Monograph on the Potential Human Reproductive and ... - OEHHA

162 CHAPIN ET AL.
concentrations in milk from 23 healthy lactating Japanese
women. Bisphenol A concentrations ranged from 0.28–
0.97 mg/L, and the mean7SD concentration was reported
at 0.6170.20 mg/L. No correlations were observed
between bisphenol A and triglyceride concentrations in
milk. Values from 6 milk samples were compared to
maternal and umbilical blood samples reported previously
in a study by Kuroda et al. (2003). Bisphenol A
values were higher in milk, and the milk/serum ratio
was reported at 1.3. Bisphenol A values in milk were
comparable to those in umbilical cord serum. [It was not
clear whether milk and serum samples were obtained
from the same volunteers in the two studies.]
Studies have measured migration of bisphenol A from
polycarbonate infant bottles or containers into foods or
food simulants. Results of those studies are summarized
in Table 4. Analyses for bisphenol A were conducted by
GC/MS or HPLC. The European Union (2003) group
noted that in many cases bisphenol A concentrations
were below the detection limit in food simulants. When
bisphenol A was detected, concentrations were typically
r50 mg/L in simulants exposed to infant bottles and
r5 mg/kg in simulants exposed to polycarbonate tableware.
An exception is one study that reported bisphenol
A concentrations at up to B192 mg/L in a 10% ethanol
food simulant and 654 mg/L in a corn oil simulant (Onn
Wong et al., 2005). In the study, cut pieces of bottles were
incubated, and the study authors acknowledged that
bisphenol A could have migrated from the cut edges.
[The Expert Panel notes that incubations were at 70 or
1001C for 240 hr, representing conditions not anticipated
for normal use of baby bottles.] One study
conducted with actual infant food (formula and fruit
juice) reported no detectable bisphenol A (Mountfort
et al., 1997). Some studies examining the effects of
repeated use of polycarbonate items noted increased
leaching of bisphenol A with repeated use (Earls, 2000;
Brede et al., 2003; CSL, 2004). It was suggested that the
increase in bisphenol A migration was caused by damage
to the polymer during use. Results from other reports
suggested that leaching of bisphenol A decreased with
repeated use, and it was speculated that available
bisphenol A was present at the surface of the product
and therefore removed by washing (Biles et al., 1997b;
Table 4
Examination of Bisphenol A in Polycarbonate Food Contact Surfaces
Bisphenol A concentration in
Sample (location) Procedure simulant Reference
Commercially available
infant bottles containing
residual bisphenol A
concentrations of 7–46
ppm (U.S.)
21 new and 12 used (1–2year-old)
infant bottles
(U.K.)
Infant bottles with residual
bisphenol A
concentrations of 26 mg/
kg [number tested not
indicated] (U.K.)
6 infant feeding bottles
(country of purchase not
known)
14 samples of new infant
feeding bottles and
tableware including a
bowl, mug, cup, and dish
recalled because residual
bisphenol A and other
phenol concentrations
exceeded 500 ppm [mg/
kg] (Japan)
Discs prepared from
commercial food-grade
polycarbonate resins
Common use: bottles were boiled for
5 min, filled with water or 10% ethanol,
and stored at room temperature for up
to 72 hr Worst case use: bottles were
boiled for 5 min, filled with water or
10% ethanol, heated to 1001C for 0.5 hr,
cooled to room temperature, and
refrigerated for 72 hr
Bottles were pre-washed, steam sterilized,
filled with boiling water or 3% glacial
acetic acid, refrigerated at 1–51C for
24 hr, and heated to 401C before
sampling
Bottles were sterilized with hypochlorite,
in dishwasher, or by steam; filled with
infant formula, fruit juice, or distilled
water; microwaved for 30 sec and left to
stand for 20 min (1 cycle); samples were
analyzed after 3, 10, 20, or 50 cycles;
other bottles were filled with distilled
water and left to stand for 10 days at
401C
Bottles were filled with water at 261C and
left to stand for 5 hr or filled with water
at 951C and left to stand overnight
Products were exposed to n-heptane,
water, 4% acetic acid, or 20% ethanol; in
some cases simulant was heated to 60
or 951C; in other cases, the object was
boiled for 5 min; analyses were usually
conducted after a 30-min contact period
Materials exposed to water, 10% ethanol,
or Miglyol (fractionated coconut oil) at
1001C for 6 hr or water, 3% acetic acid,
ND (LOD 5 ppb [lg/L];
corresponding to a food
concentration of 1.7 ppb) following
either procedure
ND (LOD 10 mg/L) [ppb] from new
bottles; ND (o10 mg/L ) to 50 mg/L
from used bottles exposed to either
simulant [mean not given]
ND (LOD 0.03 mg/kg) [o30 lg/kg or
ppb] under any condition
ND (LOD 2 ppb [lg/L]) in bottles
filled with water at 261C and 3.1–
55 ppb [lg/L] in bottles filled with
water at 951C.
Up to 40 ppb [lg/kg] from recalled
products and ND (LOD 0.2) to
5 mg/kg from commercially
available products.
ND (LOD 5 ppb [lg/L]) under all
conditions.
FDA (1996)
Earls et al.
(2000)
Mountfort
et al. (1997)
Hanai (1997) a
Kawamura
et al.
(1999) a,b
Howe and
Borodinsky
(1998)
Birth Defects Research (Part B) 83:157–395, 2008