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