Appendix - acceptable test guidelines for categorisation
The acceptable test guidelines for each hazard characteristic and property are set out in the tables below. They include:
- current Organisation for Economic Cooperation and Development (OECD) test guidelines (and their adopted versions if the version shown in the table below is only a draft version)
- deleted and superseded OECD test guidelines if the study was done before the guideline was deleted or superseded
- US EPA OPPT (Office of Prevention, Pesticides and Toxic Substances) test guidelines
- US EPA OCSPP (Office of Chemical Safety and Pollution Prevention) Harmonised Test Guidelines
- test methods for EU REACH, set out in Council Regulation (EC) No 440/2008 (Test Methods Regulation).
Acceptable test guidelines for human health hazard characteristics
| Hazard tested | OECD test guidelines | Equivalent test guidelines |
|---|---|---|
| Acute dermal toxicity – in vivo | 402 or draft 434 | EU Annex V test method B.3 OCSPP 870.1200, OPPT 798.110, OPP 81-2 |
| Acute inhalation toxicity – in vivo | 403 or 436 or draft 433 | EU Annex V test methods B.2 or B.52 OCSPP 870.1300, OPPT 798.1150, OPP 81-3 |
| Acute oral toxicity – in vivo | 420, 423, 425 or deleted 401 | EU Annex V test methods B.1, B.1 bis, B.1 tris OCSPP 870.1100, OPPT 798.1175, OPP 81-1 |
| Acute oral toxicity – in vitro | 1291 | - |
| Carcinogenicity – in vivo | 451 | EU Annex V test method B.32 OCSPP 870.4200, OPPT 798.3300, OPP 83-2 |
| 453 | EU Annex V test method B.33 OCSPP 870.4300, OPPT 798.3320, OPP 83-5 | |
| Chromosomal abnormalities – in vivo | 474 | EU Annex V test method B.12 OCSPP 870.5395, OPPT 798.5395, OPP 84-2 |
| 475 | EU Annex V test method B.11 OCSPP 870.5385, OPPT 798.5385, OPP 84-2 | |
| Chromosomal abnormalities – in vitro | 474 | EU Annex V test method B.12 OCSPP 870.5395, OPPT 798.5395, OPP 84-2 |
| 475 | EU Annex V test method B.11 OCSPP 870.5385, OPPT 798.5385, OPP 84-2 | |
| Chromosomal abnormalities – in vitro | 473 | EU Annex V test method B.10 OCSPP 870.5375, OPPT 798.5375, OPP 84-2 |
| 487 | EU Annex V test method B.49 | |
| 490 | - | |
| Chronic toxicity – in vivo | 452 | EU Annex V test method B.30 OCSPP 870.4100, OPPT 798.3260, OPP 83-1 |
| 453 | EU Annex V test method B.33 OCSPP 870.4300, OPPT 798.3320, OPP 83-5 | |
| Developmental toxicity – in vivo | 414 | EU Annex V test method B.31 OCSPP 870.3700, OPPT 798.4900 or OPP 83-3 |
| 426 | OCSPP 870.6300, OPP 83-6 | |
| 4222 | OCSPP 870.36502 | |
| Eye damage – in vitro | 437 | EU Annex V test method B.47 EURL ECVAM DB-ALM protocols No. 98 and 124 |
| 438 | EU Annex V test method B.48 EURL ECVAM DB-ALM protocol No. 80 | |
| 460 | EURL ECVAM DB-ALM protocol No. 71 | |
| 491 | - | |
| 494 | - | |
| Eye irritation – in vitro | 492 | - |
| Eye irritation – in vivo | 405 | EU Annex V test methods B.5 OCSPP 870.2400, OPPT 798.4500 or OPP 81-4 |
| Gene mutation – in vivo | 486 | EU Annex V test method B.39 |
| 488 | EU Annex V test method B.58 | |
| 489 | - | |
| Gene mutation – in vitro | 471 | EU Annex V test methods B.13 and B.14 OCSPP 870.5100, OPPT 798.5100, OPPT 798.5265, OPP 84-2 |
| 476 | EU Annex V test method B.17 OCSPP 870.5300, OPPT 798.5300, OPP 84-2 | |
| Heritable germ cell mutagenicity – in vivo | 478 | EU Annex V test method B.22 OPPT 798.5450, 870.5450 |
| 485 | EU Annex V test method B.25 OPPT 798.5460, 870.5460 | |
| Reproductive toxicity – in vivo | 421 | OCSPP 870.3550 |
| 4223 | OCSPP 870.36503 | |
| 443 | EU Annex V test method B.56 | |
| 415 | EU Annex V test method B.34 | |
| 416 | EU Annex V test method B.35 OCSPP 870.3800, OPPT 798.4700 or OPP 83-4 | |
| Skin corrosion – in vitro | 430 | EU Annex V test method B.43 EURL ECVAM DB-ALM protocol No.115 |
| 431 | EU Annex V test method B.40 EURL ECVAM DB-ALM protocols No.118 and 119 | |
| 435 | EURL ECVAM DB-ALM protocol No.116 | |
| Skin irritation – in vitro | 439 | EU Annex V test method B.46 EURL ECVAM DB-ALM protocols No.131, 135 and 138 |
| Skin irritation – in vivo | 404 | EU Annex V test method B.4. OCSPP 870.2500, OPPT 798.4470, OPP 81-5 |
| Skin sensitisation - defined approach | 497 | - |
| Skin sensitisation – in chemico (1st key event in skin sensitisation) | 442C | EU Annex V test methods B.59 EURL ECVAM DB-ALM protocol No.154 |
| Skin sensitisation – in vitro (2nd key event in skin sensitisation) | 442D | EU Annex V test method B.60 EURL ECVAM DB-ALM protocol No.155 |
| Skin sensitisation – in vitro (3rd key event in skin sensitisation) | 442E | EURL ECVAM DB-ALM protocol No.158 |
| Skin sensitisation – in vivo | 406 | EU Annex V test method B.6 OCSPP 870.2600, OPPT 798.4100 or OPP 81-6 |
| 429 | EU Annex V test method B.42 | |
| 442A | EU Annex V test method B.50 | |
| 442B | EU Annex V test method B.51 | |
| Subacute dermal toxicity – in vivo | 410 | EU Annex V test method B.9 OCSPP 870.3200 or OPP 82-2 |
| Subacute inhalation toxicity – in vivo | 412 | EU Annex V test method B.8 |
| Subacute oral toxicity – in vivo | 407 | EU Annex V test method B.7 OCSPP 870.3050 |
| Subchronic dermal toxicity – in vivo | 411 | EU Annex V test method B.28 OCSPP 870.3250, OPPT 798.2250, OPP 82-3 |
| Subchronic inhalation toxicity – in vivo | 413 | EU Annex V test method B.29 OCSPP 870.3465, OPPT 798.2450, OPP 82-4 |
| Subchronic oral toxicity – in vivo | 408 | EU Annex V test method B.26 OCSPP 870.3100, OPPT 798.2650, OPP 82-1 |
| 409 | EU Annex V test method B.27 OCSPP 870.3150, OPP 82-1 |
1 – OECD Environment, Health and Safety Publications Series on Testing and Assessment No. 129, Guidance Document on Using Cytotoxicity Tests To Estimate Starting Doses For Acute Oral Systemic Toxicity Tests (2010)
2 – Only for the purposes of the definition of 'developmental toxicity'.
3 – Only for the purposes of the definition of 'reproductive toxicity'.
Acceptable test guidelines for environment hazard characteristics and properties
| Hazard or property tested | OECD test guidelines | Equivalent test guidelines |
|---|---|---|
| Acute aquatic toxicity – in vivo (fish) | 203 | ISO 10229 EU Annex V test method C.1 OCSPP 850.1075, OPP 72-1, OPP 72-3 |
| Acute aquatic toxicity – in vivo (invertebrates) | 202 | ISO 6341 EU Annex V test method C. 2 OCSPP 850.1010 or OPP 72-2 |
| Acute aquatic toxicity – in vivo (algae or other aquatic plants) | 201 | EU Annex V test methods C.3 OCSPP 850.4550, OPPT 797.1050, OPP 122-2, OPP 123-2 |
| Bioaccumulation | 315 | OCSPP 850.1710 |
| 317 | - | |
| Bioconcentration | 305 | EU Annex V test methods C.13 OCSPP 850.1730 or OPP 72-6 |
| Chronic aquatic toxicity – in vivo (fish) | 210 | OCSPP 850.1400 EU Annex V test method C.15 |
| Chronic aquatic toxicity – in vivo (invertebrates) | 211 | OCSPP 850.1300 EU Annex V test method C.20 |
| Chronic aquatic toxicity – in vivo (algae or other aquatic plants) | 201 | OCSPP 850.4550 OCSPP 850.4500 EU Annex V test method C.3 |
| Partition coefficient | 107 | EU Annex V test methods A.8 OCSPP 830.7550, OPPT 796.1550, OPP 63-11 |
| 117 | EU Annex V test methods A.8 OCSPP 830.7570, OPPT 796.1570, OPP 63-11 | |
| 123 | EU Annex V test methods A.8 | |
| Ready biodegradability | 301 | U Annex V test methods C.4 (A-F) OCSPP 835.3110, OPPT 796.3180, 796.3200, 796.3220, 796.3240, 796.3260 |
| 310 | OPPTS 835.3140 | |
| Transformation in aquatic sediment systems | 308 | OPP 162-3, 162-4- |
Acceptable test guidelines for water solubility
| Property tested | OECD test guidelines | Equivalent test guidelines |
|---|---|---|
| Water solubility – chemicals or polymers | 105 | OPPTS 830.7840 OPPTS 830.7860 |
| Water solubility - polymers | 120 | - |
Information on this page will help you complete steps 4.4 and 5.4 in working out what the human health characteristics and environment hazard characteristics of your introduction are.