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:
The category members are exclusively produced and used directly in grease form. They have vapour pressures of less than 10 E-10 Pa and melting points above 120°C, so the potential for the generation of inhalable forms is low, also the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. In accordance with REACH Regulation, Annex VIII, 8.6.1, column 2 as well as Annex XI, 1, the performance of additional acute toxicity studies is not justified due to exposure as well as toxicological considerations.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion