Ernhrungsphysiologie und angewandte Biochemie

1
Issue Ethylhexanoic Acid

• Again a contaminant found in food jars

2
2-Ethylhexanoic Acid (2-EHA)Chemical Data

• Chemical Names
• 2-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/intermedi
ates/pdfs/2-ethylh.pdf
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2-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, gt 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

4
2-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 (n20) 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)

5
2-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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2-Ethylhexanoic Acid (2-EHA) Gasket design

• Closures for glass containers
• Twist-off cap
• Press-On Twist-Off (PT) closures

http//www.ehcan.com/JarsClosure.html
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2-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 gt 3000
  (sufficient)

8
2-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

9
2-Ethylhexanoic Acid (2-EHA) View of Critical
Press,3
Ökotest adopted the opinion of the BfR and
devaluates only EHA con-tents gt 1 mg/kg (1 of 16
samples)
Ökotest, Oct. 2004, p. 62-65
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2-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

11
2-Ethylhexanoic Acid (2-EHA) The Issue -
Chronology

• June 2004 Publication of Elss et al. is
  submitted Information is passed to the
  surveillance (BFR)
• several meetings with industry representatives
  follow
• Juli 2004 BfR publishes ist opinion

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References

• http//www.bgvv.de/cm/208/2_ethylhexansaeure_in_ba
  bynahrung.pdf2-Ethylhexansäure in glasverpackter
  Babynahrung und in FruchtsäftenStellungnahme des
  BfR vom 20. Juli 2004
• S. Elss, L. Grünewald, E. Richling, P. Schreier
  Occurrence of 2-ethylhexanoic acid in foods
  packed in glass jars, Food Addit. Contam., in
  press
• Ausgelöffelt Test Babymenüs mit Geflügel,
  Ökotest Okt. 2004, 62-65