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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.
The study was carried
out according to OECD guideline no. 405. Three rabbits were treated as
follows: One rabbit was treated first and two more aprox. one hour
later. An amount of 0.1 mL of the undiluted test substance was instilled
in the conjunctival cul-de-sac of one of the eyes of the rabbit. After
administration, the upper and the lower eye lid were carefully closed
and subsequently held together for at least one second before releasing
to prevent loss of material. The other eye remained untreated and served
as a control. The reactions of the eyes were judged at 1 h, 24 h, 48 h
and 72 h after treatment.
The only effects seen
were ocular discharge (score 1) in one rabbit at the 1 hour reading, and
slight redness with or without slight swelling of the conjunctivae
(score 1) in all rabbits at the examination at 1 hour and 24 hours after
exposure. However, these slight effects were cleared completely at the
following observations 48 and 72 hours after treatment. According to the
Globally Harmonised System of Classification and labelling of Chemicals
(GHS, UN/ECE 2003) alpha-amylase should not be classified as eye
The skin and eye irritation
potential of alpha-amylase has been tested according to OECD guidelines,
in compliance with GLP. The only reactions seen were transient skin
erythema and transient conjunctival redness with or without swelling in
the dosed rabbits. All reactions were mild, no scores were above 1 in
all rabbits. All effects in both irritation studies were totally cleared
at the 48h reading.
The conclusion was that
alpha-amylase is neither a skin nor an eye irritant.
skin and eye irritation potential of alpha-amylase has been tested
according to OECD guidelines, and in compliance with GLP. The conclusion
was that alpha-amylase
did not exert any significant skin and eye irritation.
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