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Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2009-1456

2. Registrant Information.

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. 22710      PMRA Submission No.       EPA Registration No.

Product Name: THIOPHANATE-METHYL TECHNICAL

• Active Ingredient(s)
  • THIOPHANATE-METHYL

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 Preliminary Dose Range Study with Carbendazim

Date 20-APR-09

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)

The TM/MBC Task Force-MBC Technical Committee (by way of the Canadian registrant for thiophanate-methyl) is submitting preliminary information on adverse effects determined from a Preliminary Dose Range Study with Carbendazim. Specifically, considering this study was conducted using the dietary means of exposure, effects were seen on the number of pups delivered and on pup growth at the highest dose tested (10,000 ppm). In short, groups of five time-mated female Wistar rats were exposed to four treatment levels of 0, 2500, 5000, and 10000 ppm via diet during gestation, lactation and post-weaning through PND 28. Based upon maternal toxicity, reduced number of females pregnant and pup toxicity (decreased body weight and decreased survival) found at the highest dose (10000 ppm) it is evident this dietary concentration exhibited an effect on the dams and offspring via the dietary route of exposure. The results of this preliminary study will be used to determine doses for a more definitive range-finding/pk study which will be used in the preparation of the definitive modified one-generation study slated to begin in 2010.

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?

30-JUN-09

For Registrant use only

7. Provide supplemental information here

Previous tests of this nature were conducted using gavage administration of the test item. This study administered the test item through the diet. As a result, the findings were reportable under 6-A2 to the United States Environmental Protection Agency. The registrant respectfully reports the same findings to the Canadian Pest Management Regulatory Agency. No final report of the study is available at this time.