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EC number: 232-565-6
CAS number: 9000-90-2
The acute dermal irritant effect of alpha-amylase was investigated
according to the method recommended in the OECD Guideline No 404, “Acute
Dermal Irritation/Corrosion”. The study was conducted in accordance with
The study was performed on three male New Zealand White rabbits.
They were each exposed to 0.5 mL of the undiluted liquid test item
applied under semiocclusive conditions to each of three closely-clipped
test sites, 2.5 x 2.5 cm, on the flank. After a 4 -hour exposure period,
the test item was removed from the test site and the skin was examined.
Only very slight erythema was noted at 1 h and 24 h after removal of the
test material, whereas eschar formation or oedema was not observed at
any of the test sites at any of the examinations. All reactions were
fully reversible and no erythema was observed at the test or control
sites of any of the animals at the examinations at 48 or 72 hours after
termination of exposure.
The Test Item Mean Score for erythema after 4hrs of exposure to
the test item was: 0.3
The Test Item Mean Score for oedema after 4hrs of exposure to the
test item was: 0.0
In conclusion, alpha-amylase was not irritating to skin and shall
be classified as non-irritant.
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