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 | |||
| Skin Corrosion | ||||||
Acute dermal irritation/corrosion(In Vivo Rabbit Skin (Corrosivity Test)(OECD TG 404) |
Corrositex® |
EU: Endorsed as valid by ECVAM for US: Corrositex® endorsed as valid by ICCVAM as a stand-alone assay for evaluating the corrosivity or noncorrosivity of acids, bases, and acid derivatives. For other chemical and product classes Corrositex is valid for use as part of a tiered assessment strategy (1999) |
OECD: TG 435 (2006) US: Accepted as an alternative to a procedure specified in the U.S. Department of Transportation (DOT) Hazardous Materials Regulations (DOT-SP 10904) for DOT packing group classification of corrosive materials (1999) |
Replacement OR Reduction |
April 2009 | |
Transcutaneous Electrical Resistance (TER) Test (In Vitro Skin Corrosion) |
EU: Endorsed as valid by ECVAM for distinguishing between corrosive and non-corrosive chemicals (1998) US: Endorsed as valid by ICCVAM to identify corrosive chemicals (substances identified as non-corrosive will require confirmation with animal-based tests) (2002) |
OECD: TG 430 (2004) EU: The European Scientific Committee for Cosmetic Products and Non-food products (SCCNFP) supports use of this method for the safety assessment of chemicals used as cosmetic ingredients. (1998); Accepted for corrosivity testing (Method B.40 in Annex of Commission Regulation 440/2008/EC) (2000, 2008) |
Reduction Refinement |
April 2009 | ||
Human Skin Model Test (EPISKINTM, EpiDermTM and SkinEthicTM) |
EU: EPISKINTM, EpiDermTM and SkinEthicTM endorsed as valid by ECVAM (1998, 2000, 2006) US: EPISKINTM and EpiDermTM endorsed as valid by ICCVAM (2002) |
OECD: TG 431 (EPISKINTM and EpiDermTM 2004; SkinEthicTM included retroactively in 2006) EU: EPISKINTM and EpiDermTM accepted for corrosivity testing (Method B.40 bis. in Annex of Commission Regulation 440/2008/EC) (2000, 2008) US: Accepted for corrosivity testing as part of the integrated testing strategy for corrosivity/irritation |
Replacement (EU) OR Reduction (US) |
April 2009 | ||
List of Abbreviations
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