Table 3.

Physico‐chemical properties studies in Phase IIA (EMA, 2005)

Study	Guideline
Water solubility	http://www.oecd-ilibrary.org/environment/test-no-105-water-solubility_9789264069589-en
Dissociation constants in water	http://www.oecd-ilibrary.org/environment/test-no-112-dissociation-constants-in-water_9789264069725-en
UV–Visible absorption spectrum	http://www.oecd-ilibrary.org/environment/test-no-101-uv-vis-absorption-spectra_9789264069503-en
Vapour pressurea	http://www.oecd-ilibrary.org/environment/test-no-104-vapour-pressure_9789264069565-en
n‐Octanol/water partition coefficient	http://www.oecd-ilibrary.org/environment/test-no-107-partition-coefficient-n-octanol-water-shake-flask-method_9789264069626-en, http://www.oecd-ilibrary.org/environment/test-no-117-partition-coefficient-n-octanol-water-hplc-method_9789264069824-en or http://www.oecd-ilibrary.org/environment/test-no-123-partition-coefficient-1-octanol-water-slow-stirring-method_9789264015845-en
Melting point/melting rangeb	http://www.oecd-ilibrary.org/environment/test-no-102-melting-point-melting-range_9789264069527-en

^aCalculation only, though a study is recommended when other physical–chemical properties, e.g. molecular weight, melting temperature, thermogravimetric analysis suggest that the vapour pressure may exceed 10⁻⁵ Pa at 20°C.

^bThis parameter is not strictly needed in the assessment. Nevertheless, melting point/melting range together with vapour pressure provide information on the distribution of the substance within and between the environmental media (water, soil and air).