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EC number: 950-480-9
CAS number: -
Clinical Signs as Observed on Day
NAD - No abnormality detected
Day 1 is the day of application
INITIAL TEST ON ONE ANIMAL
Application Site / Patch
immediately after patch removal
Mean Score :
(E + Oe) / 3
Primary Irritancy Index (highest mean score) : 0.00
Clarification of Irritancy as per Draize (1959) : Non-irritant
0: No Erythema/Oedema * Time after patch
removal E -
Erythema Oe – Oedema
Testing of ALGIFERT
K+ for its acute
irritation / corrosion potential in the rabbit skin was performed in
compliance with the Organization for Economic Cooperation and
Development (OECD) Guidelines for Testing of Chemicals, Section 4,N°404
- Acute Dermal Irritation / Corrosion study, adopted 24th April 2002.
This test was performed in accordance with the sequential testing
strategy recommended in this OECD Test Guideline. Three
test patches were applied sequentially to the animal tested in theinitialin
vivotest. The first patch was removed after three
minutes. Because no skin reaction was observed a second patch was
applied at a different site and removed after one hour. As the
observations at this stage indicated that exposure could be humanely
allowed to extend to four hours, a third patch was applied and removed
after four hours, and the response was graded. The response observed in
the initial test was confirmed using two additional animals, each with
one patch, for an exposure period of four hours. The test article in the
amount ofwas pulverised andmoistened
to the clipped intact dorsal skin of the rabbits and the test site was
covered with a gauze patch (approx. 6 cm2). At end of the
designated exposure period of four hours, the patches were removed and
skin reaction was evaluated immediately (initial test) and after 1, 24,
48 and 72 hours. Skin reaction scores were allotted according to the
OECD test guideline. Animals were observed for abnormal clinical signs
throughout the Test period. Body weights were recorded on the day of
treatment and at the termination of the study.
During the initial single animal and
confirmatory tests, ALGIFERT K+ did not cause any skin reaction,
as observed at 1, 24, 48 and 72 hours after the patch removal. The
primary irritancy indexdetermined from the scores of the
observed to be Zero (0.00).
Based on the ‘primary irritation index’of
0.00 observedin this study, and as
defined in the criteria for evaluation,ALGIFERT K+is classified asaNon-irritantto
skin of rabbit.
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