Appendix - acceptable test guidelines for categorisation
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.
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- deleted and superseded OECD test guidelines if the study was done before the guideline was deleted or superseded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 - 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 | |
| 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 |
| 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 |
| Transformation in aquatic sediment systems | 308 | - |
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 | - |