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REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
147
triazine
1980).
40020
110553-27-0 2,4-
Bis(octylthiomethyl)-6-
methylphenol
DIR SML(T) = 5 mg/kg
(41) with 38940
2
TDI: 0.1 mg/kg b.w.
Available: 1- and 3-month oral rat studies
and teratogenicity studies in rats.
Bioaccumulation and mutagenicity studies
and migration data. (RIVM
90/6786008/008).
+
+
40040
013259-35-3 Bis(pentaerythritol)
adipate
9
+
40060
000080-05-7 Bisphenol A
Same
13480/1360
7/19255//39
680/62540
D
http://europa.eu.int/comm/food/fs/sc/scf/out
128_en.pdf
+
40080
013879-32-8 Bis(phenoxyethyl)formal
8
+
40120
-
Bis(polyethyleneglycol)h
ydroxymethylphosphonat
e
DIR SML = 0.6 mg/kg
3
R = 0.6 mg/kg food
Available: migration data (< 0.1 mg/kg);
gene mutation assay in bacteria (negative);
chromosomal aberration assay in cultured
mammalian cells (negative); gene mutation
assay in cultured mammalian cells
(negative); 90-day oral rat study.

Remark: no accumulation is expected.
RIVM SDS, November 2000 =
CS/PM/3813/40120.

Remark (reasoning for calculating the
restriction):
Current approach is not setting a TDI based
on abovementioned data-package.
The restriction is calculated based on the
"LOAEL" of 5 mg/kg b.w. (90-day study;
change in thymus weight and liver changes)
and making use of a safety factor of 500 (10
for intraspecies; 10 for interspecies and 5 for
LOAEL to NOAEL). Body weight of 60 kg
is used in the calculation.

(Adopted at the 128th SCF meeting, 12 July
2001)
+