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Di-n-octyl phthalate CAS Number: 117-84-0
Assessor A:
B Mitcheson,
Enviros
Assessor B: S Cole, URS Final review: Panel/SF
Date 05/05/2009 Date 10/08/2009 Date 09/09/2009
Oral Dermal Inhalation Combine Oral and
Inhalation TDIs
Justification
Apply TDIoral to exposure routes
Apply IDoral to exposure routes
Yes Yes Yes
No No No
No information relating to potential carcinogenicity.
TDIoral applied to oral, dermal and inhalation routes
Apply TDIinh to exposure routes
Apply IDinh to exposure routes
No No No
No No No
NR
No information relating to potential carcinogenicity.
Insufficient information to derive TDIinhal, route-toroute
from TDIoral used.
TDI oral
Recommended TDI
oral
Units
50 ug.kg-1.d-1
Justification
Two values available: (1) 50 ug/kg/d is the temporary group restriction for phthalates with no specific TDI set by the SCF. This is based on dose-response data for DEHP (2)
approx 400 ug/kg/d based on a sub chronic study by Poon. The sub chronic study is not considered of sufficient duration for derivation of a TDIoral and therefore preference
is given to the SCF group restriction of 50 ug/kg/d as the TDIoral for di-n-octylphthalate. This assumes that the threshold toxicity of this compound is equivalent to that of
DEHP.
Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-
1.d-1
Drinking Water Inspectorate (DWI)
http://www.dwi.gov.uk/
31-Mar-09 No dose data identified -
searched for plasticiser,
phthalate, dicarboxylic.
Note that tests for
plastic pipes must
comply with BS 6920
which includes a flavour
and odour test
Confidence
rating
Basis Value Units UF UF description Study type
Food Standards Agency (FSA)
http://www.food.gov.uk/
31-Mar-09
31/03/2009 Provisional TDI for all
phthalate esters in
contact with food
50 μg/kg/day 50 Unknown Unknown Unknown Unknown Unknown Unknown Unknown
Committee on the Toxicity of Chemicals in Food,
Consumer Products and the Environment (COT)
http://cot.food.gov.uk/
Friday 5 August 2005 (On
29/04/08 (uploaded
infant milk formula file
from July 2006)
06/04/2009 Provisional TDI for all
phthalate esters in
contact with food
0.05 mg/kg.bw/day 50 The
Committee was
aware that new
evidence on the
reproductive
effects of
phthalates has
been published
since these TDIs
were set.
NOAEL Unknown Unknown 100 Unknown Unknown
Scientific Committee on Food (SCF) pre 2002 http://ec.europa.eu/food/fs/sc/scf/index_en.html 16 December 1994
report
EU Scientific Committee on Toxicity, Ecotoxicity
and the Environment (CSTEE)
http://ec.europa.eu/health/ph_risk/committees/sc
t/sct_en.htm
07/04/2009 Provisional TDI for all
phthalate esters in
contact with food
0.05 mg/kg.bw/day 50 Unknown Based on
extrapolated NOAEL
for DEHP
No info No info No info No info No info
24-Apr-98 16/05/2009 TDI 0.37 mg/kg.bw/day 370 Unknown NOAEL 36.8 mg/kg.bw/day 100 Assumed margin of safety required for
calculating TDI from NOAEL in context of
exposure to phthalates from children
sucking plastic toys
Subchronic 13week
oral study in rats
Joint FAO/WHO Meeting on Pesticide Residues
(JMPR)
http://www.who.int/ipcs/food/jmpr/en/
08/04/2009 Reference to phthalates
only relate to DMP as
solvent for dermal test
and DEHP and an
interference
JMPR 2 http://inchem.org/pages/jmpr.html 08/04/2009 Reference to phthalates
only relate to DMP as
solvent for dermal test
and DEHP and an
interference
Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 1993 16/05/2009 Report identified with
reference to tox studies
but no TDI derived
Page 1 of 6 EIC proforma di-n-octylphthalate 09/09/2009