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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4380

2. Registrant Information.

Registrant Reference Number: 2018-9-4

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).

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 Dose range-finding study for a combination study of micronucleus test and comet assay on prallethrin TG in male and female rats

Date 31-AUG-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 dose-finding study for combination study of micronucleus testing and comet assay with prallethrin. Neurotoxic effects including convulsion: observed in the 200 and 400 mg/kg dose groups in male rats and 200 mg/kg dose group in female rats; tremor was observed in the 400 mg/kg dose group in male rats and 100 and 200 mg/kg dose groups in female rats; salivation was observed in 400 mg/kg dose group in male rats.

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?

05-OCT-18

For Registrant use only

7. Provide supplemental information here

Test substance is Prallethrin (ETOC Technical Grade).