Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because skin contact in production and/or use is not likely
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, section 8.5.3, column 2 of Regulation No. 1907/2006, testing by the dermal route is appropriate if skin contact in production and/ or use is likely. Dermal exposure during manufacture of balsalazide acid and its use as an intermediate is unlikely due to the risk mitigation measures in place within the pharmaceutical facility. All processes are performed in accordance with Good Manufacturing Practices and hence strict rules wiill be in place to ensure that any form of contact between the workers and the intermediate will be avoided in order to prevent contamination of the final pharmaceutical. Furthermore, based on the lack of acute oral toxicity seen in the acute oral toxicity studies it is expected that balsalazide acid will also be non toxic via the dermal route.
Therefore, for these reasons, the performance of an acute dermal study on balsalazide acid is considered scientifically unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion