Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Long-term toxicity to fish

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

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

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. QA statement)

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.

Cross-reference 2

Reason / purpose for cross-reference:

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

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