1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts

Sediment toxicity

Link to relevant study record(s)

Reference

Reference 1

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

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 species 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.

Reference 2

Endpoint:

sediment toxicity: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
C8-C18 AAPHS and C12-18 AAPHS have the same functional groups, and general composition. The main variable resides in the alkyl chain distribution.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical = C8-18 cocamidopropyl hydroxysultaine (EC 939-455-3).
Target chemical = C12-18 cocamidopropyl hydroxysultaine (EC 939-457-4).

3. ANALOGUE APPROACH JUSTIFICATION
The alkyl C-chain distribution of the source chemical significantly overlaps with the one of the target chemical, the C12-alkyl derivative being the major constituent in both chemicals. The structural differences in side C-chains is not expected to lead to significant differences on phys-chem properties.

4. DATA MATRIX
See "Documentation and scientific justification of the read-across approach" in section 13.2.

Reason / purpose for cross-reference:

read-across source

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

Remarks on result:

other: Corophium volutator (marine sp.)

Remarks:

read-across from EC 939-455-3

Conclusions:

By analogy with the source substance EC 939-455-3, a 10d-EC50 (mortality) greater than 8302 mg solids/kg sediment dw on the marine water crustacean species Corophium volutator was reported for the target substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-457-4) .

Description of key information

As the toxicity to sediment-dwelling species of the substance EC 939-457-4 has not been investigated experimentally, a read-across approach was followed to fill in the endpoint. The acute toxicity to the marine sediment-dwelling species Corophium volutator of a structural analogue substance (= source substance 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 10d-EC50 (mortality) of the analogue substance was found to be greater than 8302.0 mg solid content/kg sediment dw based on nominal concentrations. By analogy, the same EC50 value was reported for the target substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-457-4).

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 sediment-dwelling species of the structural analogue substance (= source substance 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 of the target substance EC 939-457-4.