Table 9.
Study 4 – Two-year feeding study of glyphosate in rats (Feinchemie Schwebda 1996).
| Study owner: | Feinchemie Schwebda (1996) | ||||
|---|---|---|---|---|---|
| Reliability/Justification: | 1 Study performed according to GLP and OECD guideline requirements, with no deviations. | ||||
| Substance: | Glyphosate (96.0–96.8% pure) | ||||
| Species/Strain: | Rat/Wistar, groups of 50 ♂ and 50 ♀ | ||||
| Administration route: | Diet | ||||
| Concentration: | 0, 100, 1000, 10 000 ppm diet (♂ about 0, 6.3, 59.4, 595 mg/kg bw/day; ♀ about 0, 8.6, 88.5, 886 mg/kg bw/day) | ||||
| Duration: | 2 years | ||||
| Findings: | 10 000 ppm diet: ≥ NOAEL (♂+♀) Only mild effects on clinical chemistry (liver enzymes), without histopathological changes. |
||||
| Select neoplasms: | Hepatocellular adenoma, hepatocellular carcinoma | ||||
| Tumor | Dose (mg/kg bw/day) | ||||
| Males | 0 | 7.4 | 73.9 | 741 | |
| Findings for dead and moribund sacrificed animals | |||||
| Hepatocellular adenoma – B | 9/30 (30%) | 9/30 (30%) | 6/32 (19%) | 6/21 (29%) | |
| Hepatocellular carcinoma – M | 12/30 (40%) | 12/30 (40%) | 9/32 (28%) | 5/21 (24%) | |
| Findings for animals sacrificed at termination | |||||
| Hepatocellular adenoma – B | 15/20 (75%) | 13/20 (65%) | 4/16 (25%) | 15/20 (75%) | |
| Hepatocellular carcinoma – M | 9/20 (45%) | 16/20 (80%) | 9/16 (56%) | 19/29 (66%) | |
| Dose (mg/kg bw/day) | |||||
| Females | 0 | 7.4 | 73.9 | 741 | |
| Findings for dead and moribund sacrificed animals | |||||
| Hepatocellular adenoma – B | 2/26 (8%) | 8/23 (3%) | 3/17 (18%) | 5/29 (17%) | |
| Hepatocellular carcinoma – M | 4/26 (15%) | 4/23 (17%) | 2/17 (12%) | 5/29 (17%) | |
| Findings for animals sacrificed at termination | |||||
| Hepatocellular adenoma – B | 16/24 (67%) | 10/25 (40%) | 16/32 (50%) | 8/21 (38%) | |
| Hepatocellular carcinoma – M | 6/24 (25%) | 11/25 (44%) | 12/32 (38%) | 4/21 (19%) | |
B benign, M malignant