When considering regulatory compliance for the Notification of New Substances (NONS) or the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) it is necessary to provide Physico-chemical data along with Toxicological and Eco-toxicological information.

The amount of information required will depend upon the level of manufacture from VIIC with an annual quantity of > 10 kg, through VIIA (base set) to Level 2 with annual quantities > 1000 tonnes. The majority of tests are performed as per Annex V, Part A of the Dangerous Substances Directive 67/548/EEC and follow OECD Guidelines.

The purpose of this data is to ensure that no physical or chemical activity could take place that may endanger human life. The tests are divided into specific areas starting with physical characteristics such as Melting Point, Boiling Point, Relative Density, Vapour pressure and Surface Tension.

The next area of interest is how the material behaves in solvents, such as water, which may have an effect on how the substance reacts in the body or under environmental conditions. Water Solubility, Partition Coefficient, Dissociation Constant cover this area of physico-chemical properties.

Flammability is covered by the following tests; Flash Point, Flammability of Solids, Flammability of Gases, Flammability in Contact with water, Pyrophoric properties and Auto-flammability.
The final area of physico-chemical properties is to determine whether a material has explosive or oxidising properties.

Physico-Chemical Tests

Ref Description Ref. Description Ref. Description
OECD 101 UV-vis OECD 112 Dissociation Constant    
A1 Melting point A9 Flash Point A16 Autoflammability (solids)
A2 Boiling Point A10 Flammability of Solids A17 Oxidising solids
A3 Relative Density A11 Flammability of Gases A18 N/A
A4 Vapour pressure A12 Flammability in contact with water A19 N/A
A5 Surface Tension A13 Pyrophoric properties A20 Solution/Extraction behaviour of polymers in water
A6 Water Solubility A14 Explosive properties
A8 Partition Coefficient A15 Autoflammability (liquids) A21 Oxidising liquids (draft)

Test Methods are provided by the EU and OECD (Organisation for Economic Co-operation and Development) guidelines, blue pages which are also known as the 100 series.

All Physico-Chemical work performed by Chilworth Technology Ltd
C3-B is an informal collaboration between AstraZeneca UK Limited (Brixham Environmental Laboratory), Chilworth Technology Limited, Centre de Recherches Biologiques (CERB) and Chemsafe S.a.S. No legal relationship exists between the aforementioned entities and none of them has the authority to contract on behalf of any other of the entities.