Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27/03/2018 - 26/04/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
yes
Remarks:
See "Principles of method if other than guideline"
Principles of method if other than guideline:
The deviation from the study plan occurred in the preparation of additive solution.
The preparation of the 27.9 mg/L test item solution was performed but it was not described in the study plan.

It was concluded that there were no adverse effects on the reliability and completeness of this test, because the study plan was not corrected about this procedure, and the correct procedure was actually performed for this study.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
gas: vapour
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Buffers:
pH 4.0

The solution was prepared by mixing 4.5 mL of 1 mol/L sodium hydroxide solution and 50 mL of 0.5 mol/L potassium dihydrogen citrate solution, and then filling up to 500 mL with purified water, and then adjusting to pH 4.0 with 1 mol/L hydrochloric acid.

pH 7.0

The solution was prepared by mixing 14.8 mL of 1 mol/L sodium hydroxide solution and 50 mL of 0.5 mol/L potassium dihydrogenphosphate solution, filling up to 500 mL with purified water, and then adjusting to pH 7 .0 with 1 mol/L hydrochloric acid.

pH 9.0

The solution was prepared by mixing 10.7 mL of 1 mol/L sodium hydroxide solution and 50 mL of0.5 mol/L potassium chloride and 0.5 mol/L boric acid solution, filling up to 500 mL with purified water, and then adjusting to pH 9.0 with 1 mol/L sodium hydroxide solution.
Details on test conditions:
Test conditions
Test concentration - 1120mg/L
pH of test solution - pH4.0, pH7.0 and pH9.0
Test temperature - 50±0.5°C
Test duration - 5 days
Measurement point - At initiation and after 5 days
Number of test repetition - 2 (at measurement point)
Light condition - Light-free condition (test vessels are covered with aluminium foil)
Duration of testopen allclose all
Duration:
5 d
pH:
4
Temp.:
50 °C
Duration:
5 d
pH:
7
Temp.:
50 °C
Duration:
5 d
pH:
9
Temp.:
50 °C
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
The preliminary study indicated that the substance was hydrolytically stable at all of the tested pHs (4 - 9)
Transformation products:
no
Total recovery of test substance (in %)open allclose all
% Recovery:
>= 89.1 - <= 92.2
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
>= 90.3 - <= 90.7
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
>= 90.1 - <= 91.4
pH:
9
Temp.:
50 °C
Duration:
5 d
Dissipation DT50 of parent compound
Key result
Remarks on result:
hydrolytically stable based on preliminary test

Applicant's summary and conclusion

Conclusions:
HCFO-1233yd(Z) is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.
Executive summary:

As the results of residual percentage of the test item was larger than 90%. Therefore, the test item is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.