Certain toys classified as wagons, tricycles wheelbarrows, and trailers supplied by TOMY Canada, Limited, (the Toys), were found to exceed the Canadian regulatory migration limit of 1,000 ppm (mg/kg) of barium in toys, as outlined in the Toys Regulations under the Canada Consumer Product Safety Act. A toxicological and exposure evaluation of barium in the painted surfaces of the Toys was conducted. The purpose of this assessment was to provide a professional opinion of whether the toys that contain barium in paint at concentrations above the Health Canada migration limit could pose a danger to human health or safety.

The potential and foreseeable use of the toys and the probability that the toys would be mouthed by children were evaluated. An exposure pathway analysis was completed whereby all possible exposure pathways to barium in paint were considered. Based on this analysis, it was concluded that the Toys found to have elevated levels of barium in painted surfaces are large toys that have a very low likelihood of being mouthed by a child. In addition, the painted surfaces of the Toys are metal, and therefore are not malleable or chewable. The paint is formulated to adhere strongly to the metal as it is fused and melted with the metal and is meant to withstand outdoor conditions. Therefore, exposure to barium in painted surfaces is highly unlikely through the oral exposure pathway. However, a quantitative exposure evaluation was conducted to estimate the maximum possible daily dose of barium from the Toys, in the unlikely event that paint chips were ingested. The estimated exposure was evaluated and was found to be very low as compared to health-based reference values intended for evaluating exposure to barium every day over a lifetime.

Additional analysis revealed that the Health Canada migration limit for barium in the Toys Regulations of the Canada Consumer Product Safety Act was established more than four decades ago and no rationale is available to support it. Furthermore, the extraction method required under the Health Canada Toys Regulations is not consistent with corresponding United States and European Union extraction methods. In addition, the Health Canada extraction method is not representative of physiological conditions and will greatly overestimate the fraction of the barium available for absorption following ingestion by a child.

Based on this assessment, no adverse health effects are expected in children resulting from exposure to barium from the Toys and therefore they do not pose a danger to human health or safety.

• - Source: Executive summary of test results generated by an independent Canadian testing firm