Update the report
Incident Report Number: 2007-5829
Registrant Reference Number: 2007Jul17 DCSA
Registrant Name (Full Legal Name no abbreviations): Monsanto
Address: 800 North Lindbergh Blvd.
City: Saint Louis
Prov / State: Missouri
Country: United States of America
Postal Code: 63167
Scientific Study
PMRA Registration No. 27200 PMRA Submission No. EPA Registration No.
Product Name: Fortress Herbicide
Unknown
Unknown
Title A 90-Day Oral (Diet) Study of MON 52708 in Rats
Date 01-AUG-07
No
Increased health or environmental risk
In a 90-day rat study, DCSA was administered daily to five groups of ten male and ten female rats at dietary concentrations of 0, 500, 3000, 6000 and 12000 ppm. Substantial decreases in food consumption and weight gain were noted at 12000 ppm. Decreased weight gain was also noted in 6000 ppm females. A number of statistically significant changes in hematology, clinical chemistry and organ weight parameters were noted, especially at 12000 ppm. Histopathology results did not indicate any clear evidence of direct target organ toxicity. An increased incidence of thymic lymphoid depletion was noted, primarily in high-dose females, but this was considered to be a generalized non-specific stress response likely due to the substantial decrease in weight gain that appeared to result from poor diet palatability. In other recent studies: DCSA was slightly toxic to rats following acute oral administration, with an acute oral LD50 of 2650 mg/kg. It was negative in Ames, CHO/HGPRT and micronucleus assays, but was weakly positive at high concentrations in an in vitro chromosomal aberration assay with human lymphocytes. In a pilot rat development toxicity study, DCSA was admininstered daily by gavage to five groups of eight impregnated female rats at dose levels of 0, 50, 200, 500 and 1000 mg/kg/day. All of the animals at 1000 mg/kg/day and two of the eight animals at 500 mg/kg/day died or were sacrificed in extremis within the first five days of dosing. The surviving females at 500 mg/kg/day exhibited weight loss and/or decreased weight gain and had entirely resorbed litters. Slightly decreased maternal weight gain and significantly decreased fetal weights were noted at 200 mg/kg/day. No evidence of maternal or developmental toxicity was noted at 50 mg/kg/day.
No
01-OCT-07
Monsanto Company is currently evaluating the potential toxicity of 3,6-dichlorosalicylic acid (DCSA), which we believe to be an intermediate used in the manufacture of, and a known impurity in, as well as a plant and environmental metabolite of, the herbicide dicamba. Preliminary results from incomplete studies have come to our attention.