User Guide to Thresholds and Classification - Environmental ...

More documents

Recommendations

Info

176User Guide for Thresholds and Classifications12. Eye Corrosion and Irritation – Subclass 6.4 (8.3)12.1. General considerations12.1.1. Eye corrosion or irritation overviewSee section 9.6 in chapter 9 for definitions of the key terms used in this chapter.Before there is any in vivo testing for eye corrosion or eye irritation, all existing information on a substanceshould be reviewed. Preliminary decisions can often be made from existing data as to whether a substancecauses corrosive (that is, irreversible) damage to the eyes. If, based on this information, a substance can beclassified, no testing is required. A highly recommended way of evaluating information on existingsubstances or of approaching new uninvestigated substances is to use a tiered testing strategy for eyecorrosion and eye irritation.Several factors should be considered in determining the eye corrosive or irritation potential of a substancebefore testing is undertaken. Accumulated human and animal experience should be analysed first, as it givesinformation directly relevant to effects on the eye. In some cases, enough information may be available fromstructurally related compounds to classify the substance. Likewise, pH extremes (≤ 2 and ≥ 11.5), mayproduce eye corrosion, especially when associated with significant buffering capacity. Such substances areexpected to produce significant effects on the eyes. Possible skin corrosion must be evaluated before eyecorrosion or irritation is considered in order to avoid testing for local effects on eyes with skin corrosivesubstances. In vitro alternatives that have been validated and accepted may be used to make classificationdecisions.Although information might be gained from the evaluation of single parameters within a tier (for example,caustic alkalis with extreme pH should be considered as local corrosives), there is merit in considering thetotality of existing information and making an overall weight-of-evidence determination. This is especially truewhen there is information available on only some parameters. Generally, primary emphasis should be placedon expert judgement, considering human experience with the substance, followed by the outcome of skinirritation testing and well-validated alternative methods. Animal testing with corrosive substances should beavoided whenever possible.A tiered approach to the evaluation of initial information should be considered where applicable (Table 12.1),recognising that all elements may not be relevant in certain cases. The tiered testing approach providesgood guidance on how to organise existing information on a test material and to make a weight-of-evidencedecision about hazard assessment and hazard classification – ideally, without conducting new animal tests.Table 12.1: Testing and evaluation strategy for eye corrosivity and eye irritationStep Parameter Findings Conclusions1aData relating to historical humanor animal experienceEye corrosiveCategory 8.3AEye irritantCategory 6.4AJanuary 2012 EPA0109
177User Guide for Thresholds and ClassificationsStep Parameter Findings ConclusionsNo or don‘t know1bData relating to historical humanor animal experienceSkin corrosiveNo evaluation of effects on eyes;deemed to be Category 8.3ANo or don‘t know1cData relating to historical humanor animal experienceSkin irritantNo evaluation of effects on eyes;deemed to be Category 6.4ANo or don‘t know2aStructure activity relationships/structure property relationships(SARs/SPRs)Eye corrosive Category 8.3ANo or don‘t know2bSARs/SPRsEye irritantNo evaluation of effects on eyes;deemed to be Category 6.4ANo or don‘t know2cSARs/SPRsSkin corrosiveNo evaluation of effects on eyes;deemed to be category 8.3ANo or don‘t know3a pH/acid or alkaline reserve pH 11.5 or pH 2(considering acid oralkaline reserve)Category 8.3A3b 2 < pH < 11.5(no buffering potential)4 Other information indicating the materialis a skin corrosiveYesNo evaluation of effects on eyes;deemed to be category 8.3AJanuary 2012 EPA0109
Page 1 and 2:
Thresholds and ClassificationsUnder
Page 3 and 4:
3User Guide for Thresholds and Clas
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
11User Guide for Thresholds and Cla
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
100User Guide for Thresholds and Cl
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127: 126User Guide for Thresholds and Cl
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
Page 232 and 233:
Page 234 and 235:
Page 236 and 237:
Page 238 and 239:
Page 240 and 241:
Page 242 and 243:
Page 244 and 245:
Page 246 and 247:
Page 248 and 249:
Page 250 and 251:
Page 252 and 253:
Page 254 and 255:
Page 256 and 257:
Page 258 and 259:
Page 260 and 261:
Page 262 and 263:
Page 264 and 265:
Page 266 and 267:
Page 268 and 269:
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
Page 298 and 299:
Page 300 and 301:
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
Page 308 and 309:
Page 310 and 311:
Page 312 and 313:
Page 314 and 315:
Page 316 and 317:
Page 318 and 319:
Page 320 and 321:
Page 322 and 323:
Page 324 and 325:
Page 326 and 327:
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438:
BP House, (Level 1), 20 Customhouse
show all

User Guide to Thresholds and Classification - Environmental ...

Create successful ePaper yourself

Delete template?

Save as template?