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:

Two guinea pig maximization tests with Lanthanum carbonate according to OECD 406 and under GLP-condition were available.

The first test was performed with Lanthanum carbonate octahydrate as test substance (Vohr, 2004). After intradermal (5%) and topical induction (50%), the challenge with 50% test item led to skin effects in one animal in the test item group and to no skin effects in the animals of the control group. Therefore, under the conditions of the maximization test and with respect to the evaluation criteria Lanthanum carbonate octohydrate and consequently, Lanthanum carbonate exhibited no skin sensitisation potenial.

In the second test the sensitising potential of Lanthanum carbonate (containing water) was investigated (Ott, 2006). The induction was carried out in 3 phases: On Day 1, animals were injected by the intradermal route with Lanthanum carbonate (25% (w/w) in PEG 300) +/- Freund's Complete Adjuvant (treated) or with the vehicle (control), on Day 7, the same region received a topical application of sodium laurylsulfate in paraffinum perliquidum (10% w/w) in order to induce local irritation (all animals). Finally, a 48 hours topical occlusive application was performed on Day 8 with Lanthanum carbonate at 50% (w/w) in PEG 300 (treated) or the vehicle (control). The control and test animals were challenged topically 2 weeks after the topical induction application with Lanthanum carbonate at 50% (w/w) in PEG 300 for 24 hours (left flank) or PEG 300 alone (right flank). The challenge sites were evaluated 24 and 48 hours after removal of the patches. The reaction were graded for erythema and oedema according to a numerical scale. No clinical signs and no deaths, related to treatment were noted during the study. No cutaneous reactions were observed after challenge application.

So both tests confirmed that Lanthanum carbonate is not sensitising to the skin.

 


Migrated from Short description of key information:
About Samarium oxide no studies were available, but about the analogue substance Lanthanum carbonate:

Skin: not sensitising (GPMT)

Justification for classification or non-classification

The data on skin sensitisation is conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and 1272/2008/EC (CLP).