Registration Dossier
Registration Dossier
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EC number: 500-075-4 | CAS number: 31694-55-0 1 - 6.5 moles ethoxylated
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Glycerol, ethoxylated >1 -<6.5 was tested according to OECD Guideline 471 (Bacterial reverse mutation assay). No increase in the number of revertants was observed, neither in the standard plate nor in the preincubation test (+/- metabolic activation) (BASF SE, 2011).
Evaluation of clastogenicity in mammalian cells can reliably be performed by read- across to the stuctural analog Glycerol, propoxylated >1 -<6.5. No indications of a cytogenic potency were identified in human lymphocytes in an chromosomal abberation assay with and without metabolic activation (ISOPA, 2005).
Evaluation of mutagenicity in mammalian cells can reliably be performed by read- across to the stuctural analog 2,2´,2´´-Nitrilotriethanol, propoxylated. The results from a mammalian point mutation assay in cells (HPRT) are negative (ISOPA, 2009).
For more information on the read across rationale see report from Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2007). The report identifies that 2, 2', 2''-nitrilotriethanol, propoxylated is the most bioavailable of the polyols linked by an ether group. Glycerol, ethoxylated (31694-55-0) can be reliably included into this read accross category.
Since appropriate read-across data are available, no further testing on glycerol ethoxylated is warranted. For further details concerning the groupings consult Illing and Barratt ( 2007).Short description of key information:
Three in vitro genotoxicity tests adressing all relevant end points are available. All assays were all negative and therefore further testing is not required.
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).
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