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:

The substance has given a clear negative result in a Magnusson & Kligman maximisation study in the guinea pig (0/17 sensitisation) rate.

There is no evidence of sensitisation in humans based on experience in use.


Migrated from Short description of key information:
A GLP-compliant Magnusson & Kligman maximisation study according to OECD Guideline 406 has been conducted. Concentrations used for induction were 10% in distilled water for the injections, and 100% for the topical application (preceded by wetting with 10% aqueous SLS to create local irritation). Following challenge with Ammonium Zirconium Carbonate at a concentration of 100%, none of the 17 test group animals showed positive reactions to this application.

Respiratory sensitisation

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

No specific test data is available on respiratory sensitisation but experience in use suggests the substance is not a respiratory sensitiser.


Migrated from Short description of key information:
No specific test data is available on respiratory sensitisation but the substance has been used in industry without any incidences of respiratory sensitisation for many years.

Justification for classification or non-classification

The substance has given a clear negative result in a Magnusson & Kligman maximisation study in the guinea pig (0/17 sensitisation) rate.

There is no evidence of sensitisation in humans based on experience in use. On this basis the substance is not classified as a skin sensitiser.

No specific test data is available on respiratory sensitisation but experience in use suggests the substance is not a respiratory sensitiser

and hence no classification is required.