ABSTRACT
Bridging Principles .......................................................260 16.1.9 Classication of Mixtures Based on Ingredients
(Additivity Equation) .....................................................................260 16.1.9.1 Data Available for All Ingredients-ATE Equation .....260 16.1.9.2 Data Are Not Available for All Components ................ 261 16.1.9.3 Ingredient without Any Useable Information-
Unknown Equation ....................................................... 261 16.1.10 OSHA and CLP Label Requirements ............................................ 262
16.2 Skin Corrosion/Irritation .............................................................................. 262 16.2.1 Highly Toxic by Dermal Route ...................................................... 262 16.2.2 Corrosive Subcategories................................................................. 262 16.2.3 Corrosion and Irritation Potential .................................................. 262 16.2.4 In Vivo Skin Irritation Testing ....................................................... 272 16.2.5 Skin Corrosive Category and Subcategories: Category 1-
Corrosive ........................................................................................ 272 16.2.6 Skin Irritation Category 2-Irritant .............................................. 273 16.2.7 Animal Responses ......................................................................... 273
16.2.7.1 Classication Criteria for Substances Using Other Data Elements ............................................................... 273
16.2.7.2 Tiered Approach ............................................................ 274 16.2.8 Mixtures ......................................................................................... 274
16.2.8.1 Data Available for Complete Mixture ........................... 274 16.2.8.2 Data Not Available for Complete Mixture Bridging
Principles ....................................................................... 274 16.2.8.3 Data Are Available for All or Some Mixture
Components ................................................................... 275 16.2.8.4 Affects Occur at <1% .................................................... 276 16.2.8.5 Generic Concentration Limits ....................................... 276 16.2.8.6 Additivity Approach Not Usable ................................... 278
16.2.9 Label Requirements ....................................................................... 278 16.3 Serious Eye Damage/Eye Irritation .............................................................. 278
16.3.1 Irreversible Effects on the Eye/ Serious Damage to Eyes (Category 1) .................................................................................... 281
16.3.2 Reversible Effects on the Eye......................................................... 282 16.3.3 Classication Criteria for Substances Using Other Data Elements ... 282 16.3.4 Tiered Approach ............................................................................ 283 16.3.5 Mixtures ......................................................................................... 283
16.3.5.1 Data Available for Complete Mixture ........................... 283 16.3.5.2 Data Not Available for Complete Mixture:
Bridging Principles ....................................................... 283 16.3.5.3 Data Are Available for All or Some Mixture
Components ...................................................................284 16.3.5.4 Affects Occur at <1% ....................................................284 16.3.5.5 Generic Concentration Limits .......................................284
