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 scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly 1 slight 25% to 50% 2 visible Easily visible translucent details of 2 mild 50% to 75% 3 iris slightly obscure Opalescent areas, no details of iris 3 Greater than 75% 4 visible, size of pupil barely discernible moderate Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal 0 none No swelling 0 none No discharge 0 none Vessels definitely 1 Any swelling above 1 slight Any amount different 1 slight injected above normal slight normal from normal 2 mild More diffuse, deeper 2 mod. Obvious swelling with Discharge with 2 mod. 3 mod. crimson red with partial eversion of lids moistening of lids and 3 severe 3 severe individual vessels not adjacent hairs 4 severe Swelling with lids easily discernible Discharge with Diffuse beefy red moistening of lids and Swelling with lids hairs and considerable to completely area around eye closed 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
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 by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids Swelling with lids to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge 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 0 none 1 slight 2 mod. 3 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
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