Table 6.
Summary of the weight of evidence of the EU assessment for the different tumour types
| Tumour type/species | Significant trends | Weight of evidence in EU assessment |
|---|---|---|
| Renal tumours, mice | 2 out of 4 studies TOX9552381 (6% combined adenomas and carcinomas in males at 4841 mg/kg bw day) ASB2012-11493 (4% adenomas in males at 4348 mg/kg bw day) |
Both studies, trends observed only at high dose (>4000 mg/kg bw per day), where general toxicity (such as reduced bw, histopathological findings in liver, and bladder in one study and reduced bw gain, severe gastro-intestinal effects in the other) may be confounding factors No statistical significance in a pair-wise comparison One trend in one study did not consider the higher survival at the top dose |
| Malignant lymphomas, mice | 2 out of 4 studies ASB2012-11493 (12% males at 4348 mg/kg bw day) ASB2012-11492 (10% males at 810 mg/kg bw day) |
Malignant lymphomas is one of the most common neoplasms in CD-1 mice, females being more prone to this tumour type than males No statistical significance in a pair-wise comparison First study within historical controls and trend observed only at high dose (>4000 mg/kg bw per day), where general toxicity may be a confounding factor Second study inconsistency in results among 4 studies comparing similar dose levels |
| Haemangiosarcomas, mice | 2 out of 4 studies TOX9552382 (8% males at 1000 mg/kg bw day) ASB2012-11493 (4% males at 4348 mg/kg bw day) |
No statistical significance in a pair-wise comparison First study within historical control range Second study trend observed only at high dose (>4000 mg/kg bw per day) where general toxicity may be a confounding factor |
| Hepatocellular adenomas, rats | 1 out of 8 studies TOX9300244 (15% males at 940 mg/kg bw day) |
No statistical significance in a pair-wise comparison Marginal trends in benign tumours limited to one sex, not reproduced among 8 long term studies (3 studies in SD rats and 5 studies in Wistar rats) |
| Thyroid C-cell adenomas, rats | 1 out of 8 studies TOX9300244 (10% females at 457 and 1183 mg/kg bw day) |
No statistical significance in a pair-wise comparison Marginal trends in benign tumours limited to one sex, not reproduced among 8 long term studies (3 studies in SD rats and 5 studies in Wistar rats) |
| Pancreatic islet cell adenomas, rats | Incidences without dose response trends in 2 out of 8 studies | Lack of dose–response does not support an effect related to glyphosate administration |
| All other tumours, mice and rats | No increased incidences observed in 4 mice and 8 rat studies | No observed incidences in a large number of valid studies |