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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Feb - 06 Mar 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
2004
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)
Remarks:
Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany (11 Nov 2014)
Analytical monitoring:
yes
Remarks:
HPLC/UV-VIS
Details on sampling:
- Sampling intervals for the parent/transformation products: Preliminary test (Tier 1): 0 and 5 d
- Sampling method: Aliquots of each flask are taken in a glove box and cooled down.
- Sampling intervals/times for pH measurements: The pH values of the test item solutios were measured at the end of the experiments.
Buffers:
- pH: 4, 7, and 9
- Composition of buffers: pH 4: 21.01 g citric acid monohydrate dissolved in 200 mL sodium hydroxide solution (1 mol/L). This solution was filled up to a volume of 1000 mL with demineralized water. 44 mL of hydrochloric acid (1 mol/L) was added to 560 mL of this solution and filled up to a volume of 1000 mL with demineralized water; pH 7: 13.61 g potassium dihydrogen phosphate was dissolved in 1000 mL demineralized water. 30 mL of sodium hydroxide solution (1 mol/L) was added to 500 mL of this solution and filled up to a volume of 1000 mL with demineralized water; pH 9: 7.46 g potassium chloride and 6.18 g boric acid were dissolved in 1000 mL demineralized water. 21 mL of sodium hydroxide solution (1 mol/L) was added to 500 mL of this solution and filled up to a volume of 1000 mL with demineralized water.
Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Volumetric flasks baked out at 110 °C and flooded with nitrogen
- Measures to exclude oxygen: The volumetric flasks are flooded with nitrogen.

TEST MEDIUM
- Volume used/treatment: 50 mL
- Kind and purity of water: Demineralized water (pH 5 - 7)
- Preparation of test medium: Solutions of the test item are prepared by adding 20 mg of the test item to 50 mL of the relevant buffers at pH 4, 7 and 9.

OTHER TEST CONDITIONS
- Adjustment of pH: The pH value of the buffer solutions was adjusted to the respective pH for each hydrolysis temperature.
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
425.9 mg/L
Remarks:
Preliminary test (tier 1)
Duration:
5 d
pH:
4
Temp.:
50 °C
Initial conc. measured:
418.6 mg/L
Remarks:
Preliminary test (tier 1)
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
375.5 mg/L
Remarks:
Preliminary test (tier 1)
Duration:
5 d
pH:
7
Temp.:
50 °C
Initial conc. measured:
458.1 mg/L
Remarks:
Preliminary test (tier 1)
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
358.7 mg/L
Remarks:
Preliminary test (tier 1)
Duration:
5 d
pH:
9
Temp.:
50 °C
Initial conc. measured:
411.7 mg/L
Remarks:
Preliminary test (tier 1)
Number of replicates:
2
Positive controls:
no
Negative controls:
no
Preliminary study:
At pH 4, 7 and 9 less than 10% of the test item hydrolysed within 5 d. Therefore, additional tests (tier 2 and tier 3) were not necessary.
Transformation products:
no
Remarks on result:
hydrolytically stable based on preliminary test
Validity criteria fulfilled:
yes

Description of key information

The substance is hydrolytically stable (OECD 111, Tier 1 test, pH 4 - 9)

Key value for chemical safety assessment

at the temperature of:
50 °C

Additional information

There is one experimental study available, in which the abiotic hydrolysis of N-Acetyl-DL-tryptophan (CAS 87-32-1) was investigated according to OECD guideline 111 and GLP.

A preliminary (Tier 1) test was performed by dissolving 20 mg of the substance in 50 mL of three buffers adjusted to pH 4, 7 and 9, respectively, and incubating at 50 ± 0.5 °C for 5 d. The concentration of the test item was determined at the start and end of the test by HPLC/UV-VIS.

After 5 d less than 10% of the test item hydrolysed at pH 4, 7, and 9 (maximum decomposition: 2.6%). Therefore, the substance is considered hydrolytically stable and additional (Tier 2 and Tier 3) tests were not necessary.

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