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EC number: -
CAS number: -
1: Irritant/corrosive response data for each animal at each observation
time up to removal of each animal from the test
Score at time point / Reversibility
Max. score: 2
Max. score: 1
Average 24h, 48h, 72h
Average time (unit) for reversion
Reversibility: c. = completely reversible;= not completely reversible;
n. = not reversible
were no deaths during the study.
Observations (Table 2):
slight to slight erythema and desquamation were noted for all animals.
Very slight edema was noted for three animals. All dermal irritation
Primary Irritation Index (PII) was calculated to be 1.4, using the 24-,
48- and 72 -hour observations. The test article received a descriptive
rating classification of slightly irritating.
ACUTE DERMAL IRRITATION STUDY IN ALBINO RABBITS INDIVIDUAL DERMAL SCORES
SITE A: 0.5 ML/SITE
PII calculated using test periods: 24h, 48h, 72 h
Primary Irritaton Index (PII) = [(7+7+6)/18] + [(3+1+1)/18]
(PII) = [20/18] + [5/18]
(PII) = 1.1 + 0.3
PII = 1.4 = SLIGHTLY IRRITATING
PII calculated using test periods: 24h, 72 h
Primary Irritaton Index (PII) = [(7+6)/12] + [(3+1)/12]
(PII) = [13/12] + [4/12]
H = HOURS
D = DAYS
F = FEMALE
M = MALE
d = DESQUAMATION
s = DOSE SITE STAINED YELLOW
- = DERMAL IRRITATION PREVIOUSLY SUBSIDED; ANIMAL TERMINED FROM STUDY
Weights (Table 3):
were no remarkable body weight changes during the study.
Acute Dermal Irritation Study in Albino Rabbits
Individual Body Weights (Grams)
2693 (Day 6)
2320 (Day 6)
2504 (Day 8)
2294 (Day 7)
2507 (Day 5)
2596 (Day 6)
M = Male
F = Female
The primary dermal irritation potential of the
test material was evaluated in this study with New Zealand White
rabbits. There was one group of six young adult albino rabbits that
received a single, four-hour, semioccluded exposure. Each 0.5 ml dose of
the test article was applied to the clipped, unabraded skin. At
completion of exposure, the bandages were removed and the sites washed.
Application sites were evaluated in accordance with the method of Draize
at approximately 30-60 minutes and 24,48 and 72 hours after patch
removal and daily through day 8, if irritation persisted. Very slight to
slight erythema and desquamation were noted for all animals. Very slight
edema was noted for three animals. All dermal irritation completely
subsided by day 8. The Primary Irritation Index (PII) was calculated to
be 1.4, using the 24-, 48- and 72 -hour observations. The calcium
sulfonate read across substance (CAS 70024 -69 -0) received a
descriptive rating classification of slightly irritating. The Primary
Irritation Index (PII) was 1.4 (24, 48 and 72 hours) and 1.4 (24 and 72
hours). This is however, not considered to be irritating taking into
account the classification criteria for skin irritation by the european
global harmonised system (a dermal irritant is a substance which causes
a primary irritation index of >2.3 < 4).
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