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Regulatory Acceptance of Alternative Toxicological Methods: United States, 1998-2008

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View table comparing acceptance of alternative methods in U.S. and Europe

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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

 

 

14

Rabies Vaccine, Humane Endpoints

ICCVAM agency initiative

Yes, 9 CFR 117.4e

 

 

15

Bovine Corneal Opacity and Permeability (BCOP) Test Method

Yes, peer review and report; recommended in 2007

Yes, acceptance in 2008

(Draft TG in preparation)

 

16

Isolated Chicken Eye (ICE) Test Method

Yes, peer review and report; recommended in 2007

Yes, acceptance in 2008

(Draft TG in preparation)

 

17

Acute Toxicity In Vitro Starting Dose Procedure, 3T3 cells

Yes, 2001 workshop report; 2006 peer review and report; recommended in 2008

Yes

OECD TGs 420 (2001), 423 (2001), 425 (2006)

Yes, via OECD

18

Acute Toxicity In Vitro Starting Dose Procedure, NHK cells

Yes, 2001 workshop report; 2006 peer review and report; recommended in 2008

Yes

OECD TGs 420 (2001), 423 (2001), 425 (2006)

Yes, via OECD

1Information provided by Executive Secretary, ESAC (European Centre for the Validation of Alternative Methods Scientific Advisory Committee), April 13, 2008


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