- Practical Guide -
Page 135 of 153
In principle, all these compounds appear in list 6B, with a few exceptions classified in
· List 2 (data available for allocating a TDI)
· List 7 (hydrolysis data justify the assessment of hydrolysates, see below)
· List 9 (better identification of the substances required before decisions can be
Classification in list 6B is accompanied by a group TDI of 0.025 mg/kg b.w. and the
request for studies on
Peroxisome proliferation (with some exceptions)
Reproduction and teratogenicity
The allocation of a group TDI of 0.025 mg/kg bw is based on the following
These compounds are suspected to have "severe toxic effects" and, therefore, their
"migration should be kept as low as possible".
Often these compounds have the same use (as plasticizers) and are applied as a
mixture. It is, therefore, appropriate to define a restriction for the whole group.
The majority of these additives are peroxisome proliferators, but there is not
sufficient data to determine their potencies and compare them to that of DEHP,
considered as the most potent peroxisome proliferator among these additives.
Therefore the restriction for the whole group is fixed at the level of the TDI of
DEHP (= 0.025 mg/kg bw).
The reasons for requesting further studies are summarised below.