Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There were no available data for skin sensitisation of trizinc dicitrate. The existing data from sodium citrate indicates that any allergic effects will be zinc based rather than citrate derived. EU Risk Assessment reports (peer reviewed and reliable)

for zinc compounds analogous to trizinc dicitrate in their physico chemical properties were therefore used to assess the sensitization potential of zinc in addition to the available information on the citrate.

 

There were no available data for the sensitisation potential for zinc chloride or zinc distearate, but a set of robust studies reported in the zinc sulphate Risk Assessment Report (RAR) report the test material to be not sensitising to skin. Furthermore, zinc compounds have been used for over decades in a variety of pharmaceutical and cosmetic products without any reported effects suggesting potential for sensitisation.


Migrated from Short description of key information:
The key study for sensitisation was read across from trisodium citrate (CAS 68-04-2); the test material was found not to be a skin sensitizer in rabbit (Roche, 1995; rel 1). Weight of evidence from zinc sulphate supports the key findings (EU RAR, 2008; rel 2).

Justification for classification or non-classification

Based on the available information from other zinc compounds, it is proposed that trizinc dicitrate does not require classification or labelling in accordance with current EU Directive 67/548/EEC or Regulation 1272/2008.