1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts

Sediment toxicity

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

sediment toxicity: long-term

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

25 august 2006- 19 october 2006

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Too much lack of data : - information related to the test organisms (acclimatation, body length at the study initiation) - information related to the sediment : no data on the characteristic and the preparation of the sediment, no information concerning the ratio weight/dry sediment - no characterization of the test item No analytical monitoring showing that the concentrations of the test item were maintained during the test.

Qualifier:

according to guideline

Guideline:

other: OSPARCOM Guidelines (2005) - A Sediment bioassay using an amphipod Corophium sp.

Deviations:

yes

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on sediment and application:

- Source : Collected from the same site as the amphipods and sieved to remove organisms and debris. Stored in sealed containers until required.
- Characterisation : no data
- ratio wet/dry weight : no data

Test organisms (species):

Corophium volutator

Details on test organisms:

TEST ORGANISM
- Common name : Corophium volutator
- Source : From the Menai Straits, North Wales.
- Treatment at the laboratory : no data
- Age at study initiation : no data

ACCLIMATION :
- Acclimation period / acclimation conditions : stock amphipods were held in 13 litre storage vessels containing sieved sediment obtained from the collection site

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

Test temperature:

no data

pH:

no data

Dissolved oxygen:

no data

Salinity:

no data

Nominal and measured concentrations:

Range finding study : nomination concentrations of 10.0, 100.0 and 1000 mg/kg expressed as dry weight of sediment
Definitive study : 1000.0, 1778.3, 3162.3, 5623.4 and 10000.0 mg/kg expressed as dry weight of sediment

Details on test conditions:

TEST SYSTEM
- Test vessel:no data
- Location /organization :no data
- aeration : Air bubbled directly into the artificial seawater via polypropylene tubing for 12 hours prior to addition of test organisms and throughout the test period.

- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 5
- Biomass loading rate: no data
- Preparation of the vessels : Calculated amounts of test item were added to the vessels containing the wet sediment and mixed thoroughly with a clean spatula and 100 ml of seawater. Untreated controls were prepared in a similar way without the addition of the test material

TEST MEDIUM / WATER PARAMETERS
- Source :Artificial seawater (Coral Reef, Kent Sea, red Sea Fish Pharm) with a salinity between 25 and 35 perthousand.

OTHER TEST CONDITIONS
- Photoperiod: no data
- Light intensity: no data

Reference substance (positive control):

no

Duration:

10 d

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Executive summary:

The test item was assessed for its potential toxicity to the sediment re-worker amphipod volutator. The test was carried out based on the method detailed in the PARCOM protocol (PARCOM 1995) and in accordance with STL Runcorn SOP III.33.

Test organisms were introduced to sediment containing the test item over the nominal concentration range of 1000.0 to 10000.0 mg/kg dry weight of sediment and exposed for a period of ten days in a static test.

However, to much data failed in the report not permitting to evaluate this report correctly :

- information related to the test organisms (acclimatation, body length at the study initiation)

- information related to the sediments : no informatiion concerning the characteristic and the preparation of the sediment, no indication concerning the ratio weight/dry sediment

- no characterization of the test item

No analytical monitoring showing that the concentrations of the test item were maintained during the test.

For these reasons, the study was estimated to have a klimish 4 category.

Reference 2

Endpoint:

sediment toxicity: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 january 2009-11 march 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed according to an international guideline and according to GLP. The validity criteria were fulfilled except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, according to the long-term toxicity to Daphnia, the substance is stable during the test period (21-day). Thus, we can considered that in a short-tem study, the susbtance is also stable.

Qualifier:

according to guideline

Guideline:

other: OSPARCOM Guidelines (2005) - A Sediment bioassay using an amphipod Corophium sp.

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on sediment and application:

- Source : collected from a point adjacent to the site of Corophium collection
- Treatment on the laboratory : On return to the laboratory, the sediment was wet-sieved through 0.6 mm mesh to remove larger infaunal organisms and Corophium within the test soze range, and allowed to settle polyethylene containers. After setting, the supernatantwater was decanted and the sediment stored in a room at approximately 4 +/- 2°C, until required for testing.
- Characterisation : particule size analysis characterised the sediment as well-sorted, fine sand with a silt/clay content of 3.56% by weight. median particle was 151 µm. The organic material content was estimated from weight loss on ignition to be 1.34%.
- ratio wet/dry weight : immediately befire the initiation of the test, the sediment was thoroughly homogenised and a representative sample taken dor wet and dry weight determination. The ratio of wet weight to dry weight was subsequently used to convert nominal exposure concentrations on a wet weight basis to nominal exposure concentrations on a dry weight basis.
The wet to dry ratio of sediment was found to be of 1.66.

Test organisms (species):

Corophium volutator

Details on test organisms:

TEST ORGANISM
- Common name : Corophium volutator
- Source : collected on 12 january 2009 from a site in the bay of Suckquoy, Toab in Orkney. Specimens were gently sieved from their native sediment and held in plastic containers (approximately 5L capacity) containing some ambient water, with a small amount of detritus, until tranfer to the laboratory.
- Treatment at the laboratory : On return to the laboratory, the Corophium were transferred in ambient water to polythene tanks of approximately 200 L capacity, gentle aeration was suppplied. The tank were held in a controlled-temperature room at approximately 15 +/- 2°C.
- Age at study initiation : specimens of approximately 5 mm in body length (excluding rostum)

ACCLIMATION :
- Acclimation period / acclimation conditions : the stock anaimals were gradually acclimated from the ambient salinity of less than 5 per thousand to that of undiluted seawater (approximately 35 per thousand) in increments of approximately 10 per thousand per day. Once acclimation is complete, the stock tanks were maintained under semi-static conditions until the initiation of the test. The holding period in the laboratory was 4 days prior to testing.Sufficient detrital material is retained in each tank to provide food and some bottom cover, but not of a density that prevents daily observation of mortality and morbidity. dead or impaired are removed when observed.

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

Test temperature:

14.3-15.9

pH:

7.98-8.38

Dissolved oxygen:

91-100

Salinity:

32-37 ppt (control)

Nominal and measured concentrations:

Nominal test concentrations : 16.58, 166.19, 532.51, 1659.56 and 16604.03 mg/kg dw sediment

Details on test conditions:

TEST SYSTEM
- Test vessel: 1 L capacity glass beakers containing 2 cm depth (approximately 150 ml). the beakers
- Location /organization : the beakers were assigned positions within the test aera, arranged in rows of three to five and spaced to maintain effective separation of different treatments. Each row was covered with a rectangular sheet of perspex perforated with a small hole above the centre of each beaker.
- aeration : provided / a stream of air bubbles were released at a depth of approximately 6 cm

- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 5

TEST MEDIUM / WATER PARAMETERS
- Source : Seawater was supplied by pump from Scapa Flow, Orkney. All seawater was UV sterilised and filtered to 1µm before being employed for testing.

TEST SOLUTIONS
- Method : the test solutions were prepared without using of any organic solvent
- Stock solution : a 1000 mg/L stock solution was prepared in filtered seawater and the resulting mixture was stirred for one hour.
- Controls : treated seawater without test item
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No

OTHER TEST CONDITIONS
- Photoperiod: constant dim illumination
- Light intensity: no data

VEHICLE CONTROL PERFORMED: no

Reference substance (positive control):

no

Duration:

10 d

Dose descriptor:

LC50

Effect conc.:

> 16 604 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

10 d

Dose descriptor:

LC50

Effect conc.:

> 8 302 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

other: solid content

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

LC50

Effect conc.:

> 6 973.7 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

1 659.6 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

697.3 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

829.8 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

other: solid content

Basis for effect:

mortality

Validity criteria fulfilled:

yes

Remarks:

The test met all relevant validity criteria.

Conclusions:

The test item exhibited a 10 day LC50 value greater than 16604.03 mg/kg sediment dw (corresponding to > 8302.0 mg solid content/kg sediment dw and > 6973.7 mg active content/kg sediment dw) to the marine amphipod Corophium volutator. The result is based on nominal concentrations. There were no interferences in the test.

Executive summary:

The acute toxicity of the test item (= substance EC 939-455-3 in aqueous commercial product) to the marine benthic crustacean Corophium volutator was investigated in a GLP-compliant study performed in accordance with OSPARCOM  Guidelines 2005 (A Sediment bioassay using an amphipod Corophium sp.). The 10-day 50% effective concentration EC50 (mortality) of the test item was found to be greater than 16604.03 mg/kg sediment dw (corresponding to > 8302.0 mg solid content/kg sediment dw and > 6973.7 mg active content/kg sediment dw) based on nominal concentrations.

Description of key information

The acute toxicity to the marine benthic crustacean species Corophium volutator of the substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-455-3) was investigated in a GLP-compliant study (Hudson, 2009) performed in accordance with OSPARCOM Guidelines 2005 (A Sediment bioassay using an amphipod Corophium sp.). The 10-day EC50 (mortality) of the substance was found to be greater than 8302.0 mg solid content/kg sediment dw based on nominal concentrations.The acute toxicity to aquatic benthic crustacean species was investigated in one other study (Rendell, 2006) which was not considered in the assessment due to major methodological deficiencies and insufficient documentation.

Key value for chemical safety assessment

EC50 or LC50 for marine water sediment:

8 302 mg/kg sediment dw

Additional information

The acute toxicity to marine benthic crustacean species substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-455-3) was investigated in a GLP-compliant study (Hudson, 2009) performed in accordance with standard methods, without deviations. The study is considered as reliable with restrictions (Klimisch 2) and was selected as key study for the endpoint. The other available study (Rendell, 2006) is considered as not reliable (Klimisch 3) and was disregarded for the endpoint.