HUMAN TESTS CONFIRM: PVC TOYS ARE SAFE!
Results of the human tests for the Dutch Consensus Group
Preface
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. [56]), 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.
Results
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.
Comments:
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: February 21, 2002.
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