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EC number: 915-790-0
CAS number: -
Table 1: 3-minute exposure – Individual cutaneous examinations and
mean values of the scores recorded for the first animal (24, 48 and 72
Mean irritation score (1)
1h – D1
24h – D2
48h – D3
72h – D4
scores on days 2, 3 and 4
h = hour; D = day; * = none
Table 2: 4-hour exposure – Individual cutaneous examinations and
mean values of the scores recorded for each animal (24, 48 and 72 hours).
S = dryness of the skin
C = yellow coloration of the skin
N = necrosis
A = crust
LS = scoring masked by dryness of the skin
LA: scoring masked by the crust
- : cutaneous examination not performed
The potential of the test item to induce skin irritation was evaluated
in rabbits according to OECD (No. 404, 17th July 1992) and EC
(92/69/EEC, B.4, 31st July 1992) guidelines.The study was conducted in
compliance with the principles of Good Laboratory Practice Regulations.
In the first instance, the test item was applied for periods of 3
minutes and 4 hours to a single male New Zealand White rabbit. Since the
test item was not corrosive on this first animal, it was then applied
for 4 hours to two other animals.
A single dose of 0.5 mL of the undiluted test item was applied to the
closely-clipped skin of one flank.
The test item was held in contact with the skin by means of a
Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72
hours after removal of the dressing and then daily until the end of the
observation period. The mean values of the scores for erythema and
oedema were calculated for each animal.
After a 3-minute exposure (one animal):
A very slight to moderate erythema was observed, from day 1 up to the
end of the observation period (day 15). A slight oedema was noted on
days 4 and 5. Dryness of the skin, sometimes together with crusts, was
recorded between day 6 and day 15.
After a 4-hour exposure (three animals):
A well-defined to severe erythema was observed in all animals from day
1; it persisted up to day 5, 9 or up to the end of the observation
period (day 15).
A slight oedema was noted in all animals, from day 1 (one animal) or day
2 (two animals) up to day 5 (one animal) or 6 (two animals).
Other cutaneous reactions, including dryness of the skin and crusts,
were recorded in all animals during the study. A superficial and rapidly
reversible necrosis was observed in 2/3 animals on day 4 or 5.
A yellow coloration of the skin was noted in 2/3 animals.
Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.3 and
3.0 for erythema and 2.0, 2.0 and 2.0 for oedema.
Under these experimental conditions, the test item should be considered
as severely irritant when applied topically to rabbits. However by a
conservative approach a classification as corrosive cat. 1C. is proposed.
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