Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
We implemented different technical measures to prevent exposure of workers and the environment.
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. Discharge is also closed operation. Valsartan is charged from drums to reactor using a glovebox/PTS system located in a dedicated room close to the vessel to be charged. Glovebox minimises Technician contact with this material.

The following control measures have been identified as suitable:
- Dedicated, ventilated charge room for charging Valsartan via enclosed Isotube/PTS
- LEV Systems/glove boxes will be maintained as per LEV file/glove box file
- RPE and Personal Protective Equipment is specified
Process Safety Training regarding the use of control measures and the actions to be taken in the
event of control measure failure is performed by the Process Expert / operational Expert at the start
of the production campaign and on a three monthly basis thereafter.

Process Safety Training is completed prior to the start of production. The training is valid for 6
months and therefore needs to be repeated every 6 months or every campaign as applicable.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion