New incident report
Incident Report Number: 2023-1329
Registrant Reference Number: 32506
Registrant Name (Full Legal Name no abbreviations): Benchmark Animal Health Ltd
Address: Highdown House, Yeoman Way
City: Worthing
Country: United Kingdom
Postal Code: BN99 3HH
Scientific Study
PMRA Registration No. 32506 PMRA Submission No. EPA Registration No.
Product Name: Salmosan Vet
Unknown
Unknown
Title Pivotal Study Assessing the target animal safety and bioresidue depletion of the ectoparasiticide Salmosan Vet at double label dose in Atlantic salmon, Salmon salar L.
Date 10-JUL-23
No
New health or environmental hazard
Benchmark conducted a target animal laboratory safety study with double label dose in response to pre-application submission guidance from the UK VMD and the Norwegian Medicines Agency. This study was requested to generate margin of safety data in the event that fish are accidentally overdosed. Approximately 3.5 to 4.5 hrs into treatment exposure, three fish lost equilibrium, followed by laying on their sides at the bottom of the tank, and subsequently died. This represented a mortality rate of 4.3%. Gross necropsy and hisopathology did not reveal any findings that could be attributed to the administration of a double label dose of the product in any fish. All dose administration was confirmed to be on target throughout the 5 hr exposure.
No