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372<br />

Table 19. Results of studies of genotoxicity with procymidone<br />

End-po<strong>in</strong>t Test object Concentration Purity<br />

(% w/w)<br />

In vitro<br />

Result<br />

Reference<br />

Reverse mutation a<br />

S. typhimurium stra<strong>in</strong>s<br />

TA98, TA100, TA1535,<br />

TA1537 and E. coli<br />

(WP2 hcr - )<br />

10–1 000 μg/plate 96.9 Negative +S9 d<br />

Negative − S9<br />

Moriya & Kato<br />

(1977)<br />

Reverse mutation b<br />

S. typhimurium stra<strong>in</strong>s<br />

TA98, TA100, TA1535,<br />

TA1537<br />

10–10 000 μg/plate 96.3 Negative +S9 d<br />

Negative −S9<br />

Suzuki &<br />

Miyamoto<br />

(1976)<br />

Reverse mutation b,c,f<br />

S. typhimurium stra<strong>in</strong>s<br />

TA98, TA100, TA1535,<br />

TA1537, TA1538 and E.<br />

coli (WP2 uvrA)<br />

5–5 000 μg/plate 99.4 Negative +S9 d<br />

Negative −S9<br />

Kogiso (1991)<br />

Gene mutation<br />

(Hprt locus)<br />

Ch<strong>in</strong>ese hamster lung<br />

cells (V79)<br />

0.7–6.0 mmol/l Sumisclex<br />

50% granule<br />

Negative +S9 d<br />

Negative −S9<br />

Pr<strong>in</strong>cipe et al.<br />

(1980)<br />

Nunziata (1982)<br />

Chromosomal<br />

aberration g<br />

Ch<strong>in</strong>ese hamster ovary<br />

cells (CHO-K1)<br />

75–300 μg/ml 99.4 Negative +S9 d<br />

Negative −S9<br />

Hara (1991b)<br />

DNA damage<br />

DNA damage b<br />

Bacillus subtilis<br />

(H17 and M45rec - )<br />

Bacillus subtilis<br />

(H17 and M45rec - )<br />

20–2 000 μg/disk 96.9 Negative Moriya & Kato<br />

(1977)<br />

10–10 000 μg/disk 96.3 Negative Suzuki &<br />

Miyamoto<br />

(1976)<br />

Sister chromatid<br />

exchange h<br />

Primary cultures from<br />

ICR mouse embryos<br />

1–100 μmol/l 96.9 Negative +S9 d<br />

Negative −S9<br />

Suzuki (1980)<br />

Unscheduled DNA<br />

synthesis i<br />

Heteroploid human<br />

epithelial cells<br />

6 μmol/l–6.0 mmol/l Sumisclex<br />

50% granule<br />

Negative +S9 d<br />

Negative −S9<br />

Pr<strong>in</strong>cipe et al.<br />

(1980)<br />

Nunziata (1982)<br />

(supplement)<br />

Unscheduled DNA Primary rat hepatocytes 3–300 μg/ml 99.4 Negative Hara (1991a);<br />

synthesis c, f, j Hara (1992)<br />

In vivo<br />

Chromosomal<br />

aberration k Male ddY mice 400, 800 or<br />

1 600 mg/kg bw<br />

<strong>in</strong>traperitoneally <strong>in</strong><br />

corn oil<br />

96.9 Negative Hara & Suzuki<br />

(1980)<br />

Reverse mutation,<br />

host-mediated b Male ICR mice, S.<br />

typhimurium (G46)<br />

Reverse mutation<br />

host-mediated b, l<br />

Male ICR mice, S.<br />

typhimurium (G46)<br />

1 000 or<br />

2 000 mg/kg bw by<br />

gavage <strong>in</strong> DMSO<br />

2 × 200 and<br />

2 × 500 mg/kg bw by<br />

gavage <strong>in</strong> 5% gum<br />

arabic<br />

96.3 Negative Suzuki &<br />

Miyamoto<br />

(1976)<br />

96.9 Negative Moriya & Kato<br />

(1977)<br />

Positive controls were <strong>in</strong>cluded <strong>in</strong> all tests for genotoxicity and were performed adequately.<br />

DMSO, dimethyl sulfoxide; S9, 9000 × g supernatant from rat livers.<br />

a<br />

Each test was conducted <strong>in</strong> duplicate.<br />

PROCYMIDONE 349–401 JMPR <strong>2007</strong>

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