Registration Dossier

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 substance is exclusively produced and used in grease form and has been shown to be non-corrosive in skin and eye irritation studies. It has a low vapour pressure so the potential for the generation of inhalable forms is low, also the use of grease forms will not result in aerosols, particles or droplets of inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The substance has not been tested by the inhalation route. However, an acute oral toxicity study in rats showed evidence of a lack of acute toxicity up to the highest doses tested (2000 mg/kg). Therefore, it is considered that this waiver applies and, 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