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EC number: 611-390-2 | CAS number: 56467-43-7
Summary of results (Micronucleus part)
Dose3 times mg/kgb.w.
PCE per2000 erythrocytes
* Range of absolute numbers of micronucleated PCEs
** Cyclophosphamide was only applied once
*** Sampling time after the last treatment
Summary of results (Comet part):
Analysis of Dead Cell Index and % Tail Intensity in cells of the Liver
Dead cells onslidesper 1500 cells peranimal
Mean ofMedian (% TailIntensity)
500 mg/kgb.w. Benzophenone methacrylate
1000 mg/kgb.w. Benzophenone methacrylate
2000 mg/kgb.w. Benzophenone methacrylate
Analysis of Dead Cell Index and % Tail Intensity in cells of the Stomach
This study was performed to investigate the potential of 4-(Methacryloyloxy)benzophenone to induce mutagenic / genotoxic effects in the rat by the analysis of micronuclei induction as well as the assessment of single DNA strand breaks in cells isolated from the liver and the stomach. DNA strand breaks were analysed using the alkaline single cell gel electrophoresis (Comet) assay and micronucleus induction was assessed in polychromatic erythrocytes (PCE) using the rat bone marrow micronucleus assay.
The animals received the test item, the vehicle DMSO / PEG 400 (3/7) (negative control) or positive controls at a constant dose volume of 10 mL/kg b.w. by oral administration three times to seven males per test group at intervals of 48 h, 24 h and 4 h prior to
After the treatment period liver cells and stomach cells were isolated for the assessment of single DNA strand breaks and bone marrow cells were collected for micronuclei analysis at concentrations of 500, 1000 and 2000 mg/kg b.w..
Micronucleus assay – Bone Marrow
To describe a cytotoxic effect due to the treatment with the test item the ratio between
polychromatic and normochromatic erythrocytes was determined in the same sample and reported as the number of PCEs per 2000 erythrocytes. After treatment with the test item the number of PCEs in the bone marrow was not substantially decreased as compared to the mean value of PCEs of the negative control thus indicating that 4-(Methacryloyloxy)benzophenone did not exert any cytotoxic effects in the bone marrow.
At least 2000 polychromatic erythrocytes (PCEs) per animal were scored for micronuclei. In
comparison to the corresponding vehicle control there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei after administration of the test item and with any dose level used.
20 mg/kg b.w. cyclophosphamide administered once orally was used as positive control which showed a substantial and statistically significant increase of induced micronucleus frequency demonstrating the validity of this part of the study.
Comet assay – Liver
As a cytotoxic parameter the dead cell index (dead cells (apoptotic/necrotic cells) per 1500 nuclei per animal) was determined in the Comet assay and did not show any increased cytotoxic effects in the liver cells in comparison to the vehicle control.
For the analysis of the single DNA strand breaks 150 cells per animal (3 slides prepared for each animal, 50 cells evaluated per slide) were evaluated. The relevant parameter for DNA damage is the percentage of DNA in the Comet tail measured as intensity relative to the intensity of the nucleus (% Tail intensity).
The Comet assay on cells of the liver revealed distinct and statistically significant increases in
DNA damage at any of the tested dose levels compared to the corresponding vehicle controls on the evaluated parameter (% Tail intensity). Additionally, a dose-dependent increase could be observed. However, the values were still in the range of the historical vehicle control data.
Comet assay – Stomach
As a parameter for cytotoxicity the dead cell index (dead cells (apoptotic/necrotic cells) per 1500 nuclei per animal) was determined in the Comet assay and did not show any increased cytotoxic effects in the stomach cells in comparison to the vehicle control.
The Comet assay on cells of the stomach revealed distinct and statistically significant increases in DNA damage at any of the tested dose levels compared to the corresponding vehicle controls on the evaluated parameter (% Tail intensity). However, all obtained test item group values were clearly in the range of the historical vehicle control group and no dose-dependency could be observed.
For both tissues, the vehicle controls were in the range to ensure a valid performance of the study.
The reference mutagen [MMS, 25 mg/kg b.w. oral] showed a distinct and statistically significant increase of DNA damage as detected by % Tail intensity analysis.
In conclusion, it can be stated that under the experimental conditions reported, 4-(Methacryloyloxy)benzophenone, up to the maximum dose level tested, did not induce micronuclei as determined by the micronucleus test with bone marrow cells. Therefore, 4-(Methacryloyloxy)benzophenone is considered to be nongenotoxic in the micronucleus part of this study.
Statistically significant increases in primary DNA damage in the liver and stomach as determined by the comet assay were observed, but the values were in the range of the historical vehicle controls. In case of the liver a dose-dependent increase was found. With regard to the results described, the Comet vivo part of this study with the test item 4-(Methacryloyloxy)benzophenone is considered to be inconclusive.
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