soya flour for every cage (5–7 g flour for each rat) every day; upon delivery: the amount of soya supplement was increased by an additional g for every pup born Not reported 2 1. Pup mortality during every lactation period (the number of dead rats) 1. 1st week: T2: 31.1% (14), C2: 9% (3), R2: 4.5% (2);
2nd week: T2: 13.4% (6), C2: 0% (0), R2: 2.3% (1);
3rd week: T2: 11.1% (14), C2: 0% (0), R2: 0% (0)
  C1: F0 Wistar rats 3 C1: traditional soya variety    2. Organ mass in small pups 2. The organs of small pups from the GM group were tiny in comparison with the same of other groups except for the brain mass
3. Birth weight of F1 rats:
T2: 23.95 g ± 1.5 g
C2: 30.03 g ± 1.1 g (P < 0.005)
R2: 27.1 g ± 0.9 g (P < 0.1)
the weight distribution of F1 rats by 2 weeks of age on different diets:
10–20 g: T2: 36%, C2: 6.7% (P < 0.05), R2: 6% (P < 0.01)
  R1: F0 Wistar rats 6 R1: standard laboratory feed without any supplementation Ad libitum    
  T2: F1 Wistar rats 45 T2: Roundup-Ready soya (40.3.2 line) T2/C2: from 13–14 days of age: 2–3 g soya supplement for every pup    3. Weight of pups
  C2: F1 Wistar rats 33 C2: traditional soya variety    
  R2: F1 Wistar rats 44 R2: standard laboratory feed without any supplementation Ad libitum    
Tudisco R 2015 [69] T1: F0 pluriparae goat 10 Oat hay and commercial concentrate containing 13% of GM (MON40-3–2) soybean meal Ad libitum 120d 2 1. Body weight after 30 days in kids 1. Body weight at day 30 (p < 0.05):
T3: 8.3 ± 0.7b, T4: 8.2 ± 0.6b
C3: 9.5 ± 0.4a, C4: 9.4 ± 0.5a
body weight at slaughtering (p < 0.05):
T3: 10.3 ± 0.5b, T4: 10.1 ± 0.6b
C3: 12.5 ± 0.4a, C4: 12.3 ± 0.5a
  T2: F0 pluriparae goat 10 Oat hay and commercial concentrate containing 20% of GM (MON40-3–2) soybean meal   120d  
  C1: F0 pluriparae goat 10 Oat hay and commercial concentrate containing 13% of conventional soybean meal   120d   2. Height at the withers and chest width in kids 2. Height at withers (p < 0.05):
T3: 45.7 ± 2.1b, T4: 46.0 ± 2.0b
C3: 48.6 ± 2.6a, C4: 48.8 ± 2.4a
chest width (p < 0.05):
T3: 11.3 ± 1.0b, T4: 11.5 ± 1.1b
C3: 12.6 ± 1.03a, C4: 12.7 ± 1.1a
  C2: F0 pluriparae goat 10 Oat hay and commercial concentrate containing 20% of conventional soybean meal   120d  
  T3: male kids of T1 10 Colostrum/milk from T1   60 ± 7d   3. Carcass weight in kids 3. Hot carcass weight (p < 0.05):
T3: 6.4 ± 0.3b, T4: 6.2 ± 0.4b
C3: 7.2 ± 0.4a, C4: 7.1 ± 0.5a
Cold carcass weight (p < 0.05):
T3: 6.2 ± 0.4b, T4: 6.0 ± 0.4b
C3: 6.8 ± 0.6a, C4: 6.9 ± 0.7a
  T4: male kids of T2 10 Colostrum/milk from T2   60 ± 7d  
  C3: male kids of C1 10 Colostrum/milk from C1   60 ± 7d   
  C4: male kids of C2 10 Colostrum/milk from C1   60 ± 7d   
  1. *T/C/R refers to treatment group/control group/reference group
  2. F0 refers to parental generation
  3. F1–F4 refer to the generation of the filial generation
  4. **refers to a serious adverse event