Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Gene mutation in bacteria

DPGDB was tested against four strains of Salmonella typhimurium and one strain of Escherichia coli, (HLS 1998, VCL251/973337) both in the presence and in the absence of metabolic activation (provided by S9 mix). Relevant positive controls were tested concurrently and provided positive results, demonstrating the sensitivity of the assay. No increases in the number of revertant colonies relative to the concurrent vehicle controls were observed for the test material in any of the strains tested. It was concluded that DPGDB showed no evidence of mutagenic activity in this bacterial system.

Chromosomal aberration– in vitro

A chromosome aberration test was performed (HLS 1998, VCL230/971449) to determine the potential of DPGDB to cause chromosome aberrations in Chinese Hamster Lung (CHL) cells cultured in vitro. In both the presence and the absence of metabolic activation (S9 mix), DPGDB caused no statistically significant increase in the proportion of metaphase figures containing chromosomal aberrations at any dose level when compared with the solvent control in either of two tests. It was concluded that DPGDB had shown no evidence of clastogenic activity in this in-vitro cytogenetic test system.

Gene mutation in mammalian cells

A mammalian cell mutation assay (HLS 1998, VCL229/971625) was conducted and toxicity was observed after treatment with DPGDB in all the tests both in the absence and the presence of metabolic activation (S-9 mix). No biologically significant increases in mutant frequency were observed in any of the tests either in the absence or the presence of S-9 mix. It was concluded that DPGDB did not demonstrate mutagenic potential in this in vitro mammalian cell mutation assay.

Short description of key information:
No evidence of genetic toxicity was seen in any of the studies.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

From the results of the three different in-vitro investigations, and according to the criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) the test item DPGDB, is considered as non-mutagenic and is not classified.