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Physical & Chemical properties

pH

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Administrative data

Endpoint:
pH
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A weight of evidence analysis revealed that during a skin irritation study, DIGIRENA SA TEMABF4 anhydrous may hydrolyse on the test site when in contact with water and maintained at body temperature under the semi-occlusive bandag. Accordingly the pH of an aqueous 10% formulation was determined following storage at approximately 37°C for 24 hours.
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2005-06-09

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DIGIRENA SA TEMABF4 anhydrous
- Physical state: White odourless powder
- Storage condition of test material: Room temperature in the dark, desiccated, under inert gas
No further information on the test material was stated.

Results and discussion

pH valueopen allclose all
pH value:
5
Temp.:
37 °C
Concentration:
10 other: % formulation of DIGIRENA SA TEMABF4 anhydrous
Remarks on result:
other: pH after 0 h of storage
pH value:
3.5
Temp.:
37 °C
Concentration:
10 other: % formulation of DIGIRENA SA TEMABF4 anhydrous
Remarks on result:
other: pH after 6 h of storage
pH value:
3
Temp.:
37 °C
Concentration:
10 other: % formulation of DIGIRENA SA TEMABF4 anhydrous
Remarks on result:
other: pH after 24 h of storage

Applicant's summary and conclusion

Conclusions:
The pH value of an aqueous 10% formulation of DIGIRENA SA TEMABF4 anhydrous was determined following storage at approximately
37oC for 24 hours. The following results were found:
0 hours: pH is 5.0
6 hours: pH is 3.5
0 hours: pH is 3.0