| Endpoint |
Method Name |
Test Type1 |
Endorsement of Scientific Validity |
Regulatory Acceptance |
| |
|
|
Lead Authority |
Subsequent Endorsement(s) |
International (click here for approved OECD TGs and here for Draft TGs) |
National/ Regional (for methods not yet accepted internationally) |
| Acute aquatic toxicity |
Upper threshold concentration step-down approach |
In vivo |
ESAC (2006) |
|
|
|
| Acute mammalian toxicity (oral) |
Deletion of Acute Oral Toxicity Test, Lethal Dose (LD50) |
In vivo |
EU (2001) |
|
OECD TG 401 deleted (2002) |
|
| |
Acute toxic class method |
In vivo |
|
ESAC (2007) |
OECD TG 423 (2001) |
|
| |
Fixed dose procedure |
In vivo |
|
ESAC (2007) |
OECD TG 420 (2001) |
|
| |
Up-and-down procedure |
In vivo |
ICCVAM (2001) |
ESAC (2007) |
OECD TG 425 (2006) |
|
| |
Normal human keratinocyte neutral red uptake (NHK NRU) assay |
In vitro2 |
ICCVAM (2006) |
|
Draft OECD TG |
US agencies (2008) |
| |
Balb/c 3T3 neutral red uptake assay |
In vitro2 |
ICCVAM (2006) |
|
Draft OECD TG |
US agencies (2008) |
| Acute mammalian toxicity (inhalation) |
Acute toxic class method |
In vivo |
|
|
OECD TG 436 |
|
| |
Fixed concentration procedure |
In vivo |
|
|
Draft TG OECD 433 |
|
| Chronic toxicity |
Ending 1-year dog studies of pesticides |
In vivo |
ESAC (2006) |
|
|
Revised US EPA Pesticide Data Requirements |
| Dermal penetration |
In vitro skin absorption methods |
In vitro |
OECD Expert Group (2002) |
|
OECD TG 428 (2004) |
|
| Endocrine mechanistic screens |
Androgen receptor binding assay (rat prostate) |
In vitro |
|
|
|
OPPTS TG 890.1150 (EPA, 2009) |
| |
Aromatase inhibition assay (human recombinant) |
In vitro |
|
|
|
OPPTS TG 890.1200 (EPA, 2009) |
| |
ER-alpha transcriptional activation assay for estrogen agnoists3 |
In vitro |
|
|
OECD TG 455 (2009) |
|
| |
Estrogen receptor binding assay |
In vitro |
|
|
|
OPPTS TG 890.1250 (EPA, 2009) |
| |
Steroidogenesis (H295R human cell line) |
In vitro |
|
|
|
OPPTS TG 890.1550 (EPA, 2009) |
| |
US EPA Tier 1 Screening Battery |
In vitro/In vivo |
|
|
|
US EPA (2009) |
| Genotoxicity |
Bacterial reverse mutation (Ames) test |
In vitro |
|
|
OECD TG 471 (1997) |
|
| |
In vitro cell gene mutation test |
In vitro |
|
|
OECD TG 476 (1997) |
|
| |
In vitro chromosomal aberration test |
In vitro |
|
|
OECD TG 473 (1997) |
|
| |
In vitro micronucleus test |
In vitro |
ESAC (2006) |
|
Draft OECD TG 487 |
REACH Regulation |
| |
In vitro sister chromatid exchange test |
In vitro |
|
|
OECD TG 479 (1986) |
|
| |
In vitro unscheduled DNA synthesis test |
In vitro |
|
|
OECD TG 482 (1986) |
|
| |
Saccharomyces cerevisiae gene mutation assay |
In vitro |
|
|
OECD TG 480 (1986) |
|
| |
Saacharomyces cerevisiae mitotic recombination assay |
In vitro |
|
|
OECD TG 481 (1986) |
|
| Hematotoxicity: acute neutropenia |
Colony forming unit granulocyte macrophage (CFU-GM) assay |
In vitro |
ESAC (2006) |
|
|
|
| Ocular irritation |
Cytotoxicity/cell-function based in vitro assays: Cytosensor Microphysiometer modified and Fluorescein Leakage |
In vitro |
ESAC (2009) |
|
|
|
| Ocular corrosion |
Bovine corneal opacity permeability (BCOP) test |
In vitro |
ICCVAM (2007) |
ESAC (2007) |
OECD TG 437 (2009)
OECD Proficiency Standards |
|
| |
Isolated chicken eye (ICE) test |
In vitro or Ex vivo |
ICCVAM (2007) |
ESAC (2007) |
OECD TG 438 (2009)
OECD Proficiency Standards |
|
| |
Hen's egg test-chorioallantoic membrane (HET-CAM) |
In vitro |
|
|
|
EU Competent Authorities for Dangerous Substances Directive |
| |
Isolated rabbit eye test |
In vitro or Ex vivo |
|
|
|
EU Competent Authorities for Dangerous Substances Directive |
| Phototoxicity |
3T3 Neutral Red Uptake Phototoxicity Test |
In vitro |
ESAC (1997) |
|
OECD TG 432 (2004) |
|
| |
3T3 NRU Phototoxicity Test: Application to UV filter chemicals |
In vitro |
ESAC (1998) |
|
OECD TG 432 (2004) |
|
| Pyrogenicity |
Human whole blood IL-1 |
In vitro |
ESAC (2006) |
ICCVAM (2008)4 |
|
European Pharmacopeia; US agencies |
| |
Human whole blood IL-6 |
In vitro |
ESAC (2006) |
ICCVAM (2008)4 |
|
European Pharmacopeia; US agencies |
| |
Human cryopreserved whole blood IL-1 |
In vitro |
ESAC (2006) |
ICCVAM (2008)4 |
|
European Pharmacopeia; US agencies |
| |
PBMC IL-6 |
In vitro |
ESAC (2006) |
ICCVAM (2008)4 |
|
European Pharmacopeia; US agencies |
| |
MM6 IL-6 |
In vitro |
ESAC (2006) |
ICCVAM (2008)4 |
|
European Pharmacopeia; US agencies |
| |
Limulus amebocyte lysate (LAL) test |
In vitro |
|
|
|
EDQM/European Pharmacopeia (5.0); US Pharmacopeia (85) |
| Reproductive & developmental toxicity |
Embryonic stem cell test |
In vitro |
ESAC (2002) |
|
|
|
| |
Micromass assay |
Ex vivo |
ESAC (2002) |
|
|
|
| |
Whole rat embryo assay |
Ex vivo |
ESAC (2002) |
|
|
|
| Skin corrosion |
EST-1000 human reconstructed epidermis |
In vitro |
ESAC (2009) |
|
OECD TG 431 (2004) |
|
| |
Corrositex® |
In vitro |
ICCVAM (1999) |
ESAC (2000) |
OECD TG 435 (2006) |
|
| |
EpiSkin® |
In vitro |
ESAC (1998) |
ICCVAM (2002) |
OECD TG 431 (2004)
Draft Revised TG 431 |
|
| |
EpiDermTM |
In vitro |
ESAC (1998) |
ICCVAM (2002) |
OECD TG 431 (2004)
Draft Revised TG 431 |
|
| |
Rat skin transcutaneous electrical resistance (TER)assay |
Ex vivo |
ESAC (1998) |
ICCVAM (2002) |
OECD TG 430 (2004)
Draft Revised TG 430 |
|
| |
SkinEthicTM human skin model |
In vitro |
ESAC (2006) |
|
OECD TG 431 (2004)
Draft Revised TG 431 |
|
| Skin irritation |
EpiSkin® skin irritation test |
In vitro |
ESAC (2007) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| |
EpiDerm® skin irritation test |
In vitro |
ESAC (2007) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| |
EpiDermTM SIT model |
In vitro |
ESAC (2008) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| |
SkinEthic RHE model |
In vitro |
ESAC (2008) |
|
Draft OECD TG |
EU test method B.46 in COM regulation 440/2008/EC |
| Skin sensitization |
Local lymph node assay (LLNA) |
In vivo |
ICCVAM (1999) |
ESAC (1999) |
OECD TG 429 (2002)
Draft Revised TG 429 |
|
| |
Reduced LLNA |
In vivo |
ESAC (2007) |
ICCVAM (2009)
Performance Standards (2009) |
|
|
| |
Nonradiolabelled LLNA: DA |
In vivo |
ICCVAM (2009)5 |
|
Draft OECD TG |
|
| |
LLNA: BrdU-ELISA |
In vivo |
ICCVAM (2009)5 |
|
Draft OECD TG |
|
| Vaccine potency |
ELISA for erysipelas vaccines batch potency testing |
In vitro |
ESAC (2002) |
|
|
EDQM/European Pharmacopeia |
| |
ELISA for human tetanus vaccines batch potency testing |
In vitro |
ESAC (2000) |
|
|
EDQM/European Pharmacopeia |
| |
Toxin binding inhibition test for human tetanus vaccines batch potency testing |
In vitro |
ESAC (2000) |
|
|
EDQM/European Pharmacopeia |