Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
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
other:
Justification for type of information:
According to REACH regulation Annex VIII column 2, in addition to the oral route, information shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The dermal route is considered as the major route of exposure for N-(3(5)-Methyl-lH-pyrazol-l-yl-methyI)-acetamid (P 70/05). In addition, as determined by the particle size distribution study, no particles are smaller than the respirable particle size of 10 μm. In conclusion further testing on vertebrate animals is not justified, thus the conduct of an acute inhalation toxicity study is not required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion