Allergenic potential

Cyclodextrins have ecologically advantageous properties. Not only are they produced from natural and replenishable sources, they are biodegradable, non-toxic and possess no allergenic potential [32,33]. They are commercially available in bulk quantities at an optional degree of purity and have been used for many years in pharmaceuticals. 

Aida, T. et al., Evaluation of allergenic potential of low-molecular compounds by mouse popliteal lymph node assay. J. Toxicol. Sci., 23, 425, 1998. 

Basketter, D.A., Gerberick, G.F. and Kimber, I., Measurement of allergenic potential using the local lymph node assay, Trends Pharmacol. Sci., 22, 264, 2001. 

Animal Models for Assessment of the Allergenic Potential of Proteins.. 614... 

In summary, it is reasonable to conclude that bioinformatic analysis of structural similarities to, or of sequence homology with, known protein allergens, and evaluation of stability with SGF, can both contribute, if interpreted cautiously, to an overall assessment of sensitizing hazard. However, these analyses, neither alone nor in combination, provide a definitive answer regarding allergenic potential, and for this reason there has been interest in exploring a more holistic approach (and more definitive assessment) that may be provided by suitable animal models. 

With the aim of developing animal models appropriate for safety assessment of allergenic potential a number of species has been considered, including swine [94,99] and dogs [94,100-102], Although these species have their advantages, discussion here... 

Some of the key needs in this area were discussed during a workshop Assessment of the Allergenic Potential of Genetically Modified Foods held in 2001 in North Carolina, [122], and many of the research requirements identified then are still current today. 

Kimber, I. and Dearman, R.J., Approaches to the assessment of the allergenic potential of novel proteins in food from genetically modified crops. Toxiol. Sci., 68, 4, 2002. 

Metcalfe, D.D., Introduction What are the issues in addressing the allergenic potential of genetically modified foods Environ. Health Perspect., Ill, 1110, 2003. 

Metcalfe, D.D., Astwood, J.D., Townsend, R., Sampson, H.A., Taylor, S.L. and Fuchs, R.L., Assessment of the allergenic potential of foods derived from genetically engineered crop plants. Crit. Rev. FoodSci. Nutr., 36(S), S165-S186, 1996. 

Kimber, I., Stone, S. and Dearman, R.J., Assessment of the inherent allergenic potential of proteins in mice. Environ. Health Perspect., Ill, 227, 2003. 

The tolerability and safety of TCS have been evaluated in human volunteers with little indication of toxicity or sensitization. Clinical data demonstrated that TCS was not a dermal or oral mucosal irritant and was shown to have very low sensitization/allergenic potential at concentrations found in PCPs (<1%) [149]. 

Compounds (I) through (IV) were assayed for their cytotoxic and allergenic potential on guinea pigs, which are effective indicators of contact allergenicity in humans (10). The same compounds were also tested on Tenebrlo sp. (mealworm beetles), an experimental Insect used to test the potential of insecticides. Geranyl-benzoquinone proved to be a very potent elicitor of allergic skin reactions as well as a potent insecticide (10). 

In cases where a protein is derived from a source that is not known lu be allergenic, it is not possible to predict definitively allergenic potential. While it is unlikely that a new protein that occurs in very low concentrations in food will be an allergen (as is ihe case for most proteins introduced via genetic engineering at this time), developers have taken steps to minimize... 

The MRL is based on the type and amount of residue considered to be without any direct or indirect toxicological hazard for human health. It is established on the basis of an ADI or, where this is not possible because of insufficient scientific knowledge, on the basis of a temporary ADI that includes an additional safety factor. It takes into account factors such as the development of resistance to the drug, allergenic potential and other undesirable side effects, which may have either a direct or indirect effect on human health. The MRL may also need to be reduced to accommodate residues that may be present in other food products and/or the environment. 

Lanolin and its numerous derivatives have been widely used in the pharmaceutical and cosmetic industries for many years as vehicles for active ingredients and for their beneficial effects on skin function.3 Although purified lanolin is used without incident by millions of people, confusion still exists concerning the possible allergenic potential of lanolin. The extremely low incidence of sensitization of healthy individuals to purified lanolin used in the cosmetic and pharmaceutical industries has been comprehensively reviewed.4-6... 

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