1,1,1"((methylsilanetriyl)tris)(oxy))tris(2-methylpropan-2-amine)

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two hydrolysis studies as-
WoE 2 and WoE 3.

GLP compliance:

not specified

Radiolabelling:

not specified

Analytical monitoring:

not specified

Details on test conditions:

WoE 2:
- The test substance was dissolved in buffer at pH 4, 7 and 9 and maintained at 50°C for a total of 125 hr in a preliminary test
- The incubated vessels were sampled at approximately 5.5, 22.8, 28.7, 95.1, 100.8, 119.4 and 125 hours after starting the incubation
- The samples taken from the vessels were assays for test material using capillary electrophorsis
- If the test material demonstrated hydrolysis in a certain range, further test would be conducted to better define the kinetics of the reaction

WoE 3: no data available

Duration:

125 h

Temp.:

50 °C

Remarks:

WoE 2: pH was reported as 4, 7 and 9, respectively.

Temp.:

25 °C

Remarks:

WoE 3: Other details not known

Positive controls:

not specified

Negative controls:

not specified

Preliminary study:

WoE 2:
- After incubation at pH 4, 7 or 9 for up to 125 hours the concentration of test material was similar with the starting concentration
- Concentration of the test material did not decrease with time and was as follows at the beginning and end of the incubation period
- A secondary test was not required according to the OECD 111 criteria

WoE 3: no data available

Test performance:

WoE 2: The hydrochloride salt and the free base are identical in buffered solution
WoE 3: no data available

Transformation products:

not specified

Details on hydrolysis and appearance of transformation product(s):

WoE 2: - No degradation products
WoE 3: no data available

Key result

Temp.:

50 °C

DT50:

> 1 yr

Remarks on result:

other: at temperature 25°C/50°C and at pH 4, 7 and 9, respectively.

WoE 2:

pH	Time = 0 h	Time = 125 h
	[mg/L]	[mg/L]
4	657.8	656.9
7	684.2	689.0
9	694.0	702.2

Validity criteria fulfilled:

not specified

Conclusions:

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the results, the hydrolysis half-life value of test chemical can be expected as >1 yr at 25°C/50°C and pH of 4, 7 and 9, respectively. Thus, test chemical was considered to be hydrolytically stable.

Executive summary:

Data available of the read across chemicals has been reviewed to determine the hydrolysis half-life value of test chemical. The studies are as mentioned below:

Hydrolysis study was carried out for determining the half-life value of test chemical. The study was performed in accordance with the OECD Guideline 111 (Hydrolysis as a Function of pH). The test substance was dissolved in buffer at pH 4, 7 and 9 and maintained at 50°C for a total of 125 hr in a preliminary test. The incubated vessels were sampled at approximately 5.5, 22.8, 28.7, 95.1, 100.8, 119.4 and 125 hours after starting the incubation. The samples taken from the vessels were assays for test material using capillary electrophoresis. If the test material demonstrated hydrolysis in a certain range, further test would be conducted to better define the kinetics of the reaction. After incubation at pH 4, 7 or 9 for up to 125 hours the concentration of test material was similar with the starting concentration. Concentration of the test material did not decrease with time and was as follows at the beginning and end of the incubation period. A secondary test was not required according to the OECD 111 criteria. The hydrochloride salt and the free base are identical in buffered solution. No degradation products were formed. Hydrolysis half-life value of test chemical was determined to be >1 yr at 50°C and pH of 4, 7 and 9, respectively. Thus, test chemical was considered to be hydrolytically stable.

Another hydrolysis study was carried out for determining the half-life value of test chemical. The hallf-life value of test chemical was determined to be 1 yr at 25°C. Thus, test chemical was considered to be stable in water.

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the results, the hydrolysis half-life value of test chemical can be expected as >1 yr at 25°C/50°C and pH of 4, 7 and 9, respectively. Thus, test chemical was considered to be hydrolytically stable.

Description of key information

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the results, the hydrolysis half-life value of test chemical can be expected as >1 yr at 25°C/50°C and pH of 4, 7 and 9, respectively. Thus, test chemical was considered to be hydrolytically stable.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

50 °C

Additional information

Data available of the read across chemicals has been reviewed to determine the hydrolysis half-life value of test chemical. The studies are as mentioned below:

 

Hydrolysis study was carried out for determining the half-life value of test chemical. The study was performed in accordance with the OECD Guideline 111 (Hydrolysis as a Function of pH). The test substance was dissolved in buffer at pH 4, 7 and 9 and maintained at 50°C for a total of 125 hr in a preliminary test. The incubated vessels were sampled at approximately 5.5, 22.8, 28.7, 95.1, 100.8, 119.4 and 125 hours after starting the incubation. The samples taken from the vessels were assays for test material using capillary electrophoresis. If the test material demonstrated hydrolysis in a certain range, further test would be conducted to better define the kinetics of the reaction. After incubation at pH 4, 7 or 9 for up to 125 hours the concentration of test material was similar with the starting concentration. Concentration of the test material did not decrease with time and was as follows at the beginning and end of the incubation period. A secondary test was not required according to the OECD 111 criteria. The hydrochloride salt and the free base are identical in buffered solution. No degradation products were formed. Hydrolysis half-life value of test chemical was determined to be >1 yr at 50°C and pH of 4, 7 and 9, respectively. Thus, test chemical was considered to be hydrolytically stable.

 

Another hydrolysis study was carried out for determining the half-life value of test chemical. The hallf-life value of test chemical was determined to be 1 yr at 25°C. Thus, test chemical was considered to be stable in water.

 

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the results, the hydrolysis half-life value of test chemical can be expected as >1 yr at 25°C/50°C and pH of 4, 7 and 9, respectively. Thus, test chemical was considered to be hydrolytically stable.