Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2007-8956

2. Registrant Information.

Registrant Reference Number: 113007-01 DTF

Registrant Name (Full Legal Name no abbreviations): Industry Task Force II on 2,4-D Research Data (members: Agro-Gor Corporation, Dow AgroSciences and Nufarm USA, Inc.)

Address: 1900 K Street, NW

City: Washington

Prov / State: DC

Country: USA

Postal Code: 20006-1108

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.       PMRA Submission No. 2004-3086      EPA Registration No.

Product Name: 2,4-D Acid

  • Active Ingredient(s)
    • 2,4-D (PRESENT AS ACID)

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 2,4-D pharmacokinetics (PK) rangefinding study

Date 30-NOV-07

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)

Study initiated in response to US EPA 2,4-D RED Data Call-In. Preliminary findings from the PK study using Sprague-Dawley rats; five doses: 0, 100, 400, 800, 1200, 1600 ppm in a feed diet. Study initiated Aug 17, 2007; Exposure: 4 week pre-breed, continued exposure through 2 weeks mating, gestation, lactation and continued exposure to PND 35. Prelim results: 1. Statistically significant decreased feed consumption in females at 1600 ppm first week of gestation; 2. Biologically significant decreased weight gain in females during lactation at 1200 and 1600 ppm; statistically significant decreased feed consumption during lactation in females at 800, 1200, and 1600 ppm; 3. Statistically significant decreased weight gain of pups at 800, 1200 and 1600 ppm during lactation; 4. 1600 ppm pups discontinued for humane concerns at PND 17 because of significant decreased weight gain and morbidity; 5. 1200 ppm pubs sacrificed based on humane concerns at PND 21 because of significant decreased weight gain, immaturity, and a few pup deaths; 6. Adult males have not to date shown significant signs of toxicity except for biologically significant decreased weight gain at 2000 ppm early in the pre-breed period; 7. There were no treatment-related effects on live litter size, number of dead pups at birth or pup weight at birth; and, 8. There is no evidence of unique susceptibility to the offspring in this study.

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?

16-JUN-08

For Registrant use only

7. Provide supplemental information here