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EC number: 200-001-8
CAS number: 50-00-0
In a reliable GLP-conform study similar to OECD TG 453, a combined chronic toxicity/carcinogenicity study, 70 male and 70 female Wistar rats per dose (subgroups of 10 rats/sex/dose killed 12 or 18 months after start of exposure) received via the drinking water 0, 1.2, 15, 82 mg/kg bw/day (males) or 0, 1.8, 21, 109 mg/kg bw/day (females) for 105 weeks (concentration: 0, 20, 260, or 1900 mg/L or 0, 0.002, 0.026, 0.19%).
At the high dose body weight gain was decreased in males & females and food and water consumption decreased. Other parameters (except pathology) were not altered.Pathological alterations in the kidney like the renal papillary necrosis detected in high dose males and females is discussed as an effect of the reduced water intake and is indirectly treatment related. Treatment related lesions were detected in the forestomach (focal papillary epithelial hyperplasia, ulceration and hyperkeratosis) and the glandular stomach (chronic atrophic gastritis, ulceration and hyperplasia) of males and females in the high dose group. No gastric tumours were induced. This study did not provide any evidence of carcinogenicity in rats after oral administration of formaldehyde.
Oral exposure via the drinking water induced local effects in the stomach of rats at a concentration of 0.19% corresponding to 82 mg/kg bw/d in males and 109 mg/kg bw/d in females; the NOAEC is 0.026% corresponding to 15 mg/kg bw/d in males and 21 mg/kg bw/d in females.
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