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