DIR SML(T) = 5 mg/kg
(41) with 38940
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
000080-05-7 Bisphenol A
DIR SML = 0.6 mg/kg
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 =
Remark (reasoning for calculating the
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