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 Annex VIII of REACH, Column 2, testing via inhalation is only appropriate if exposure of humans is likely. Vapour pressure of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was investigated during a study performed in accordance with ASTM D2879 - 97 Standard Test Method for Vapour Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope, which concluded that the substance has a vapour pressure below 100 Pa. In addition formation of aerosols during the use of the substance is unlikely. It is therefore concluded that exposure to 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is unlikely and that it is not appropriate to investigate this route exposure.

Data source

Materials and methods

Results and discussion

Clinical signs:
other:

Applicant's summary and conclusion