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EC number: 810-298-1
CAS number: 194934-66-2
Interpretation of Results
Calculation of Primary Irritation Index and Grading of Irritancy
Potential Using the Draize Scheme
The scores for erythema and edema at
the 24 and 72‑Hour readings were totaled for the two test rabbits (8
values) and this total was divided by 4 to give the primary irritation
index of the test item. The test item was classified according to the
following scheme devised by Draize, J.H. (1959):
Primary Irritation Index
Classification of Irritancy
> 0 to 2
> 2 to 5
> 5 to 8
If irreversible alteration of the
dermal tissue is noted in any rabbit, as judged by the Study Director,
which include ulceration and clear necrosis or signs of scar tissue, the
test item is classified as corrosive to rabbit skin. Classification
according to Draize may, therefore, not be applicable.
The results were also interpreted
according to theGlobally Harmonized Systemof Classification and
Labelling of Chemicals.
Table1 Individual Skin
ReactionsFollowing 3-Minute and 1-Hour Exposures
Observation Time(following patch removal)
Rabbit Number and Sex
D= Moderate desquamation
Table2 Individual Skin
Reactions Following 4-Hour Exposure
( 3 )
( 4 )
( 1 )
( 0 )
Sum of 24 and 72‑Hour Readings (S) : 11
Primary Irritation Index (S/4) : 11/4 = 2.8
Classification : MODERATEIRRITANT
( ) = Total values not
used for calculation of primary irritation index
D* = Slight desquamation
- = Not applicable
Table3 Individual and Mean
Scores for Skin Reactions Following 4-Hour Exposure
Individual Scores – Rabbit Number and Sex
+= Positive criterion
Globally Harmonized System of Classification and Labelling
Table4 Individual Body
Weights and Body Weight Change
Rabbit Numberand Sex
Individual Body Weight (kg)
Body Weight Change (kg)
The study was performed to assess the
irritancy potential of the test item following single, 3‑Minute, 1 and
4‑Hour, semi‑occluded applications to the intact rabbit skin.
3‑Minute and 1‑Hour semi-occluded
applications of the test item to the intact skin of one rabbit produced
well-defined erythema, very slight edema and moderate desquamation. Both
treated skin sites appeared normal at the 14‑Day observation.
A single 4‑Hour, semi occluded
application of the test item to the intact skin of two rabbits produced
well‑defined erythema and slight edema. Slight or moderate desquamation
was noted at the treated skin sites at the 7‑Day observation. One
treated skin site appeared normal at the 14‑Day observation. No
corrosive effects were noted.
item produced a primary irritation index of 2.8 and was
classified as a moderate irritant
to rabbit skin according to the Draize classification scheme. No
corrosive effects were noted.
test item was also classified as Category 3 (Mild irritant) according to
the Globally Harmonized System of Classification and Labelling of
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