Allgemeine Toxikologie II - Institut für Analytische Chemie

Substance
DEHP
DBP
BBP
Key studies for toxicological re-evaluation of phthalates
for use as food contact materials
Structure
Key study
developmental- and
testis toxicity (rat)
developmental toxicity
(rat)
testis toxicity (rat)
developmental toxicity
(rat)
Endpoint
germ cell depletion
testis weight ()
germ cell
development
epididymal spermconcentration
()
anogenital distance
()*** male rat, F1dnd
F2-generation
NOAEL/
LOAEL
(mg/kg KG/day)
5 (NOAEL)
5 (NOAEL)
2 (LOAEL)
20 (NOAEL)
200 (LOAEL)
50 (NOAEL)
Assessmentfactor
0,01
0,02
0,01
reduced fertility and
histopathological findings in testis,
but only at 2200 mg/kg. Study not
used for TDI-derivation
0,01
TDI-value
(mg/kg KG/day)
EFSA 2005
Key studies for toxicological re-evaluation of phthalates
for use as food contact materials
Substance
DINP*
DIDP**
Structure
Key study
liver- and kidney
toxicity (rat),
independent of
peroxisome
proliferation
liver toxicity (dog),
independent of
peroxisome
proliferation
developmental
toxicity (rat)
Endpoint
Spongiosis hepatis
microskopic lesions
(enlarged and
vacuolized
hepatocytes)
survival of F2generation
NOAEL/
LOAEL
(mg/kg KG/day)
15 (NOAEL)
15 (NOAEL
33 (NOAEL)
Assessment
factor
0,01
0,01
0,15
0,05
0,5
TDI-value
(mg/kg KG/day)
EFSA 2005
0,15
lowest NOAEL used for TDI-derivation
*DINP: mixture of esters of ortho-phthalic acid with C8-C10 alkylalkoholes (R1 and R2, C9 rich); two types DINP, different mixtures of isomers
(CAS-Nr. 68515-48-0 und CAS-Nr. 28553-12-0).
**DIDP:two types of C9-C11 (R1 und R2, C10-rich) branched alkylesters (CAS-Nr. 68515-49-1 und CAS-Nr. 26761-40-0); : reduction
Ref.
Wolfe
and
Leyton
2003
Lee et
al.
2004
NTP
1997
Tyl et
al.
2001,
2004
73
EFSA, 2005
Ref.
Aristech
1994,
Exxon
1996a,b
Hazelton
Lab. 1968
Exxon
2000
74
EFSA, 2005
37