Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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:

Given that inhalation is not a relevant route of exposure, testing by the inhalation route is not necessary according to REACH Regulation Annex VIII 8.5.2 Column 2. Inhalation is not a relevant route of exposure to C1618FA-TEPA-compound. This applies to both workers and the general population and is due to the physicochemical properties of the substance and the nature of the products where it is used. C1618FA-TEPA-compound is solid at room temperature, and the substance is manufactured and marketed as flakes. Generation of inhalable particles such as dust or aerosols is not to be expected.

Vaporisation needs not to be considered due to the substance’s low vapour pressure (<0.001 Pa at 20°C).

The generation of aerosols is excluded by technical means or product design. The substance is not used in spray applications. The most likely route of human exposure for workers and consumers is the dermal route. Results of laboratory animal studies show a low acute toxicity after oral and dermal exposure. Therefore the acute intrinsic toxic activity of C1618FA-TEPA-compound is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.