Registration Dossier

Diss Factsheets

Administrative data

short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
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:
In accordance with point 8.6.1, column 1 of Annex IX of Regulation (EC) No. 1907/2006, testing for this endpoint should be performed using an appropriate route of exposure. A 28 day oral study was submitted to fulfil the subacute toxicity endpoint. Exposure via the oral route is considered an appropriate route of exposure for the submitted substance, as it is known to be readily absorbed following oral administration. Further testing for this endpoint via inhalation is considered less appropriate and is therefore omitted on this basis.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion