Testing proposals on vertebrate animals

If your registration is for a substance manufactured or imported in quantities of 100 tonnes or more (REACH Annex IX), or respectively of 1 000 tonnes or more (Annex X), you need to submit a testing proposal for studies on vertebrate animals if a valid test result is not available.

As a registrant, you have to make an effort to consider the potential availability of non-animal testing methods before proposing testing on vertebrate animals. As part of the technical completeness check, ECHA verifies that your registration includes considerations for alternative methods for each proposed vertebrate study included in the endpoint study records.

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Need help?

If you have questions related to technical completeness check, use ECHA’s contact form:

  • ECHA’s contact form
    • In the contact form, select ‘Registration’ under Topic.

      Provide the following details related to your question in the ‘Question’ field:
    • Indicate clearly that your question concerns the technical completeness check.
    • If you are still preparing your dossier and need help to understand how to fill in a particular IUCLID section, provide as many details as possible on your situation and approach to fulfil the information requirement.
    • If you have already submitted your dossier and need help to understand the completeness check outcome, include the submission number assigned to your submission by ECHA.
 

For questions related to the Validation assistant, there is a separate instruction available: