DIR SML = 6 mg/kg
TDI = 0.1 mg/kg b.w.
90-day oral rat study, mutagenicity tests
negative, absence of bioaccumulation.
000111-17-1 Thiodipropionic acid
Group R: 0.05 mg/kg bw.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
000123-28-4 Thiodipropionic acid,
DIR SML(T) = 5 mg/kg
Group R: 5 mg/kg of food (with
thiodipropionic acid, dioctadecyl
Available: Adequate migration data from
PVC and ABS; acute toxicity data; 28-day
oral rat study; 90-day oral rat study;
inadequate data on long-term toxicity; three
oral teratogenicity studies using mice,
hamsters and rabbits; studies on absorption,
distribution, metabolism and excretion;
study (this study deviated from the SCF
guidelines on peroxisomal
proliferation); two Ames assays (negative);
in vitro chromosomal
aberration assay (negative); gene mutation
assay in mouse limphoma cells (negative).
Remark: Data insufficient for allocating a
TDI (no reproduction
study and no long-term study). The WG
decided not to ask for a new peroxisome
proliferation study, since the 90-day study
showed only increased liver weights (no
morphological changes) at very high doses
(1000 mg/kg b.w.). In view of the structure
of the compound and the metabolism data
provided there is no need for demonstration
of the absence of potential for accumulation.