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EC number: 231-843-4
CAS number: 7758-94-3
In a well conducted and documented skin irritation study (reliability
score 1) conducted to OECD 404 and GLP, a single dose of 500 mg ferrous
sulfate (moistened with water) was applied to the clipped skin (6cm2 on
flank) of three male New Zealand white rabbits. The test substance was
held in contact with the skin by means of a semi-occlusive dressing for
four hours. Cutaneous reactions were recorded at 1, 24, 48 and 72 hours
after removal of the dressing, and then daily until day 14 in order to
observe the reversibility of the reactions. Residual test substance was
removed by means of a dry compress. The mean score for erythema and
oedema were recorded for each animal using 24, 48 and 72 hours values.
Very slight or well-defined cutaneous reactions were observed after
application of the test substance during 3 minutes and 1 hour. Severe
cutaneous reactions were observed after application of the test
substance during 4 hours. No necrosis or ulceration of the skin was
observed. All lesions were reversible before the end of the 14-day
observation period. It was concluded that ferrous sulfate was irritating
to the skin.
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