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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0721

2. Registrant Information.

Registrant Reference Number: 2012 Captan AE (PMRA)

Registrant Name (Full Legal Name no abbreviations): Captan Task Force c/o Makhteshim Agan of North America, Inc.

Address: 3120 Highwoods Boulevard, Suite 100

City: Raleigh

Prov / State: NC

Country: USA

Postal Code: 27604

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. 21107      PMRA Submission No.       EPA Registration No.

Product Name: Captan Technical

  • Active Ingredient(s)
    • CAPTAN

PMRA Registration No. 27904      PMRA Submission No.       EPA Registration No.

Product Name: CAPTAN TECHNICAL 1

  • Active Ingredient(s)
    • CAPTAN

PMRA Registration No. 18221      PMRA Submission No.       EPA Registration No.

Product Name: CAPTAN TECHNICAL FUNGICIDE

  • Active Ingredient(s)
    • CAPTAN

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 The Hershberger Bioassay (OPPTS 890.1400); Captan

Date 05-JAN-12

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)

Starting on day 4 of the study, animals in the high and mid dose groups started to show signs of abnormal breathing (gasping), abdominal distention, and rapid weight loss. These animals were euthanized in extremis. Upon necropsy the small and large intestines were found to be severely distended with air. Subsequent to symptom onset, all rats died at the high dose in the agonist group (400 mg/kg/day) and in the mid (200 mg/kg/day +TP) and in the high dose (and 400 mg/kg/day + TP, respectively) in the antagonist groups. An assessment of these effects suggest that morbundity is likely due to gavage-related reflux of the test material resulting from a combination of the vehicle, the irritating properties of the test substance and the gavage administration. Therefore, these effects are unlikely to be causally related to the toxicity of the compound.

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?

For Registrant use only

7. Provide supplemental information here