Print | Need Larger Text?

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-4549

2. Registrant Information.

Registrant Reference Number: 2010-02

Registrant Name (Full Legal Name no abbreviations): Nippon Soda Company Limited

Address: Shin-Ohtemachi Blg., 2-1, 2-Chrome Ohtemachi, Chiyoda-Ku

City: Tokyo

Country: Japan

Postal Code: 100-8165

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. 27125      PMRA Submission No.       EPA Registration No. 8033-20

Product Name: ACETAMIPRID TECHNICAL INSECTICIDE

• Active Ingredient(s)
  • ACETAMIPRID

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 Range-Finder Study Prior to the Conduct of an Acute Avian Oral LD50 Study with a Passerine Bird Species

Date 19-AUG-10

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Increased health or environmental risk

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 range-finding work in preparation for the conduct of a guideline acute avian oral toxicity test using a passerine bird species, two zebra finches were dosed with acetamiprid in a corn oil carrier by oral gavage at 20 mg a.i./kg and two birds at 100 mg a.i./kg based on previously reported acute toxicity to avian species. Both the 20 and 100 mg a.i./kg dosages resulted in mortality. Afterwards two additional birds were dosed at 1 mg a.i./kg and two birds at 5 mg a.i./kg. The 5 mg a.i./kg dose resulted in mortality. The birds in the 1 mg a.i./kg dose survived without signs of toxicity. Should these doses causing mortality be confirmed in the definitive study also to be conducted at Wildlife International, the resulting acute oral LD50 value for zebra finch will be lower than that determined previously for mallard duck (98 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?

24-DEC-10

For Registrant use only

7. Provide supplemental information here

The final report of this laboratory study will be submitted as per 40 CFR Part 159.165 should the definitive study result in an LD50 value at a level 50 percent lower than previous acute toxicity studies conducted with an avian species. Data generated from acute toxicity studies conducted in the laboratory are often used as relative indicators of toxicity and do not take into account components contributing to bioavailability and potential exposure such as the environmental factors, dilution factors, or residue on feed items found under circumstances where the product will typically be used. Therefore it is suggested that the preliminary results of this range finder work be viewed only as an estimate of the acute toxicity of acetamiprid to passerine bird species under laboratory conditions.