New incident report
Incident Report Number: 2022-1482
Registrant Reference Number: M-800579-01-1
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: Suite 200, 160 Quarry Park Boulevard SE
City: CALGARY
Prov / State: AB
Country: Canada
Postal Code: T2C 3G3
Scientific Study
PMRA Registration No. 19204 PMRA Submission No. EPA Registration No.
Product Name: Phenmedipham TC
Unknown
Unknown
Title Phenmedipham - Extended Amphibian Metamorphosis Assay with African Clawed Frog (Xenopus laevis)
Date 31-JAN-22
No
New health or environmental hazard
Statistical analysis concluded that there was a treatment-related effect observed on fecundity, in terms of the cumulative number of eggs produced and the number of eggs produced per female per reproductive day, at the 0.176 mg phenmedipham+MHPC/L (0.0956 mg phenmedipham/L) treatment level compared to the control. This appears to be lower than the current chronic 28-day fish LOEC for fry survival (0.181 mg phenmedipham+MHPC/L), thus would meet the criteria for adverse effects reporting [Matlock, et. al. 2014; Early Life Stage Toxicity of Phenmedipham to the Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions]. However, this study is not considered appropriate for assessing chronic risk to amphibians for 2 reasons. First, this study is an endocrine screening study. Second, there are a limited number of test concentrations employed and a specific dose-spacing factor and these constraints do not provide for the type of dose-response analysis that lends to a robust risk assessment endpoint.
No
The amphibian metamorphosis assay was conducted to meet endocrine testing requirements for active ingredients in the European Union. The study met reportability criteria under Canadian adverse effects reporting guidelines. The new information for endocrine testing will not affect the current aquatic risk assessment.