Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In the European Union Risk Assessment Report (RAR) on Chromium trioxide, Sodium chromate, Sodium dichromate, Ammonium dichromate, and Potassium dichromate, the skin sensitizing potential of these Chromium compounds was reviewed. Skin sensitization has been demonstrated in workers who were exposed to hexavalent Chromium compounds. Patch testing of contact dermatitis patients and other investigations of different occupational groups confirm skin sensitizing potential. Furthermore, available animal studies, including standard and modified guinea pig maximization tests and a mouse ear swelling test, confirm the skin sensitizing potential of hexavalent Chromium compounds.


Migrated from Short description of key information:
Review hexavalent Chromium compounds: skin sensitiser

Justification for selection of skin sensitisation endpoint:
Conclusion on skin sensitisation was based on the skin sensitising properties of hexavalent Chromium compounds.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In the European Union Risk Assessment Report (RAR) on Chromium trioxide, Sodium chromate, Sodium dichromate, Ammonium dichromate, and Potassium dichromate, the respiratory sensitizing potential of these Chromium compounds was reviewed.

Based on the available case reports and evidence from well-conducted bronchial challenge tests, it is concluded that hexavalent Chromium compounds can cause occupational asthma and should therefore be classified as respiratory sensitiser.

Migrated from Short description of key information:
Review hexavalent Chromium compounds: respiratory sensitising

Justification for selection of respiratory sensitisation endpoint:
Conclusion on skin sensitisation was based on the respiratory sensitising properties of hexavalent Chromium compounds.

Justification for classification or non-classification

Based on the skin and respiratory sensitising properties of hexavalent Chromium compounds, C. I. Pigment Yellow 34 should be classified as skin and respiratory sensitiser in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC. However, this was not confirmed by tests for the pigment itself.