Registration Dossier

Administrative data

Endpoint:
adsorption / desorption: screening
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance has a low octanol water partition coefficient and the adsorption potential of this substance is related to this parameter
the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption
the study does not need to be conducted because the substance and its relevant degradation products decompose rapidly
Justification for type of information:
The substance is highly soluble in water and dissociates to triethanolamine and succinic acid. These substances biodegrade rapidly (as indicated by the biodegradation study).
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Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
biodegradation in water: screening test, other
Remarks:
Seawater : Closed bottle
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 day
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study performed to GLP.
This study is known to be more stringent on assessment of biodegradation than screening studies using sewage treatment plant innoculum and a pass in this study is a good indicator of biodegradation potential.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 306 (Biodegradability in Seawater)
Version / remarks:
Closed bottle using natual seawater
Principles of method if other than guideline:
28 day closed-bottle test, using natural seawater.
The seawater was enhanced with trace elements and a low level of phosphates and checks made that microbial counts were within specification.
Nitrification inhibitors were added to prevent distortion of results from nitrate metabolism.
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Batch SRK 184/14
Purity 43%
clear yellow liquid
Oxygen conditions:
aerobic
Inoculum or test system:
natural water: marine
Details on inoculum:
Natural sea water, pH 7.9. Test performed at ca 20 C
The seawater was enhanced with trace elements and a low level of phosphates and checks made that microbial counts were within specification.
Nitrification inhibitors were added to prevent distortion of results from nitrate metabolism.
Duration of test (contact time):
28 d
Initial conc.:
2 mg/L
Based on:
formulation
Initial conc.:
ca. 0.9 mg/L
Based on:
act. ingr.
Parameter followed for biodegradation estimation:
DOC removal
Reference substance:
acetic acid, sodium salt
Parameter:
% degradation (DOC removal)
Value:
39
Sampling time:
6 d
Parameter:
% degradation (DOC removal)
Value:
55
Sampling time:
14 d
Parameter:
% degradation (DOC removal)
Value:
55
Sampling time:
20 d
Key result
Parameter:
% degradation (DOC removal)
Value:
61
Sampling time:
28 d
Details on results:
60% acheived over 28 days as percentage of ThOD
Results with reference substance:
Valid, with ca 100% degradation recorded
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
The interprestion as 'readily biodegradable, but failing 10-day window' typically applies to sewage-based screening methods that are typically less difficult to pass. The sewater protocol has a very low microbial count to mimic the impact of spills in marine use.

Therefore a 'pass' in the marine assay is seen as a good indicator of rapid biodegradation in water treatment plants.
Executive summary:

Considered rapidly biodegradable for purposes of classification and is probably passing the 10 -day window if tested by sewage-system assays.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Substance is manufactured in water and considered fully soluble at 40% solution.
On heating to reduce water content, the substance starts to decompose.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The substance is manuafactured as ca 40% in water. An attempt was made to reduce the water level (ie increase concentration > 40%), but on heating, the substance appears to decompose.
The 40% solution is fully miscible in water, with a slight haze (impurities?)
GLP compliance:
no
Type of method:
other: Attempt to concentrate an existing solution
Key result
Water solubility:
> 400 g/L
Conc. based on:
act. ingr.
Temp.:
20 °C
pH:
ca. 6.2

Sample Description Percentage Non-Volatiles

Sample as received 40.33%

Sample after drying 93.92

The results show that the product contains ~60% water, and that ~95% has been removed after drying.

Conclusions:
Considered very soluble in water, but slight haze indicated present of less soluble fractions / impurities

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion