Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Study period:
This study was conducted between 26 July 2016 and 15 August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 122 (Determination of pH, Acidity and Alkalinity)
Version / remarks:
26 July 2013
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Remarks:
Clear, colorless

Reagents

Reagent:
water

Titration of acidity and alkalinity

Details on titrant used:
Performance of the Test

Calibration Procedure
A pH meter, fitted with a 25 °C temperature compensation probe, was confirmed for satisfactory calibration at pH 4, pH 7 and pH 10 before use, using certified reference buffer solutions.

Sample Preparation
An aliquot of test item (1.0068 g and 1.0044 g for determination A and B respectively) was added to 50 mL of high purity water and then diluted to 100 mL with high purity water. Finally the samples were shaken vigorously for 1 minute.
Each sample was then allowed to settle for a period of 1 minute and the pH value then determined.
The pH value was recorded from the pH meter, without stirring of the sample, after a period of 1 minute equilibration and a second reading was recorded after a period of 2 minutes equilibration. If the difference between the two readings did not exceed 0.1 pH units, the pH value was considered stable. If a pH drift greater than 0.1 pH units was observed between the two readings, a final pH value reading was taken after 10 minutes equilibration.

Results and discussion

pH value
Key result
pH value:
> 5.63 - < 5.93
Concentration:
> 10.044 - < 10.068 g/L

Any other information on results incl. tables

The test item formed opaque dispersions in water at a loading rate of 1% w/v.  The results of duplicate determinations of pH value are shown in the following table The test item formed opaque dispersions in water at a loading rate of 1% w/v.  The results of duplicate determinations of pH value are shown in the following table:

Determination   pH Value      Overall Mean pH*
   After 1 Minute   After 2 Minute  After 10 Minute   
 1  5.63  5.63  not applicable  5.78
 2  5.88  5.93  not applicable  

 *Calculated from the 2 minute sample readings where the pH values are confirmed as not demonstrating any significant drift.

pH of the high purity water used in the sample preparation:  5.87

Applicant's summary and conclusion

Conclusions:
The pH value of the test item, as a 1% w/v aqueous dispersion, has been determined to be 5.8 at 25 ºC. This value was the mean of duplicate sample preparations, with individual replicate pH values of 5.6 and 5.9 being obtained.
Executive summary:

The general physico-chemical properties of FRET 10-0367 have been determined.  

pH Value. The pH value of the test item, as a 1% w/v aqueous dispersion, has been determined to be 5.8 at 25 ºC. This value was the mean of duplicate sample preparations, with individual replicate pH values of 5.6 and 5.9 being obtained.  The determination was carried out using a procedure designed to be compatible with Method 122 of the OECD Guidelines for the Testing of Chemicals, 26 July 2013.