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 1 Very slight oedema (barely 1 perceptible) perceptible) Well-defined erythema 2 Slight oedema (edges of area 2 well-defined by definite raising Moderate to severe erythema 3 Moderate oedema (raised 3 approx. 1 mm) Severe erythema (beet redness) 4 Severe oedema (raised more 4 than 1 mm and extending beyond area of exposure) The Draize 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 slight 25% to 50% 2 clearly visible Easily visible translucent areas, 2 mild 50% to 75% 3 details of iris slightly obscure Opalescent areas, no details of 3 iris visible, size of pupil barely Greater than 75% 4 moderate discernible Opaque, iris invisible 4 severe normal injected above slight different from Obvious swelling normal normal with partial mod. mild eversion of lids More diffuse, deeper Discharge with 2 mod. crimson red with moistening of lids Swelling with lids individual vessels and adjacent hairs half-closed mod. not easily 3 Discharge with discernible 3 Swelling with lids severe moistening of lids severe half-closed to 4 Diffuse beefy red and hairs and completely closed severe considerable area around eye 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 1 perceptible) Well-defined erythema 2 Slight oedema (edges of area 2 well-defined by definite raising Moderate to severe erythema 3 Moderate oedema (raised 3 approx. 1 mm) Severe erythema (beet redness) 4 Severe oedema (raised more 4 than 1 mm and extending beyond area of exposure) The Draize 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 Easily visible translucent areas, details of iris slightly obscure slight 25% to 50% 2 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 injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red slight mod. 3 severe normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed mild mod. 4 severe different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 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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