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Administrative data

Key value for chemical safety assessment

Additional information

In vitro studies:

2 -(2 -aminoethoxy)ethanol was evaluated for mutagenicity in the Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program. Doses of 0, 12.5, 25, 50, 100, 500, 2500, 5000 µg/plate were tested in four Salmonella typhimurium strains (TA98, TAl00, TAl535 and TAl537) in the presence and absence of Aroclor-induced rat or hamster liver S9. These tests were negative and the highest ineffective dose level tested in all four Salmonella tester strains under all treatment conditions was 2500 µg/plate (Zeiger et al. 1988; reliability score: 2).

A further AMES-test with 5 strains (TA98, TA100, TA 1535, TA1537 and TA1538) confirmed the negative results (Huntsman, 1982; reliability score: 2). Several other AMES-tests could not be taken into consideration because the test substance was a unknown mixture containing 2-(2-aminoethoxy)ethanol and several other substances (composition confidential, concentration of test substance unclear): In these assays the test substance showed ambiguous results (Chemfirst 1992-1997; reliability:3)

 

In an In-vitro mammalian cell transformation assay using Mouse BALB/3T3 Cells, both in the absence and presence of metabolic activation (S9 mix) no dose response relationship was observed and transformed foci were not considered to be significant over control dose ranges (Huntsman, 1982; reliability score: 2).

 

In an unscheduled DNA damage and repair assay with male F344 rat hepatocytes, according to the OECD Guideline 482, no genotoxic potential could be observed (Huntsman, 1982; reliability score: 2).

In vivo studies:

In an in vivo MNT (Huntsman, 2001) the test result was negative for chromosomal aberration.


Short description of key information:
All endpoints are considered addressed. Reliable experimental data are
available with the test substance (AEE) in the Ames Assay, in vitro cell transformation assay
(BALB/3T3 Assay), in vitro Unscheduled DNA Synthesis (UDS) Assay and the in vivo Mouse
Micronucleus Assay. In each case, a guideline method was followed under GLP conditions
which resulted in negative findings.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Two Ames-test (with and without metabolic activation), an in-vitro mammalian cell transformation assay and an in-vitro unscheduled DNA damage and repair assay failed to provide any evidence for a mutagenic effect of 2-(2-aminoethoxy)ethanol.