Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Results of available in vitro studies:

- AMES test: negative

- Micronucleus test in human lymphocytes: positive.

Genetic toxicity in vivo

Description of key information

No in vivo genetic toxicity studies are available for Tris(ethyl acetoacetato-O1',O3)aluminium but some in vivo studies with equivocal results for similar aluminium compounds are known and are under CORAP evaluation.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Tris(ethyl acetoacetato-O1',O3)aluminium was negative in AMES test but it was positive in vitro micronucleus test confirming the behavior observed for a lot of aluminium compounds. In comparison with many other aluminium compounds, no classification is proposed even though the reason for no classification is inconclusive. The possible exposure may derive only from mixture where the substance is present in quantity below 1%. The inconclusive classification is harming neither workers nor consumers.

Some aluminium compounds are under evaluation by CORAP as suspected CMR (see aluminium chloride EC 231-208-1 CAS 7446-70-0 and aluminium sulphate EC 233-135-0 CAS 10043-01-3, the latter is also suspected sensitiser). The CORAP decision is not yet available. Even though aluminium chloride and aluminium sulphate are totally inorganic compound and aluminium compounds with organic ligands (e.g. aluminium lactate EC 242-670-9 CAS 18917-91-4) are preferred for similarity with target substance, as soon as CORAP decision will be public possible update of genotoxicity evaluation of Tris (ethyl acetoacetato-O1’,O3) aluminium will be considered.

Justification for classification or non-classification

The classification for genetic toxicity of Tris(ethyl acetoacetato-O1',O3)aluminium is inconclusive according to the CLP Regulation (EC.n.1272/2008). For justification see the results of available studies on Tris(ethyl acetoacetato-O1',O3)aluminium and on aluminium compounds under CORAP evaluation.