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Diss Factsheets

Administrative data

Endpoint:
dissociation constant
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Start of experiment: 09 December 2009 End of experiment: 14 January 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which did not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 112 (Dissociation Constants in Water)
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 13th to the 22nd of October 2008 (GLP certificate is valid for 2 years)

Test material

Constituent 1
Reference substance name:
Pellicer
IUPAC Name:
Pellicer
Details on test material:
Name: Pellicer
Lot No.: 01-09-17
Chemical name: L-Lysine, N2,N6-bis[N-(1-oxododecyl)-L-α(or γ)-glutamyl]-, sodium salt (1;?)
Appearance: White powder
Storage condition: Room temperature (15-25 °C), in the dark and protected from humidity (with desiccant)
Manufacture date: 17 January 2009
Expiry Date: 17 January 2011
Safety precautions: Routine safety and hygienic procedures sufficient to ensure personnel health and safety

Results and discussion

Dissociating properties:
not determined
Dissociation constantopen allclose all
No.:
#1
pKa:
>= 7.97 - <= 8.01
Temp.:
20 °C
Remarks on result:
other: titrated with standard base solution
No.:
#2
pKa:
>= 5.2 - <= 5.29
Temp.:
20 °C
Remarks on result:
other: titrated with standard acid solution

Any other information on results incl. tables

Considering that the molecular weight of the test item is not accurately known (769 – 833 g/mol) the dissociation constants can be given as range: - titrated with standard base solution pKa (at 20 °C) = 8.0 (7.97 - 8.01) - titrated with standard acid solution pKa (at 20 °C) = 5.2 (5.20 - 5.29).

Applicant's summary and conclusion

Conclusions:
Considering that the molecular weight of the test item is not accurately known (769 – 833 g/mol) the dissociation constants can be given as a range:
- titrated with standard base solution pKa (at 20 °C) = 8.0 (7.97 - 8.01)
- titrated with standard acid solution pKa (at 20 °C) = 5.2 (5.20 - 5.29)
Executive summary:

The disocciation constant was determined using OECD Guideline 112.

Considering that the molecular weight of the test item is not accurately known (769 – 833 g/mol) the dissociation constants can be given as a range:

- titrated with standard base solution pKa (at 20 °C) = 8.0 (7.97 - 8.01)

- titrated with standard acid solution pKa (at 20 °C) = 5.2 (5.20 - 5.29)