Registration Dossier

Diss Factsheets

Administrative data

repeated dose toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

C36-alkylenediaminehas proven to be severely irritating to skin showing to beirreversible within the 14-day observation period, and corrosive to the eyes. Following these dermal irritative / corrosive properties, dermal exposure has to be limited / minimized.C36-alkylenediamineis only used as intermediate in industrial settings where adequate PPE are applied, limiting direct dermal exposures. Consequently, skin contact in production and/or use is not likely. Testing by the dermal route is therefore not appropriate as stipulated in Annex IX, point 8.6.2, column 2 of REACH regulation (EC) 1907/2006.

Also available information suggests that dermal route is not the most sensitive route of exposure. Furthermore, following the severe irritating / corrosive properties of the substance, dermal testing should not be performedalso based on animal welfare grounds.