Registration Dossier
Registration Dossier
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EC number: 270-112-4 | CAS number: 68411-27-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 03.05.2018 – 26.06.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- Hydrolysis of benzoic acid esters was determined and evaluated as described in the EFSA guidelines “Note for Guidance for Food Contact Materials.”
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzoic acid isononylester
- Cas Number:
- 670241-72-2
- IUPAC Name:
- Benzoic acid isononylester
- Details on test material:
- Labelled : Isononylbenzoat
Batch Number : 04/3945-3947
Retest date : 12 July 2005
Received from : Oxeno GmbH
Date received : 21 February 2005
Amount received : Approximately 2 kg
Description : Clear liquid
Storage at RTC : Room temperature
RTC reference number : 9428
Constituent 1
Results and discussion
Any other information on results incl. tables
Purity
Sample 1 shows benzoic acid esters, the derivatization showed no by-products like alcohols or acids.
Hydrolysis with gastric-fluid simulant
The hydrolysis rates in acidic medium after 2 hours for the benzoic acid esters are 30-40%. The degradation rate of the sum of all isomers of the benzoic acid esters is about 35%.
Hydrolysis with intestinal-fluid simulant
In low alkaline-enzyme medium all detected esters in sample 1 indicates a continuously degradation. The hydrolysis rates after 4 hours for the benzoic acid esters are 50-70%. The degradation rate of the sum of all isomers of the benzoic acid esters is about 62%.
Mass balance
Because of the not identified structures of almost all esters present in the solution there is no possibility for the calculation of the mass balance.
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Applicant's summary and conclusion
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