Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

GLDA-Na4 was found to be non-mutagenic in the Ames assay and was non-mutagenic to Chinese Hamster Ovary (CHO) cells (HGPRT test). In a chromosome aberration test in Chinese hamster lung (CHL) cells, GLDA-Na4 induced no statistically significant increases in the frequency of cells with aberrations in Experiment 1. In Experiment 2 small, but statistically significant increases in the frequency of cells with aberrations were observed in three exposure groups. The increase in aberrant cell frequency was small and restricted to the maximum dose level and appeared to have a threshold response. GLDA-Na4 was, therefore, shown to be weakly clastogenic to CHL cells in vitro. GLDA-Na4 did not produce damage to chromosomes or aneuploidy when administered at levels up to 400 mg/kg bw via the intraperitoneal route to mice. At this level, clinical signs and premature deaths were observed and this suggested that systemic absorption had occurred and that the bone marrow was exposed.

Short description of key information:

GLDA-Na4 was tested in vitro in the Ames test, the HGPRT test, a chromosome aberration test, and in an in vivo micronucleus test. GLDA-Na4 did not show mutagenicity in 3 out of 4 of these tests; and was only weakly clastogenic to CHL cells in vitro.    

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the information indicated above, no classification for genetic toxicity is needed.