| Endpoint |
Method Name |
Endorsement of Scientific Validity |
Regulatory Acceptance |
| |
|
Lead Authority |
Subsequent Endorsement(s) |
International |
National/ Regional |
| Acute aquatic toxicity |
Upper threshold concentration step-down approach |
ESAC (2006) |
|
|
|
| Acute mammalian toxicity (oral) |
Acute toxic class method |
|
|
OECD 423 |
|
| |
Fixed dose procedure |
|
|
OECD 420 |
|
| |
Up-and-down procedure |
ICCVAM (2000) |
|
OECD 425 |
|
| |
Normal human keratinocyte neutral red uptake assay for determining oral starting dose |
ICCVAM (2006) |
|
|
|
| |
Balb/c 3T3 neutral red uptake assay for determining oral starting dose |
ICCVAM (2006) |
|
|
|
| Acute mammalian toxicity (inhalation) |
Acute toxic class method |
|
|
Draft OECD 436 |
|
| |
Fixed dose procedure |
|
|
Draft OECD 433 |
|
| Acute mammalian toxicity (skin) |
Fixed dose procedure |
|
|
Draft OECD 434 |
|
| Chronic toxicity |
Ending 1-year dog studies of pesticides |
ESAC (2006) |
|
|
|
| Embryotoxicity |
Embryonic stem cell test |
ESAC (2002) |
|
|
|
| |
Micromass assay |
ESAC (2002) |
|
|
|
| |
Whole rat embryo assay |
ESAC (2002) |
|
|
|
| Eye irritation |
Bovine corneal opacity permeability (BCOP) test |
ESAC (2007) |
ICCVAM (2007) |
|
EU Competent Authorities |
| |
Hen's egg test-chorioallantoic membrane (HET-CAM) |
|
|
|
EU Competent Authorities |
| |
Isolated chicken eye (ICE) test |
ESAC (2007) |
ICCVAM (2007) |
|
EU Competent Authorities |
| |
Isolated rabbit eye (IRE) test |
|
|
|
EU Competent Authorities |
| Genotoxicity |
Bacterial reverse mutation (Ames) test |
|
|
OECD 471 |
|
| |
In vitro cell gene mutation test |
|
|
OECD 476 |
|
| |
In vitro chromosomal aberration test |
|
|
OECD 473 |
|
| |
In vitro micronucleus test |
ESAC (2006) |
|
Draft OECD 487 |
REACH Regulation |
| |
In vitro sister chromatid exchange test |
|
|
OECD 479 |
|
| |
In vitro unscheduled DNA synthesis test |
|
|
OECD 482 |
|
| |
Saccharomyces cerevisiae gene mutation assay |
|
|
OECD 480 |
|
| |
Saacharomyces cerevisiae mitotic recombination assay |
|
|
OECD 481 |
|
| Hematotoxicity: acute neutropenia |
Colony forming unit granulocyte macrophage (CFU-GM) assay |
ESAC (2006) |
|
|
|
| Non-genotoxic cell transformation |
Cell transformation assay |
|
|
|
EU Method B.21 |
| Phototoxicity |
3T3 Neutral Red Uptake (NRU) Phototoxicity Test |
ESAC (1998) |
|
OECD 432 |
EU Method B.41 |
| Pyrogenicity |
Human whole blood IL-1 |
ESAC (2006) |
|
|
|
| |
Human whole blood IL-6 |
ESAC (2006) |
|
|
|
| |
Human cryopreserved whole blood IL-1 |
ESAC (2006) |
|
|
|
| |
PBMC IL-6 |
ESAC (2006) |
|
|
|
| |
MM6 IL-6 |
ESAC (2006) |
|
|
|
| |
Limulus amebocyte lysate (LAL) test |
|
|
|
EUP (5.0) / EDQM, USP (85) |
| Skin absorption |
In vitro skin absorption |
|
|
OECD 428 |
|
| Skin corrosion |
CORROSITEX® |
ICCVAM (2000) |
ESAC (2000) |
OECD 435 |
|
| |
EPISKIN® |
ESAC (1998) |
ICCVAM (2002) |
OECD 431 |
|
| |
EpiDermTM |
ESAC (1998) |
ICCVAM (2002) |
OECD 431 |
|
| |
Rat skin transcutaneous electrical resistance (TER) assay |
ESAC (1998) |
ICCVAM (2002) |
OECD 430 |
|
| |
SkinethicTM human skin model |
ESAC (2006) |
|
OECD 431 |
|
| Skin irritation |
EPISKIN® skin irritation test |
ESAC (2007) |
|
|
|
| |
EpiDermTM skin irritation test |
ESAC (2007) |
|
|
|
| Skin sensitization |
Local lymph node assay (LLNA) |
ICCVAM (1999) |
ESAC (1999) |
OECD 429 |
|
| |
Reduced LLNA (rLLNA) |
ESAC (2007) |
Draft ICCVAM (2008) |
|
|
| Vaccine potency |
ELISA test for erysipelas vaccines |
ESAC (2002) |
|
|
EUP/EDQM |
| |
ELISA test for human tetanus vaccines |
ESAC (2000) |
|
|
EUP/EDQM |
| |
Toxin binding inhibition (ToBI) test |
ESAC (2000) |
|
|
EUP/EDQM |
|
