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CHLOROTHALONIL<br />

- 4 -<br />

APPENDIX II<br />

END POINTS AND RELATED INFORMATION<br />

1. Toxicology and metabolism<br />

20 December 2004<br />

Eye irritation:<br />

Skin sensitization (test<br />

method used and result):<br />

irritant<br />

skin sensitizer (Maximisation test)<br />

Sh<strong>or</strong>t term toxicity<br />

Target / critical effect:<br />

Lowest relevant <strong>or</strong>al<br />

NOAEL / NOEL:<br />

Lowest relevant dermal<br />

NOAEL / NOEL:<br />

Lowest relevant inhalation<br />

NOAEL / NOEL:<br />

Ge<strong>not</strong>oxicity<br />

stomach and kidneys<br />

(histopathological changes and<br />

increased <strong>or</strong>gan weights in kidneys)<br />

1.5 mg/kg bw/day (90-day rat)<br />

< 60 mg/kg bw (21-day rat)<br />

no data; <strong>not</strong> required<br />

Some positive response in vitro<br />

(without activation). No convincing<br />

evidence f<strong>or</strong> ge<strong>not</strong>oxicity in vivo<br />

Long term toxicity and carcinogenicity<br />

Target / critical effect:<br />

Lowest relevant NOAEL:<br />

Carcinogenicity:<br />

kidney and (f<strong>or</strong>e)stomach (preneoplastic<br />

and neoplastic lesions)<br />

chronic study, rat :1.8 mg/kg bw/day<br />

Most relevant NOAEL f<strong>or</strong> setting the<br />

AOEL: 2.7 mg/kg bw/day<br />

f<strong>or</strong>e-stomach tumours in rats and<br />

mice, kidney tumours in rats<br />

Reproductive toxicity<br />

Target / critical effect -<br />

Reproduction:<br />

decreased pup weight and<br />

histopathological changes in stomach<br />

at parental toxic doses.

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