| Endpoint |
Method Name |
Endorsement of Scientific Validity |
Regulatory Acceptance |
| |
|
Lead Authority |
Subsequent Endorsement(s) |
International (click here for a listing of all approved OECD TGs) |
National/ Regional (for methods not yet accepted internationally) |
| Acute aquatic toxicity |
Upper threshold concentration step-down approach |
ESAC (2006) |
|
|
|
| |
Fish Embryo Test |
|
|
Draft OECD TG |
German Waste Water Dues Law (2001) |
| Acute mammalian toxicity (oral) |
Acute toxic class method |
|
ESAC (2007) |
OECD TG 423 (2001) |
|
| |
Fixed dose procedure |
|
ESAC (2007) |
OECD TG 420 (2001) |
|
| |
Up-and-down procedure |
ICCVAM (2001) |
ESAC (2007) |
OECD TG 425 (2006) |
|
| |
Normal human keratinocyte neutral red uptake (NHK NRU) assay |
ICCVAM (2006) |
|
|
US agencies |
| |
Balb/c 3T3 neutral red uptake assay |
ICCVAM (2006) |
|
|
US agencies |
| Acute mammalian toxicity (inhalation) |
Acute toxic class method |
|
|
Draft TG OECD 436 |
|
| |
Fixed concentration procedure |
|
|
Draft TG OECD 433 |
|
| Acute mammalian toxicity (skin) |
Fixed dose procedure |
|
|
Draft TG OECD 434 |
|
| Dermal Penetration |
In vitro skin absorption methods |
OECD Expert Group (2002) |
|
OECD TG 428 (2004) |
|
| Chronic toxicity |
Ending 1-year dog studies of pesticides |
ESAC (2006) |
|
|
Revised US EPA Pesticide Data Requirements |
| Eye irritation/corrosion |
Bovine corneal opacity permeability (BCOP) test |
ICCVAM (2007) |
ESAC (2007) |
Draft OECD TG |
EU Competent Authorities for Dangerous Substances Directive; US agencies (2008) |
| |
Isolated chicken eye (ICE) test |
ICCVAM (2007) |
ESAC (2007) |
Draft OECD TG |
EU Competent Authorities for Dangerous Substances Directive; US agencies (2008) |
| |
Hen's egg test-chorioallantoic membrane (HET-CAM) |
|
|
|
EU Competent Authorities for Dangerous Substances Directive |
| |
Isolated rabbit eye test |
|
|
|
EU Competent Authorities for Dangerous Substances Directive |
| Genotoxicity |
Bacterial reverse mutation (Ames) test |
|
|
OECD TG 471 (1997) |
|
| |
In vitro cell gene mutation test |
|
|
OECD TG 476 (1997) |
|
| |
In vitro chromosomal aberration test |
|
|
OECD TG 473 (1997) |
|
| |
In vitro micronucleus test |
ESAC (2006) |
|
Draft OECD TG 487 |
REACH Regulation |
| |
In vitro sister chromatid exchange test |
|
|
OECD TG 479 (1986) |
|
| |
In vitro unscheduled DNA synthesis test |
|
|
OECD TG 482 (1986) |
|
| |
Saccharomyces cerevisiae gene mutation assay |
|
|
OECD TG 480 (1986) |
|
| |
Saacharomyces cerevisiae mitotic recombination assay |
|
|
OECD TG 481 (1986) |
|
| Hematotoxicity: acute neutropenia |
Colony forming unit granulocyte macrophage (CFU-GM) assay |
ESAC (2006) |
|
|
|
| Phototoxicity |
3T3 Neutral Red Uptake Phototoxicity Test |
ESAC (1997) |
|
OECD TG 432 (2004) |
|
| |
3T3 NRU Phototoxicity Test: Application to UV filter chemicals |
ESAC (1998) |
|
OECD TG 432 (2004) |
|
| Pyrogenicity |
Human whole blood IL-1 |
ESAC (2006) |
ICCVAM (2008)1 |
|
|
| |
Human whole blood IL-6 |
ESAC (2006) |
ICCVAM (2008)1 |
|
|
| |
Human cryopreserved whole blood IL-1 |
ESAC (2006) |
ICCVAM (2008)1 |
|
|
| |
PBMC IL-6 |
ESAC (2006) |
ICCVAM (2008)1 |
|
|
| |
MM6 IL-6 |
ESAC (2006) |
ICCVAM (2008)1 |
|
|
| |
Limulus amebocyte lysate (LAL) test |
|
|
|
EDQM/European Pharmacopeia (5.0); US Pharmacopeia (85) |
| Reproductive & Developmental Toxicity |
Embryonic stem cell test |
ESAC (2002) |
|
|
|
| |
Micromass assay |
ESAC (2002) |
|
|
|
| |
Whole rat embryo assay |
ESAC (2002) |
|
|
|
| Skin corrosion |
Corrositex® |
ICCVAM (2000) |
ESAC (2000) |
OECD TG 435 (2006) |
|
| |
EpiSkin® |
ESAC (1998) |
ICCVAM (2002) |
OECD TG 431 (2004) |
|
| |
EpiDermTM |
ESAC (1998) |
ICCVAM (2002) |
OECD TG 431 (2004) |
|
| |
Rat skin transcutaneous electrical resistance (TER)assay |
ESAC (1998) |
ICCVAM (2002) |
OECD TG 430 (2004) |
|
| |
SkinEthicTM human skin model |
ESAC (2006) |
|
OECD TG 431 (2004) |
|
| Skin irritation |
EpiSkin® skin irritation test |
ESAC (2007) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| |
EpiDermTM SIT model |
ESAC (2008) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| |
SkinEthic RHE model |
ESAC (2008) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| Skin sensitization |
Local lymph node assay (LLNA) |
ICCVAM (1999) |
ESAC (1999) |
OECD TG 429 (2002) |
|
| |
Reduced LLNA |
ESAC (2007) |
ICCVAM (2008) |
|
|
| Vaccine potency |
ELISA for erysipelas vaccines batch potency testing |
ESAC (2002) |
|
|
EDQM/European Pharmacopeia |
| |
ELISA for human tetanus vaccines batch potency testing |
ESAC (2000) |
|
|
EDQM/European Pharmacopeia |
| |
Toxin binding inhibition test for human tetanus vaccines batch potency testing |
ESAC (2000) |
|
|
EDQM/European Pharmacopeia |
|
