Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area well-defined 2 by definite raising Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm 4 and extending beyond area of exposure) The Draize for evaluation of eye reactions is as follows: of iris slightly obscure 3 Opalescent areas, no details of iris Greater than 75% 4 moderate visible, size of pupil barely discernible Opaque, iris invisible 4 severe area around eye Any swelling above 1 normal slight Vessels definitely slight Obvious swelling with injected above normal Any amount different partial eversion of lids mod. from normal More diffuse, deeper mild slight Swelling with lids half- crimson red with Discharge with closed individual vessels not moistening of lids and easily discernible adjacent hairs mod. Swelling with lids half- severe mod. closed to completely Diffuse beefy red Discharge with closed moistening of lids and 4 severe hairs and considerable severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe FULL PUBLIC REPORT 2 November, 2000 2/26 NA/
Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area well-defined 2 by definite raising Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm 4 and extending beyond area of exposure) The Draize for evaluation of eye reactions is as follows: of iris slightly obscure Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 1 slight mod. severe Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half- closed Swelling with lids half- closed to completely closed slight mild mod. 4 severe Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye slight mod. severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe FULL PUBLIC REPORT 2 November, 2000 NA/ 2/26
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