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No adverse effects were observed upon subacute gavage dosing of rats (GLP, OECD 407) at the highest dose of 1000 mg/kg bw.

Key value for chemical safety assessment

Additional information

The repeated dose oral toxicity study in rats was conducted under Japanese Guideline under Chemical Substances Control Law (28-Day Repeated Dose Toxicity Test in Mammalian Species) in compliance with GLP (MHW,Japan,1994). Monosodium 4-amino-5-hydroxynaphthalene-2,7-disulphonate (purity; 87.4%) was administered orally by gavage to male and femaleCrj:CD(SD)rats (6 or 12animals/sex/group) for 28 days at doses of 0 (vehicle control: 1 w/v % methylcellulose), 30, 100, 300, 1000mg/kg bw/day.The doses have been recalculated to take account of the impurities. Sixmale and 6 female rats from 0 and 1000 mg/kg bw/day groups were allocated as the recovery groups.

No death was observed in both sexes. There were no adverse effects on any observationsincludingbody and organ weights, blood and urine analyses, and microscopic examination of the liver and kidney.Based on the results, the NOAEL of repeated dose oral toxicity was 1000 mg/kg bw/dayin both sexes.

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