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 sensitisation potential of Lanthane oxide was evaluated on Dunkin-Hartley guinea pigs according to the maximisation method of Magnusson and Kligman, described in Directive 67/548/EEC, method B.6, and in compliance with Good Laboratory Practice.

Ten test and five control guinea pigs were included in this study. Induction was carried out as the following:

- on day one, animals were injected by the intracutaneous route with Lanthane oxide (15 and 25% % w/w in PEG 300) +/- Freund Complete Adjuvant (treated group) or with PEG 300 +/- Freund Complete Adjuvant (control group) or with Freund Complete Adjuvant alone (both groups);

- on day 7, the same region received a topical application of sodium lauryl sulfate (10 % w/w in paraffinum perliquidum) in order to induce local irritation;

- on day 8, a 48-hour topical occlusive application was performed with Lanthane oxide at 50 % w/w in PEG 300 (test animals) or the vehicle (controls).

- on day 22, the control and test animals were challenged by a cutaneous application of the test substance at 50 % w/w in PEG 300 to the left flank. The right flank served as control and received the vehicle only. The test substance and the vehicle were maintained under an occlusive dressing for 24 hours.

Skin reactions (erythema and oedema) were evaluated approximately 24 and 48 hours after removal of the dressing.

No clinical signs and no deaths related to treatment were noted during the study.

After the challenge application, at the 24-hour and 48-hour readings, no cutaneous reactions were noted.

In this study, Lanthane oxide is not a dermal sensitizer.


Migrated from Short description of key information:
The substance was not sensitiizing in a guinea pig maximisation test according to Dir. 67/548/EEC method B.6.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
There are no reported cases of respiratory sensitization to Lanthanumtrioxide in the literature. Industry experience confirms the absence of cases of respiratory sensitisation to the substance. Due to the negative result of the skin sensitization test, no respiratory sensisitization potential of the substance is expected.

Justification for classification or non-classification

The substance was not sensitiizing in a guinea pig maximisation test according to Dir. 67/548/EEC method B.6.

There are no reported cases of respiratory sensitization to Lanthanumtrioxide in the literature. Industry experience confirms the absence of cases of respiratory sensitisation to the substance. Due to the negative result of the skin sensitization test, no respiratory sensisitization potential of the substance is expected.