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EC number: 200-001-8
CAS number: 50-00-0
Incidence of lesions in the forestomach and glandular stomach of rats
Type of lesion
Males, dose in mg/kg bw/d
Females, dose in mg/kg bw/d
Number of rats examined
Focal papillary epithelial hyperplasia
Chronic atrophic gastritis
*** : p<0.001
The study is comparable to OECD Guideline 453.
In 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 (see Section 7.7).
Conclusion: 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
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