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Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2007-5830

2. Registrant Information.

Registrant Reference Number: 2007July18 Dicamba

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. 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 Chromosomal Aberrations in Cultured Human Peripheral Blood Lymphocytes with MON 11900

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)

Dicamba was negative in Ames, CHO/HGPRT, and micronucleus assays. It was also negative in an in vitro chromosomal aberration assay with human lymphocytes, with and without S-9, following a 3-hour treatment period in the initial assay. In the confirmatory assay, there was an increase in cells with chromosomal aberrations with S-9, but only at the highest level tested and in the presence of a precipitate and concomitant cytotoxicity. There was also an increase in cells with chromosomal aberrations following a 22-hour treatment period without S-9 at the highest levels tested and with concomitant cytotoxicity. Based on information reported in the Reregistration Eligibility Decision Document (RED) for dicamba, the chemical was negative in an in vitro chromosomal aberration assay with CHO cells. Furthermore, the RED also indicates that dicamba is not carcinogenic based on chronic studies performed with rats and mice. Based on the weight of evidence, the findings of the current study do not alter the conclusion that dicamba does not pose a genotoxic/carcinogenic risk to humans.

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 the herbicide dicamba. Preliminary results from incomplete studies have come to our attention.