Guidelines for animal toxicity studies

TABLE 1.2. Synopsis of General Guidelines for Animal Toxicity Studies (U.S. FDA)... 

The Guidelines for Developmental Toxicity Risk Assessment (US-EPA 1991) outline principles and methods for evaluating data from animal and human studies, exposure data, and other information to characterize risk to human development, growth, survival, and function because of exposure prior to conception, prenatally, or to infants and children. 

Second, meanwhile, no international guidelines have been provided for the manufacture, marketing, and distribution of household insecticides on such a level as those of agricultural chemicals, and not even manufacturing registration is required in some countries. Of course, the minimal required toxicity studies are conducted with synthetic pyrethroids for household insecticides to examine absorption, distribution, metabolism, and genotoxicity in animals. 

In the test guidelines for 90-day toxicity studies (OPPTS 870.3100, 870.3150, 870.3250, 870.3465), the following definition in relation to the term subchronic is provided Subchronic... toxicity is the adverse effects occurring as a result of the repeated daily exposure of experimental animals to a chemical by the... route for a part (approximately 10 percent) of the test animal s life span. ... 

After one or more lead compounds have been selected for further development, more preclinical investigations are needed before it is possible to start studies in humans. The main studies during this phase are toxicity studies in animals. It is important to note that the goal of these studies is not so much to find safe compounds and rejecf unsafe ones, but rather to learn under which conditions a potentially beneficial compound can be harmful, and to find out how it can be used safely in humans, if at all. Details on the type, duration and extent of toxicity studies needed can be found in various regulatory guidelines issued by ICH, FDA and EMEA and are easily accessible via the internet sites of these bodies. Although there are still differences in the requirements... 

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