Results of the human tests for the Dutch Consensus Group
In The Netherlands, a group consisting of the Government, industry, retailers and a consumer's organisation, tried to asses the real migration and find a consistent test for phthalate migration from soft PVC toys. The work (see ref. ), carried out by the Dutch Scientific Research organisation TNO, was divided in four parts: a human volunteer test, where the phthalate migration into saliva of sucking and chewing adults was tested. Second a child observation study, where the behaviour of children for mouth contact with toys was observed and the development of a reliable laboratory test for the migration of phthalates from toys. Further a new review was made of the exposure of children to DINP, the most important phthalate used in children's toys.
Based on the results of these studies, and assuming that soft PVC toys are the most important source of exposure of babies to DINP, it is concluded that exposure levels of children older than 12 months were well below the Maximum Tolerable Daily Intake (TDI) of 0.15 mg/kg/day, for the sample tested. For children 3-12 months, in rare cases the exposure may approximate or exceed the TDI, if the sample tested would be representative for products of the market.In 99% of the cases the exposure would remain below 0.1 mg/kg/day. In 95% of the cases the exposure would remain under 0.04 mg/kg/day. For the interpretation of the data it should be emphasised that exceeding the 0.1 mg/kg/day level does not mean that a negative health impact will occur (because of the safety factors used in deriving the TDI), but only that the safety cannot be guaranteed.
As the TDI is a safety factor of 100 below the NOAEL (no observed adverse effect level) in rats and the NOAEL is for liver peroxisome proliferation, which only occurs in rodents, not in humans, and any other adverse effect is only seen in at least a factor 10 or higher levels, then we can conclude that ALL PVC samples tested are safe. While there still are problems with the reproducibility of the mechanical migration test (it gives average higher values), that is no reason to reject all PVC toys, as the Dutch Consumer's Organisation and Greenpeace still do. Every toy that gives migrations below the limits when tested with the proposed test, in any case will be safe for any child, no matter what its age or behaviour might be.
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Created: October 11, 1998.
Last update: November 18, 1998
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