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: Study according to OECD 111

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
name: Cyanamide, (4,5-dihydroxy-2-thiazolyl)-
molecular formula: C4 H5 N3 S
molecular weight: 127.2
physical state: solid
analytical purity: 99.8 %
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals for the parent/transformation products: After approx. 12 hrs. of incubation at 50 °C the for each buffer and each test substance 2 samples were taken out of the incubator and were worked up to get the initial value. The same was done with 2 samples after 8 days of storage at 50°C counting from the time the initial samples were taken. Four more samples were stored and kept in reserve.
- Sampling intervals/times for pH measurements: see above
- Sampling intervals/times for sterility check: At the start time of the test (initial value) and after 8 days of storage at 50 °C samples in each buffer were taken to check the sterility of the test solutions.
Buffers:
pH4(0.01mol) = 2.10g C6H8O7x1H2O/1IH2O; adjusted to pH4 (NaOH in H2O)
pH7(0.01mol) = 3.58g Na2HPO4x12H2O/1IH2O; adjusted to pH7 (H3PO4 in H2O)
pH9(0.01mol) = 3.81g Na2B4O7x10H20/1IH2O; adjusted to pH9 (H3PO4 in H2O)





Details on test conditions:
TEST SYSTEM
- Type, material and volume of test flasks, other equipment used:
- Sterilisation method:
- Lighting:
- Measures taken to avoid photolytic effects:
- Measures to exclude oxygen:
- Details on test procedure for unstable compounds:
- Details of traps for volatile, if any
- If no traps were used, is the test system closed/open
- Is there any indication of the test material adsorbing to the walls of the test apparatus?
TEST MEDIUM
- Volume used/treatment
- Kind and purity of water:
- Preparation of test medium:
- Renewal of test solution:
- Identity and concentration of co-solvent:
OTHER TEST CONDITIONS
- Adjustment of pH:
- Dissolved oxygen:
Duration of test
Duration:
8 d
Initial conc. measured:
ca. 50 mg/L
Number of replicates:
2 at each pH
Positive controls:
no
Negative controls:
no

Results and discussion

Preliminary study:
As the substance was found to be stable at 50 °C at pH 4, 7 and 9.
Transformation products:
no
Details on results:
TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
CIT is hydrolytically stable.
Executive summary:

The hydrolysis of CIT was performed according to the OECD Guidelines No. 111 in 0.01 mol aqueous buffer solutions adjusted to pH 4, 7 and 9. CIT was found to be stable at 50 °C in buffered solutions at pH 4, 7 and 9 corresponding to a half-life of greater than 1 year at 25 °C.