Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The results from an Ames test, according to OECD Guideline 471, have been ‘read across’ from diethanolamine, propoxylated. Diethanolamine, propoxylated was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and TA 102, performed according to OECD TG 471. The test material was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test. Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed.

 

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.

 

The results of chromosome aberration assays have been 'read across' from glycerol, propoxylated and D-glucitol, propoxylated. Both test materials were considered to be non-clastogenic to human lymphocytes under the conditions tested.


Short description of key information:
Four in vitro mutagenicity tests using different end points were all negative. Therefore further testing is not required.
All four in vitro assays have negative results, all are 'read across', as permitted by Annex XI para 1.5, one nominally from 2, 2', 2''-nitrilotriethanol, propoxylated, one from glycerol, propoxylated, one from D-glucitol, propoxylated and the last one from diethanolamine, 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).

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).