Registration Dossier

Administrative data

Endpoint:
flammable liquids: obsolete as covered by section 'Flash point'
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 a liquid
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
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. As the substance as a 50% w.w. concentration in pharmaceutical white oil is a liquid, its flammability is determined on the basis of its flash point and boiling point. Experience in manufacture and handling shows that the substance in a grease base does not ignite spontaneously on coming into contact with air or water at normal temperatures and therefore does not meet the criteria for classification as a pyrophoric substance or a substance which in contact with water emits flammable gases.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion