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EC number: 205-793-9 | CAS number: 151-56-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The Ames test was performed with and without metabolic activation using induced male Sprague Dawley rat liver S9 (RLI) or induced male Syrian hamster liver S9 (HLI).
Without metabolic activation, concentrations >= 1000 µg/plate of the test substance were cytotoxic.
In this study it was clearly shown that the number of reverse mutations increased in the strain TA100 with increasing amounts of the test substance. Using 10 µg/plate of the test substance the number of reverse mutations was about 3-fold (without activation) and 4.4-fold (30%RLI) or 5-fold (30%HLI) higher than in the control (NTP, 2003).
In an in vitro gene mutation assay in fungi, mitotic recombination and gene conversion were observed. Treatment for 30 minutes at 25ºC resulted in a 11-fold increase for conversion at the ade2- and ade-15 for the trp5 gene locus with no concommittant killing. This effect increased with 50 and 100 mM; the dose response curve was quite linear. Killing at 100 mM was ca 20% (Zimmermann 1971&1984).
In an in vivo micronucleus test, 2.9 or 1.16 µL of the test substance was applied intraperitoneally (BASF AG 1975). After single application of the test substance, the rats were sacrificed 4, 24 or 48h after application. After repeated application (5 times) of the test substance, the rats were sacrificed 4h after the last application.
The test substance showed a chromosome damaging effect under the experimental conditions used.
In an in vivo chromosome aberration test, 2.9 or 1.16 µL/kg bw of the test substance were applied intraperitoneally (BASF AG 1975). After single application of the test substance rats were sacrificed 6, 24 or 48h after application. After repeated application (5 times) of the test substance, the rats were sacrificed 6h after the last application.
The test substance had a slight clastogenic effect under the test conditions chosen.
Short description of key information:
Genetic toxicity studies were performed, showing that ethyleneimine is positive in an Ames test, an in vivo micronucleus and an in vivo chromosome aberration test.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
According to Annex I of Directive 67/548/EEC, the substance is classified as category 2 mutagen (R46).
According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification is H340, Cat. 1B.
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