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REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
203
MBT was calculated not to exceed 22 ug/kg
b.w. for a baby weighing 2 kg, fed 8 times a
day using a new teat of 5 g at each occasion
and
- In view of the existing toxicological
studies, albeit insufficient for establishing a
TDI, which show a NOAEL of 94 mg/kg
b.w. from a 90-day oral mouse study leading
to a margin of safety of around 4200,
The Committee concludes that the potential
oral exposure to MBT resulting from
materials in compliance with the proposed
CEN limit of 8 mg/kg rubber extracted over
a 24 hour period does not constitute a health
hazard.
However, the Committee is aware that MBT
has been reported, primarily in occupational
settings, to induce sensitisation after dermal
contact. As this issue is not related to food
safety it is considered to be outside the remit
of the Committee.
Therefore the SCF recommends that the
Commission seeks appropriate advice to
consider whether direct contact exposure to
MBT, through teats and soothers, constitutes
a sensitisation hazard.

Available: inadequate migration data and
worst case calculations; gene mutation
assays in bacteria (negative); chromosomal
aberration assay in cultured mammalian
cells (positive); gene mutation assays in
cultured mammalian cells (one assay
negative and one assay weakly positive);
SCE assay in vitro (positive); mouse bone
marrow micronucleus assay (negative); in
vivo rat liver UDS assay (negative); limited
in vivo DNA binding assay (negative); three
16-day oral mouse and rat studies (one
inadequate); two 90-day oral mouse and rat