Yellow staining of the treated skin by the test substance was observed. Very slight erythema was observed in 2/10 animals and slight oedema in one animal at the end of 60 mins. The skin irritation was reversed within 24 hours after exposure in all three animals. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. The results of this test indicate that PF-310 is not a skin irritant. Eye Irritation (4) The test was conducted in accordance with OECD Guidelines for Testing of Chemicals No 405 One hundred milligrams of PF-310 was instilled into the conjunctival sac of one eye of three New Zealand strain albino rabbits. The other eye served as the control. The eyes of each animal were examined 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation of the test substance. After the 24 hr observation a solution of 2% fluorescein was instilled into both eyes to quantitatively determine corneal epithelial damage. This procedure was repeated in all the animals on days 4, 8, 15 and 22. At the end of 1 hr congestion, swelling and circumcorneal hyperaemia were observed in the iris of all three rabbits. PF- 310 also caused redness and chemosis of the conjunctivae of the three rabbits. The injection of the iris was reversed within 21 days after instillation in 2/3 rabbits. The three animals showed translucent corneal opacity and neovascularisation, diffuse beefy redness of the conjunctivae and some discharge on day 22. Treatment of the eyes with 2% fluorescein revealed corneal epithelial damage in all three animals. No systemic symptoms were observed in the animals and no mortality occurred. The results of this test indicate that PF-310 is corrosive to the eye. Skin Sensitisation (5) This study was carried out in accordance with the OECD Guidelines for the Testing of Chemicals No 406.
Yellow staining of the treated skin by the test substance was observed. Very slight erythema was observed in 2/10 animals and slight oedema in one animal at the end of 60 mins. The skin irritation was reversed within 24 hours after exposure in all three animals. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. The results of this test indicate that PF-310 is not a skin irritant. Eye Irritation (4) The test was conducted in accordance with OECD Guidelines for Testing of Chemicals No 405 One hundred milligrams of PF-310 was instilled into the conjunctival sac of one eye of three New Zealand strain albino rabbits. The other eye served as the control. The eyes of each animal were examined 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation of the test substance. After the 24 hr observation a solution of 2% fluorescein was instilled into both eyes to quantitatively determine corneal epithelial damage. This procedure was repeated in all the animals on days 4, 8, 15 and 22. At the end of 1 hr congestion, swelling and circumcorneal hyperaemia were observed in the iris of all three rabbits. PF- 310 also caused redness and chemosis of the conjunctivae of the three rabbits. The injection of the iris was reversed within 21 days after instillation in 2/3 rabbits. The three animals showed translucent corneal opacity and neovascularisation, diffuse beefy redness of the conjunctivae and some discharge on day 22. Treatment of the eyes with 2% fluorescein revealed corneal epithelial damage in all three animals. No systemic symptoms were observed in the animals and no mortality occurred. The results of this test indicate that PF-310 is corrosive to the eye. Skin Sensitisation (5) This study was carried out in accordance with the OECD Guidelines for the Testing of Chemicals No 406.
NA136FR.docx