Table 5.
Summary of selected tumour incidences in male CD-1 mice from four studies with glyphosate and historical control data
| Dose range | Tumour incidence/number of animals examined | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control group | Low dose | Intermediate dose | High dose | Very high dose*** | ||||||||||||
| Dose (mg/kg bw per day) | 0 | 0 | 0 | 0 | 71 | 100 | 157 | 165 | 234 | 300 | 810 | 814 | 838 | 1000 | 4348 | 4841 |
| Study ID | A | B | C | D | D | B | A | C | D | B | D | A | C | B | C | A |
| Study duration (months) | 24 | 24 | 18 | 18 | 18 | 24 | 24 | 18 | 18 | 24 | 18 | 24 | 18 | 24 | 18 | 24 |
| Survival | 20/50 | 26/50 | 26/50 | 39/51 | 41/51 | 25/50 | 16/50 | 34/50 | 39/51 | 29/50 | 35/51 | 17/50 | 27/50 | 25/50 | 29/50 | 26/50 |
| Renal tumours# | 1/49 | 2/50 | 0/50 | 0/51 | 0/51 | 2/50 | 0/49 | 0/50 | 0/51 | 0/50 | 0/51 | 1/50 | 0/50 | 0/50 | 2/50 | 3/50 |
| Malignant lymphoma* | 2/48 | 4/50 | 2/50 | 0/51 | 1/51 | 2/50 | 5/49 | 2/50 | 2/51 | 1/50 | 5/51 | 4/50 | 0/50 | 6/50 | 6/50 | 2/49 |
| Haemangiosarcoma** | 0/48 | 0/50 | 0/50 | 2/51 | 1/51 | 0/50 | 0/49 | 0/50 | 2/51 | 0/50 | 1/51 | 1/50 | 0/50 | 4/50 | 2/50 | 0/49 |
Study ID: A = TOX9552381 (1983), PWG re-evaluation; B = TOX9552382 (1993); C = ASB2012-11493 (1997); D = ASB2012-11492 (2009)
*Study A: Malign lymphoblastic tumours (3 categories) instead of malignant lymphoma which was not mentioned as a pathological entity
**Whole body/multiple organ
***Dosage exceeded the OECD-recommended limit dose of 1000 mg/kg bw/day and the MTD
Numbers in bold refer to values within acceptable HCD; no HCD is available for the other values (not bold) and no exceedance of HCD was recorded in mice treated with glyphosate
#Renal tumours: combined incidence of adenoma and carcinoma