Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Fatty acid C16-18, sodium salt
IUPAC Name:
Fatty acid C16-18, sodium salt
Details on test material:
Batch No: #10-10449
Radiolabelling:
no

Study design

Details on sampling:
see below
Buffers:
- Buffer pH 4: Potassium hydrogen phthalate
- Buffer pH 7: Potassium dihydrogenphosphate/di-Potassium hydrogenphosphate
- Buffer pH 9: Boric acid /Potassium chloride / Sodium hydroxide
Details on test conditions:
see below
Positive controls:
no
Negative controls:
no

Results and discussion

Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
For pH 4, pH 7 and pH 9: The test item hydrolyses completley by immediate protonation to yield the fatty acid. The whole amount of test item is quantified as the corresponding free fatty acid. the recovery rate of the fatty acid is about 100%.
Total recovery of test substance (in %)open allclose all
% Recovery:
100
pH:
4
Temp.:
50 °C
Duration:
24 h
% Recovery:
100
pH:
7
Temp.:
50 °C
Duration:
24 h
% Recovery:
100
pH:
9
Temp.:
50 °C
Duration:
24 h
Details on results:
For pH 4, pH 7 and pH 9: The test item hydrolyses completley by immediate protonation to yield the fatty acid. The whole amount of test item is quantified as the corresponding free fatty acid. the recovery rate of the fatty acid is about 100%.

Any other information on results incl. tables

For pH 4, pH 7 and pH 9: The test item hydrolyses completley by immediate protonation to yield the fatty acid. The whole amount of test item is quantified as the corresponding free fatty acid. the recovery rate of the fatty acid is about 100%.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
For pH 4, pH 7 and pH 9: The test item hydrolyses completley by immediate protonation to yield the fatty acid. The whole amount of test item is quantified as the corresponding free fatty acid. the recovery rate of the fatty acid is about 100%.
Executive summary:

Hydrolysis rate of test item Fatty acid C16 -18, sodium salt as function of pH has been determined according to OECD guideline for the testing of chemicals No 111. The following results could be obtained:

For pH 4, pH 7 and pH 9: The test item hydrolyses completley by immediate protonation to yield the fatty acid. The whole amount of test item is quantified as the corresponding free fatty acid. The recovery rate of the fatty acid is about 100%.

Fatty acid C16-18, sodium salts are not hydrolysed as a function of pH