Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-03-08 to 2012-03-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
(2004)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
(2008)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
Samples were taken at 0 h and after 120 h. All samples were stabilised with methanol (dilution factor 1:2) within the test container and analysed. All test item containing samples were analysed immediately (within 30 min for pH 7, for technical reasons slightly later for pH 4 and 9).
Buffers:
pH 4: 45 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2-Citrate and diluted to 500 mL with double distilled water.
pH 7: 148.15 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2PO4, diluted to 500 mL with double distilled water.
pH 9: 106.5 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L H3BO3 in 0.1 mol/L KCL, diluted to 500 mL with double distilled water
Details on test conditions:
Stock solution: 100 mg/L in acetonitrile
Co-solvent: Methanol, 10 % (v/v)
Test concentration: 150 µg/L in buffer solution(s)
Control: Sterile buffer solutions (pH value 4, 7 and 9)
Temperature: 50 ± 0.5 °C, checked automatically once in an hour and manually once per working day: minimum 49.7 °C, maximum of 50.3 °C
Duration:
120 h
Temp.:
50 °C
Initial conc. measured:
>= 124 - <= 133 µg/L
Number of replicates:
Duplicates
Positive controls:
no
Negative controls:
yes
Remarks:
(Sterile buffer solutions, pH 4, 7 and 9)
Statistical methods:
average of two determinations
Preliminary study:
The test item was found to be stable in the preliminary test at pH 4, 7 and 9 at 50 °C. Initial and final concentrations are reported below.
Test performance:
Main test: not required
Transformation products:
no
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
pH:
9
Temp.:
25 °C
DT50:
> 1 yr

pH-Value of the Test System (50 °C)

measured at test temperature on day of preparation (before sterilisation)

 

Intended pH-value

Measured pH-value at

50 °C

4.0 ± 0.1

4.07

7.0 ± 0.1

7.02

9.0 ± 0.1

9.00

Hydrolysis Results at pH 4 and 50 °C

 

Hydrolysis Time

[hours]

Replicate

Concentration

 

[µg/L]

Mean

Degradation

 

[%]

0

1

126

126

-

2

126

120

1

109

120

4.76

2

131

 

Hydrolysis Results at pH 7 and 50 °C

 

Hydrolysis Time

[hours]

Replicate

Concentration

 

[µg/L]

Mean

Degradation

 

[%]

0

1

124

124

-

2

124

120

1

140

139

0.00

2

138

 

 

Hydrolysis Results at pH 9 and 50 °C

 

Hydrolysis Time

[hours]

Replicate

Concentration

 

[µg/L]

Mean

Degradation

 

[%]

0

1

129

131

-

2

133

120

1

126

127

3.05

2

127

 

Validity criteria fulfilled:
yes
Conclusions:
According to the guideline a half life of > 1 year under environmental conditions can be assumed.
Executive summary:

The hydrolysis of 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane was tested according to OECD TG 111 (2004) and EU Method C.7 (2008). In the preliminary test, less than 10% of the test substance was observed to hydrolyse at 50 °C at pH 4,7 and 9 after 120 hours. Performance of the main test was not required. According to the guideline a half life of > 1 year under environmental conditions can be assumed.

Description of key information

The hydrolysis of 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane was tested according to OECD TG 111 (2004) and EU Method C.7 (2008). In the preliminary test, less than 10% of the test substance was observed to hydrolyse at 50 °C at pH 4,7 and 9 after 120 hours. Performance of the main test was not required. According to the guideline a half life of > 1 year under environmental conditions can be assumed.

Key value for chemical safety assessment

Additional information