Number of animals for sequential testing

Springer, Janet A.; Chambers, Wiley A.; Green, S.; Gupta, Kailash C.; Hill, Richard N.; Hurley, Pamela M.; Lambert, L.A.; Lee, C.C.; Lee, J.K.; Liu, P.T.; Lowther, D.K.; Roberts, Colin; Seabaugh, V.M.; Wilcox, N.L.

doi:10.1016/0278-6915(93)90122-f

Cited by 10 publications

(17 citation statements)

References 5 publications

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“…The U.S. proposed revisions to OECD Test Guideline 405: Acute Eye Irritation/Corrosion (OECD 1987) to reduce the maximum number of required animals from 6 to 3 (deSilva et al 1997; OECD 1999; Springer et al 1993). The revised Test Guideline 405 was adopted in 2002 (OECD 2002).…”

Section: Testing Requirementsmentioning

confidence: 99%

“…It is important to note that this approach is similar to the approach used by Springer et al (1993) except for the fact that we assumed two different underlying positive response rates for irritants, whereas Springer et al used only one (i.e., they assumed that every irritant has exactly the same likelihood of producing a positive response in an animal). Based on the distribution of positive animals in a 6-animal test in the NICEATM database, the use of two different underlying positive response rates for irritants provided a much better fit to the data.…”

Section: Comparison Of Three Strategies For Reducing Animal Use Fomentioning

confidence: 99%

“…Springer et al (1993) also conducted analyses to determine if the standard group size of 6 rabbits for ocular safety testing could be reduced in order to use fewer animals and concluded that a 3-animal test and a decision rule requiring at least 2 positive animals to classify a substance as an irritant yielded accuracy of 98%.…”

Section: Previous Proposals To Reduce the Number Of Animals Used Fmentioning

confidence: 99%

“…As indicated above, the model used by Springer et al (1993) assumed two mutually exclusive populations: irritants and nonirritants, each population having a single underlying positive response rate estimated from the data. They fit a mixture of two binomial models to each of four different databases, but the only database with a distribution of outcomes that closely matched the NICEATM database of 481 rabbit eye test studies was an EPA database of 48 substances.…”

Section: Previous Proposals To Reduce the Number Of Animals Used Fmentioning

confidence: 99%

“…They fit a mixture of two binomial models to each of four different databases, but the only database with a distribution of outcomes that closely matched the NICEATM database of 481 rabbit eye test studies was an EPA database of 48 substances. Springer et al (1993) reported the following parameter estimates for the EPA database:…”

Section: Previous Proposals To Reduce the Number Of Animals Used Fmentioning

confidence: 99%

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Using fewer animals to identify chemical eye hazards: Revised criteria necessary to maintain equivalent hazard classification

Haseman

Allen

Lipscomb

et al. 2011

Regulatory Toxicology and Pharmacology

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U.S. Federal Hazardous Substances Act (FHSA) regulations specify eye safety testing procedures and hazard classification criteria for substances regulated by the U.S. Consumer Product Safety Commission (CPSC). Current regulations require up to three sequential 6-animal tests. Testing consistent with the Organisation for Economic Cooperation and Development (OECD) test guideline for eye irritation/corrosion, which specifies 3 animals, can also be submitted to U.S. agencies. However, current FHSA regulations do not provide criteria to classify results from 3-animal tests. An analysis was conducted to determine criteria using results from 3-animal tests that would provide equivalent labeling to FHSA regulations. The frequency that FHSA requirements identify substances as ocular irritants was compared with the frequency that a criterion of either ≥1/3 or ≥2/3 positive animals would identify these substances. A database of rabbit eye tests was also used to estimate over- and underprediction rates for each criterion. In each instance, a criterion of ≥1/3 positive animals more closely matched the expected outcome based on FHSA requirements, while a criterion of ≥2/3 positive animals identified far fewer irritants. Using a classification criterion of ≥1/3 positive animals provided equivalent or greater eye hazard labeling as current FHSA requirements, while using 50–83% fewer animals.

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Section: Testing Requirementsmentioning

confidence: 99%

Section: Comparison Of Three Strategies For Reducing Animal Use Fomentioning

confidence: 99%

Section: Previous Proposals To Reduce the Number Of Animals Used Fmentioning

confidence: 99%

Section: Previous Proposals To Reduce the Number Of Animals Used Fmentioning

confidence: 99%

Section: Previous Proposals To Reduce the Number Of Animals Used Fmentioning

confidence: 99%

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