New incident report
Incident Report Number: 2020-5304
Registrant Reference Number: M-754099-01-1
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: Suite 200, 160 Quarry Park Blvd S.E.
City: Calgary
Prov / State: Alberta
Country: Canada
Postal Code: T2C 3G3
Scientific Study
PMRA Registration No. 28952 PMRA Submission No. EPA Registration No.
Product Name: SPIROTETRAMAT TECHNICAL INSECTICIDE
Unknown
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Title Spirotetramat - Short-Term Reproduction Assay with Fathead Minnow(Pimephales promelas)
Date 01-SEP-20
No
Increased health or environmental risk
A study was conducted with spirotetramat according to the U.S. EPA OCSPP 890.1350/OECD TG 231 guidelines following Good Laboratory Practices (GLP). This study, :Spirotetramat-Short-Term Reproduction Assay with Fathead Minnow (Pimephales promelas) (DART No. M-754099-01-1), is a chronic 21-day study intended to screen for interference of a substance with the hypothalamic-pituitary-gonadal (HPG) axis. No effects were observed in the study consistent with interference with the HPG axis. In the highest test level, 0.48 mg/L, a 50% reduction in male survival was observed at test termination. No effects were observed at the next lowest test level, 0.15 mg/L. The current most sensitive chronic fish endpoint is a NOAEC of 0.534 mg/L, based on a fathead minnow early life stage study with reduced fry survival. As the fish short term reproduction assay is an endocrine screening assay not designed or intended to produce quantitative no effect levels, Bayer does not believe that results from this study are suitable for setting hazard endpoints to be used in an ecological risk assessment.
No
This study is also being submitted to the USEPA under 6(a)2 reporting requirements according to 40 CFR 159.165(b)(2 ) .