Commission Regulation (EC) No 761/2009Show full title

3. REPORTING

3.1. TEST REPORT

The test report should include the following information:

Test and Control Substances:

• chemical name(s) such as IUPAC or CAS name and CAS number, if known,

• purity and composition of the substance (in percentage(s) by weight),

• physical-chemical properties relevant to the conduct of the study (e.g. physical state, stability and volatility, pH, water solubility if known),

• treatment of the test/control substances prior to testing, if applicable (e.g. warming, grinding),

• storage conditions.

Justification of the skin model and protocol used.

Test Conditions:

• cell system used,

• calibration information for measuring device, and bandpass used for measuring cell viability (e.g. spectrophotometer),

• complete supporting information for the specific skin model used including its performance. This should include, but is not limited to:

  (i)

  viability;

  (ii)

  barrier function;

  (iii)

  morphology;

  (iv)

  reproducibility and predictivity;

  (v)

  quality controls (QC) of the model;

• details of the test procedure used,

• test doses used, duration of exposure and post treatment incubation period,

• description of any modifications of the test procedure,

• reference to historical data of the model. This should include, but is not limited to:

  (i)

  acceptability of the QC data with reference to historical batch data;

  (ii)

  acceptability of the positive and negative control values with reference to positive and negative control means and ranges,

• description of evaluation criteria used including the justification for the selection of the cut-off point(s) for the prediction model.

Results:

• tabulation of data from individual test samples,

• description of other effects observed.

Discussion of the results.

Conclusions.