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Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 November - 12 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
- Sample preparation: extraction in toluene (in duplicate)
- Sampling frequency: at time 0, 2.4 hours, 3 days and 5 days
Buffers:
- Preparation buffers: using Titrisol reagents (Merck), filtered and degassed for sterility
- Buffer solutions: pH 4.0, pH 7.0 and pH 9.0 (precision of 0.02 pH units)
- Batch no: 00408901 (pH 4), OC180288 (pH 7), 00449130 (pH 9)
Details on test conditions:
Test solutions (in 250 mL buffer solution, in test tube protected from light)
- pH 4.0: 0.0274 g test substance
- pH 7.0: 0.0161 g test substance
- pH 9.0: 0.0208 g test substance
Duration:
5 d
pH:
4
Initial conc. measured:
100 mg/L
Duration:
5 d
pH:
7
Initial conc. measured:
71 mg/L
Duration:
5 d
pH:
9
Initial conc. measured:
78.9 mg/L
Number of replicates:
2
Preliminary study:
Hydrolysis of the test substance was tested at 3 pH values (4.0, 7.0 and 9.0) at 50 deg C
Transformation products:
not measured
% Recovery:
106
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
102
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
90
pH:
9
Temp.:
50 °C
Duration:
5 d
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Details on results:
In preliminary test hydrolysis was below 10% after 5 days at all 3 pH values. In agreement with the guideline the test was considered complete and no further testing has been performed.
Validity criteria fulfilled:
yes
Conclusions:
The test substance is hydrolytically stable, with an estimated half life of more than 1 year at 25 degree C.
Executive summary:

Hydrolysis of 2,2 -bis(chloromethyl)trimethylene bis(bis(2 -chloroethyl)phosphate) at 100.0, 71.0 and 78.9 mg/L (measured concentration of test substance in buffer of pH 4.0, 7.0 and 9.0 at test initiation) was studied in the dark at 50ºC in sterile aqueous buffered solutions for 5 days.  The experiment was conducted in accordance with the EU Method C.7 and in compliance with the GLP standards. Samples were analysed at 0, 2.4 hours, 3 days and 5 days by extracting with toluene and the test material residues were analysed by GLC/FID.

 

At test termination, the concentration of the test compound decreased from 100% at day 0, to 106% of the initial at pH 4, from 100 to 102% of the initial at pH 7, and from 100 to 90% of the initial at pH 9.

 

The half-life (lives)/DT50 of the test material was estimated to be more than 1 year at pH 4, pH7, and pH 9, respectively.

 

This study is classified reliable without restrictions and satisfies the guideline requirement for hydrolysis study.

Description of key information

The test substance is hydrolytically stable, with an estimated half life of more than 1 year at 25 degreeC

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information

Read Across with 2,2 -bis(chloromethyl)trimethylene bis[bis(2-chloroethyl)phophate.


In a preliminary test hydrolysis was below 10% after 5 days at all 3 pH values. In agreement with the guideline, the test was considered complete and no further testing has been performed.