Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Several in vitro mutagenicity tests using different end points were all negative. Therefore further testing is not required. All in vitro assays have negative results, one used the test substance and the others are 'read across', as permitted by Annex XI para 1.5, from 2, 2', 2''-nitrilotriethanol, propoxylated. See report from Paul Illing Consultancy Services Ltd and Marlin Consultancy Illing and Barratt, 2007 and 2009.

Additional information

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 result of chromosome aberration assays have been 'read across' from glycerol, propoxylated was also negative.

 

Based on these results diethanolamine, propoxylated was considered to be non-mutagenic in V79 Chinese Hamster cells and non-clastogenic to human lymphocytes under the conditions tested.

 

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 CLP and DSD.