New incident report
Incident Report Number: 2018-0613
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
Scientific Study
PMRA Registration No. 31461 PMRA Submission No. EPA Registration No.
Product Name: Chlormequat Chloride Technical
Unknown
Unknown
Title OCSPP 850 2100 Avian Toxicity Study Preliminary Range Finder with Passerine Birds to Chlormeqat Chloride CAS Registry 999815
Date 04-APR-17
No
New health or environmental hazard
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.
Yes
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.
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.