Animal Toxicity Test

Daylight fluorescent pigments (qv) are considered to be nontoxic. Since they are combinations of polymers and dyestuffs, the combined effect of the ingredients must be taken into account when considering the net toxic effect of these materials. Table 5 gives results of laboratory animal toxicity tests of standard modified melamine—formaldehyde-type pigments, the Day-Glo A Series, and the products recommended for plastic mol ding, Day-Glo Z-series. 

Table 5. Results of Laboratory Animal Toxicity Tests...

Safety is assessed by subjecting the antioxidant to a series of animal toxicity tests, eg, oral, inhalation, eye, and skin tests. Mutagenicity tests are also carried out to determine possible or potential carcinogenicity. Stabilizers are being granulated and Hquid products are receiving greater acceptance to minimize the inhalation of dust and to improve flow characteristics. 

A manufacturer seeks approval from the FDA for the marketing of a new non-caloric sweetening agent. The manufacturer has conducted extensive animal toxicity testing on this new food additive, and has also provided to the FDA information about the chemical s use rates in foods and the expected rate of intake consumers might experience. Is it possible to predict whether the new additive will pose a health risk to consumers if it were to be approved for use in food ... 

Toxicology, the study of poisoning and the harmful effects of chemicals on living organisms, can be divided into different branches or fields. Descriptive toxicology or experimental toxicology refers to the study of animal toxicity testing, intended to provide... 

As provided in the Botanical Guidance, clinical studies have been permitted for many botanical preparations prior to a complete set of conventional animal toxicity testing. The decisions were not difficult for submissions with substantial and well-documented history of past human use. But some other applicants had not presented an adequate summary of the past human experiences and had failed even to document well-known toxicity of the herbal ingredients. Between these two extremes, how to adjust the requirements of animal toxicity data and substitute that with large quantity but poor quality of human experiences is another big challenge to the regulatory agency in the review of botanical applications. 

Langley, G. (2001) The Way Forward Action to End Animal Toxicity Testing, British Union for the Abolition of Vivisection, London... 

Such simple procedures, however, cost a lot of money. To obtain a single toxicity figure, for example, many tests need to be conducted to answer questions of interest such as Does this chemical cause cancer Does this chemical cause malformation and so forth. In fact, more than 20 animal toxicity tests are needed to answer such questions and obtain a toxicity figure. This could cost approximately USD 15 million. Similarly, to obtain a single exposure figure, the tests on residue analysis and environmental behaviour can cost up to USD 5 million. To examine the toxicity of natural organisms usually three aquatic species are tested as representatives of the water environment fish, water flea, and algae. For terrestrial species, earthworms, honey bees, and birds are tested. For these tests, approximately USD 1 million is needed. 

Dibutyl sebacate is used in cosmetics, foods, and oral pharmaceutical formulations, and is generally regarded as a nontoxic and nonirritant material. Following oral administration, dibutyl sebacate is metabolized in the same way as fats. In humans, direct eye contact and prolonged or repeated contact with the skin may cause very mild irritation. Acute animal toxicity tests and long-term animal feeding studies have shown no serious adverse effects to be associated with orally administered dibutyl sebacate. 

The human predictive value of combined animal toxicity testing... 

In summary, combined animal toxicity testing, including toxic effects and signals recognized from safety pharmacology, clinical and histopathology, and toxicokinetics endpoints, provides a predictive and useful basis for human safety... 

Dibutyl adipate is not toxic in acute oral or dermal animal toxicity tests. 

Most toxicity studies are performed by using test animals. Humans obviously cannot be exposed to lethal concentrations of toxic materials to determine toxicity. Please note that there are some differences in chemical tolerance levels for humans and animals. The differences include metabolism and other factors. Thus, toxicity tests are not always easy to interpret. However, the results of animal toxicity tests are used to guide the selection of acceptable exposure limits for humans. 

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