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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Biodegradation in water: screening tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: SETAC-Europe guidelines (published March 1995)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Substance ID: [14C-POP]DPX-JE874
Lot Number: 3048-237
Radiochemical Purity: 99.2%
Specific Activity: 61.8 µCi/mg

Substance ID: [14C-PA]DPX-JE874
Lot Number: 3048-238
Radiochemical Purity: 98.7%
Specific Activity: 58.5 µCi/mg
Oxygen conditions:
aerobic
Inoculum or test system:
other: Aerobic Water/sediment systems
Duration of test (contact time):
>= 21 - <= 30 d
Initial conc.:
50 µg/L
Parameter followed for biodegradation estimation:
radiochem. meas.
Key result
Parameter:
other: DT50 water ([14C-POP]test substance pH 7.1 system)
Remarks on result:
other: 0.07 h
Key result
Parameter:
other: DT50 system ([14C-POP]test substance pH 7.1 system)
Remarks on result:
other: 0.8 d
Key result
Parameter:
other: DT50 water ([14C-POP]test substance pH 7.7 system)
Remarks on result:
other: 0.43 h
Key result
Parameter:
other: DT50 system ([14C-POP]test substance pH 7.7 system)
Remarks on result:
other: 0.68 d
Key result
Parameter:
other: DT50 water ([14C-PA]test substance pH 7.7 system)
Remarks on result:
other: 0.48 h
Key result
Parameter:
other: DT50 system ([14C-PA]test substance pH 7.7 system)
Remarks on result:
other: 2.05 d
Conclusions:
Based on this study, the test substance and its degradation products should dissipate rapidly from natural water/sediment systems.
The DT50 values in water and system were 0.007 hours and 0.80 days for the [14C-POP]test substance pH 7.1 system. The DT50 values in water and system were 0.43 hours and 0.68 days or the [14C-POP]test substance pH 7.7 system. The DT50 values in water and system were 0.48 hours and 2.05 days for the [14C-PA]test substance pH 7.7 system.
Executive summary:

The objectives in this study were to determine the rate and pattern of degradation of the test substance in two water/sediment systems and to determine mass balance. The rate of degradation of the test substance was evaluated using the [14C-POP]test substance in two water/sediment systems with differing characteristics: pH 7.1 and pH 7.7 systems (pH of the aqueous phase). The route of degradation of [14C-PA]test substance was characterized in the pH 7.7 system so that the degradation and metabolism of the parent molecule could be fully assessed. This study demonstrated that the test substance is readily and completely degraded under aerobic conditions in a water/sediment system.


The DT50 values in water and system were 0.007 hours and 0.80 days for the [14C-POP]test substance pH 7.1 system. The DT50 values in water and system were 0.43 hours and 0.68 days for the [14CPOP]test substance pH 7.7 system. The DT50 values in water and system were 0.48 hours and 2.05 days for the [14C-PA]test substance pH 7.7 system.


The DT90 values in water and system were 23 hours and 15 days for the [14C-POP]test substance pH 7.1 system. The DT90 values in water and system were 1.6 hours and 14 days for the [14C-POP]test substance pH 7.7 system. The DT90 values in water and system were 1.7 hours and 54 days for the [14C-PA]test substance pH 7.7 system.


The DT50 and DT90 values were generally in good agreement between all systems, even though the [14C-PA]test substance system was designed to assess the route of degradation only (smaller number of sample intervals). The difference between the DT90 value in the PA and POP labels may be caused by the smaller number or time points which may have skewed the data. The mean mass balance in all systems was over 92%.


In both [14C-POP]test substance systems, the major terminal degradation products of the test substance were CO2 and unextractable residues. The patterns of formation and decline of IN-KZ007, IN-H3310, IN-JL856, and IN-JS940 were well established in all systems by 21 to 30 days. As the test substance and its metabolites declined in the water/sediment systems, CO2 and unextractable residues increased.


In the [14C-PA]test substance system, the major terminal degradation product of the test substance was unextractable residues. The patterns of formation and decline of IN-KZ007, IN-JL856 and the polar degradation products were well established by 21 days. The formation of organic volatile component(s) reached a plateau at 14 days of <10% of the applied radioactivity. As the test substance and its metabolites declined in the water/sediment systems, the unextractable residues increased.


Based on this study, the test substance and its degradation products should dissipate rapidly from natural water/sediment systems.

Description of key information



















Study Type



 Study Details



Value



 Guideline



Reliability 



Biodegradation in water



Biodegradation in Aerobic Water/sediment systems



Readily Biodegradable



SETAC-Europe guidelines



1


Key value for chemical safety assessment

Additional information