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Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2009-1991

2. Registrant Information.

Registrant Reference Number: 2009Jun DCGA

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.

PMRA Registration No.       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 An Oral (Gavage) Dose Range-Finding Prenatal Developmental Toxicity Study of MON 52724 in Rats

Date 19-JUN-09

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

No

3. Type of incident identified in the study

New health or environmental hazard

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)

DCGA, a minor plant metabolite of dicamba, was administered by oral gavage to five groups of eight impregnated female rats from gestation days 6 to 19, at dose levels of 0, 50, 200, 500, and 1000 mg/kg/day. Five of the eight animals at 1000 mg/kg/day died or were sacrificed in extremis between gestation days 12-19. Maternal body weight, maternal body weight changes, and food consumption were reduced at the 500 and 1,000 mg/kg/day doses. Clinical signs of rales and material observations of findings around the nose, mouth, and urogenital/anogenital areas were noted in the 200, 500, and 1000 mg/kg/day doses. No evidence of maternal toxicity was noted at 50 mg/kg/day. There were no effects of the test substance on litter size, fetal weight, or gross changes in fetal morphology at any dose level. Based on these results and the fact that anticipated exposures to this minor plant metabolite are very low, DCGA residues present no significant dietary risk.

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?

30-NOV-09

For Registrant use only

7. Provide supplemental information here

Monsanto Company is currently evaluating the potential toxicity of 3,6-dichlorogentisic acid (DCGA), previously identified as a minor metabolite of dicamba in plant metabolism studies. DCGA also occurs as a mixture of glucose conjugates at very low levels (average residues less than 0.03 ppm) in soybeans that have been genetically modified to be tolerant to dicamba. Preliminary results from incomplete studies have come to our attention. Final reports for these studies are expected to be issued by November 2009. We anticipate submitting these reports, as well as other studies to support a new use of dicamba.