Time Animal No. treatment 1 2 3 4 5 6 7 8 (days) Erythema 1 1 0 0 0 0 0 0 0 2 0 1 0 0 0 0 0 0 3 1 0 0 0 0 0 0 0 Oedema 1 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 a see Attachment 1 for Draize scales The experimental SS produced only marginal effects, and was similar in Comment: irritancy to analogues. SS was slightly irritating to the skin of rabbits Result: Eye Irritation Eye irritation with FA (Younger Laboratories, 1968b) New Zealand White rabbit Species/strain: 3 (2 males, 1 female) Number/sex of animals: 1 to 7 days after treatment Observation period: 100 mg of finely ground FA powder were placed into the Method of administration: conjunctival sac of the right eye of each rabbit. The eyes were examined for signs of irritation after 1, 24, 48, 72, 120 and 168 hours. The treated eyes were rinsed with warm isotonic saline 24 hours after treatment later. After the reading, fluorescein (concentration not stated) was instilled to detect corneal damage. Not stated Test method: Treated eyes were graded according to the severity of erythema, oedema, Comment: discharge, corneal opacity and iridial reactions on an arbitrary scale of 0 to 110. Moderate discharge and erythema, mild oedema and mild corneal cloudiness developed in all treated eyes after 1 hour. Iris clarity improved overnight and discharge had nearly ceased within 3 days. A slight degree of redness and oedema remained after 7 days.
Time Animal No. treatment (days) 1 2 3 4 5 6 7 8 Erythema 1 1 0 0 0 0 0 0 0 2 0 1 0 0 0 0 0 0 3 1 0 0 0 0 0 0 0 Oedema 1 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 a see Attachment 1 for Draize scales Comment: The experimental SS produced only marginal effects, and was similar in irritancy to analogues. Result: SS was slightly irritating to the skin of rabbits Eye Irritation Eye irritation with FA (Younger Laboratories, 1968b) Species/strain: New Zealand White rabbit Number/sex of animals: 3 (2 males, 1 female) Observation period: 1 to 7 days after treatment Method of administration: 100 mg of finely ground FA powder were placed into the conjunctival sac of the right eye of each rabbit. The eyes were examined for signs of irritation after 1, 24, 48, 72, 120 and 168 hours. The treated eyes were rinsed with warm isotonic saline 24 hours after treatment later. After the reading, fluorescein (concentration not stated) was instilled to detect corneal damage. Test method: Not stated Comment: Treated eyes were graded according to the severity of erythema, oedema, discharge, corneal opacity and iridial reactions on an arbitrary scale of 0 to 110. Moderate discharge and erythema, mild oedema and mild corneal cloudiness developed in all treated eyes after 1 hour. Iris clarity improved overnight and discharge had nearly ceased within 3 days. A slight degree of redness and oedema remained after 7 days.
NA857FR.docx