# Commission Regulation (EC) No 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance), Division 3.1: TEST REPORT

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2009/761/annex/III/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2009-761/annex-III/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.