# Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance), Division 3.1: TEST REPORT

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

The test report must include the following information:
Rationale for in vivo testing: weight-of-evidence analysis of pre-existing test data, including results from sequential testing strategy:
description of relevant data available from prior testing;
data derived at each stage of testing strategy;
description of in vitro tests performed, including details of procedures, results obtained with test/reference substances;
weight-of-the-evidence analysis for performing in vivo study.
Test substance:
identification data (e.g., CAS number; source; purity; known impurities; lot number);
physical nature and physicochemical properties (e.g. pH, volatility, solubility, stability);
if mixture, composition and relative percentages of components.
Vehicle:
identification, concentration (where appropriate), volume used;
justification for choice of vehicle.
Test animals:
species/strain used, rationale for using animals other than albino rabbit;
number of animals of each sex;
individual animal weights at start and conclusion of test;
age at start of study;
source of animals, housing conditions, diet, etc.
Test conditions:
technique of patch site preparation;
details of patch materials used and patching technique;
details of test substance preparation, application, and removal.
Results:
tabulation of irritation/corrosion response scores for each animal at all time points measured;
descriptions of all lesions observed;
narrative description of nature and degree of irritation or corrosion observed, and any histopathological findings;
description of other adverse local (e.g., defatting of skin) and systemic effects in addition to dermal irritation or corrosion.
Discussion of results

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n5/division/B/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n5/division-B/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.