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ICCVAM was established to facilitate the review and adoption of scientifically valid safety testing methods designed to
protect human health, animal health and the environment while refining, reducing or replacing animal use where feasible.
Below is a list of alternative safety testing methods that are accepted by U.S. regulatory authorities.
Appropriate use of these test methods can significantly reduce animal use and improve animal welfare.
ICCVAM has also identified critical research, development, and validation efforts needed to
further advance numerous other alternative methods.
Acute Oral Systemic Toxicity
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
Up and Down Procedure (UDP) |
ICCVAM peer review and report; recommended in 2001 |
Yes, accepted by U.S. in 2003; as OECD TG 425 |
OECD TG 425 (2001) |
Yes, via OECD |
Fixed Dose Procedure (FDP) |
ICCVAM Working Group (WG) contributed to TG development |
Yes, as OECD TG 420 in 2001 |
OECD TG 420 (2001) |
Yes, via OECD |
Acute Toxic Class Method (ATC) |
ICCVAM WG contributed to TG development |
Yes, as OECD TG 423 in 2001 |
OECD TG 423 (2001) |
Yes, via OECD |
Acute Toxicity In Vitro Starting Dose Procedure, 3T3 cells |
Yes, 2001 workshop report; 2006 peer review and report; recommended in 2008 |
Yes |
OECD Guidance Document in review |
OECD Guidance Document in review |
Acute Toxicity In Vitro Starting Dose Procedure, NHK cells |
Yes, 2001 workshop report; 2006 peer review and report; recommended in 2008 |
Yes |
OECD Guidance Document in review |
OECD Guidance Document in review |
Acute Inhalation Toxicity
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
Acute inhalation toxicity - acute toxic class method |
ICCVAM contributed to U.S. OECD TG review |
Yes, as OECD TG 436 in 2009 |
OECD TG 436 (2009) |
Yes, via OECD |
Dermal Corrosivity
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
CORROSITEX Skin Corrosivity Test |
ICCVAM peer review and report; recommended in 1999 |
Yes, accepted by U.S. in 2000; as OECD TG 435 in 2006 |
OECD Test Guideline (TG) 435 (2006) |
Yes, via OECD |
EpiSkin Skin Corrosivity Test |
ICCVAM review and report; recommended in 2002 |
Yes, as OECD TG 431 in 2004 |
OECD TG 431 (2004) |
67/548/EEC |
EpiDerm Skin Corrosivity Test |
ICCVAM review and report; recommended in 2002 |
Yes, as OECD 431 in 2004 |
OECD TG 431 (2004) |
67/548/EEC |
SkinEthic Skin Corrosivity Test |
ICCVAM contributed to U.S. OECD TG review |
Yes, as OECD 431 in 2004 |
OECD 431 (2004) |
Yes, via OECD |
Rat TER Skin Corrosivity Test |
ICCVAM review and report; recommended in 2002 |
Yes, as OECD TG 430 in 2004 |
OECD TG 430 (2004) |
67/548/EEC |
Ocular Corrosivity and Irritation
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
Bovine Corneal Opacity and Permeability (BCOP) Test Method |
Yes, peer review and report; recommended in 2007 |
Yes, acceptance in 2008 |
OECD TG 437 (2009) |
Yes, via OECD |
Isolated Chicken Eye (ICE) Test Method |
Yes, peer review and report; recommended in 2007 |
Yes, acceptance in 2008 |
OECD TG 438 (2009) |
Yes, via OECD |
Immunotoxicity: Allergic Contact Dermatitis
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
Local Lymph Node Assay for skin sensitization |
ICCVAM peer review and report; recommended in 1999 |
Yes, accepted by U.S. in 1999; as OECD TG 429 in 2002 |
OECD TG 429 (2002); ISO (2002) |
Yes, via OECD |
Dermal Phototoxicity
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
3T3 NRU Phototoxicity Test |
ICCVAM contributed to U.S. OECD TG review |
Yes, as OECD TG 432 in 2004 |
OECD TG 432 (2004) |
67/548/EEC |
3T3 NRU Phototoxicity Test: Application to UV Filter Chemicals |
ICCVAM contributed to U.S. OECD TG review |
Yes, as OECD TG 432 in 2004 |
OECD TG 432 (2004) |
OECD TG 432 |
Dermal Absorption
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
In vitro dermal absorption methods |
ICCVAM contributed to U.S. OECD TG review, expert consultation meetings |
Yes, as OECD TG 428 in 2004 |
OECD TG 428 (2004) |
Yes, via OECD |
Pyrogen Testing
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
Human Whole Blood/Interleukin-1Β In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Yes, acceptance in 2009 |
NA |
Accepted by European Pharmacopeia |
Human Whole Blood/Interleukin-1Β In Vitro Pyrogen Test:
Application of Cryopreserved Human Whole Blood |
ICCVAM peer review and report; recommended in 2008 |
Yes, acceptance in 2009 |
NA |
Accepted by European Pharmacopeia |
Human Whole Blood/Interleukin-6 In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Yes, acceptance in 2009 |
NA |
Accepted by European Pharmacopeia |
Human Peripheral Blood Mononuclear Cell/Interleukin-6 In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Yes, acceptance in 2009 |
NA |
Accepted by European Pharmacopeia |
Monocytoid Cell Line Mono Mac 6/Interleukin-6 In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Yes, acceptance in 2009 |
NA |
Accepted by European Pharmacopeia |
Biologics Testing
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement |
Use of Humane Endpoints in Animal Testing of Biological Products |
ICCVAM agency initiative |
Yes, 9 CFR 117.4e |
NA |
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Rabies Vaccine, Humane Endpoints |
ICCVAM agency initiative |
Yes, 9 CFR 117.4e |
NA |
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ELISA Test for Batch Potency Testing of Erysipelas Vaccines
(refinement) |
ICCVAM coordinated agency consideration |
Yes, per 27 CFR 610.10; are reviewed on a case-by-case basis |
NA |
Published in European Pharmacopeia |
Relevance of the Target Animal Safety Test for batch safety testing of vaccines for veterinary use |
ICCVAM coordinated agency consideration |
Yes, per 9 CFR 113.4 |
NA |
Published in European Pharmacopeia |
ELISA Test for Batch Potency Testing of Human Tetanus Vaccines refinement |
ICCVAM coordinated agency consideration |
Yes, per 27 CFR 610.10; are reviewed on a case-by-case basis |
NA |
Published in European Pharmacopeia |
ToBI Test for Batch Potency Testing of Human Tetanus Vaccines refinement |
ICCVAM coordinated agency consideration |
Yes, per 27 CFR 610.10; are reviewed on a case-by-case basis |
NA |
Published in European Pharmacopeia |
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