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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5461

2. Registrant Information.

Registrant Reference Number: 2016-C-01

Registrant Name (Full Legal Name no abbreviations): ARYSTA LIFESCIENCE NORTH AMERICA, LLC

Address: 15401 Weston Parkway, Suite 150

City: Cary

Prov / State: NC

Country: USA

Postal Code: 27513

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. 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 Acute Oral Toxicology (Acute Toxic Class Method) in the Rat with Tetrahydrophthalimide

Date 08-MAY-15

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)

In this report female Wistar rats were treated with terahydrophthalimide (THPI), suspended in cottonseed oil, via oral gavage. Specifically, three female rats were administered 2000 mg/kg THPI and 6 female rats were administered 300 mg/kg THPI. Animals treated with 2000 mg/kg THPI were sacrificed on study day 2 for ethical reasons, animals treated with 300 mg/kg were not sacrificed. Based on this data the LD50 value was calculated to be 500 mg/kg.The present acute oral study represents an estimation of the acute oral LD50 for THPI, and confirms its previous classification category. However, for ecotoxicology risk assessments an exact LD50 value is required. Therefore, a follow up study is currently in progress at Product Safety Labs in the USA to determine an exact LD50 value for THPI. The results of this study are anticipated to be available November 2016. Based on the available data that the exact LD50 of THPI is expected to be greater than the estimated LD50 of 500 mg/kg.

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

The attached report is a supplemental acute oral toxicity study of terahydrophthalimide, a manufacturing impurity and plant and animal metabolite of captan technical fungicide. The existence of the study, which we understand was initiated in support of the reevaluation of captan technical fungicide in Europe, was only recently shared with the North American division of Arysta LifeScience.