Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für...

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


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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


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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


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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)


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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


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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


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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)


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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


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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)


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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


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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


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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

http://www.bgvv.de/cm/208/2_ethylhexansaeure_in_babynahrung.pdf



Issue: 2-EHA Ernährungsphysiologie und angewandte Biochemie T.J. Simat, Institut für...

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