Registration Dossier
Registration Dossier
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EC number: 237-486-0 | CAS number: 13814-96-5
pH
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- 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. QA statement)
- Remarks:
- signed 2005-06-09
Test material
- Reference substance name:
- 69444-47-9
- EC Number:
- 614-970-3
- Cas Number:
- 69444-47-9
- IUPAC Name:
- 69444-47-9
- 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.
Constituent 1
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
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