Testing of chemicals

Draft new and updated OECD Test Guidelines included in the rolling work-plan with 3R relevance

 

Considerably more harmonised validation and regulatory acceptance procedure has been achieved at the OECD and a number of new Test Guideline proposals with animal welfare aspects are under development.

 

 

TG Title Project 3R relevance
2xx Fish Embryo Toxicity Test Draft new Test Guideline Embryo test introducing reduction and refinement compared with the existing Acute Fish Test TG 203. Under validation.
4xx Extended One-Generation
Reproduction Toxicity Study
Draft new Test
Guideline
Animal test. An extended one-generation test as a possible reduction alternative to TG 416 (2 generation test) is under development.
4xx In vitro SHE Cell Transformation Test Draft new Test Guideline A  possible  reduction  method  if  used  in  a  testing strategy.
4xx In vitro BALB/C3T3 Cell Transformation Test Draft new Test
Guideline
A  possible  reduction  method  if  used  in  a  testing strategy.
487 In Vitro Mammalian Cell Micronucleus Test Draft new Test
Guideline
Provisionally adopted by WNT 20 in April 2008. In vitro  test  (part  of  a  test  battery, it  does  not  fully replace the in vivo TG 474 test), awaits outcome of additional testing.
4xx TG for a Stably Transfected Transcriptional Activation Assay for the Detection of Estrogen Receptor Agonists and Antagonists (LUMI-CELL® ER assay) Draft new Test
Guideline
In vitro test that could possibly introduce reduction in animal usage if used in a testing strategy for detection of endocrine disrupting chemicals.
4xx TG for human recombinant estrogen receptor alpha binding assays (hrERa, 2 protocols) Draft new Test
Guideline
In vitro test that could possibly introduce reduction in animal usage if used in a testing strategy for detection of endocrine disrupting chemicals.
4xx TG for the H295R Cell-Based Steroidogenesis Assay Draft new Test
Guideline
In vitro test that could possibly introduce reduction in animal usage if used in a testing strategy for detection of endocrine disrupting chemicals.
4xx TG for a Stably Transfected Transcriptional Activation (STTA) Assay for the Detection of Androgenic and Anti- Androgenic Activity of Chemicals Draft new Test
Guideline
In vitro test that could possibly introduce reduction in animal usage if used in a testing strategy for detection of endocrine disrupting chemicals.
4xx TG for a Stably Transfected Transcriptional Activation (STTA) Assay for the Detection of Anti-Estrogenic Activity of Chemicals Draft new Test
Guideline
In vitro test that could possibly introduce reduction in animal usage if used in a testing strategy for detection of endocrine disrupting chemicals.
4xx In Vitro Skin Irritation Test Guideline with a Reconstructed Human Epidermis Model Draft new Test
Guideline
Could be used as an in vitro test in the sequential testing strategy of TG 404, under development.
4xx Test Guideline for the Comet in vitro Assay in Genotoxicity Testing Draft new Test
Guideline
In vitro test for unscheduled DNA synthesis assay (to be a part of a test strategy).
429 Skin Sensitisation: Local Lymph Node Assay Draft updated Test Guideline (Original adoption: 24 April 2002) Revision of TG429 is underway possibly introducing reduction of animal usage.
xx Using Cytotoxicity Tests to estimate Starting Doses for Acute Oral Systemic Toxicity Tests Draft new Guidance Document Guidance Document under development possibly introducing  reduction  of   animal   usage   in   acute toxicity testing.

 

 

 

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