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EC number: 278-780-9
CAS number: 77881-13-1
A bacterial reverse mutation assay with S.
typhimurium was conducted using AD-Cyanhydrin concentrations from 25 to
1000 µg per plate. AD-Cyanhydrin was examined for mutagenic activity in
the five histidine-dependent Salmonella typhimurium strains TA 1535, TA
100, TA 1537, TA 1538 and TA 98 with and without metabolic activation.
Growth inhibition could be observed on TA 1535, TA 1537 and TA 1538
starting at 500 µg/plate and on TA 98 at 1000 µg/plate without S9-mix.
Precipitates in the agar were found at least in the highest
There was no evidence for a mutagenic
activity of AD-Cyanhydrin, when tested up to the dose level of 1000
µg/plate in the absence and presence of S9 mix.
For assessment of the clastogenic potential
of AD-Cyanhydrin (= ZK 74.804) a chromosome aberration test in vitro was
conducted in human peripheral blood lymphocytes. The cells were treated
with 5, 10 and 25 µg/ml AD-Cyanhydrin without S9 mix and with 10, 50 and
100 µg/ml with S) mix. In both assays ZK 74.804 was clearly cytotoxic at
the highest concentration as proven by the reduction of the mitotic
index and neither assay showed an increase in structural chromosomal
aberrations in the cultures treated with ZK 74.804 as compared with the
Based on this, AD-Cyanhydrin showed no
clastogenic potential in human lymphocytes in vitro with and without
Additionally, a mouse micronucleus test was
conducted to investigate the potential of AD-Cyanhydrin (= ZK 74.804) to
induce chromosome breakage or malfunction of the spindle apparatus. Male
and female NMRI mice were treated once by gavage with 1.0, 2.5 or 5.0
g/kg body weight. Control animals were given the vehicle at 40 ml/kg in
the same manner. Triaziquone (0.15 mg/kg; single i.p. treatment) served
as positive control. Animals of the control and treatment groups were
killed at intervals of 24, 48 and 72 hours after treatment. The positive
control animals were killed 24 hours after treatment. Femur bone marrow
smears were prepared and stained using May-Gruenwald and Giemsa
solutions. The coded slides were examined for the presence of
micronuclei in 1000 polychromatic and 1000 normochromatic erythrocytes
and for the ratio of polychromatic to normochromatic erythrocytes. The
micronucleated cell counts obtained with ZK 74.804 were comparable with
the concurrent control values. No bone marrow depression was observed.
Therefore, AD-Cyanhydrin showed no mutagenic
potential when administered by gavage up to 5 g/kg in the mouse
Based on the study results a classification according to Directive
67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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