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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2007-5829

2. Registrant Information.

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

3. Select the appropriate subform(s) for the incident.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No. 27200      PMRA Submission No.       EPA Registration No.

Product Name: Fortress Herbicide

  • Active Ingredient(s)
    • DICAMBA (PRESENT AS ACID, AMINE SALT, ESTER, OR SODIUM SALT)

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform VII: Scientific Study

1. Study Reference

Title A 90-Day Oral (Diet) Study of MON 52708 in Rats

Date 01-AUG-07

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Increased health or environmental risk

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

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.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

01-OCT-07

For Registrant use only

7. Provide supplemental information here

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.