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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.

On this page:

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  • deleted and superseded OECD test guidelines if the study was done before the guideline was deleted or superseded 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 -

 

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