Oligomerisation products of 2,2'- oxydiethanol with ethylene oxide and propylene oxide

Endpoint summary

Additional information

An Ames test with 2,2’oxydiethanol, ethoxylated and propoxylated (>1<4.5 EO and >1<4.5 PO) was performed according to OECD TG 471 in the tester strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 with and without metabolic activation. No relevant increase in the number of his+ or trp+ revertants was observed in any experiment, thus, under the experimental conditions chosen here, it is concluded that 2,2`-Oxybisethanol ethoxylated and propoxylated is not a mutagenic test substance.

Evaluation of clastogenicity in mammalian cells can reliably be performed by read-across to the structural analogues

2, 2', 2''-nitrilotriethanol, propoxylated, glycerol, propoxylated and D-glucitol, propoxylated. All 3 test substances have been tested negative for chromosomal aberrations in human lymphocytes under the conditions tested, each in absence and presence of a metabolic activating system.

 

The results from a mammalian point mutation assay have been 'read across' from 2, 2', 2''-nitrilotriethanol, propoxylated. 2,2',2''-Nitrilotriethanol, propoxylated did not induce mutagenic effects in the in vitro gene mutation assay (HPRT test) with Chinese hamster V79 cells in the presence and absence of a metabolic activation system.

 

Short description of key information:
Five in vitro mutagenicity tests using different end points were all negative. Therefore further testing is not required.
The Ames assay on mutagenicity in bacterial cells was performed with 2,2’-oxydiethanol, ethoxylated and propoxylated, >1<4.5 EO and >1<4.5 PO), whereas all other end point (mutagenicity and genetic toxicity in mammalian cells) were reliably read-acrossed from near structural analogues (molecules with similar core molecules and/or side chains), as permitted by Annex XI para 1.5.
One nominally from 2, 2', 2''-nitrilotriethanol, propoxylated, one from glycerol, propoxylated, and one from D-glucitol, propoxylated see report from Paul Illing Consultancy Services Ltd and Marlin Consultancy Illing and Barratt, 2007 and 2010. The report identifies that these substances are the most bioavailable of the polyols. Thus, it is inappropriate to undertake the tests on diethyleneglycol, propoxylated. For further details concerning the groupings consult Illing and Barratt (2007 and 2010).
All assays in vitro assays presented indicated negative results, furthermore the molecule does not contain a structural allert for genotoxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Findings from in-vitro genotoxicity testing do not warrant classification and labelling according to GHS (EU).