Registration Dossier
Registration Dossier
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EC number: 800-036-4 | CAS number: 1422423-64-0
Dissociation constant
Administrative data
- Endpoint:
- dissociation constant
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 112 (Dissociation Constants in Water)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trisodium (2S)-2,6-bis(3-carboxylatopropanamido)hexanoate
- EC Number:
- 948-778-9
- Molecular formula:
- C14O8H19N2Na3
- IUPAC Name:
- trisodium (2S)-2,6-bis(3-carboxylatopropanamido)hexanoate
- Test material form:
- liquid
- Details on test material:
- Active ingredient (%): 48.9% dry substance
Purity (%): 95.50 %
Stability: 5 years
Sterilization: None
Solubility: Soluble in water
Storage: Room Temperature
1
- Specific details on test material used for the study:
- Batch number: 23ADB/50
Manufacturing date: November 22nd, 2018
Expiry date: November 21st, 2023
Name: Trisodium (2S)-2,6-bis (3- carboxylatopropanamido) hexanoate_Disuccinyl lysine sodium salt
Appearance: Liquid
Colour: Brown
Odour: Characteristic
Container: n/a
Results and discussion
- Dissociating properties:
- no
Dissociation constant
- Remarks on result:
- not determinable
- Remarks:
- A definitive equivalence point could not be determined, but there was evidence of an acidic pKa over the pH range of approximately 3 to 6.
Any other information on results incl. tables
Temperature during the preliminary tests ranged from 19.3 to 20.1°C.
The preliminary test indicated there was no difference between the curves generated from titration of water with the base titrant compared to the titration of the test substance solution (aq) with the base titrant, which means the test substance does not have a dissociation constant in basic conditions. The titration of the test substance with acid titrant did indicate a difference. A definitive equivalence point could not be determined, but there was evidence of an acidic pKa over the pH range of approximately 3 to 6.
Applicant's summary and conclusion
- Conclusions:
- The test substance, disuccinyl lysine sodium salt, showed evidence of an acidic pKa over the pH range of approximately 3-6.
- Executive summary:
An experimental test has been conducted to determine the pKa of the test substance, disuccinyl lysine sodium salt, by potentiometric titration (according to test method OECD 112). A definitive equivalence point could not be determined, but there was evidence of an acidic pKa over the pH range of approximately 3-6.
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