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

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

other:

Justification for type of information:

Rapid biodegradation and high water solubility means entry to soil compartment not likely
Work on marine sediment organisms shows very low toxicity, possibly due to rapid biodegradation under natural conditions.
No uses that could lead to direct contact with soil

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

sediment toxicity: short-term

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

10 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Justification for type of information:

Performed according to PARCOM guidelines, accepted fof assessment of off-shore chemicals

Qualifier:

according to guideline

Guideline:

ASTM E1367 (10-day Static Sediment Toxicity Test (Media: Sediment-marine))

Version / remarks:

PARCOM 2005

Principles of method if other than guideline:

According to PARCOM

GLP compliance:

yes

Specific details on test material used for the study:

40% actives commercial grade material

Analytical monitoring:

no

Vehicle:

yes

Remarks:

Artificial seawater, 25 - 35% salinity

Details on sediment and application:

Natural sediments from Irish sea at the same sites as the Coropium were taken

Test organisms (species):

Corophium volutator

Details on test organisms:

Collected from Irish Sea at same site as sediment used.
Study started 2 days after collection

Study type:

laboratory study

Test type:

static

Water media type:

saltwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

10 d

Exposure phase:

total exposure duration

Nominal and measured concentrations:

Range-finder up to 10 000 mg/kg dry weight of sediment, expressed as 40% actives supplied (4000 mg/kg actives)
Main study 0, 1000, 1778, 3162, 5623 and 10 000 mg/kg, expressed as 40% actives (up to 4000 mf/kg actives)

Reference substance (positive control):

no

Key result

Duration:

10 d

Dose descriptor:

EC0

Effect conc.:

> 4 000 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

EC0

Effect conc.:

> 10 000 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Mortality rates of 7 - 33% were seen in the various groups, but this was not dose concentration related, with control group showing 21% mortality (marginally higher than recommended limit of 20%.

Validity criteria fulfilled:

yes

Remarks:

although control mortality of 21% was marginally higher than recommended limit of 20%

Conclusions:

Considered non-hazardous in sediments

Cross-reference 2

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 3

Reason / purpose for cross-reference:

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