Alternative Test Methods: Validation and Regulatory Status
- Acute Aquatic Toxicity
- Acute Mammalian Oral Toxicity
- Acute Mammalian Inhalation Toxicity
- Acute Mammalian Skin Toxicity
- Biologics (non-vaccine)
- Carcinogenicity
- Chronic/Repeated Dose Toxicity
| Conventional test method | Alternative Test Method | Infor- mation Last Updated | ||||
|---|---|---|---|---|---|---|
| Name & Description | Validation Status | Regulatory Status | Effect or Potential Effect on Animal Use | |||
| Reproductive and developmental toxicity | ||||||
One-Generation Reproduction Toxicity Study (OECD TG 415) AND Developmental Neurotoxicity Study (OECD TG 426) AND |
Extended One-Generation Reproduction Toxicity Study Description and references |
No information |
OECD: Draft new test guideline | Reduction (Use of fewer animals; more data collected from each animal) |
April 2009 | |
Repeated Dose 28-day Oral Toxicity Study in Rodents (OECD TG 407) AND Reproduction/Developmental Toxicity Screening Test (OECD TG 421) |
Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test Description and references |
No information |
OECD: TG 422 (1996) |
Reduction | April 2009 | |
Prenatal Developmental Toxicity Study (OECD TG 414) |
Embryonic Stem Cell Test (EST) |
EU: Endorsed as valid by ECVAM for identifying non-, weakly and strongly embryotoxic chemicals |
None |
Reduction (For use as in vitro component of in vitro/in vivo reproductive toxicity testing strategy) |
April 2009 | |
| Micromass Embryotoxicity Assay Description and references |
EU: Validated by ECVAM for identifying strong embryotoxic chemicals (2002) |
None |
Refinement |
April 2009 | ||
| Whole Rat Embryo Embryotoxicity Assay Description and references |
EU: Validated by ECVAM for identifying strong, weakly and non-embryotoxic chemicals (2000) |
No information | Refinement (Uses embryos from killed animals) |
April 2009 | ||
| Frog Embryo Teratogenesis Assay- Xenopus (FETAX) Description and references |
US: ICCVAM review concluded that FETAX was not sufficiently validated or optimized for regulatory purposes. Future activities were recommended (2000). |
None | Replacement OR Reduction |
April 2009 | ||
List of Abbreviations
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