Fatty acids, C16-18 (even numbered), reaction products with diethylene triamine, di-Me sulfate quaternized

Acute Toxicity: inhalation

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
Conduct of an acute inhalation study is regarded unnecessary for the following reasons: IQACs share the property of having a very low vapour pressure (3.93 x 10E-20 Pa at 25°C) and an averaged molecular weight of 700 g/mol, thus, unintended exposure to vapours can be excluded at room temperature. However, IQACs are handled as liquids. Generation of aerosols can also be excluded because the substance is not used in spray applications but rather in wet tissue applications. Evaporation from these applications is unlikely based on its physicochemical properties. Based on its use unintended exposure to aerosols can also be excluded. The risk to aerosol inhalation for workers can also be ruled out because its production and spreading on tissues is performed in closed circuits. Thus, based on its use and results of laboratory animal studies showing a low acute toxicity after oral exposure the conduct of an acute inhalation study with hydrogenated tallow/nortallow based IQACs is regarded unjustified in terms of animal welfare.