Registration Dossier

Administrative data

Description of key information

In a bio-elution test it was shown that only 17.45 µg/L zirconium was released after 72 hours in artificial perspiration fluid (see IUCLID section 7.1.1). Moreover, the test substance was highly insoluble (below detection limit) in a T/D test conducted in accordance with OECD 29 (see IUCLID section 4.8). Thus, the bioavailability of zirconium, as the toxicological relevant part of the target substance, after administration to the skin, can be expected to be very low. No information was found in the public domain, which would indicate any skin sensitising properties of zirconium. Based on the results and in line with the 3R principles, the study is scientifically unjustified.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a bio-elution test it was shown that only 17.45 µg/L zirconium was released after 72 hours in artificial perspiration fluid (see IUCLID section 7.1.1). Moreover, the test substance was highly insoluble (below detection limit) in a T/D test conducted in accordance with OECD 29 (see IUCLID section 4.8). Thus, the bioavailability of zirconium, as the toxicological relevant part of the target substance, after administration to the skin, can be expected to be very low. No information was found in the public domain, which would indicate any skin sensitising properties of zirconium. Based on the results and in line with the 3R principles, the study is scientifically unjustified.