Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Pentaerythritol, propoxylated was tested according to OECD Guideline 471 (Bacterial reverse mutation assay). There were negative findings both with and without metabolic activation.

The results from a mammalian point mutation assay have been 'read across' from 2, 2', 2''-nitrilotriethanol, propoxylated. They are negative.

The results of chromosome aberration assays have been 'read across' from 2,2',2''-nitrilotriethanol, propoxylated, glycerol, propoxylated (alpha, alpha', alpha''-1,2,3-propanetriyltris[w-hydroxypoly(oxy-(methyl-1,2-ethanediyl))] and D-glucitol, propoxylated.

They are negative.


Short description of key information:
Three in vitro mutagenicity tests using different end points were all negative. Therefore further testing is not required.
In all three in vitro assays, one by direct test and two by 'read across,' as permitted by Annex XI para 1.5, one nominally from 2, 2', 2''-nitrilotriethanol, propoxylated and the other nominally from 2, 2', 2''-nitrilotriethanol, propoxylated, glycerol propoxylated and D-glucitol, propoxylated; 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. Thus, it is inappropriate to undertake the tests on pentaerythritol, propoxylated. For further details concerning the groupings consult Illing and Barratt (2007).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The findings from in-vitro genotoxicity testing do not warrant classification.