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Administrative data

Key value for chemical safety assessment

Additional information

In the study BASF 2003, Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as E. coli WPA were exposed to the test item in the presence and absence of a mammalian metabolic activation system (S9-mix) according to the Ames test (1975). Apart from a very slight decrease of the number of revertants that was occasionally observed, results were unanimously indicating the validity of the assay. In this assay, the test item was not mutagenic.

In a mammalian cell micronucleus assay V79 cell cultures were exposed to Acetylmorpholin at concentrations of 0, 40.6, 81.3, 162.5, 325, 650 or 1300 µg/mL (with and without metabolic activation, exp. I), with concentrations of 0, 81.3, 162.5, 325, 650 or 1300 µg/mL (without metabolic activation, exp. II) and 250.0, 500.0, 1000.0 or 1300.0 µg/mL (with metabolic activation, exp. II) and 0, 162.5, 325, 650 or 1300 µg/mL (without metabolic activation, exp. III). Acetylmorpholin was tested up to the limit concentration of 1300 µg/mL (approx. 10 mM). There was no evidence of an induction of micronuclei over background. This study is classified as acceptable. This study satisfies the requirement for Test Guideline In vitro Mammalian Cell Micronucelus Test, OECD 487.

In a mammalian cell gene mutation assay (HPRT), CHO cells cultured in vitro were exposed to Acetylmorpholin at concentrations of  0; 162.5, 325.0, 650.0, 1300.0 µg/mL (1st experiment) in the presence and absence of phenobarbital and β-naphthoflavone-induced rat liver S9 mix and in a 2nd experiment at concentrations of 0; 162.5, 325.0, 650.0, 1300.0 µg/mL (without metabolic activation) and 0; 400.0, 800.0, 1000.0, 1300.0 µg/mL (with metabolic activation). Acetylmorpholin was tested up to limit concentrations of 1300 µg/mL (approx. 10m M). The positive controls did induce the appropriate response.  There was no evidence or a concentration related positive response of induced mutant colonies over background. This study is classified as acceptable.  This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.


Justification for selection of genetic toxicity endpoint
No stduy was selected because all tests were negative.

Short description of key information:
The test item was not mutagenic in vitro in the Ames test with and without metabolic activation.
The test item was not clastogenic/aneugenic in the in vitro Micronucleus test in V79 cells with and without metabolic activation.
The test item was not mutagenic in vitro in the HPRT test in CHO cells with and without metabolic activation.
Results from a Mouse Lymphoma Test on the substance Ethylmorpholin (CAS Nr.: 100-74-3), used here as a read across study, were negative with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Considering the negative results observed in all genotoxicity tests, Acetylmorpholine is not subject to classification for mutagenicity according to Directive 67/548/EEC and Regulation 1272/2008/EC.