Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Preparing extracts was the only relevant method to test beryllium metal in vitro, because the test item is barely soluble in (aqueous) cell culture media. Extraction was conducted at 37 °C in the dark under non-abrasive shaking, simulating human lung conditions. Three days were choosen as extraction period, to have the best compromise (highest possible beryllium-ion-concentration while keeping essential cell culture ingredients like vitamins etc. intact).

The Ames-test, the chromosome aberration test in human lymphocytes and the mammalian cell gene mutation assy (HPRT) were negative both in presence and absence of metabolic activation system (rat liver S9). The unscheduled DNA repair assay did not reveal a general DNA damaging potential of the beryllium metal extract. There was a reduction in the mean net grain count (reflecting active DNA repair) when beryllium extract was incubated in parallel with the mutagen 2 -acetylaminofluorene. However, there was no clear dose-response for this effect. The Syrian hamster cell transformation test indicated a cell transforming potential. The relevance of this finding in absence of any effects on DNA damage, cytogenicity and gene mutation remains unclear.


Short description of key information:
The following tests were conducted to assess the genotoxic potential of beryllium metal powder: Ames-test, HPRT-test, chromosome aberration, UDS. All these tests were conducted with extracts of beryllium metal powder as it was the only relevant method to test beryllium metal in vitro.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No genotoxicity was observed in the classical investigations in vitro. The observed effect on cell transformation remains unclear, but in absence of a DNA damaging potential/ absence of a potential to inhibit DNA repair, this is not considered to reflect a classical genotoxic action. Consequently, no classification is applied.