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EC number: 932-420-3 | CAS number: -
(24 h after
Doses in mg/kg/day
FOR 1000 PCE
Mann Whitney (p)
25 mg/kg/day (x1)
The potential clastogenic activity of CIMENT FONDU ® (batch 91478) provided by KERNEOS was tested using the in vivo micronucleus test in the rat, in compliance with the Commission Regulation (EC) No. 440/2008 and the OECD Guideline 474 (1997), by oral route, using 2 successive daily
treatments at the maximum dose recommended by OECD guidelines.
The test item CIMENT FONDU ® was suspended in CMC at 0.5% in distilled water, previously heated at 37°C. The suspension was also maintained at 37°C. For the preliminary and confirmatory toxicity assays, suspensions at a maximum concentration of 200 mg/mL were prepared and administered to the animals at a dose volume of 10 mL/kg, giving a final dose of 2000 mg/kg. In the main genotoxicity assay, three suspensions of the test item at the concentrations of 200 - 100 and 50 mg/mL were prepared, giving final doses of 2000 - 1000 and 500 mg/kg, respectively when administered at 10 mL/kg.
Taking into account the nature of the test item (i.e.cement), it rapidly hardened. The suspensions were thus maintained in constant agitation. However, even maintained under constant agitation, solidification under a gelatinous piece was noted, but the test item could be homogeneously resuspended after a vigorous agitation.
Animals were treated twice with 2000 mg/kg/day: preliminary test: 2 males and 2 females and confirmatory test: 5 males and 5 females.
The highest dose retained for the micronucleus assay was set at 2000 mg/kg/day (x2).Two inferior doses of 1000 and 500 mg/kg/day (x2) were also tested.
The weight homogeneity of the animals used in this test after random-distribution, was verified for males and females separately, by comparing the weight mean of the treatment groups with that of the control group. There was no statistically significant difference between the weights of males treated with the test item and those of control rats, except in the case of the positive control in male rats, and the low dose treated group in female rats. However, it was considered that this slight deviation affected neither the quality nor the integrity of the current study.
The ratio of polychromatic (PCE) to normochromatic erythrocytes (NCE) was established at each dose level. No statistically significant decrease in the ratio PCE to NCE was noted in the 3 CIMENT FONDU ® treatment groups when compared to the negative control group, either in treated male and female separately or with both sexes pooled. Thus, no proof of systemic exposure was evidenced.
The results obtained on negative control animals and those treated with the positive reference substance were similar to those generally obtained in the laboratory. A statistically significant increase in the frequency of micronuclei was noted in the group treated with Cyclophosphamide, demonstrating the sensitivity of the animal strain used to a clastogenic agent. The validity criteria for the test were fulfilled and the test was validated.
Regarding the frequency of micronuclei, no statistically significant increase in the frequencies of micronucleated polychromatic erythrocytes was found in the animals treated withCIMENT FONDU® at any dose, both sexes combined or males and females separately, when compared with the control group.
The validity criteria for the study were fulfilled. The current study was thus considered as valid. The test item CIMENT FONDU® (batch 91478) provided by KERNEOS was investigated by means of thein vivomicronucleus test, in male and female OFA Sprague Dawley rats treated orally twice with 2000 – 1000 and 500 mg/kg/day, followed by one sampling time 24 hours after the last treatment. As a conclusion, CIMENT FONDU® induced no genotoxic activity under these experimental conditions.
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