Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
explosive properties of explosives
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with explosive properties
Justification for type of information:
As enzymes are proteins produced by fermentation, they are not associated with explosive properties in aqueous solution. The only part of the manufacturing process where the substance is presented as powder is during the post-lyophilization step where the enzyme is mechanically crushed for packaging. The enzyme is treated as a dust hazard at this point of the manufacturing process where personal protective equipment are used to avoid breathing dust and contact with eyes, skin and other mucous membranes. Additionally during this crushing step, the facility is equipped with containment equipment to prevent airborne dust. After crushing, the subsequent process step is contained dust free packaging.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion