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EC number: 942-466-6 | CAS number: -
Interpretation of Results
Classification According to a Modified Version of the Kay and Calandra System
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 opacity). 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, 1. SOC. Cosmet. Chem., 1962 13
281-289 was used to classify the ocular irritancy potential of the test material. 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 material. If any rabbit shows irreversible ocular damage the test material will be classified as corrosive to the eye.
Individual and group mean scores for ocular irritation are given. Dulling of the normal lustre of the cornea was noted in two treated eyes one hour after treatment. Diffuse corneal opacity was noted in all treated eyes at the 24 and 48-hour observations. Translucent corneal opacity was noted in one treated eye with diffuse corneal opacity in one other treated eye at the 72-hour observation.
Iridial inflammation was noted in all treated eyes one hour after treatment and at the 24-hour observation, in two treated eyes at the 48-hour observation and persisted in one treated eye at the 72-hour observation.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with severe conjunctival irritation in all treated eyes at the 24-hour observation. Severe conjunctival irritation was noted in one treated eye with moderate conjunctiva irritation in two treated eyes at the 48 and 72-hour observations. One animal was killed for humane reasons, immediately after the 72-hour observation, due to the severity of the reactions noted, in accordance with Safepharm company policy and current UK Home Office guidelines. The two remaining treated eyes appeared normal at the 7-day observation.
According to OECD Guideline 405, a study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit in compliance with GLP. Local eye effects were observed 1 h, 24 h, 48 h, 72 h and 7 d after test material application and evaluated by the method of Draize (1977) and by the modified Kay and Calandra classification system. A single instillation (0.1 mL) of phosphoric acid, mono- and di-(C8 -C10) ester, compds. with C12 -14 amine to the non-irrigated eye of three rabbits produced diffuse to translucent corneal opacity, iridial inflammation and severe conjunctival irritation. One animal was killed for humane reasons, immediately after the 72-hour observation. The remaining treated eyes appeared normal at the 7-day observation. The test material produced a maximum group mean score of 35.0 and was classified as at least a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material was also considered to be irritant according to EU labelling regulations. It is reasonable to assume that the symbol "Xi", the indication of danger "irritant" and the highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are therefore required.
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