Registration Dossier
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EC number: 955-780-3 | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Remarks:
- Experimental data of read across substances
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data for the target chemical is summarized based on the read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- WoE report is based on hydrolysis studies as-
WoE 2 ,WoE 3 and WoE 4. - GLP compliance:
- not specified
- Radiolabelling:
- not specified
- Analytical monitoring:
- yes
- Buffers:
- WoE 4- pH: 4, 7,9
- Details on test conditions:
- WoE 4- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Brown glass reaction flasks
- Sterilisation method: The buffered aqueous solutions were heated at 121 °C for 15 min.
- Measures taken to avoid photolytic effects: By using brown glass reaction flasks - pH:
- 7
- Temp.:
- 25 °C
- Remarks:
- WoE -2
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Remarks:
- WoE -4
- Positive controls:
- not specified
- Negative controls:
- not specified
- Transformation products:
- not specified
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 - < 46 yr
- Type:
- not specified
- Remarks on result:
- other: Test chemical was found to be stable in water.
- Validity criteria fulfilled:
- not specified
- Conclusions:
- On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the hydrolysis of test chemical in water, the half-life, DT50 value of test chemical was found to be > 1 to < 46 years at pH 4 to 9 and temperature of 25°C.
- Executive summary:
Data available of the structurally similar read across chemicals has been reviewed to determine the hydrolysis of test chemical in water. The studies are as mentioned below:
The first study of hydrolysis was carried out for test chemical in water. The half-life, DT50 value of test chemical was found to be 46 years at pH 7 and temperature of 25°C. On the basis of result the test chemical was found to be stable in water.
The second study of hydrolysis was carried out for test chemical in water. The half-life, DT50 value of test chemical was found to be > 1 year at pH 4 to 9. On the basis of result the test chemical was found to be stable in water.
The third study of hydrolysis was carried out by Directive 84/449/EEC, C.10. The test was performed at pH 4, 7, and 9 and a temperature of 50 °C. Analytical monitoring of test substance was done by HPLC using an external standard. The buffered aqueous solutions were heated at 121 °C for 15 min before use to assure sterility. The exclusion of photolytic effects was done by using brown glass reaction flasks. The half-life, DT50 value of test chemical was found to be > 1 year at pH 4, 7 and 9 and a temperature of 25 °C. On the basis of result, the test chemical was found to be stable in water.
On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the hydrolysis of test chemical in water, the half-life, DT50 value of test chemical was found to be > 1 to < 46 years at pH 4 to 9 and temperature of 25°C. On the basis of result the test chemical was found to be stable in water
Reference
Description of key information
On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the hydrolysis of test chemical in water, the half-life, DT50 value of test chemical was found to be > 1 to < 46 years at pH 4 to 9 and temperature of 25°C.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
Data available of the structurally similar read across chemicals has been reviewed to determine the hydrolysis of test chemical in water. The studies are as mentioned below:
The first study of hydrolysis was carried out for test chemical in water. The half-life, DT50 value of test chemical was found to be 46 years at pH 7 and temperature of 25°C. On the basis of result the test chemical was found to be stable in water.
The second study of hydrolysis was carried out for test chemical in water. The half-life, DT50 value of test chemical was found to be > 1 year at pH 4 to 9. On the basis of result the test chemical was found to be stable in water.
The third study of hydrolysis was carried out by Directive 84/449/EEC, C.10. The test was performed at pH 4, 7, and 9 and a temperature of 50 °C. Analytical monitoring of test substance was done by HPLC using an external standard. The buffered aqueous solutions were heated at 121 °C for 15 min before use to assure sterility. The exclusion of photolytic effects was done by using brown glass reaction flasks. The half-life, DT50 value of test chemical was found to be > 1 year at pH 4, 7 and 9 and a temperature of 25 °C. On the basis of result, the test chemical was found to be stable in water.
On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the hydrolysis of test chemical in water, the half-life, DT50 value of test chemical was found to be > 1 to < 46 years at pH 4 to 9 and temperature of 25°C. On the basis of result the test chemical was found to be stable in water
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