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EC number: 225-590-9
CAS number: 4948-15-6
Table 1: Linear trend-test
* The linear trend-test testing for an increased number of micronucleated cells is significant (significance level of 5%), if the one-sided p-value is lower than 0.05.Values indicating a statistically significant trend are printed in bold characters.
Table 2: Summary of results
Exposure/ Recovery/ Preparationintervall
Micronucleated cells *
* Relative number of binucleated cells with micronuclei per 2000 cells scored per test group
s Frequency statistically significantly higher than corresponding control values
n.d. Not determined; n.s. Not scorable due to strong cytotoxicity
VC vehicle control; PC positive control
1 0.05% BSA-water (w/v); 2 MMC 0.04 μg/mL; 3 Col 0.05 μg/mL
Table 3: HISTORICAL NEGATIVE CONTROL DATA
Period: April 2018 - November 2020
Micronucleated cells [%]
95% Lower Control Limit
95% Upper Control Limit
No. of Experiments
Table 4: HISTORICAL POSITIVE CONTROL DATA
Period: April 2018 – November 2020
Mitomycin C (0.04 µg/mL)
Colchicin (0.05 µg/mL)
The test substance was tested for its potential to induce micronuclei in primary human lymphocytes in vitro (clastogenic or aneugenic activity). Two independentexperiments were carried out, incubating the cells for 20 h (20 h harvest time) with the test substance at concentrations in the range of 1.0 to 256 µg/mL. A sample of at least 1000 cells for each culture was analyzed for micronuclei, i.e. 2000 cells for each test group. In this study, 0.05% w/v BSA-water was selected as vehicle. The characterization of the nanomaterial in cell culture medium showed, that the particles were successfully dispersed into a stable suspension with partial agglomeration, that did not change significantly during the treatment period. The vehicle controls gave frequencies of micronucleated cells within our historical negative control data range for primary human lymphocytes. The positive control substances, Mitomycin C (MMC), Colchicine (Col) and the nanomaterial positive control Tungsten Carbide-Cobalt (WC-Co), led to the expected increase in the number of cells containing micronuclei.
The test substance was formulated in the given vehicle according to the NANOGENOTOXProject (Grant Agreement No 2009 21 01); Version 1.2, dated 06 May 2018.
In this study, no cytotoxicity indicated by reduced proliferation index (CBPI) was observed up to the highest applied test substance concentration. On the basis of the results of the present study, the test substance did not cause any biologically relevant increase in the number of cells containing micronuclei.Thus, under the experimental conditions described, test material is considered not to have a chromosome-damaging (clastogenic) effect nor to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in primary human lymphocytes.
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