Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
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:
JUSTIFICATION FOR DATA WAIVING
In accordance with Column 2 of REACH, Annex VIII, information requirement 8.5.2 (acute toxicity by inhalation) testing is not appropriate as exposure of humans via inhalation is unlikely taking account of the operating conditions applied to substance manufacture and use and the risk manamegement measures that are applied. Furthermore, particle size distribution data indicates that the test material particles are too large to enter the thoracic region of the airways (D10 = 23.64 µm; D50 = 50.11 µm, D90 = 90.01 µm), and are not respirable, and are therefore not available to the airway to cause a toxic effect.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion