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REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
235
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
75760
014117-96-5 Phthalic acid, di-n-
octadecyl ester
8
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B to List 8. In first instance more
data on the migration and use are needed in
order to judge if further toxicity data are also
needed.

Group R: 0.05 mg/kg b.w.
Needed: toxicological data depending on
migration level (see SCF guidelines) and, if
migration exceeds 0.05 mg/kg, peroxisome
proliferation studies too.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
pdf
+
75840
000117-84-0 Phthalic acid, di-n-octyl
ester
7
Due to the lack of data according to new
SCF guidelines, the substance is transferred
from List 6B 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
needed.

Group R: 0.05 mg/kg b.w.
Available: Ames test, peroxisome
proliferation study, oral mouse reproduction
study, inadequate oral rat 90-day study,
inadequate oral rat chronic
toxicity/carcinogenicity study.
Needed: gene mutation and chromosome
aberration study in mammalian cells in vitro
and migration data in the first instance.
http://www.efsa.eu.int/science/afc/afc_docu
ments/469/statement01_afc_phthalates_en1.
+
+