Table 4 Adverse events/effects—reproductive toxicity

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