Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2016-02-03 to 2016-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
CIPAC MT 75 (Determination of pH Values)
Deviations:
yes
Remarks:
In the water solubility test, the test item was diluted at 50 g/L. The water solubility of the test item is considerably below 1%.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid
Details on test material:
Minimum purity 95% w/w

Reagents

Reagent:
water

Results and discussion

pH value
pH value:
ca. 6.4
Temp.:
24 °C
Concentration:
ca. 50 g/L

Any other information on results incl. tables

The test item was diluted at 50 g/L in the water solubility test. The pH measured was around 6.4 at 24°C whereas the pH of the blank was 4.5. It was shown that the water solubility of the test item was only 45.7 mg/L and thus well below the 1% normally tested for pH. Based on these results, it can be concluded that the test item is very slightly alkaline.

Applicant's summary and conclusion