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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2007-7268

2. Registrant Information.

Registrant Reference Number: 2007Oct Canada DCSA 2Gen

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: Rustler Herbicide

  • Active Ingredient(s)
    • DICAMBA (PRESENT AS ACID, AMINE SALT, ESTER, OR SODIUM SALT)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE 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 Dietary Two-Generation Reproductive Toxicity Study of MON 52708 in Rats

Date 02-OCT-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 2-generation reproduction study, DCSA was administered daily to three groups of 30 male and 30 female rats at dietary concentrations of 0, 50, 500, and 5000 ppm for approximately 70 days. The animals were then mated; impregnated females were then allowed to carry their offspring to term, after which they delivered first generation pups. Parental toxicity was observed in the 5000 ppm F0 animals. Findings were statistically significantly decreased absolute body weights, body weight gains, and food consumption in both males and females. Statistically significantly decreased food consumption was also noted in 500 ppm F0 males. The F1 pups appeared to be comparable at birth relative to sex ratio, body weight, and general appearance based on external evaluations. By the fourth day of lactation, some of the 5000 ppm F1 pups were observed as having "ventral abdominal area blackened." Additional findings in these pups included bodies that were cool to touch and pale. Many of these pups died or were sacrificed in extremis. By the end of the 21-day lactation period surviving 5000 ppm F1 pups had absolute body weights that were >50% reduced compared to controls. Pups at 500 ppm had moderate but statistically significantly decreased body weights compared to controls at the post-natal day 14 and 21 time points.

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?

31-AUG-08

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 an incomplete study have come to our attention.