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EC number: - | CAS number: -
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2 Score for iris = D x 5 Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem.13, 281‑289 (see Appendix 3) was used to classify the ocular irritancy potential of the test item. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test item.
If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.
Table 1 Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex
IPR = 2
Time After Treatment
E = Degree of Opacity
F = Area of Cornea Involved
Score (E x F) x 5
Score (D x 5)
A = Redness
B = Chemosis
C = Discharge
Score (A + B + C) x 2
IPR= Initial pain reaction
Table 2 Individual Total Scores and Group Mean Scores for Ocular Irritation
Individual Total Scores At:
Group Mean Score
Table 3 Individual Bodyweights and Bodyweight Changes
Rabbit Numberand Sex
Individual Bodyweight (kg)
Bodyweight Change (kg)
Introduction. The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed tobe compatible with thefollowing:
OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008
Result. A single application of the test item to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48‑Hour observation and one treated eye appeared normal at the 72‑Hour observation.
Conclusion. The test item produced a maximum group mean score of 5.3 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test item did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.
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