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 | |||
| Eye Irritation/Corrosion | ||||||
Acute Eye Irritation/Corrosion |
Bovine Corneal Opacity and Permeability (BCOP) Test Method |
EU: Endorsed as valid by ESAC (2007) US: Endorsed as valid by ICCVAM (2007) |
OECD: Draft new Test Guideline (2008) EU: Accepted for use to positively identify and label substances as severe eye irritants (R41) (2002) US: Accepted as a screening test to detect ocular corrosives and severe irritants in a tiered testing strategy (2008) |
Reduction |
April 2009 | |
| Isolated Chicken Eye (ICE) Test Method Description and references |
EU: Endorsed as valid by ESAC (2007) US: Endorsed as valid by ICCVAM (2007) |
OECD: Draft new Test Guideline (2008) EU: Accepted for use to positively identify and label substances as severe eye irritants (R41) (2002) US: Accepted as a screening test to detect ocular corrosives and severe irritants in a tiered testing strategy (2008) |
Reduction (Substances identified as irritants by test will not progress to animal testing) |
April 2009 | ||
| Hen’s Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method Description and references |
EU: Concluded not sufficiently validated by ESAC (2007) US: Concluded not sufficiently validated by ICCVAM (2007) |
EU: Although not formally validated, accepted for use to positively identify and label substances as severe eye irritants (R41) (2002) |
Reduction (Substances identified as irritants by test will not progress to animal testing) |
April 2009 | ||
| Isolated Rabbit Eye (IRE) Test Method Description and references |
EU: Concluded not sufficiently validated by ESAC (2007) US: Concluded not sufficiently validated by ICCVAM (2007) |
EU: Although not formally validated, accepted for use to positively identify and label substances as severe eye irritants (R41)(2002) |
Reduction (Substances identified as irritants by test will not progress to animal testing) |
April 2009 | ||
| Slug Mucosal Irritation (SMI) Assay Description and references |
EU: Prevalidation study results have been submitted to ECVAM for evaluation. |
No information |
Replacement | April 2009 | ||
List of Abbreviations
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