Registration Dossier

Administrative data

Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The substance was not very hazardous fish in acute studies and from tier 1 tests, invertebrates appear to be more sensitive organisms than fish. Further animal testing is not justified
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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:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
48 hours
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Performed on marine invertebrate
Guideline study 2008, well reported to GLP
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 72-3 (Estuarine/Marine Fish, Mollusk, or Shrimp Acute Toxicity Test)
Principles of method if other than guideline:
Concentrations of up to 2000 mg/l of the 40% actives material was tested (up to 800 mg/l actives)
GLP compliance:
yes
Specific details on test material used for the study:
Tested as supplied at ca 40% actives in water
Analytical monitoring:
no
Remarks:
Substance supplied in water and considered soluble and stable under the conditions of the test. However, reduced solublity in seawater was reported.
Vehicle:
no
Details on test solutions:
Direct addition to water
Test organisms (species):
other: Acartia tonsa
Details on test organisms:
At the start of the test, the invertebrates were 13 - 15 days old
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20 C
pH:
8.1
Salinity:
31.2 g/l
Nominal and measured concentrations:
0, 200, 355, 632, 1124, 2000 mg/l expressed as 40% solution as supplied (ie maximum 800 mg/l actives)
Reference substance (positive control):
yes
Remarks:
3,5-dichlorophenol at 1 mg/l
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 1 242 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
40% actives
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 500 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
< 800 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
coagulation of the embryo
Details on results:
The top dose of 2000 mg/l of substance supplied (800 mg/l actives) reslted in 100% effect
Results with reference substance (positive control):
65% effect at 1 mg/l; considered valid
Validity criteria fulfilled:
yes
Conclusions:
EC50 on marin invertebrate > 100 mg/l.
On this basis, classification is not required

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion