# 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 1.4: INFORMATION ON THE TEST SUBSTANCE

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

Non-labelled or isotope-labelled test substance can be used to measure the rate of transformation although labelled material is preferred. Labelled material is required for studying the pathway of transformation and for establishing a mass balance. 14C-labelling is recommended, but the use of other isotopes, such as 13C, 15N, 3H, 32P, may also be useful. As far as possible, the label should be positioned in the most stable part(s) of the molecule. The chemical and/or radiochemical purity of the test substance should be at least 95 %.
Before carrying out a test, the following information about the test substance should be available:
(a) solubility in water (Method A.6);
(b) solubility in organic solvents;
(c) vapour pressure (Method A.4) and Henry's Law constant;
(d) n-octanol/water partition coefficient (Method A.8);
(e) adsorption coefficient (Kd, Kf or Koc, where appropriate) (Method C.18);
(f) hydrolysis (Method C.7);
(g) dissociation constant (pKa) [OECD Guideline 112] (13);
(h) chemical structure of the test substance and position of the isotope-label(s), if applicable.
Other useful information may include data on toxicity of the test substance to microorganisms, data on ready and/or inherent biodegradability, and data on aerobic and anaerobic transformation in soil.
Analytical methods (including extraction and clean-up methods) for identification and quantification of the test substance and its transformation products in water and in sediment should be available (see section 1.7.2).

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/2I/division/C.24/division/1/division/1.4 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-2I/division-C.24/division-1/division-1.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.