Registration Dossier
Registration Dossier
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EC number: 238-925-9 | CAS number: 14858-73-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-12-06 to 2013-04-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to standards (EFSA-guideline study)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EFSA guidelines "Note for Guidance for Food Contact Materials"
- GLP compliance:
- no
- Remarks:
- ISO 17025 compliant
Test material
- Reference substance name:
- Bis(2-ethylhexyl) carbonate
- EC Number:
- 238-925-9
- EC Name:
- Bis(2-ethylhexyl) carbonate
- Cas Number:
- 14858-73-2
- Molecular formula:
- C17H34O3
- IUPAC Name:
- bis(2-ethylhexyl) carbonate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Bis-(2-ethylhexyl)-carbonate
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: in vitro test
Administration / exposure
- Vehicle:
- other: acetonitrile
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25.77 ppm
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- other: hydrolysis (gastric fluid): 65% within 4 h
- Toxicokinetic parameters:
- other: hydrolysis (intestinal fluid): 15% within 4 h
Any other information on results incl. tables
Hydrolysis of the test item with gastric-fluid simulant:
Contact time [h] |
Ester [ppm] |
Ester [%] |
Alcohol [ppm]* |
0 |
25.77 |
100.0 |
- |
1 |
17.60 |
68.3 |
- |
2 |
15.57 |
60.4 |
- |
4 |
9.62 |
37.3 |
- |
*No increase of the alcohol was detectable
Hydrolysis of the test item with intestinal-fluid simulant:
Contact time [h] |
Ester [ppm] |
Ester [%] |
Alcohol [ppm] |
0 |
25.77 |
100.0 |
0.00 |
1 |
22.75 |
88.3 |
1.35 |
2 |
22.22 |
86.2 |
1.32 |
4 |
21.91 |
85.0 |
1.37 |
Recoveries:
Ester (from pancreatic medium) |
Ester (from gastric medium) |
||||
[ppm] calculated |
[ppm] experimental |
Recovery [%] |
[ppm] calculated |
[ppm] experimental |
Recovery [%] |
25.77 |
22.68 |
88.0 |
25.77 |
24.34 |
94.4 |
Alcohol (from pancreatic medium) |
Alcohol (from gastric medium) |
||||
16.34 |
11.51 |
70.4 |
16.34 |
14.20 |
86.9 |
36.32 |
24.92 |
68.6 |
36.32 |
30.41 |
83.7 |
54.48 |
40.85 |
75.0 |
54.48 |
48.50 |
89.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: hydrolysis of approx. 80% within 4 h (gastric and intestinal fluid combined)
The results showed a hydrolysis of Bis(2-ethylhexyl) carbonate of about 65% within 4 hours in gastric-fluid simulant and a hydrolysis of about 15% within 4 hours in intestinal-fluid simulant. - Executive summary:
In an in vitro hydrolysis study according to EFSA guidelines "Note for Guidance for Food Contact Materials", Bis(2-ethylhexyl) carbonate degraded to about 65% within 4 hours in gastric-fluid simulant and to about 15% within 4 hours in intestinal-fluid simulant.
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