Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

particle size distribution (granulometry)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is marketed or used in a non solid or granular form
Justification for type of information:
The particle size distribution test has been waived because the substance is manufactured or used in a non-solid or granular form. The substance only exists in the presence of an inert carrier. As the substance is only manufactured in situ in a generic inert carrier, typically base oil, and the base oil retards the surface oxidation of the isolated substance, the hazard testing was conducted on the substance in situ in a carrier. All endpoints, where possible, were determined using a 50% w.w. concentration in pharmaceutical white oil.

Data source

Materials and methods

Results and discussion

Particle size
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Applicant's summary and conclusion