Table 19.
Study owner: | Nufarm (2009b) | |||
Reliability/Justification: | 1 Study performed according to GLP and OECD guideline requirements, with no deviations | |||
Substance: | Glyphosate (94.6–97.6% pure) | |||
Species/Strain: | mouse/CD-1, groups of 51 ♂ and 51 ♀ | |||
Administration route: | Diet | |||
Concentration: | 0, 500, 1500, and 5000 ppm diet (♂ about 0, 0, 71.4, 234, 810 mg/kg bw/day; ♀ about 0, 97.9, 300, 1081 mg/kg bw/day) | |||
Duration: | 18 months | |||
Findings: | ≥ 5000 ppm diet: NOAEL (♂/♀) No treatment-related effects |
|||
Select neoplasms: | Bronchiolar-alveolar adenoma, Bronchiolar-alveolar adenocarcinoma, hepatocellular adenoma (males), hepatocellular carcinoma (males), lymphoma, pituitary adenoma (females) | |||
Dose (mg/kg bw/day) | ||||
Males | 0 | 157 | 814 | 4841 |
Bronchiolar-alveolar adenoma – B | 9/51 (18%) | 7/51 (14%) | 9/51 (18%) | 4/51 (8%) |
Bronchiolar-alveolar adenocarcinoma – M | 5/51 (10%) | 5/51 (10%) | 7/51 (14%) | 11/51 (22%) |
Hepatocellular adenoma – B | 1/51 (2%) | 1/51 (2%) | 4/51 (8%) | 2/51 (4%) |
Hepatocellular carcinoma – M | 6/51 (12%) | 11/51 (22%) | 7/51 (14%) | 4/51 (8%) |
Lymphoma – M | 0/51 | 1/50 (2%) | 2/51 (4%) |
5/51 (10%) |
Dose (mg/kg bw/day) | ||||
Females | 0 | 190 | 955 | 5873 |
Bronchiolar-alveolar adenoma – B | 2/51 (4%) | 4/51 (8%) | 2/51 (4%) | 2/51 (4%) |
Bronchiolar-alveolar adenocarcinoma – M | 5/51 (10%) | 2/51 (4%) | 2/51 (4%) | 3/51 (6%) |
Lymphoma – M | 11/51 (22%) | 8/51 (16) | 10/51 (20%) | 11/51 (22%) |
Pituitary adenoma – B | 0/51 | 1/50 (2%) | 0/51 | 2/51 (4%) |
B benign, M malignant