Health Canada
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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-1329
2. Registrant Information.
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
3. Select the appropriate subform(s) for the incident.
Scientific Study
4. Date registrant was first informed of the incident.
5. Location of incident.
6. Date incident was first observed.
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)PMRA Registration No. 32506 PMRA Submission No. EPA Registration No.
Product Name: Salmosan Vet
- Active Ingredient(s)
- AZAMETHIPHOS
7. b) Type of formulation.
Application Information
8. Product was applied?
Unknown
9. Application Rate.
10. Site pesticide was applied to (select all that apply).
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform VII: Scientific Study
1. Study Reference
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
2. a) Is an extension needed to translate the document?
No
3. Type of incident identified in the study
New health or environmental hazard
4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)
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.
5. a) Was the study discontinued before completion?
No
