The biometric evaluation of the acute-toxic-class method (oral)

Abstract

The acute toxic class method (ATC method) is an alternative to the LD50 test, with the use of substantially fewer animals needed for the classification of substances. Like the classical LD50 test the biometry of the ATC method is based on the probit model. The biometric calculations of the ATC method were carried out not only for the classification categories of the European Union but also for the classification criteria of various countries and organizations, currently in use. It is demonstrated that in comparison with the LD50 test in general the same classification is obtained with the ATC method and with the use of substantially fewer animals. Substances with high slopes are likely to be allocated to the predicted toxicity class in comparison with substances having low slopes, with both the ATC method and the LD50 test. Substances are more likely to be allocated into a lower toxicity class with the LD50 test than with the ATC method.

Biometric Evaluation of the ATC Method for the Determination of the Acute Dermal Toxicity of Chemicals

“…For example, for n 5 the area A from (6) would be A 0.672. The LD 50 test itself leads to probabilities of correct classification for substances with an LD 50 value nearby the class limits of approximately 0.5, when the test is performed with doses at the class limits (Diener et al, 1994).…”

Classification of the Substances on the Basis of the Acute-Toxic-Class Method (ATC)

“…This also results in substantially fewer moribund and dead animals (Schlede, Mischke, Diener, & Kayser, 1995). The ATC method is based on biometric evaluations that, together with the experimental results, demonstrate that this method is a sensitive and reliable alternative to the LD 50 test (Diener, Siccha, Mischke, Kayser, & Schlede, 1994).…”

The biometrical evaluation of the OECD modified version of the acute toxic class method (oral)

“…Option 1 is comparable to the previous procedures (Diener et al 1994), and it is part of the new Guideline. For reasons of animal welfare, the dose of 5000 mg/kg is not part of the Guideline, and for formal reasons the dose of 5 mg/kg is not part of option 1.…”

“…Previous test procedures (Diener et al 1994) have been slightly modified. These modifications were agreed upon at the OECD Expert Meeting held in Berlin on January [26][27][28]1994.…”