Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

DEGDB was tested against four strains of Salmonella typhimurium and one strain of Escherichia coli, 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 DEGDB showed no evidence of mutagenic activity in this bacterial system. A much earlier study (non-GLP) the test compound DEGDB was found not to demonstrate any genetic activity in this test, and was considered not mutagenic under the test conditions.

A mammalian cell mutation assay was conducted and toxicity was observed after treatment with DEGDB 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 DEGDB did not demonstrate mutagenic potential in this in vitro mammalian cell mutation assay.

A chromosome aberration test was performed to determine the potential of DEGDB 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), DEGDB 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 DEGDB had shown no evidence of clastogenic activity in this in-vitro cytogenetic test system.

 

 

 


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 DEGDB, is considered as non-mutagenic and is not classified.