Alkanes, C14-17-branched and linear

Sediment toxicity

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

sediment toxicity: long-term

Type of information:

(Q)SAR

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

Detailed information covering the calculation model, compositional data used as input, validity, applicability and adequacy of the result are in the attached document.

The registered substance is a complex petroleum UVCB whose constituents have variable physicochemical properties. Therefore, a modeling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole.

The target lipid model (TLM) is a framework that relates toxicity to the physicochemical properties of a nonpolar organic constituent. The TLM, and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. This framework utilizes organic carbon partition coefficients (KOC) to convert aquatic based effect levels (CW) to bulk soil- and sediment-based effect levels. The combined TLM-EqP framework was validated previously for soil and sediment acute and chronic toxicity endpoints. The constituents in this substances are within the scope of the TLM and EqP frameworks. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry.

Principles of method if other than guideline:

The target lipid model (2015) and equilibrium partitioning model as described in the cited references were used to determine soil or sediment effect levels following an estimation of initial loading of the registered substance and its constituents in the substrate. A full explanation of the calculation method is provided in the 'attached justification'. For model description and justification of QSAR prediction: see fields 'justification for type of information' and 'attached justification'

Test organisms (species):

Lumbriculus variegatus

Duration:

28 d

Key result

Duration:

28 d

Dose descriptor:

other: LL50

Effect conc.:

32 456 mg/kg sediment dw

Nominal / measured:

estimated

Conc. based on:

other: QSAR prediction

Basis for effect:

mortality

Remarks on result:

other: QSAR predicted value

Key result

Duration:

28 d

Dose descriptor:

other: EL10

Effect conc.:

6 218 mg/kg sediment dw

Nominal / measured:

estimated

Conc. based on:

other: QSAR prediction

Basis for effect:

other: reproduction

Remarks:

biomass

Remarks on result:

other: ACR 5.22 (McGrath et al., 2018)

Remarks:

QSAR predicted value

Details on results:

Chronic endpoints were estimated using typical acute-to-chronic ratio of 5.22 (McGrath et al., 2018).

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of this substance to sediment dwelling organisms has been predicted using the target lipid model (TLM) and HC5, and using the equilibrium partitioning (EqP) model. The predicted 28-d LL50 (mortality) of this substance to Lumbriculus variegatus is 32456 mg/kg sediment dw and the predicted 28-d EL10 (reproduction/biomass) is 6218 mg/kg sediment dw.

Executive summary:

The registered substance is a complex petroleum UVCB whose constituents have variable physicochemical properties. Therefore, a modeling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole. The target lipid model (TLM) and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. As such, modeled data are considered fit for purpose. The model used for the calculations was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry.

The predicted 28-d LL50 (mortality) of this substance to Lumbriculus variegatus is 32456 mg/kg sediment dw and the predicted 28-d EL10 (reproduction/biomass) is 6218 mg/kg sediment dw.

Reference 2

Endpoint:

sediment toxicity: short-term

Type of information:

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

Adequacy of study:

key study

Study period:

3rd October 2006 to 14th October 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good guideline study. However, there is little information on sediment(collection, characteristics...) and organisms (collection, holding and acclimation).

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: PARCOM Protocols on Methods for the testing of chemicals used in the offshore industry. Part A: A sediment bioassay using an amphipod Corophium sp. (1995)

Deviations:

no

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No test surrogate material is tested

Analytical monitoring:

not required

Details on sampling:

Not applicable (no analytical monitoring)

Vehicle:

yes

Details on sediment and application:

PREPARATION OF SPIKED SEDIMENT
- Natural sediment from the same unpolluted site as the amphipods (organic content: 3.3%; silt fraction: 73%), homogenized before preparing the test sediment.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone

- Spiked test sediment: 5 Ll acetone containing test substance added to 130 g pre-dried sediment. After the acetone had dried off in a fume cupboard, the sample was added to 460 g of damp sediment.

- Reference substance: fluoranthene dissolved in 5 mL of acetone added to app. 110 g pre-dried sediment.After the acetone had dried off in a fume cupboard, the sample was added to app. 510 g of damp sediment in a plastic bucket.

- The sediment in the blanks (with and without acetone) was treated like the test sediment but without adding test substance.

All sediments (test concentrations, reference substance and blanks) were prepared in plastic buckets. 130 mL of seawater was added to each bucket and the bucket were shaken (120 rpm) for 5 hrs.

Test organisms (species):

Corophium volutator

Details on test organisms:

TEST ORGANISM
- Details on collection: collected 23.09.2006 by Biotrix, Norway and transported by car and airplane to the laboratory.
- Size of animals at beginning of exposure: 5-10 mm long
- Feeding during test: no feeding

ACCLIMATION
- Acclimation period: 4 days (29.09-0.3.10.2006)
- Acclimation conditions (same as test or not): temperature 15+/-2 °C

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

Post exposure observation period:

No post exposure observation

Hardness:

Not relevant (seawater study)

Test temperature:

15 +/- 2°C

pH:

8.1

Dissolved oxygen:

88-96 % saturation

Salinity:

34 per thousand

Ammonia:

No data provided

Nominal and measured concentrations:

Test substance nominal concentrations: 126, 308, 668, 1495 mg/kg dw

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 600 mL glass containers
- Weight of wet sediment: 200 g
- Overlying water volume: 450 mL

EXPOSURE REGIME
- No. of organisms per container (treatment): 9-10
- No. of replicates per treatment group: 3
- No. of replicates per control: 3
- No. of replicates per vehicle control: 3


OVERLYING WATER CHARACTERISTCS
- Natural sea water from an unpolluted site at about 80 m depth in Byfjord, filtrated through a sand filter
- Salinity: 34 per thousand


SOURCE OF NATURAL SEDIMENT
- same unpolluted site as the amphipods


HANDLING OF NATURAL SEDIMENT
- Time of collection: 23.09.2006


CHARACTERIZATION OF SEDIMENT
- Particle size distribution
- % silt: 73%
- Total organic content (%): 3.3


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.28

Reference substance (positive control):

yes

Remarks:

Fluoranthene

Duration:

10 d

Dose descriptor:

LC10

Effect conc.:

207 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.:

503 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

10 d

Dose descriptor:

other: LC90

Effect conc.:

1 220 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

126 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality of test animals at end of exposure period: from 3.7 (126 mg/kg dw) to 96.3 % (96.3 mg/kg dw)
- Mortality in control: 3.3 %

Results with reference substance (positive control):

- Results with reference substance valid
- Relevant effect levels: LC50 = 13.3 mg/kg dw

Reported statistics and error estimates:

LC50, LC10 and LC90 values calculated by using the standard procedure PROBIT analysis, National Swedish Environmental Protection Board (Version 2.3, 1990).
Calculation of NOEC by single factor ANOVA followed by Dunnett's procedure for comparing each concentation mean with the control mean.

Test substance concentration	Initial values		Oxygen (% saturation)
	pH	O2%	5 d	10 d
Blank	8.1	95	96	96
126 mg/kg dw	8.1	95	96	90
308 mg/kg dw	8.1	95	96	93
668 mg/kg dw	8.1	95	93	88
1495 mg/kg dw	8.1	96	90	93
Reference, 5.57 mg/kg dw	8.1	95	90	96
Reference, 10.3 mg/kg dw	8.1	95	90	93
Reference, 18.9 mg/kg dw	8.1	95	93	95
Reference, 32.0 mg/kg dw	8.1	95	96	91

Concentration (mg/kg dw)	Total number of specimen per concentration	Number of specimen per vessel			Number of dead (10 days)
		A D	B E	C F	A D	B E	C F	Total
Control	60	10 10	10 10	10 10	2 0	0 0	0 0	2
126	27	9	9	9	1	0	0	1
308	27	9	9	9	3	1	2	6
668	27	9	9	9	6	5	6	17
1495	27	9	9	9	8	9	9	26
Ref., 5.57	30	10	10	10	0	0	0	0
Ref., 10.3	27	9	9	9	2	3	3	8
Ref., 18.9	27	9	9	9	8	7	6	21
Ref., 32.0	27	9	9	9	9	9	9	27

Test substance (mg/kg sediment dw)	LC10	LC50	LC90	NOEC
Fluoranthene (reference substance)	8.2	13.3	21.6	5.57
DEV 2006-16	207	503	1220	126

Test acceptability:

The test acceptance criteria given were fulfilled :

- the amphipods were not held without sediment for more than 14 days before they were used for testing;

- the mortality in the individual control replicate did not exceed 40%;

- the entire batch was from the same population;

- the percentage mortality in the blank was less than 15 %;

- the oxygen contnentwas greater than 40%;

- the 10 -d LC50 for the fluoranthene was 13.3 mg/kg.

Validity criteria fulfilled:

yes

Remarks:

Amphipods held without sediment for less than14 days; Mortality in the individual blank less than 40%; All amphipods from the same population; Mortality in the blank less than 15%; 10-d LC50 of reference substance (fluoranthen) = 19.9 +/- 10.3 mg/kg sedim

Conclusions:

10-d LC50 = 503 mg/kg sediment dw
10-d NOEC = 126 mg/kg sediment dw

Executive summary:

An acute toxicity test was conducted on the marine amphipod Corophium volutator. The test substance concentrations ranged from 126 to 1495 mg/kg sediment dw. The test sediment was from the same unpolluted site as the amphipods. The seawater was natural seawater from an unpolluted site at about 80 m depth in Byfjord, filtered through sand filter at the collection. The test substance was dissolved in acetone and added to the sediment as follows: 5 mL acetone containing the test substance was added to 130 g pre-dried sediment; after the acetone had dried off in a fume cupboard, the sample was added to 510 g of damp sediment in a plastic bucket, 130 mL seawater was added to the bucket and the bucket was shaken (120 rpm) for 5 hrs. The spiked sediment was then split into three beakers, 400 mL of seawater was added to each beaker, and they were aerated overnight before the test organisms were introduced. The blanks were prepared the same way (three with and three without acetone). In the test, 4 concentrations were tested in a geometric series: 126, 308, 668 and 1495 mg/kg. Three replicates were used for each concentration and each blank.

Dissolved oxygen was > 40% during the study. The pH was 8.1. The temperature was 15 +/- 2 °C.

The test organisms (5 -10 mm) were obtained from the same unpolluted site as the sediment.

No deviation from the protocol was noted. No analytical monitoring was performed.

The results mean that the 10-d LC50 is 503 mg/kg sediment dry weight.

Reference 3

Endpoint:

sediment toxicity: short-term

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

7th May 1995 to 14th May 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good guideline study. However, There is little information on sediment (collection, characteristics...) and organisms (collection, holding and acclimation).

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: PARCOM Ring test protocol for the Abra test, November 1990

Deviations:

no

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No test surrogate material is tested

Analytical monitoring:

no

Details on sampling:

Not applicable (no analytical monitoring)

Vehicle:

no

Details on sediment and application:

TEST MEDIUM
Standard sediment suspension with 8% sediment particle content (dry weight) and particle size <= 45 µm ,and with a salinity of 31-35 per thousand, contaminated with test substance, stored 4-16 hrs at 11 °C under continuous aeration before exposure.
The test substance was a liquid insoluble in water. A 1/100 stock solution was prepared using microencapsulation. The test substance was microencapsulated to stock solution together with sediment particles. The microcapsule wall (gelatine + acacia gum) is permeable to small molecules and water soluble components will enter the water phase until equilibrium; The final test media are prepared in 500 ml glass bottles, which are shaken vigourously by hand for 30 seconds before transfer to the test aquaria.

Sediment:
collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature.

Test organisms (species):

other: Abra alba

Details on test organisms:

TEST ORGANISM
- Common name: White furrow shell
- Details on collection: no data
- Diameter > 4 mm (largest diameter)
- feeding: organic material may be added to obtain a minimum fecal production rate

ACCLIMATION
- Acclimation period: 5 days before the start of the pre-exposure period
- Holding conditions: in natural sediment under continuous flow of natural seawater at ambient temperature.

Study type:

laboratory study

Test type:

static

Water media type:

saltwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

5 d

Exposure phase:

total exposure duration

Remarks:

Pre-exposure: 2 d

Post exposure observation period:

No post exposure observation

Hardness:

Not relevant (seawater study)

Test temperature:

11 +/- 1 °C

pH:

No data

Dissolved oxygen:

No data

Salinity:

31 - 35 per thousand

Ammonia:

No data

Nominal and measured concentrations:

Nominal concentrations: 5, 10, 20, 52 and 118 mg/kg (weight test substance/weight total test medium)

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Polyethylene tubes with inner diameter of 36 mm, outer diameter of 40 mm, and mesh size of 90 µm. Series of 15 tubes are glued together in a rack of 3x5 sieves put in containers with 250 g of 8% (dw) standard sediment suspension.
- Aeration: no


EXPOSURE REGIME
- No. of organisms per container (treatment): 1 test organism per sieve, which makes 15 individuals per container in 250 g of 8%(dw) standard sediment suspension.
- No. of replicates per treatment group: 2
- No. of replicates per control / vehicle control: 4
- Feeding regime: organic material may be added to obtain a minimum fecal production rate


HANDLING OF NATURAL SEDIMENT
Collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature



EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fecal pellet production



TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol

Key result

Duration:

5 d

Dose descriptor:

EC50

Effect conc.:

36 other: mg/kg 8% (dw) sediment suspension

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Fecal pellet production

Remarks on result:

other: +/- 11 mg/kg

Details on results:

No mortality observed

Results with reference substance (positive control):

Defecation rate of 42 % relative to the control, in the acceptable range for the reference substance (25-45%)

Reported statistics and error estimates:

Calculation of the EC50:
The pre-exposure fecal pellet production is used to normalise the 5d esposure fecal pellet production, to reduce the biological variation due to individual differences in fecal pellet production.
The data points are fitted to the non-linear equation:
Y = aX + b logX + c
where Y is the response and X the exposure.

The plotted test values resulted in the following equation:
Y = -0.009 X - 58.9 logX + 163.0 (R²=1.00)

Concentration (mg/kg std sed. susp.)	Fecal pellet production (mg/ind./d)
	Pre-exposure	5-d exposure	Normalized	%
0	3.34	2.80	2.91	100
5	3.24	2.36	2.52	87
10	3.71	2.52	2.35	81
20	3.52	1.97	1.94	67
52	3.77	1.14	1.05	36
118	3.00	0.67	0.77	26

Validity criteria fulfilled:

yes

Conclusions:

5d EC50 = 36 +/- 11 mg test substance / kg 8% (dw) standard sediment suspension

Executive summary:

An acute toxicity test was conducted on the marine mollusc bivalve Abra alba. The test substance concentrations ranged from 5 to 118 mg test substance / kg 8% standard sediment suspension. Test medium were prepared using microencapsulation because of the hydrophobicity of the susbtance. The standard sediment used for microencapsulation (together with gelatine and acacia gum) and standard sediment suspension (8% (dw) standard sediment in natural seawater) was a natural sediment from a location where Abra alba were present, sieved on 45 µm mesh. Test systems consisted of polyethylene tubes (inner diameter: 36 mm; outer diameter: 40 mm) with 90 µm mesh, glued together in 3x5 racks and introduced in containers containing 250 g of standard sediment suspension. 5 concentrations were tested: 5, 10, 20, 52, and 118 mg test substance / kg 8% (dw) standard sediment suspension. Two replicates for the test substance and four replicates for the control were used, with 1 organism per tube (15 organisms per container).

The temperature was 11 +/- 1 °C. Analytical monitoring was not performed.

The test organisms were acclimated for 5 days prior to the exposure. A 2-d pre-exposure was performed to establish the normal fecal pellet production before exposure.

5d EC50 = 36 +/- 11 mg test substance / kg 8% (dw) standard sediment suspension

Reference 4

Endpoint:

sediment toxicity: short-term

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

24th August 1996 to 31st August 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good guideline study. However, There is little information on sediment (collection, characteristics...) and organisms (collection, holding and acclimation).

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: PARCOM Ring test protocol for the Abra test, November 1990

Deviations:

no

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No test surrogate material is tested

Analytical monitoring:

no

Details on sampling:

Not applicable (no analytical monitoring)

Vehicle:

no

Details on sediment and application:

TEST MEDIUM
Standard sediment suspension with 8% sediment particle content (dry weight) and particle size <= 45 µm ,and with a salinity of 31-35 per thousand, contaminated with test substance, stored 4-16 hrs at 11 °C under continuous aeration before exposure.
The test substance was a liquid insoluble in water. A 1/100 stock solution was prepared using microencapsulation. The test substance was microencapsulated to stock solution together with sediment particles. The microcapsule wall (gelatine + acacia gum) is permeable to small molecules and water soluble components will enter the water phase until equilibrium; The final test media are prepared in 500 ml glass bottles, which are shaken vigourously by hand for 30 seconds before transfer to the test aquaria.

Sediment:
collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature.

Test organisms (species):

other: Abra alba

Details on test organisms:

TEST ORGANISM
- Common name: White furrow shell
- Details on collection: no data
- Diameter > 4 mm (largest diameter)
- feeding: organic material may be added to obtain a minimum fecal production rate

ACCLIMATION
- Acclimation period: 5 days before the start of the pre-exposure period
- Holding conditions: in natural sediment under continuous flow of natural seawater at ambient temperature

Study type:

laboratory study

Test type:

static

Water media type:

saltwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

5 d

Exposure phase:

total exposure duration

Remarks:

Pre-exposure: 2 d

Post exposure observation period:

No post exposure observation

Hardness:

Not relevant (seawater study)

Test temperature:

10.6 - 10.8 °C

pH:

No data

Dissolved oxygen:

No data

Salinity:

31 - 35 per thousand

Ammonia:

No data

Nominal and measured concentrations:

Nominal concentrations: 27, 59, 119, 240, 611 mg/kg (weight test substance/weight total test medium)

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Polyethylene tubes with inner diameter of 36 mm, outer diameter of 40 mm, and mesh size of 90 µm. Series of 15 tubes are glued together in a rack of 3x5 sieves put in containers with 250 g of 8% (dw) standard sediment suspension.
- Aeration: no


EXPOSURE REGIME
- No. of organisms per container (treatment): 1 test organism per sieve, which makes 15 individuals per container in 250 g of 8% (dw) standard sediment suspension.
- No. of replicates per treatment group: 2
- No. of replicates per control / vehicle control: 4
- Feeding regime: organic material may be added to obtain a minimum fecal production rate


HANDLING OF NATURAL SEDIMENT
Collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature



EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fecal pellet production



TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2

Reference substance (positive control):

no

Key result

Duration:

5 d

Dose descriptor:

EC50

Effect conc.:

83 other: mg/kg 8% (dw) sediment suspension

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Fecal pellet production

Remarks on result:

other: +/- 21 mg/kg

Details on results:

No mortality observed

Results with reference substance (positive control):

Nos applicable (no reference substance)

Reported statistics and error estimates:

Calculation of the EC50:
The pre-exposure fecal pellet production is used to normalise the 5d esposure fecal pellet production, to reduce the biological variation due to individual differences in fecal pellet production.
The data points are fitted to the non-linear equation:
Y = aX + b logX + c
where Y is the response and X the exposure.

The plotted test values resulted in the following equation:
Y = -0.009 X - 58.9 logX + 163.0 (R²=1.00)

Concentration (mg/kg std sed. susp.)	Fecal pellet production (mg/ind./d)
	Pre-exposure	5-d exposure	Normalized	%
0	5.83	7.04	6.64	100
27	5.57	5.20	5.14	77
59	5.38	3.93	4.02	61
119	5.12	2.61	2.80	42
240	5.42	1.36	1.38	21
611	5.03	0.00	0.00	0

Validity criteria fulfilled:

yes

Conclusions:

5d EC50 = 83 +/- 21 mg test substance / kg 8% (dw) standard sediment suspension

Executive summary:

An acute toxicity test was conducted on the marine mollusc bivalve Abra alba. The test substance concentrations ranged from 27 to 611 mg test substance / kg 8% standard sediment suspension. Test medium were prepared using microencapsulation because of the hydrophobicity of the susbtance. The standard sediment used for microencapsulation (together with gelatine and acacia gum) and standard sediment suspension (8% (dw) standard sediment in natural seawater) was a natural sediment from a location where Abra alba were present, sieved on 45µm mesh. Test systems consisted of polyethylene tubes (inner diameter: 36 mm; outer diameter: 40 mm) with 90 µm mesh, glued together in 3x5 racks and introduced in containers containing 250 g of standard sediment suspension. 5 concentrations were tested: 27, 59, 119, 240, and 611 mg test substance / kg 8% (dw) standard sediment suspension. Two replicates for the test substance and four replicates for the control were used, with 1 organism per tube (15 organisms per container).

The temperature was 10.6 -10.8 °C. Analytical monitoring was not performed.

The test organisms were acclimated for 5 days prior to the exposure. A 2-d pre-exposure was performed to establish the normal fecal pellet production before exposure.

5d EC50 = 83 +/- 21 mg test substance / kg 8% (dw) standard sediment suspension

Reference 5

Endpoint:

sediment toxicity: short-term

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

15th June 1996 to 22nd June 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good guideline study. However, There is little information on sediment (collection, characteristics...) and organisms (collection, holding and acclimation).

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: PARCOM Ring test protocol for the Abra test, November 1990

Deviations:

no

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No test surrogate material is tested

Analytical monitoring:

no

Details on sampling:

Not applicable (no analytical monitoring)

Vehicle:

no

Details on sediment and application:

TEST MEDIUM
Standard sediment suspension with 8% sediment particle content (dry weight) and particle size <= 45µm ,and with a salinity of 31-35 per thousand, contaminated with test substance, stored 4-16 hrs at 11 °C under continuous aeration before exposure.
The test substance was a liquid insoluble in water. A 1/100 stock solution was prepared using microencapsulation. The test substance was microencapsulated to stock solution together with sediment particles. The microcapsule wall (gelatine + acacia gum) is permeable to small molecules and water soluble components will enter the water phase until equilibrium; The final test media are prepared in 500 ml glass bottles, which are shaken vigourously by hand for 30 seconds before transfer to the test aquaria.

Sediment:
collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature.

Test organisms (species):

other: Abra alba

Details on test organisms:

TEST ORGANISM
- Common name: White furrow shell
- Details on collection: no data
- Diameter > 4 mm (largest diameter)
- feeding: organic material may be added to obtain a minimum fecal production rate

ACCLIMATION
- Acclimation period: 5 days before the start of the pre-exposure period
- Holding conditions: in natural sediment under continuous flow of natural seawater at ambient temperature

Study type:

laboratory study

Test type:

static

Water media type:

saltwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

5 d

Exposure phase:

total exposure duration

Remarks:

Pre-exposure: 2 d

Post exposure observation period:

No post exposure observation

Hardness:

Not relevant (seawater study)

Test temperature:

11.2 - 11.4 °C

pH:

No data

Dissolved oxygen:

No data

Salinity:

31 - 35 per thousand

Ammonia:

No data

Nominal and measured concentrations:

Nominal concentrations: 23, 52, 103, 203, and 525 mg/kg (weight test substance/weight total test medium)

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Polyethylene tubes with inner diameter of 36 mm, outer diameter of 40 mm, and mesh size of 90 µm. Series of 15 tubes are glued together in a rack of 3x5 sieves put in containers with 250 g of 8% (dw) standard sediment suspension.
- Aeration: no


EXPOSURE REGIME
- No. of organisms per container (treatment): 1 test organism per sieve, which makes 15 individuals per container in 250 g of 8% (dw) standard sediment suspension.
- No. of replicates per treatment group: 2
- No. of replicates per control / vehicle control: 4
- Feeding regime: organic material may be added to obtain a minimum fecal production rate


HANDLING OF NATURAL SEDIMENT
Collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature



EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fecal pellet production



TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2

Reference substance (positive control):

no

Key result

Duration:

5 d

Dose descriptor:

EC50

Effect conc.:

103 other: mg/kg 8% (dw) sediment suspension

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Fecal pellet production

Remarks on result:

other: +/- 22 mg/kg

Details on results:

No mortality observed

Results with reference substance (positive control):

Nos applicable (no reference substance)

Reported statistics and error estimates:

Calculation of the EC50:
The pre-exposure fecal pellet production is used to normalise the 5d esposure fecal pellet production, to reduce the biological variation due to individual differences in fecal pellet production.
The data points are fitted to the non-linear equation:
Y = aX + b logX + c
where Y is the response and X the exposure.

The plotted test values resulted in the following equation:
Y = -0.009 X - 58.9 logX + 163.0 (R²=1.00)

Concentration (mg/kg std sed. susp.)	Fecal pellet production (mg/ind./d)
	Pre-exposure	5-d exposure	Normalized	%
0	4.78	4.87	4.46	100
23	3.98	4.61	5.06	113
52	5.18	3.83	3.23	72
103	4.82	2.97	2.69	60
203	4.42	0.85	0.85	19
525	3.73	0.30	0.35	8

Validity criteria fulfilled:

yes

Conclusions:

5d EC50 = 103 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension

Executive summary:

An acute toxicity test was conducted on the marine mollusc bivalve Abra alba. The test substance concentrations ranged from 23 to 525 mg test substance / kg 8% standard sediment suspension. Test medium were prepared using microencapsulation because of the hydrophobicity of the susbtance. The standard sediment used for microencapsulation (together with gelatine and acacia gum) and standard sediment suspension (8% (dw) standard sediment in natural seawater) was a natural sediment from a location where Abra alba were present, sieved on 45µm mesh. Test systems consisted of polyethylene tubes (inner diameter: 36 mm; outer diameter: 40 mm) with 90 µm mesh, glued together in 3x5 racks and introduced in containers containing 250 g of standard sediment suspension. 5 concentrations were tested: 23, 52, 103, 203, and 525 mg test substance / kg 8% (dw) standard sediment suspension. Two replicates for the test substance and four replicates for the control were used, with 1 organism per tube (15 organisms per container).

The temperature was 11.2 -11.4 °C. Analytical monitoring was not performed.

The test organisms were acclimated for 5 days prior to the exposure. A 2-d pre-exposure was performed to establish the normal fecal pellet production before exposure.

5d EC50 = 103 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension

Reference 6

Endpoint:

sediment toxicity: short-term

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

24th August 1996 to 31st August 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good guideline study. However, There is little information on sediment (collection, characteristics...) and organisms (collection, holding and acclimation).

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: PARCOM Ring test protocol for the Abra test, November 1990

Deviations:

no

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No test surrogate material is tested

Analytical monitoring:

no

Details on sampling:

Not applicable (no analytical monitoring)

Vehicle:

no

Details on sediment and application:

TEST MEDIUM
Standard sediment suspension with 8% sediment particle content (dry weight) and particle size <= 45µm ,and with a salinity of 31-35 per thousand, contaminated with test substance, stored 4-16 hrs at 11 °C under continuous aeration before exposure.
The test substance was a liquid insoluble in water. A 1/100 stock solution was prepared using microencapsulation. The test substance was microencapsulated to stock solution together with sediment particles. The microcapsule wall (gelatine + acacia gum) is permeable to small molecules and water soluble components will enter the water phase until equilibrium; The final test media are prepared in 500 ml glass bottles, which are shaken vigourously by hand for 30 seconds before transfer to the test aquaria.

Sediment:
collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature.

Test organisms (species):

other: Abra alba

Details on test organisms:

TEST ORGANISM
- Common name: White furrow shell
- Details on collection: no data
- Diameter > 4 mm (largest diameter)
- feeding: organic material may be added to obtain a minimum fecal production rate

ACCLIMATION
- Acclimation period: 5 days before the start of the pre-exposure period
- Holding conditions: in natural sediment under continuous flow of natural seawater at ambient temperature

Study type:

laboratory study

Test type:

static

Water media type:

saltwater

Type of sediment:

natural sediment

Limit test:

no

Duration:

5 d

Exposure phase:

total exposure duration

Remarks:

Pre-exposure: 2 d

Post exposure observation period:

No post exposure observation

Hardness:

Not relevant 'seawater study)

Test temperature:

11 +/- 1 °C

pH:

No data

Dissolved oxygen:

No data

Salinity:

31 - 35 per thousand

Ammonia:

No data

Nominal and measured concentrations:

Nominal concentrations: 19, 52, 111, 215, and 554 mg/kg (weight test substance/weight total test medium)

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Polyethylene tubes with inner diameter of 36 mm, outer diameter of 40 mm, and mesh size of 90 µm. Series of 15 tubes are glued together in a rack of 3x5 sieves put in containers with 250 g of 8% (dw) standard sediment suspension.
- Aeration: no


EXPOSURE REGIME
- No. of organisms per container (treatment): 1 test organism per sieve, which makes 15 individuals per container in 250 g of 8%(dw) standard sediment suspension.
- No. of replicates per treatment group: 2
- No. of replicates per control / vehicle control: 4
- Feeding regime: organic material may be added to obtain a minimum fecal production rate


HANDLING OF NATURAL SEDIMENT
Collected from a locality where Abra alba is present and sieved through a 45 µm mesh. Storage at room temperature



EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fecal pellet production



TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2

Reference substance (positive control):

no

Key result

Duration:

5 d

Dose descriptor:

EC50

Effect conc.:

89 other: mg/kg 8% (dw) sediment suspension

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Fecal pellet production

Remarks on result:

other: +/- 22 mg/kg

Details on results:

No mortality observed

Results with reference substance (positive control):

Not applicable (no reference substance)

Reported statistics and error estimates:

Calculation of the EC50:
The pre-exposure fecal pellet production is used to normalise the 5d esposure fecal pellet production, to reduce the biological variation due to individual differences in fecal pellet production.
The data points are fitted to the non-linear equation:
Y = aX + b logX + c
where Y is the response and X the exposure.

The plotted test values resulted in the following equation:
Y = -0.009 X - 58.9 logX + 163.0 (R²=1.00)

Concentration (mg/kg std sed. susp.)	Fecal pellet production (mg/ind./d)
	Pre-exposure	5-d exposure	Normalized	%
0	5.83	7.04	6.64	100
19	5.83	6.40	6.03	91
52	4.95	3.61	4.01	60
111	4.85	2.59	2.93	44
215	5.91	2.07	1.92	29
554	4.20	0.00	0.00	0

Validity criteria fulfilled:

yes

Conclusions:

5d EC50 = 89 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension

Executive summary:

An acute toxicity test was conducted on the marine mollusc bivalve Abra alba. The test substance concentrations ranged from 19 to 554 mg test substance / kg 8% standard sediment suspension. Test medium were prepared using microencapsulation because of the hydrophobicity of the susbtance. The standard sediment used for microencapsulation (together with gelatine and acacia gum) and standard sediment suspension (8% (dw) standard sediment in natural seawater) was a natural sediment from a location where Abra alba were present, sieved on 45µm mesh. Test systems consisted of polyethylene tubes (inner diameter: 36 mm; outer diameter: 40 mm) with 90 µm mesh, glued together in 3x5 racks and introduced in containers containing 250 g of standard sediment suspension. 5 concentrations were tested: 19, 52, 111, 215, and 554 mg test substance / kg 8% (dw) standard sediment suspension. Two replicates for the test substance and four replicates for the control were used, with 1 organism per tube (15 organisms per container).

The temperature was 11 +/- 1 °C. Analytical monitoring was not performed.

The test organisms were acclimated for 5 days prior to the exposure. A 2-d pre-exposure was performed to establish the normal fecal pellet production before exposure.

5d EC50 = 89 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension

Description of key information

There is no data available for this substance. However, key, WOE and supporting data for short-term studies is available for structural analogues. The data is read across to this substance based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13. Key and weight-of-evidence information is summarised below:

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d LC50 for Corophium volutator of 503 mg/kg sediment dry weight.

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 5-d EC50 (fecal pellet production) for Abra alba of 83 +/- 21 mg test substance / kg 8% (dw) standard sediment suspension.

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 5-d EC50 (fecal pellet production) for Abra alba of 103 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension.

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 5-d EC50 (fecal pellet production) for Abra alba of 89 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension.

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 5-d EC50 (fecal pellet production) for Abra alba of 36 +/- 11 mg test substance / kg 8% (dw) standard sediment suspension.

The registered substance is a complex petroleum UVCB whose constituents have variable physicochemical properties. Therefore, a modeling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole. The target lipid model (TLM) and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. As such, modeled data are considered fit for purpose.The model used for the calculations of long-term toxicity to sediment was the PETROTOX v4.0 model. PETROTOX is a well-documented and peer reviewed model that is widely used across the chemicals industry. This substance fits within the criteria of the model and there are no reservations about the validity of the model runs. It is expected that this data is reliable with restrictions.

Additional information

In fourteen studies, the marine amphipod Corophium volutator was exposed to sediment spiked with Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics for 10 days. The geometric mean of LC₅₀ is 537 mg/kg sediment (dw). In most of the studies, LC₁₀ were calculated and the geometric mean of the 12 available values is 112.6 mg/kg sediment (dw). At last, the 7 more recent studies reported NOEC values and the lowest one was 100 mg/kg (dw).

In four studies, the marine mollusc bivalve Abra alba was exposed to sediment spiked with Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics for 5 days. The 5-day LC₅₀ value ranged from is 36 +/- 11 to 103 +/- 22 mg test substance / kg 8% (dw) standard sediment suspension.