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.
No. |
Method |
ICCVAM Evaluation |
U.S. Regulatory Acceptance/ Endorsement |
OECD Adoption |
EU Regulatory Acceptance/ Endorsement1 |
1 |
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 |
2 |
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) |
Yes, via OECD |
3 |
Up and Down Procedure (UDP) |
ICCVAM peer review and report; recommended in 2001 |
Yes, accepted by U.S. in 2003; as OECD TG 425 in 2003 |
OECD TG 425 (2006) |
Yes, via OECD |
4 |
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 |
5 |
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 |
6 |
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 |
7 |
EpiDerm Skin Corrosivity Test |
ICCVAM review and report; recommended in 2002 |
Yes, as OECD 431 in 2004 |
OECD TG 431 (2004) |
67/548/EEC |
8 |
SkinEthic Skin Corrosivity Test |
ICCVAM contributed to U.S. OECD TG review |
Yes, as OECD 431 in 2004 |
OECD 431 (2004) |
Yes, via OECD |
9 |
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 |
10 |
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 |
11 |
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 |
12 |
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 |
13 |
Use of Humane Endpoints in Animal Testing of Biological Products |
ICCVAM agency initiative |
Yes, 9 CFR 117.4e |
NA |
|
14 |
Rabies Vaccine, Humane Endpoints |
ICCVAM agency initiative |
Yes, 9 CFR 117.4e |
NA |
|
15 |
Bovine Corneal Opacity and Permeability (BCOP) Test Method |
Yes, peer review and report; recommended in 2007 |
Yes, acceptance in 2008 |
Draft TG approved, formal adoption June 2009 |
Draft TG approved, formal adoption June 2009 |
16 |
Isolated Chicken Eye (ICE) Test Method |
Yes, peer review and report; recommended in 2007 |
Yes, acceptance in 2008 |
Draft TG approved, formal adoption June 2009 |
Draft TG approved, formal adoption June 2009 |
17 |
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 preparation |
OECD Guidance Document in preparation |
18 |
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 preparation |
OECD Guidance Document in preparation |
19 |
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 |
20 |
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 |
21 |
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 |
22 |
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 |
23 |
Human Whole Blood/Interleukin-1Β In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Sent to agencies October 2009; response due April 2009 |
NA |
|
24 |
Human Whole Blood/Interleukin-1Β In Vitro Pyrogen Test:
Application of Cryopreserved Human Whole Blood |
ICCVAM peer review and report; recommended in 2008 |
Sent to agencies October 2009; response due April 2009 |
NA |
|
25 |
Human Whole Blood/Interleukin-6 In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Sent to agencies October 2009; response due April 2009 |
NA |
|
26 |
Human Peripheral Blood Mononuclear Cell/Interleukin-6 In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Sent to agencies October 2009; response due April 2009 |
NA |
|
27 |
Monocytoid Cell Line Mono Mac 6/Interleukin-6 In Vitro Pyrogen Test |
ICCVAM peer review and report; recommended in 2008 |
Sent to agencies October 2009; response due April 2009 |
NA |
|
Totals |
27 |
27 |
14 |
16 |
