Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Effects upon inhalation of the produt were not investigated. This is not required as repeat-dose toxicity was assessed by oral route, the product is non-volatile (vapour pressure of 6.66x10-5 Pa) and the granulometry of the product (only 0.7% of particles are smaller than 100µm as the product is in the form of pellets or flakes) would lead to negligible exposure of terminal airways.
Executive summary:

Effects upon inhalation of the produt were not investigated. This is not required as repeat-dose toxicity was assessed by oral route, the product is non-volatile (vapour pressure of 6.66x10-5 Pa) and the granulometry of the product (only 0.7% of particles are smaller than 100µm as the product is in the form of pellets or flakes) would lead to negligible exposure of terminal airways.