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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0613

2. Registrant Information.

Registrant Reference Number: 1

Registrant Name (Full Legal Name no abbreviations): Taminco US LLC

Address: Suite 411 Two Windsor Plaza 7540 Windsor Dr.

City: Allentown

Prov / State: PA

Country: USA

Postal Code: 18195

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.

Active(s)

PMRA Registration No. 31461      PMRA Submission No.       EPA Registration No.

Product Name: Chlormequat Chloride Technical

  • Active Ingredient(s)
    • CHLORMEQUAT CHLORIDE

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 OCSPP 850 2100 Avian Toxicity Study Preliminary Range Finder with Passerine Birds to Chlormeqat Chloride CAS Registry 999815

Date 04-APR-17

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 registrant received preliminary, unaudited data for an Avian Oral Toxicity Study conducted with Zebra finches (Taeniopygia guttata), conducted with chlormequat chloride under OCSPP 850 21001 and Good Laboratory Practice (GLP) Guidelines. Mortality rates reached 0 percent, 25 percent, 25 percent, 100 percent and 100 percent in the 62.5, 125, 250,500, and 1000 mg a.i kg body weight (bwt) treatment groups, respectively. Regurgitation was also observed in the range finder, and occurred at 0 percent, 25 percent, 25 percent, 25 percent, 0 percent, in the 62.5, 125, 250,500, and 1000 mg a.i kg body weight (bwt) treatment groups. Due to the limited number 4 of birds in the range finding study, reportable endpoints were not calculated Le., NOEC. The appropriate EPA guidelines will be followed for conduct of the definitive testing of chlormequat chloride.

5. a) Was the study discontinued before completion?

Yes

5. b) Provide the reason for discontinuation

The contract laboratory terminated the passerine acute toxicity range finder with Chlormequat Chloride on March 2 2017. Mortality rates reached 0 percent, 25 percent, 25 percent, 100 percent and 100 percent in the 62.5, 125, 250,500, and 1000 mg a.i kg body weight (bwt) treatment groups, respectively.The absence of regurgitation in the 1000 mg a.i kg body weight treatment groupe was likely due to the rapidity after dosing with which mortality occurred. Commonly there are difficulties associated with the passerine acute oral toxicity test. Two memos from the EPA related to this test include, Guidance for Reviewing OCSPP 850 2100 Avian Oral Toxicity Studies Conducted with Passerine Birds, August 20 2014 and Guidance for Use when Regurgitation is Observed in Avian Acute Toxicity Studies with Passerine Species. April 9 2012. The memos outline the different options available when regurgitation is observed. The definitive test will be conducted without the use of a range finding study.

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

The registrant has made no determination as to whether these results do in fact represent an unreasonable adverse effect on the environment under the Agency s current guidance. However, out of an abundance of caution, the registrant submits these results so as to discharge any PCPA obligations that may exist.