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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3431

2. Registrant Information.

Registrant Reference Number: 2002-0723

Registrant Name (Full Legal Name no abbreviations): MCPA Task Force Three (members: Nufarm Ltd [formerly AH Marks Co. Ltd], Dow Agrosciences, and Nufarm UK Ltd.)

Address: 8325 Old Deer Trail

City: Raleigh

Prov / State: NC

Country: USA

Postal Code: 27615

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

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

Country: UNITED STATES

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. Chem No. 03056419267

Product Name: MCPA 2EHE

• Active Ingredient(s)
  • MCPA (PRESENT AS ESTERS)

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 Notification of Incident re: MCPA-2-EHE Developmental Neurotoxicity in Wistar Rats Administration to the Dams and Pups Via the Diet

Date 28-JUL-08

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)

The MCPA Task Force Three is submitting this new information under 6(a)(2) because it recently received interim results to a study in progress which provides new information on a Developmental Neurotoxicity study with MCPA 2EHE. This study was conducted with MCPA 2EHE as the test substance and time mated Wistar rats as the test system. Details of the protocol had been agreed previously with OPPTS. Test article was incorporated into the diet at 0 (control), 300, 900 or 1800 ppm. These inclusion rates were reduced to 0, 200, 600 or 1200 ppm during lactation as partial compensation for the increased effective dose rates consequent on the substantial increase in maternal feed consumption seen after parturition. The rats were in good condition throughout. Environmental conditions were stable and within protocol. No procedural or husbandry problems were encountered. During the gestation period, there were no clinical signs attributable to the inclusion of MCPA in the diet. All rats showed normal growth apart from minor bodyweight differences (see below). The only compound-related change was food intake. At the high dose, this was reduced by about 10% from day 6 when compared with controls (Table 1). There was a concomitant small decrease in bodyweight gain in the dams at the high dose, so that by day 21 of gestation these rats weighed about 5% less than concurrent controls (Table 2). At parturition, there were more dams with litters at the high dose than in the controls and, consequently, the number of live births was statistically significantly increased although the litter size was unaffected. Also at the high dose, the number of stillborn pups and peri-natal deaths (some of which were cannibalised) was increased significantly from control values (Table 3). A major contribution to this difference was the total loss/cannibalisation of one litter by day 4. The mid and high doses were unaffected. (See attached file for complete text)

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-JUN-09

For Registrant use only

7. Provide supplemental information here

The attached letter addressed to U.S. EPA outlines the complete details of this notification/incident.