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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.

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  • deleted and superseded OECD test guidelines if the study was done before the guideline was deleted or superseded 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 testedOECD test guidelinesEquivalent test guidelines
Acute dermal toxicity – in vivo402 or draft 434

EU Annex V test method B.3

OCSPP 870.1200, OPPT 798.110, OPP 81-2

Acute inhalation toxicity – in vivo403 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 vivo420, 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 vitro1291-
Carcinogenicity – in vivo451

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 vivo474

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 vitro474    

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 vitro473

EU Annex V test method B.10

OCSPP 870.5375, OPPT 798.5375, OPP 84-2

 487EU Annex V test method B.49
 490-
Chronic toxicity – in vivo452

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 vivo414

EU Annex V test method B.31

OCSPP 870.3700, OPPT 798.4900 or OPP 83-3

 426OCSPP 870.6300, OPP 83-6
 4222OCSPP 870.36502
Eye damage – in vitro437

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

 460EURL ECVAM DB-ALM protocol No. 71
 491-
 494-
Eye irritation – in vitro 492-
Eye irritation – in vivo405

EU Annex V test methods B.5

OCSPP 870.2400, OPPT 798.4500 or OPP 81-4

Gene mutation – in vivo486EU Annex V test method B.39
 488EU Annex V test method B.58
 489-
Gene mutation – in vitro471

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 vivo421OCSPP 870.3550
 4223OCSPP 870.36503
 443EU Annex V test method B.56
 415EU 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 vitro430

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

 435EURL ECVAM DB-ALM protocol No.116
Skin irritation – in vitro439

EU Annex V test method B.46

EURL ECVAM DB-ALM protocols No.131, 135 and 138

Skin irritation – in vivo404

EU Annex V test method B.4.

OCSPP 870.2500, OPPT 798.4470, OPP 81-5

Skin sensitisation - defined approach497-
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)442EEURL ECVAM DB-ALM protocol No.158
Skin sensitisation – in vivo406

EU Annex V test method B.6

OCSPP 870.2600, OPPT 798.4100 or OPP 81-6

 429EU Annex V test method B.42
 442AEU Annex V test method B.50
 442BEU Annex V test method B.51
Subacute dermal toxicity – in vivo410

EU Annex V test method B.9

OCSPP 870.3200 or OPP 82-2

Subacute inhalation toxicity – in vivo412EU Annex V test method B.8
Subacute oral toxicity – in vivo407

EU Annex V test method B.7

OCSPP 870.3050

Subchronic dermal toxicity – in vivo411

EU Annex V test method B.28

OCSPP 870.3250, OPPT 798.2250, OPP 82-3

Subchronic inhalation toxicity – in vivo413

EU Annex V test method B.29

OCSPP 870.3465, OPPT 798.2450, OPP 82-4

Subchronic oral toxicity – in vivo408

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 testedOECD test guidelinesEquivalent 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

Bioaccumulation315OCSPP 850.1710
 317-
Bioconcentration305

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 coefficient107

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

 123EU Annex V test methods A.8
Ready biodegradability301

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 systems308OPP 162-3, 162-4-

Acceptable test guidelines for water solubility

Property testedOECD test guidelinesEquivalent test guidelines
Water solubility – chemicals or polymers105

OPPTS 830.7840

OPPTS 830.7860

Water solubility - polymers120-

 

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