Registration Dossier

Administrative data

Endpoint:
boiling point
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is a solid which decomposes before boiling
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Enzymes are polymers built of different combinations of the 20 common amino acids in various length and order. The amino acid sequence determines the structure of the enzyme, since at biological conditions the structure of this polymer is defined by the energy minimum fold. The enzyme fold and structure is held together primarily by hydrogen bonds, hydrophobic interactions, ion bonds and van der Waals forces between the different amino acids and cofactors. When heating the enzymes above the biological conditions (typically 80°C and higher) the attracting forces are broken, the fold is disrupted and the enzyme is denatured. Denatured enzymes lose their activity and typically coagulate. Therefore, it is not possible to determine the boiling point of an enzyme. In accordance with column 2 of REACH Annex VII, boiling point does not need to be conducted since the substance decomposes before boiling.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion