Forsøksdyr: GLP safety study

Godkjenningsdato 15.05.2020

Godkjenningsperiode 15.05.2020-15.06.2021

1 Formål
The purpose of this study is to investigate the safety of a new product when administered to lumpsucker (Cyclopterus lumpus).
The study will be conducted in accordance with the OECD principles of Good Laboratory Practice (GLP). The results from the study will be used to document safety of the product and the results will be included in documentation to health authorities.

2 Skadevirkninger
The negative effects on the fish is expected to be mild.

3 Forventet nytteverdi
The product is to be used against Lepeophtheirus salmonis in Atlantic salmon (Salmo salar) and rainbow trout (Oncorhynchus mykiss) and against Caligus elongatus in Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss) and lumpsucker (Cyclopterus lumpus). Different species of sea lice are a major problem in salmon aquaculture production. L. salmonis have developed resistance to many of the products on the market. A new product will be important in a new strategy for sea lice control. Salmon lice (L. salmonis) and the sea lice C. elongatus are the main species causing disease in the production of salmon. Lumpsucker fish are used as a biological control of L. salmonis in sea cages. Infestation of Caligus sp. on lumpsuckers is an increasing problem. Safety data for lumpsucker when treated with this product is therefore required.

4 Antall dyr og art
280 lump suckers with an average weight of 15-40 grams will be used in this study.

5 Hvordan etterleve 3R
The amount of fish used in this study is based on VICH guidelines and statistical analysis with regards to samples for histopathological analysis.
There is no other method to establish safety data on this fish species that in vivo trials.
The husbandry and management are optimized for the test animals. Humane endpoints will be used.