Table 15.

Study 10 – Two-year feeding study with glyphosate in mice (Monsanto 1983).

Study owner:	Monsanto (1983)
Reliability/Justification	2 Study was performed prior to institution of GLP and OECD guideline requirements
Substance:	Glyphosate (99.7% pure)
Species/Strain:	Mouse/CD-1, groups of 50 ♂ and 50 ♀
Administration route:	Diet
Concentration:	0, 1000, 5000, 10 000 ppm diet (♂ about 0, 157, 814, 4841 mg/kg bw/day; ♀ about 0, 190, 955, 5874 mg/kg bw/day)
Duration:	24 months
Findings:	1000 ppm diet: NOAEL (♂ + ♀) 5000 ppm diet: body weight ↓, histological changes in liver and urinary bladder (slight to mild epithelial hyperplasia in males at mid and high doses)
Select neoplasms:	Lymphoreticular neoplasms, bronchiolar-alveolar adenocarcinoma
			Dose (mg/kg bw/day)
Males		0	157	814	4841
Lymphoreticular system
Lymphoblastic lymphosarcoma with leukemia – M		1/48 (2%)	4/49 (8%)	3/50 (6%)	2/49 (4%)
Lymphoblastic lymphosarcoma without leukemia – M		0/48	1/49 (2%)	0/50 (0%)	0/49
Composite lymphosarcoma – M		1/48 (2%)	0/49	1/50 (2%)	0/49
Histiocytic sarcoma – M		0/48	1/49 (2%)	0/50	0/49
Total lymphoreticular neoplasms#		2/48 (4%)	6/49 (12%)	4/50 (8%)	2/49 (4%)
			Dose (mg/kg bw/day)
Females		0	190	955	5873
Lymphoreticular system
Lymphoblastic lymphosarcoma with leukemia – M		1/50 (2%)	4/48 (8%)	5/49 (10%)	1/49 (2%)
Lymphoblastic lymphosarcoma without leukemia – M		0/50 (0%)	1/48 (2%)	0/49 (0%)	3/49 (6%)
Composite lymphosarcoma – M		4/50 (8%)	1/48 (2%)	1/49 (2%)	6/49 (12%)
Histiocytic sarcoma – M		0/50 (0%)	0/48 (0%)	0/49 (0%)	0/49 (0%)
# Total lymphoreticular neoplasms		5/50 (10%)	6/48 (13%)	6/49 (12%)	10/49 (20%)

^#Sum of lymphoblastic lymphosarcoma, composite lymphosarcoma, and histiocytic sarcoma.

M malignant