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Vertebrates testing: when are ecotoxicity studies necessary for the product / metabolite?

In the context of the vertebrates testing regulation (regulation to prevent duplicate animal testing), it is important that tests on vertebrates be limited as much as possible. Below a number of general guidelines are given relating to avoiding studies with products and metabolites on birds, fish and other vertebrates.

Ecotoxicity studies with the product

In the context of ‘evaluating submitted animal tests’ this refers to studies with vertebrates. In relation to ecotoxicology, this particularly refers to acute product toxicity studies with birds and fish.

Toxicity studies with the product on birds should be avoided in the following cases:

  • If toxicity studies on birds have been submitted for comparable products.
  • If the active substance’s TERacute for birds is not between 10 and 100.
  • If the results of tests on mammals show that the product is not significantly more toxic than the active substance.
  • If birds will not be exposed to the product (such as use in greenhouses).

Toxicity studies with the product on fish should be avoided in the following cases:

  • If the toxicity based on product toxicity studies on Daphnia and algae, expressed in the amount of the active substance, is equal to or lower than the toxicity of the active substance based on studies with the active substance.
  • If the active substance data show that fish are not the most sensitive species (a difference greater by a factor of 10 or more as compared to another group of organisms).
  • If toxicity studies on fish have been submitted for comparable products.
  • If fish will not be exposed to the product (such as with granules or seed coating).

Sometimes, product studies with mammals specifically performed for the ecotoxicological risk assessment (e.g. palatability studies) or amphibians are needed. For these, general guidelines cannot yet be given apart from avoiding studies when studies are available with a comparable product.

Ecotoxicity studies with metabolites

In the context of ‘evaluating submitted animal tests’ this usually refers to ecotoxicity studies with birds and fish.

Toxicity studies with metabolites on birds should be avoided in the following cases:

  • If the metabolite is formed in birds.
  • If toxicity data on mammals are available for the metabolite.
  • If toxicity data on birds for the metabolite have already been submitted in the context of the evaluation of another application.

Toxicity studies with metabolites on fish should be avoided in the following cases:

  • If the toxicity of the metabolite for Daphnia and algae is equal to or lower than the toxicity of the active substance for these organisms.
  • If the active substance data shows that fish are not the most sensitive species (a difference greater by a factor of 10 or more as compared to another group of organisms).
  • If fish toxicity data for the metabolite have already been submitted in the context of the evaluation of another application.

The above information should be seen as a guideline. If, in the applicant’s opinion, the risk of a metabolite can be clarified by a statement, that is a possibility.