Registration Dossier

Diss Factsheets

Administrative data

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:
In accordance with Column 2 of REACH Annex VIII, in addition to the oral route (8.5.1), for sub stances other than gases, the information mentioned under 8.5.2 (acute toxicity by inhalation) and 8.5.3 (acute toxicity by the dermal route) 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. In the present case, inhalation exposure will be lower than dermal exposure because the registered substance has a very low vapour pressure (0.054 Pa at 20°C), so the potential to generate vapor is low. Nonetheless, considering the use of the substance, exposure to mist can occur. However, based on the absence of acute toxicity by oral route, no mortality is anticipated during the exposure to mist. Hence, dermal exposure is the more likely route of exposure during the manufacture and the use of the substance leading to the low penetration of the substance based on its partition coefficient (Log Kow = 5.09°C).
Reason / purpose for cross-reference:
data waiving: supporting information

Data source

Materials and methods

Results and discussion

Clinical signs:

Applicant's summary and conclusion