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

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164 CHAPIN ET AL.<br />

Food (no. sampled) a<br />

Table 5<br />

Surveys of Bisphenol A C<strong>on</strong>centrati<strong>on</strong>s in Canned Infant Formulas or Food<br />

Bisphenol A c<strong>on</strong>centrati<strong>on</strong> mg/kg<br />

or mg/L Country Reference<br />

Infant formula (14) Mean 5 (0.1–13.2 ppb [lg/L]); when U.S. Biles et al. (1997a) FDA (1996)<br />

diluted with water to make<br />

prepared formula mean<br />

c<strong>on</strong>centrati<strong>on</strong>s would be 2.5 (0.05–<br />

6.6)<br />

Infant formula (4) ND (LOD 2 mg/kg) U.K. Goods<strong>on</strong> et al. (2002) UKFSA (2001)<br />

Infant formula (5) 44–113 mg/kg Taiwan Kuo <strong>and</strong> Ding (2004)<br />

Infant dessert (3) 18.9–77.3 mg/kg U.K. Goods<strong>on</strong> et al. (2002)<br />

Infant vegetable food (4) oLOQ (LOQ 10 mg/kg) New Zeal<strong>and</strong> Thoms<strong>on</strong> <strong>and</strong> Grounds (2005)<br />

Infant dessert (3) oLOQ (LOQ 10 mg/kg)<br />

a<br />

Values before <strong>and</strong> after heating in can <strong>and</strong> from n<strong>on</strong>-dented <strong>and</strong> dented cans; values did not differ under <strong>the</strong> various c<strong>on</strong>diti<strong>on</strong>s <strong>and</strong><br />

were presented toge<strong>the</strong>r.<br />

ND, not detected.<br />

dem<strong>on</strong>strated that infant bottles exposed to 50 or 95%<br />

ethanol at 651C for 240 hr leached bisphenol A at<br />

c<strong>on</strong>centrati<strong>on</strong>s exceeding residual m<strong>on</strong>omer c<strong>on</strong>centrati<strong>on</strong>s,<br />

<strong>and</strong> it was suggested that hydrolysis of <strong>the</strong><br />

polymer had occurred.<br />

High molecular weight, heat-cured bisphenol A-based<br />

epoxy resins are used as protective linings in cans for<br />

food <strong>and</strong> beverages <strong>and</strong> may be used in wine storage<br />

vats (European-Uni<strong>on</strong>, 2003). Residual bisphenol A<br />

m<strong>on</strong>omer can migrate from <strong>the</strong> coatings to foods or<br />

beverages c<strong>on</strong>tained within cans. Studies were c<strong>on</strong>ducted<br />

to measure actual c<strong>on</strong>centrati<strong>on</strong>s of bisphenol A<br />

in commercially available foods or to measure c<strong>on</strong>centrati<strong>on</strong>s<br />

of bisphenol A leaching from can linings into<br />

food simulants. Because <strong>the</strong> actual measurement of<br />

bisphenol A c<strong>on</strong>centrati<strong>on</strong>s in canned foods represents<br />

<strong>the</strong> most realistic situati<strong>on</strong>, <strong>the</strong> CERHR review will focus<br />

<strong>on</strong> those data. Studies c<strong>on</strong>ducted with simulants will not<br />

be reviewed, with <strong>the</strong> excepti<strong>on</strong> of <strong>on</strong>e study by Howe<br />

et al. (1998) that was c<strong>on</strong>sidered by <strong>the</strong> FDA (1996) in<br />

<strong>the</strong>ir estimates of bisphenol A intake.<br />

Bisphenol A c<strong>on</strong>centrati<strong>on</strong>s detected in infant foods<br />

are summarized in Table 5, <strong>and</strong> bisphenol A c<strong>on</strong>centrati<strong>on</strong>s<br />

detected in n<strong>on</strong>-infant foods are summarized in<br />

Table 6. With <strong>the</strong> excepti<strong>on</strong> of isolated cases in which<br />

bisphenol A c<strong>on</strong>centrati<strong>on</strong>s were measured at up to<br />

B0.8 mg/kg food, most measurements were below<br />

0.1 mg/kg. The European Uni<strong>on</strong> also noted an extracti<strong>on</strong><br />

study c<strong>on</strong>ducted with an epoxy resin that is occasi<strong>on</strong>ally<br />

used to line wine vats. Based <strong>on</strong> that study, a worst-case<br />

scenario of 0.65 mg/L bisphenol A in wine was used. The<br />

European Uni<strong>on</strong> noted that <strong>the</strong> value represents a very<br />

worst-case exposure scenario but decided to use that<br />

number in risk estimates because no o<strong>the</strong>r value was<br />

available. [The Expert Panel notes that a study of<br />

bisphenol A in wine (Brenn-Struckhofova <strong>and</strong> Cichna-<br />

Markl, 2006) identified a maximum c<strong>on</strong>centrati<strong>on</strong> of<br />

2.1 lg/L (Table 6).]<br />

In <strong>on</strong>e study, empty cans were filled with soup, beef,<br />

evaporated milk, carrots, or 10% ethanol (Goods<strong>on</strong> et al.,<br />

2004). The cans were <strong>the</strong>n sealed, processed at 5, 20, or<br />

401C, <strong>and</strong> sampled at 1 or 10 days or 1, 3, or 9 m<strong>on</strong>ths.<br />

Half <strong>the</strong> cans processed according to each c<strong>on</strong>diti<strong>on</strong> were<br />

dented. It was determined that 80–100% of <strong>the</strong> bisphenol<br />

A migrated to food immediately after processing, <strong>and</strong><br />

that bisphenol A c<strong>on</strong>centrati<strong>on</strong>s did not change during<br />

storage or as a result of denting. The study authors<br />

c<strong>on</strong>cluded that most migrati<strong>on</strong> occurred during can<br />

processing. Boiling <strong>the</strong> cans or heating to 2301C did not<br />

increase migrati<strong>on</strong> of bisphenol A, but that finding<br />

appears to c<strong>on</strong>trast with findings of o<strong>the</strong>rs. Kang et al.<br />

(2003) examined <strong>the</strong> effects of temperature, durati<strong>on</strong> of<br />

heating, glucose, sodium, <strong>and</strong> oil <strong>on</strong> migrati<strong>on</strong> of<br />

bisphenol A from cans. In cans filled with water, heating<br />

to 1211C compared to 1051C increased migrati<strong>on</strong> of<br />

bisphenol A but <strong>the</strong> durati<strong>on</strong> of heating had no<br />

significant effect. Compared to cans filled with water,<br />

increased amounts of bisphenol A migrated from cans<br />

filled with 1–10% sodium chloride, 5–20% glucose, or<br />

vegetable oils <strong>and</strong> heated to 1211C. Takao et al. (2002)<br />

reported increased leaching of bisphenol A from cans<br />

into water when <strong>the</strong> cans were heated to Z801C.<br />

A study examining aggregate exposures of U.S.<br />

preschool age children measured bisphenol A c<strong>on</strong>centrati<strong>on</strong>s<br />

in liquid food <strong>and</strong> solid food served to <strong>the</strong> children<br />

at home <strong>and</strong> at child care centers (Wils<strong>on</strong> et al., 2003).<br />

Duplicate plates of food served to nine children were<br />

collected over a 48-hr period. GC/MS analyses were<br />

c<strong>on</strong>ducted <strong>on</strong> four liquid food samples <strong>and</strong> four solid<br />

food samples from <strong>the</strong> child care center <strong>and</strong> nine liquid<br />

food samples <strong>and</strong> nine solid food samples from home.<br />

Bisphenol A was detected in all solid food samples, three<br />

liquid food samples from <strong>the</strong> child care center, <strong>and</strong> two<br />

liquid food samples from <strong>the</strong> home. C<strong>on</strong>centrati<strong>on</strong>s of<br />

bisphenol A ranged from o0.100–1.16 ng/g [lg/kg] in<br />

liquid foods <strong>and</strong> from 0.172–4.19 ng/g [lg/kg] in solid<br />

food.<br />

The study examining aggregate exposures of U.S.<br />

preschool age children was repeated with a larger sample<br />

<strong>and</strong> again measured bisphenol Ac<strong>on</strong>centrati<strong>on</strong>sinliquid<br />

food <strong>and</strong> solid food served to <strong>the</strong>childrenathome<strong>and</strong> at<br />

child care centers (Wils<strong>on</strong> et al., 2006). Bisphenol A<br />

c<strong>on</strong>centrati<strong>on</strong>s were measured by GC/MS in food served<br />

over a 48-hr period to at least 238 children at home <strong>and</strong> 49<br />

children at daycare centers. Bisphenol A was detected in<br />

83–100% of solid food samples; c<strong>on</strong>centrati<strong>on</strong>s were<br />

reported at oLOD (0.8) to 192 ng/g [lg/kg]. Sixty-nineto<br />

80% of liquid food c<strong>on</strong>tained detectable c<strong>on</strong>centrati<strong>on</strong>s of<br />

bisphenol A; c<strong>on</strong>centrati<strong>on</strong>s were reported at oLOD (0.3)–<br />

17.0 ng/mL in liquid food. Data were also collected for<br />

h<strong>and</strong> wipes of 193 children at daycare centers <strong>and</strong> 60<br />

children at home. Bisphenol A was detected in 94–100% of<br />

Birth Defects Research (Part B) 83:157–395, 2008

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