Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Waiving: Additional testing of C36-alkylenediamine (Dimerdiamine) for inhalation toxicity is not appropriate, as exposure of humans via inhalation is not likely. Due to the very low vapour pressure (2.2 x10-5 hPa @ 20°C) inhalation of vapours leading to irritation of airways will not occur. Also aerosol exposures are not likely to occur in view of its only use as industrial intermediate under conditions that do not lead to aerosol formation. Testing for toxicity by inhalation route is therefore generally not needed according to REACH regulation (EC) 1907/2006 (Annex IX, point 8.6.2, column 2).

Furthermore, testing would also not be justified because of animal welfare reasons. C36-alkylenediamine is severely irritating / corrosive to skin and is classified as corrosive to the eyes, whereas its systemic toxicity is low. Due the very low vp (2.2 x10-7 Pa @ 20°C) and viscosity of substance, inhalation exposures would only be possible in the form of aerosol, consisting of larger droplets depositing in upper airways. It can be expected that aerosol levels which would lead to severe local damage in the airways will not lead to systemic toxicity following absorption from larger and smaller bronchi, as most of the inhaled amounts will deposit in larger airways and will be ingested after mucociliary transport to the pharynx.

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