New incident report
Incident Report Number: 2021-5297
Registrant Reference Number: M-770024-01-1
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. 24563 PMRA Submission No. EPA Registration No.
Product Name: FOSETYL-AL TECHNICAL
Unknown
Unknown
Title Fosetyl-Aluminium Technical - Modified Amphibian Metamorphosis Assay with African Clawed Frog (Xenopus laevis)
Date 28-MAY-21
No
Increased health or environmental risk
There were a number of endpoints (snout-vent length, mean hind limb length, mean whole body wet weight, and increase in time to Stage 62) which were significantly reduced at the 1.1 mg/L treatment level. The next lowest concentration tested was 0.097 mg/L. This appears to be lower than the current chronic fish NOEC that PMRA is considering in their risk assessment and thus would meet the criteria for adverse effects reporting.
No
The modified amphibian metamorphosis assay was conducted to meet endocrine testing requirements for active ingredients in the EU. The study met reportability criteria under Canadian adverse effects reporting guidelines. The aquatic risk assessment for fosetyl-al determined that there was a low chronic risk to fish and the lower endpoint for the amphibian metamorphosis assay does not change this conclusion.