Tier-testing industrial chemicals

This is an area of significant advancement for industrial chemical notification and registration where several in vitro techniques have been legislated in favor of animal tests in certain scenarios or take their place in tier-testing strategies. The European Medicines Evaluation Agency (EMEA) has also taken a positive stand on the replacement of animal studies by in vitro methods. 

In 2000, the U.S. EPA published requirements for tier 2 fuels and also mandated the test methods that can be used for sulfur determination in these fuels. ASTM D 6428 was chosen as the mandatory method for diesel fuels with ASTM D 2622, D 3120, and D 5453 methods allowed as alternates if their accuracy and precision were shown to be equivalent to those of D 6428 method. The petroleum industry widely uses the latter three test methods for sulfur but had virtually no experience with the mandated D 6428 method, which is under the jurisdiction of ASTM D 16 Committee on Aromatic Hydrocarbons and Related Chemicals. The method was written for the sulfur determination of liquid aromatic hydrocarbons, their derivatives, and related chemicals. The precision quoted in this method was for aromatic hydrocarbons and not for petroleum products. Moreover, it was inadequate (10 analyses by one operator on two samples) and did not conform to the statistical protocols used in the D02 Committee test methods for calculating the precision and bias estimates. 

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