Toxicological studies on the botanical supplement LI12542F6 containing extracts of flower heads and (mango tree) bark.

LI12542F6, a botanical extract composed of and , was evaluated for mutagenicity in bacteria clastogenicity in mouse bone marrow, acute oral and dermal toxicity in the rat, irritation (dermal, eye) in rabbit, and subacute and subchronic toxicity (28 and 90 days) in the rat. All studies followed standard OECD test protocols, in accordance with the principles of Good Laboratory Practice (GLP). LI12542F6 did not induce mutations in the bacterial assay using and strains, nor did it induce genotoxic effects in erythrocytes from mouse bone marrow.

Critical review of the current literature on the safety of sucralose.

Sucralose is a non-caloric high intensity sweetener that is approved globally for use in foods and beverages. This review provides an updated summary of the literature addressing the safety of use of sucralose. Studies reviewed include chemical characterization and stability, toxicokinetics in animals and humans, assessment of genotoxicity, and animal and human feeding studies.

Safety of micronized palmitoylethanolamide (microPEA): lack of toxicity and genotoxic potential.

Palmitoylethanolamide (PEA) is a natural fatty acid amide found in a variety of foods, which was initially identified in egg yolk. MicroPEA of defined particle size (0.5-10 m) was evaluated for mutagenicity in for clastogenicity/aneuploidy in cultured human lymphocytes, and for acute and subchronic rodent toxicity in the rat, following standard OECD test protocols, in accordance with Good Laboratory Practice (GLP).

A reassessment of risk associated with dietary intake of ochratoxin A based on a lifetime exposure model.

Mycotoxins, such as ochratoxin A (OTA), can occur from fungal growth on foods. OTA is considered a possible risk factor for adverse renal effects in humans based on renal tumors in male rats. For risk mitigation, Health Canada proposed maximum limits (MLs) for OTA based largely on a comparative risk assessment conducted by Health Canada (Kuiper-Goodman et al.

Pulmonary applications and toxicity of engineered nanoparticles.

Because of their unique physicochemical properties, engineered nanoparticles have the potential to significantly impact respiratory research and medicine by means of improving imaging capability and drug delivery, among other applications. These same properties, however, present potential safety concerns, and there is accumulating evidence to suggest that nanoparticles may exert adverse effects on pulmonary structure and function. The respiratory system is susceptible to injury resulting from inhalation of gases, aerosols, and particles, and also from systemic delivery of drugs, chemicals, and other compounds to the lungs via direct cardiac output to the pulmonary arteries.

Chromosome aberration test of Pigment Yellow 34 (lead chromate) in Chinese hamster ovary cells.

Lead chromate pigment in the form of the commercial pigment, Pigment Yellow 34, CAS No. 1344-37-2, used in the plastics and coatings industries, did not induce chromosome aberrations in Chinese hamster ovary (CHO) cell line WB(L). Lead chromate pigment is essentially insoluble in water, and in an effort to test the material under realistic conditions, no attempt to solubilize the pigment was made.

Method for calculating ADI-derived guidance values for drug carryover levels in medicated feeds.

There exists the possibility that non-target livestock may receive trace exposure to medications in feed due to residue carryover from previous production runs of medicated feeds at feed mills. We have developed a method by which ADI-Derived Drug Carryover Levels (ADCLs) can be established. It is a practical approach compared to the "zero" levels of residue carryover that may be expected or required by regulatory authorities.

An innovative model for regulating supplement products: natural health products in Canada.

On 1 January 2004, Health Canada officially added a new term to the global list of synonyms for dietary supplements: natural health products (NHP). Developed with the intent of providing Canadian consumers with ready access to NHP that are safe, effective, and of high quality, the Natural Health Products Regulations (the NHP regulations) are applicable to the sale, manufacture, packaging, labelling, importation, distribution, and storage of NHP, and are administered by the recently formed Natural Health Products Directorate (NHPD) within Health Canada. This paper provides an overview of the process for regulating supplement products in Canada.