Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental starting date and Experimental completion date: 03 March 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
CIPAC MT 75 (Determination of pH Values)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Results and discussion

pH value
Key result
pH value:
6.6
Temp.:
22 °C
Concentration:
1 other: % solution
Remarks on result:
other: This result represent a mean value of two tested samples.

Any other information on results incl. tables

The determination of the pH value of a mixture of the test item with water (1% of test item) by means of a pH meter and a glass electrode were performed during this study.

Rationale: The test system and test method are recommended by international guidelines.

Reagents and Apparatus

- 100 mL stoppered test vessel

- pH-meter Metrohm 654

- Electrode Metrohm 6.0232.100

- Buffer solution pH 4.0 J.T. Baker Art. No. 5657

- Buffer solution pH 7.0 J.T. Baker Art. No. 5656

- Buffer solution pH 9.0 J.T. Baker Art. No. 7145

- Water RCC Milli-Q water supply

Performance of the Test

About 1.00 g of ground test item was weighed into a test vessel containing about 50 mL of water. Afterwards the volume was made up to 100 mL with water. The test vessel was shaken until all test item was dissolved or dispersed. The mixture was allowed to settle for 1 minute. The pHvalue of the supernatant liquid was measured and recorded after 1 min using the abovementioned pH-meter and electrode.

The test was conducted in duplicate at room temperature (22 °C). The final result was rounded to one decimal place.

Prior to the test, the pH-meter was calibrated using the commercial buffer (pH 4.0 and pH 7.0) as indicated above. The buffer solution pH 9.0 was measured with reference to the calibration curve. The found pH value and the slope of the calibration curve are in accordance with the criteria as described in the standard operating procedure (SOP).

Applicant's summary and conclusion

Conclusions:
The pH value of a 1% solution of the test item in water was determined to be: pH = 6.6 at 22 °C
Executive summary:

The pH value of the test item was measured in an aqueous solution according to CIPAC method MT 75.3.

The test was carried out in duplicate.

The pH value of a 1% solution of the test item in water was determined to be: pH = 6.6 at 22 °C.