For fish medicines where direct entry into the aquatic environment is intended,
Phase II Tier A studies are always required unless the environmental introduction
concentration (EIC) is 1mg/l or less. The basic data needed are:
- Octanol / water partition coefficient
- Rate of hydrolysis
- Rate of photodegradation in water
- Basic ecotoxicology data in fresh water and / or marine species according
to proposed use
If the EIC is greater than the predicted no effect concentration (PNEC) or
the DT50 of the VMP in water is greater than 4 days, then further work is needed.
This would include a water / sediment degradation study under fresh water or
marine conditions (OECD 308) and assessment of the toxicity to additional aquatic
or sediment-dwelling species.
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