Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)

Endpoint summary

Additional information

Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol 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 (Nern, 2011). Doses of up to and including 5000 µg per plate did not cause any bacteriotoxic effects and no inhibition of growth was observed. 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. This result is confirmed by the negative outcome of an Ames Test with the read-across substance 1 -amino-2 -propanol (Ministery of Health and Welfare, Japan, 2005) (for justification of read-across see IUCLID chapter 13).

Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was examined for mutagenic activity (chromsome breakage and misdistribution of chromosomes) in the in vitro micronucleus test using Chinese Hamster V79 cells in accordance to OECD Guideline 487 (Sutter, 2012). The negative control and appropriate positive controls with known mutagens demonstrated the suitability and sensitivity of the test system. The test item showed no biologically relevant increase in the frequency of micronucleus containing V79 cells in the absence (both pulse and continuous treatment) or in the presence of S9 mix (pulse treatment) when tested up to cytotoxic concentrations.

Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was tested in an in vitro gene mutation assay in V79 cells (HPRT) according to OECD TG 476 in concentrations of up to and including the limit concentration of 2000 µg/mL (according to 10 mM) with and without metabolic activation (Wollny, 2012). No relevant cytotoxic effects indicated by a relative cloning efficiency below 50% were observed. No relevant and reproducible increase of the mutation frequency was observed in the cultures with and without S9 mix. Based on these results the test substance is considered to be non-mutagenic in this V79/HPRT test under the conditions tested.

In conclusion, Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) did not show any mutagenic effects in bacteria and mammalian cells.

Justification for selection of genetic toxicity endpoint
No study was selected since all three in vitro genotoxicity studies were negative.

Short description of key information:
Clearly negative in vitro studies - both with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results of several mutagenicity tests with carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol no classification is required with regard to genetic toxicity.