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:

Only limited data were available on the skin sensitization potential of cadmium metal and cadmium compounds. Cadmium chloride did not show any skin sensitization effects at 0.5% in a GMPT test. Cadmium chloride and sulphate were patch-tested in human volunteers but, across several studies, the evidence remained inconclusive.

If at all, significant exposure is expected to occur principally in occupational settings.Given the carcinogen properties of cadmium metal and some of the cadmium compounds, risk reduction measures are in place to prevent contact.Therefore, skin sensitization is not expected to be an issue for human health and further testing is not considered necessary, in accordance with Annex XI (3) of the REACH directive.This is in line with the conclusions of the EU RAR (ECB, 2007).

At present, none of the cadmium substances covered in the present assessment is classified for skin sensitization in Annex I of Directive 67/548/EEC.


Migrated from Short description of key information:
The only skin sensitization study that could be found was a guinea-pig maximization test (GMPT) conducted with water soluble cadmium chloride, which indicated no contact sensitisation following epicutaneous exposure at concentrations up to 0.5% after intradermal or topical sensitisation (Wahlberg and Boman, 1979). However, due to incomplete reporting and deviations from the current regulatory test protocols, the study was considered unreliable.
No skin sensitization studies were located on cadmium metal or any of the other cadmium compounds.

Positive patch-test reactions to cadmium chloride and sulphate in human volunteers are summarised by Wahlberg (1977). The results are not consistent and, according to the authors, the percentage of positive reactions may have varied with the vehicle used for the cadmium solution (ethanol or water) or with possible impurities contained in the test substance. No clear conclusion could therefore be drawn on the skin sensitization potential of the substances (ECB, 2007).
With regard to cadmium metal and cadmium oxide, the accumulated experience in occupational practice over decades does not indicate any sensitizing potential (ECB, 2007).
No further human information was located on cadmium metal or the other cadmium compounds.

Respiratory sensitisation

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

Only limited data were available on the respiratory sensitization potential of cadmium metal and cadmium compounds.

If at all, significant exposure is expected to occur principally in occupational settings.Given the carcinogen properties of cadmium metal and some of the cadmium compounds, risk reduction measures are in place to prevent contact.Therefore, respiratory tract sensitization is not expected to be an issue for human health and further testing is not considered necessary, in accordance withAnnex XI (3) of the REACH directive.This is in line with the conclusions of the EU RAR (ECB, 2007).

At present, none of the cadmium substances covered in the present assessment is classified for respiratory tract sensitization in Annex I of Directive 67/548/EEC.


Migrated from Short description of key information:
No studies were located on respiratory sensitisation in humans or animals. However, given the carcinogen properties of cadmium metal and some of the cadmium compounds, risk reduction measures are in place at the workplace to prevent contact. Therefore, respiratory sensitization is not expected to be an issue for human health and further testing is not considered necessary, in accordance with Annex XI (3) of the REACH directive.

Justification for classification or non-classification

Only limited data were available on the skin or respiratory sensitization potential of cadmium metal and cadmium compounds. Cadmium chloride did not show any skin sensitization effects at 0.5% in a GMPT test. Cadmium chloride and sulphate were patch-tested in human volunteers but, across several studies, the evidence remained inconclusive.

If at all, significant exposure is expected to occur principally in occupational settings.Given the carcinogen properties of cadmium metal and some of the cadmium compounds, risk reduction measures are in place to prevent contact.Therefore, neither skin nor respiratory tract sensitization are expected to be an issue for human health and further testing is not considered necessary, in accordance withAnnex XI (3) of the REACH directive.This is in line with the conclusions of the EU RAR (ECB, 2007).

At present, none of the cadmium substances covered in the present assessment is classified for sensitization in Annex I of Directive 67/548/EEC.