Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
The substance is received onto the site and it is chemically converted into the active pharmaceutical ingredient. The substance is chemically converted into the active pharmaceutical ingredient in a system designed to ensure rigorous containment of the substance. Reaction step is carried out in closed system. Charging takes place in a ventilated keg unloading booth. The dust produced by the operation is extracted. Operators are trained in the procedure and also PSS training is performed. Personal protective clothing is specified as per PSS. The waste AHT packaging is placed into a waste container which is fitted with the appropriate WDRF label and sent for disposal.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion