Division 9.2 Content of the final report

The final report should include, but not be limited to, the following information:

1. 1..

   Identification of the study, the test item and reference item

   1. (a)

      A descriptive title

   2. (b)

      Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.)

   3. (c)

      Identification of the reference item by name

   4. (d)

      Characterisation of the test item including purity, stability and homogeneity.

2. 2..

   Information concerning the sponsor and the test facility

   1. (a)

      Name and address of the sponsor

   2. (b)

      Name and address of any test facilities and test sites involved

   3. (c)

      Name and address of the study director

   4. (d)

      Name and address of the principal investigator(s) and the phase(s) of the study delegated, if applicable

   5. (e)

      Name and address of scientists having contributed reports to the final report.

3. 3..

   Dates

   Experimental starting and completion dates.

4. 4..

   Statement

   A quality assurance programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.

5. 5..

   Description of materials and test methods

   1. (a)

      Description of methods and materials used

   2. (b)

      Reference to OECD test guideline or other test guideline or method.

6. 6..

   Results

   1. (a)

      A summary of results

   2. (b)

      All information and data required by the study plan

   3. (c)

      A presentation of the results, including calculations and determinations of statistical significance

   4. (d)

      An evaluation and discussion of the results and, where appropriate, conclusions.

7. 7..

   Storage

   The location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.