Registration Dossier
Registration Dossier
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EC number: 906-256-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
There is no mutagenicity data available on the multiconstituent substance, but data is available on the main components from which it can be concluded that mutagenicity/genotoxicity are not important characteristics.
Data on individual components:
Ethylene glycol (ethan-1,2-diol) :
BASF (2013) reported a negative result with and without metabolic activation, when tested ethylene glycol in a bacterial reverse mutation test. Concentrations of up to 5000 ug/plate were used. BRRC (1985) reported an in vitro mammalian chromosome aberration test using Chinese hamster ovary cells. Concentrations ranged from 10 - 100 mg/ml. Results obtained with and without metabolic activation indicated that ethylene glycol did not produce significant increases in chromosome aberrations in comparison to values of control cultures. Ethylene glycol was not considered to be a clastogenic agent under the conditions of this in vitro test system. McGregor et al. (1991) found a negative result with and without metabolic activation, when ethylene glycol was tested in a mammalian cell gene mutation assay. Mouse lymphoma cells were used; concentrations were up to 5000 ug/ml.
Diethylene glycol (2,2’-oxydiethanol
BASF (2013) reported a negative Ames test result according to EU Method B.10. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and and E Coli WP2 uvra were used with and without metabolic activation. Concentrations ranged up to 5000 ug/plate. Diethylene glycol was neither genotoxic nor cytotoxic to CHO cells when tested with and without metabolic activation in an in vitro mammalian chromosome aberration test with a concentration of 50 mg/ml (Union Carbide, 1984). A negative result with and without metabolic activation was found in a sister chromatid exchange assay using CHO cells. Concentrations used ranged from 30 - 50 mg/ml (Union Carbide, 1984).
Triethylene glycol (2,2’-(ethylenedioxy)diethanol):
Triethylene glycol was tested in an Ames test (BASF, 2012). Four Salmonalla strains and E coli WP" uvra were used, concentrations ranged up to 5000ug/plate. This test showed a negative result with and without metabolic activation. In an in vitro mammalian chromosome aberration test with Chinese hamster ovary cells, trieethylene glycol did not produce increases in chromosome aberrations in comparison to values of control cultures with and without metabolic activation.. No evidence of clastogenic or cytotoxic effects were observed. Concentrations tested were 35, 42 and 50 mg/l (BRRC, 1986).
Short description of key information:
Bacterial reversion mutation assays: MEG, DEG, TEG: negative
Chromosome abberation in vitro studies: MEG, DEG, TEG: negative
Mouse lymphoma studies: MEG: negative
Sister Chromatid exchange assays: DEG, TEG: negative.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Classification for mutagenicity/genotoxicity is not warranted based on the available data.
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