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Table 1 Protocol used and comparison to existing assessment and to non-mandatoryregulatory tests

From: Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerantgenetically modified maize

Treatments and analyses

In this work

Hammond et al. 2004

Regulatory tests

Animals measured/group/sex

10/10 SD rats (200 rats measured)

10/20 SD rats (200 rats measured/total 400)

At least 10 rodents

Duration in months

24 (chronic)

3 (subchronic, 13 weeks)

3

Doses by treatment

3

2

At least 3

Treatments + controls

GMO NK603, GMO NK603 + Roundup, Roundup, and closest isogenicmaize

GMO NK603 + Roundup, closest isogenic maize, and 6 other maize linesnon substantially equivalent

GMOs or Chemicals (in standard diet or water)

Animals by cage (same sex)

1 to 2

1

1 or more

Monitoring/week

2

1

1 or more

Organs and tissues studied

  

For high dose and controls

Organs weighted

10

7

At least 8

Histology/animal

34

17/36

At least 30

Electronic microscopy

Yes

No

No

Feed and water consumptions

Measured

For feed only

At least feed

Behavioral studies (times)

2

1 (no protocol given)

1

Ophthalmology (times)

2

0

2

Blood parameters

31 (11 times for most)

31 (2 times)

At least 25 (at least 2 times)

Plasma sex steroids

Testosterone, estradiol

No

No, except if endocrine effects suspected

Number of blood samples/animal

11, each month (0 to 3) then every 3 months

2, weeks 4 and 13

1, at the end

Urine parameters studied

16

18

7 if performed

Number of urine samples

11

2

Optional, last week

Liver tissue parameters

6

0

0

Roundup residues in tissues

Studied

Not studied

Not mandatory

Microbiology in feces or urine

Yes

Yes

No

Transgene in tissues

Studied

Not studied

Not studied

  1. The protocol used in this work was compared to the regulatory assessment ofNK603 maize by the company (Hammond et al. 2004), and to non-mandatoryregulatory in vivo tests for GMOs, or mandatory for chemicals (OECD408). Most relevant results are shown in this paper.