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The test substance was judged negative because the number of revertant colonies for the test substance treatment groups in all test strains was less than twice that of the negative control regardless of a presence or absence of S9 mix.

The number of revertant colonies in the positive controls were above two times that of the negative control. The test results showed that the numbers of revertant colonies in the negative control and positive controls were within the range of the historical data at Hita laboratory. It was also confirmed that the test system was free from bacterial contamination, which indicates the test results to be valid.

The ability of FP-100 to induce chromosomal aberrations was investigated by using Chinese hamster lung fibroblasts (CHL/IU cells). Acetome was used as a solvent.

Based on the results of the cell growth inhibition test, the doses in the chromosomal aberration test were set at 1250, 2500 and 5000 µg/ml in the short term treatment without S9 and in the 24 hour continuous treatment, and 158, 500, 1580 and 5000µg/ml in the short term treatment with S9 mix.

In the chromosomal aberration test, the doses for the observation were selected at 1250, 2500 and 5000 µg/ml in the short term treatments without S9 and in the 24 hour continuous treatment, and at 500, 1580 and 5000µg/ml for the short term treatment with S9 mix. In observation, the frequencies of cells with structural aberrations and numerical cells were scored.

As a result of observation of the specimens, frequencies of cells with structural aberrations or numerical aberration cells showed below 5% at all dosse of the test substance in the short term treatments without and with S9 mix and 24 hours continuous treatment, therefore the structural aberrations and numerical aberations were judged to be negative.

On the other hand the freauencies of cells with structural aberrations and numerical aberration cells in the negative control treated for acetone showed below 5% and the frequencies of cells with structural aberrations in the positive controls treated with mitomycin C and cyclophosphamide showed abvoe 20% indicating the proper performance of the present study.

It is concluded that FP-100 does not possess an ability to induce chromosomal abberations under the present test conditions.

From the above results, it was concluded that FP-100 had no ability to induce mutations under the present test conditions.


Short description of key information:
The test substance was judged negative because the number of revertant colonies for the test substance treatment groups in all test strains was less than twice that of the negative control regardless of a presence or absence of S9 mix.
In each treatment method, the frequencies of cells with chromosomal aberrations did not fluctuate markedly between two culture dishes, and the frequencies of cells with chromosomal aberrations were below 5% in the negative controls, and the frequencies of cells with structural aberrations excluding gaps were over 20% with positive controls, indicating that the present study was appropriately performed.
In the short-term treatments without and with S9 mix and the continuous treatment, the frequencies of cells with structural aberration cells were below 5% at all observation doses of the test substance. Consequently, the structural aberration and the numerical aberration were judged to be negative.
Based on the above results, it was considered that FP-100 did not possess an abiltiy to induce chromosomal aberrations under the present test conditions.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative study result