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EC number: 290-140-0 | CAS number: 90082-51-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Pelargonium graveolens, Geraniaceae.
The test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) test, in accordance with OECD guideline 438 and GLP. In the ICE test, 3 eyes were exposed to 30 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL 5% Benzalkonium Chloride (BAC)) were tested. After the exposure, the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. Mean fluorescein retention score was determined at 30 minutes post-treatment. The test substance caused corneal effects consisting of slight corneal swelling (mean of 14%), moderate opacity (mean score of 2.0) and moderate fluorescein retention (mean score of 2.0). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with the test substance revealed slight erosion, moderate necrosis and very slight (2/3 corneas) or slight (1/3 corneas) vacuolation of the epithelium. In addition, basophilic spherical inclusions were observed in the superficial epithelial layer of the three corneas, and two corneas showed a focal wedge of necrotic cells up to the basement membrane. Currently, no criteria to interpreted the histopathological findings for this type of chemical exist. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. Microscopic examination of the corneas treated with the positive control BAC 5% generally revealed severe erosion and very slight vacuolation of the epithelium. Based on these results, the substance is considered to be an eye irritant.
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