Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 111 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Study design

Analytical monitoring:
yes
Details on sampling:
At least six time points for the hydrolysis study were chosen for each of the pH levels 4.0, 7.0, and 9.0 at 12.5°C, 25°C and 50°C.
Buffers:
The study pH 4.0 buffer solution was prepared by adding 4.8 mL of 0.1 N NaOH solution, 600 mL of 0.1 M KHP solution and 595 mL water (Reagent grade) into a 1000 mL volumetric flask. The pH 7.0 buffer solution was prepared by adding approximately 356 mL of 0.1 N NaOH solution, 600 mL of 0.1M KH2PO4 solution and 244 mL water into a 1000 mL volumetric flask. The pH 9.0 buffer solution was prepared by adding approximately 256 mL of 0.1 N NaOH solution, 600 mL of 0. 1M H3B03 solution and 344 mL water into a 1000 mL volumetric flask. All buffer solutions for the testing were sonicated for 10 minutes after adding appropriate contents into its respective container and stored in an incubator set at 20°C.
Details on test conditions:
The test sample solutions for the testing at 12.5°C, 25°C, and 50°C were prepared by adding approximately 0.011-0.018 g of test substance into a 30 mL amber bottle and 25 mL of appropriate buffer solution (pH 4.0, pH 7.0, and pH 9.0). There were six replicate samples for each pH level. The solutions were sonicated for 5 minutes and analyzed by HPLC for Day 0. The bottles were set in incubators set at the appropriate temperature in between analysis times when the contents were analyzed and compared to Day 0.
Duration of testopen allclose all
Duration:
144 h
pH:
9
Temp.:
25 °C
Duration:
144 h
pH:
7
Temp.:
25 °C
Duration:
144 h
pH:
4
Temp.:
25 °C
Number of replicates:
Six
Positive controls:
no
Negative controls:
no
Statistical methods:
No data

Results and discussion

Transformation products:
not measured
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
Hydrolysis rate constant:
ca. 0.085 min-1
DT50:
ca. 10.5 h
Type:
(pseudo-)first order (= half-life)
pH:
7
Temp.:
25 °C
Hydrolysis rate constant:
ca. 0.091 min-1
DT50:
ca. 9.4 h
Type:
(pseudo-)first order (= half-life)
pH:
9
Temp.:
25 °C
Hydrolysis rate constant:
ca. 0.173 min-1
DT50:
ca. 8.96 h
Type:
second order

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test substance had a half-life of 10.5 to 8.96 hours over a pH range of 4 - 9 at 25°C in aqueous solution.
Executive summary:

When evaluated in an O.E.C.D. test guideline 111 for Hydrolysis, the test substance, 2,3-epoxypropyl o-tolyl ether had a half-life of 10.5 to 8.96 hours over a pH range of 4 - 9 at 25°C in aqueous solution.