studies; metabolism study; two-generation
reproduction study in rats; two teratogenicity
studies in rats (one is limited); mutagenicity
data; human data; 90-day mouse and rat
studies; 2-generation reproduction study; 5
teratogenicity studies with rats; placental
transfer study; androgen-regulated
developmental study; peroxisome
proliferation study; estrogenicity studies;
conclusion of other scopes (a.o. CSTEE
RIVM SDS, July 2000 = CS/PM/853 REV.
NOTE: The TDI is based on the LOAEL of
52 mg/kg b.w. from the 2-generation rat
study with a continuous breeding protocol.
Making use of an uncertainty factor of 500
(10 for interspecies; 10 for intraspecies and
5 for extrapolating from a LOAEL to a
NOAEL), a TDI of 0.1 mg/kg b.w. is
Remark: no long-term/carcinogenicity study
is available: not considered necessary.
(To be adopted by the SCF)
000084-61-7 Phthalic acid,
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 2 to List 7. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
t-TDI: 0.1 mg/kg b.w.
Available: three 90-day oral rat studies,
limited in vitro mutagenicity studies (RIVM
Needed: reproduction and teratogenicity
studies, tests for gene mutation and
chromosome aberrations in mammalian cells