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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2436

2. Registrant Information.

Registrant Reference Number: AM02

Registrant Name (Full Legal Name no abbreviations): Arysta Life Sciences America Inc.

Address: 1450 Broadway, 7th Floor

City: New York

Prov / State: New York

Country: USA

Postal Code: 10018

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. 23485      PMRA Submission No.       EPA Registration No.

Product Name: AMITRAZ TECHNICAL (INSECTICIDE)

• Active Ingredient(s)
  • AMITRAZ

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 Extended One-Generation Reproductive Toxicity Study

Date 03-MAY-16

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)

Oral (gavage) administration of Amitraz to F1-Generation rats for at least 83 days at a concentration of 7.5 mg/kg, preceded by exposure in utero and via lactation route, resulted in significant increases in the number of primordial follicles for left, right, and both ovaries compared to those animals administered the Control article (Group 1). Pairwise comparisons were not significant for the mid- or low dose levels. The mean total primordial follicles were reported to be 100, 109, 119 and 156 for the 0, 0.5, 1.5 and 7.5 mg/kg/day treatment groups. Although corpora lutea were present for all animals on study, seven of the 23 Group 4 animals had noted regression of this structure throughout, compared to one Group 1 animal.The incidences of this observation were 5 and 6 in the low and mid-dose level animals.

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?

31-AUG-16

For Registrant use only

7. Provide supplemental information here

The Consortium believes that these observations will not prove to be toxicologically relevant following planned additional observations as outlined below. However, the Consortium is reporting these preliminary observations in an abundance of caution.