Paragraph 9
A description of the proposed test including details of—
the nature and purpose of the test,
the species and maximum number of animals to be included in the test,
the criteria to be used in the selection of animals for, or exclusion or withdrawal of animals from, the test,
the proposals for monitoring the safety of the product during the test, including details of precautions to be followed by users of the product, and when the product is to be disposed of,
the arrangements for the disposal of animals involved in the test,
the proposed dosage for the product, and its duration, and the method, route and frequency of administration,
the name and qualifications of the person who is to be responsible for the overall supervision of the test, and
the address of every site at which the test is to be carried out and the number of animals involved in the proposed test at each site, but if these particulars are not known to the applicant at the time of application, they may be omitted, so long as the applicant gives an explanation why they are not known.