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Non-animal Methods for Toxicity Testing

Validated/Accepted Alternative Methods


Last Updated: June 10, 2008
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Validation & Regulatory Acceptance Status of Alternative Test Methods & Testing Strategies

 

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