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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.