# 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-the-evidence analysis of pre-existing test data, including results from sequential testing strategy
description of relevant data available from prior testing;
data derived in each step of testing strategy;
description of in vitro tests performed, including details of procedures, results obtained with test/reference substances;
description of in vivo dermal irritation/corrosion study performed, including results obtained;
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, reactivity with water);
in case of a mixture, composition and relative percentages of components;
if local anaesthetic is used, identification, purity, type, dose, and potential interaction with test substance.
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;
age of each animal at start of study;
number of animals of each sex in test and control groups (if required);
individual animal weights at start and conclusion of test;
source, housing conditions, diet, etc.
Results:
description of method used to score irritation at each observation time (e.g., hand slitlamp, biomicroscope, fluorescein);
tabulation of irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test;
narrative description of the degree and nature of irritation or corrosion observed;
description of any other lesions observed in the eye (e.g., vascularization, pannus formation, adhesions, staining);
description of non-ocular local and systemic adverse effects, and histopathological findings, if any.
Discussion of results.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2E/division/B/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2E/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.