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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4901

2. Registrant Information.

Registrant Reference Number: 2018-09-24

Registrant Name (Full Legal Name no abbreviations): Sumitomo Chemical Co. Ltd.

Address: 27-1, Shinkawa, 2-Chome

City: Tokyo

Prov / State: Chuo-ku

Country: Japan

Postal Code: 104-8260

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. 27387      PMRA Submission No.       EPA Registration No. 10308-12

Product Name: Prallethrin (ETOC Technical Grade)

• Active Ingredient(s)
  • PRALLETHRIN

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).

Site: Unknown / Inconnu

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 Combination study of micronucleus test and comet assay on SI-181 (ETOC Technical Grade) in rats

Date 24-SEP-18

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)

New adverse effects in a combination study for of micronucleus testing and comet assay with prallethrin. The following neurotoxic signs were observed: convulsion and salivation observed in 300 mg/kg/day dose group; tremor observed in 200 and 300 mg/kg/day dose groups.

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?

06-NOV-18

For Registrant use only

7. Provide supplemental information here

Test substance is Prallethrin (ETOC Technical Grade).