Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HAIssue: Ethylhexanoic Acid

Again a contaminant found in food jars

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA)Chemical Data

Chemical Names2-Ethyl hexanoic acid

- CAS Nr. 149-57-5 ethylhexanoic acid- formula C8H16O2 - MW 144,2 g/Mol

use- metal salts (Ca-, Zn-, Ba-salts) as PVC co-stabilizers- Zn-dihexylhexanate as catalyst for foamed plastic and hardener for silicone resins- intermediate in the production of + plasticizers + lubricants (as decylester)

http://www.basf.com/businesses/chemicals/intermediates/pdfs/2-ethylh.pdf

COOH

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Toxicology

Toxicity1 (available information 10/2004)

Low acute toxicity (LD50, rat: 2000 – 3500 mg/kg)

Absorption via skin, oral or inhalation Weak irritant on skin and eyes, no sensitizing effect According to 67/548/EWG possibly fetotoxic

NOAEL rats: 100mg/kg, 250 mg/kg NOAEL rabbits: 25mg/kg, > 250 mg/kg

Mutagenicity Assays negative in bacterial mutagenicity tests Neg, in diverse micronucleus tests questionable positive sister chromatid exchange-test on human

lymphocytes Repeated Dose Toxicity (subacute, rats)

liver alteration (increasing weight) NOAEL rats: 62 mg/kg

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Exposition

Food Sources Detection of 2-EHA in lid gaskets2

2-EHA was detected in 80% of the investigated baby foods (n=20) and 70 % of the fruit juices (n = 15)

the amounts ranged from 0,25 to 3,2 mg/kg (baby food) and 0,01 – 0,59 mg/kg (fruit juices), respectively

The plastic gaskets inside the metal lids was revealed as the origin of 2-EHA

Other sources Endogenous formation of EHA from 2-ethylhexanol, which is part

of most plasticizers (human metabolisation pathway)

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Design of a glass jar

Basic parts of a glass jar

http://www.ehcan.com/JarsClosure.html

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Gasket design

Closures for glass containers Twist-off cap

Press-On Twist-Off® (PT) closures

Top seal

http://www.ehcan.com/JarsClosure.html

Safety ButtonFlip Panel

Top and side seal

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Exposition

Exposition infant, 4 months

Worst case: 0,2 mg/kg body weight*(daily intake of 360g jar food (= 3 glass jar á 125g), contaminated with 3,2 mg/kg 2-EHA for a 6 kg weight baby)= 0,2 mg EHA/kg Margin of Safety (MOS): NOAELrepeated dose toxicity, rat: 62 mg/kg

= 62/0,2= 310 is not sufficient, expecially with the view on other sources of contamination

Not worst case: 0,019 mg/kg body weight (daily intake of 190g jar food (= 1 glass jar), contaminated with 0,6 ppm 2-EHA of a 6 kg weight baby)= 0,02 mg EHA/kg MOS = 62/0,02 > 3000 (sufficient)

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Exposition

Exposition Appraisal of the BfR/Germany

High amounts like 3,2 mg EHA/kg baby food may be critical in view of additional exposure from plasticisers

Contaminations in most of the samples were below 0,6 mg/kg

this should be unobjectionable

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) View of Critical Press*,3

*Ökotest, Oct. 2004, p. 62-65

‚Ökotest‘ adopted the opinion of the BfR and devaluates only EHA con-tents > 1 mg/kg (1 of 16 samples)

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) Conclusion

2-EHA was detected in different types of baby food in glass jars Amounts ranged from not detectable to 3,2 mg/kg the plastic gasket was identified as the contaminant source Metal salts of 2-EHA are used as PVC heat stabilizers and

therefore are the source of contamintion 2-EHA is a weak teratogen and provides a low subcute toxicity Considering worst case (and contmination from other sources)

infants exposure the margin of safety for 2-EHA might be small Since 2-EHA is not used by all manufacturers, technological

inevitableness is not given, formulations should be modified and 2-EHA excluded

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HA2-Ethylhexanoic Acid (2-EHA) The Issue - Chronology

June 2004 Publication of Elss et al. is submittedInformation is passed to the surveillance

(BFR)several meetings with industry representatives

follow Juli 2004 BfR publishes ist opinion

Ernährungsphysiologie und angewandte BiochemieT.J. Simat, Institut für Lebensmittelchemie, TU-Dresden, Oktober 2004

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HAReferences

1. http://www.bgvv.de/cm/208/2_ethylhexansaeure_in_babynahrung.pdf2-Ethylhexansäure in glasverpackter Babynahrung und in FruchtsäftenStellungnahme des BfR vom 20. Juli 2004

2. S. Elss, L. Grünewald, E. Richling, P. Schreier: Occurrence of 2-ethylhexanoic acid in foods packed in glass jars, Food Addit. Contam., in press

3. Ausgelöffelt: Test Babymenüs mit Geflügel, Ökotest Okt. 2004, 62-65