Registration Dossier

Ecotoxicological information

Sediment toxicity

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2006-10-03 to 2006-10-14
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:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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
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
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 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.

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

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.

Results:

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

The results mean that the 10 -d LC50 is 503 mg/kg sediment dry weight as shown in the following table:

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

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 1996-08-24 to 1996-08-31
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:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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:
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
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)

No other information is available

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.

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

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

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 1996-06-15 to 1996-06-22
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:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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
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)

No other information is available

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.

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

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

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 1996-08-24 to 1996-08-31
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:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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
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)

No other information is available

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.

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

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

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 1995-05-07 to 1995-05-14
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:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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: 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
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)

No other information is available

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 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: 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.

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

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

Endpoint:
sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

The 10d-LC50 and 10d-NOEC for the marine sediment amphipod Corophium volutator were reported to be respectively 537 and 171 mg/kg sediment (dw) (geometric mean).

However, as long-term data is not available for this end-point, the environmental risk is assessed using the Petrorisk model.

Key value for chemical safety assessment

Additional information

Short-term studies:

The marine amphipod Corophium volutator was exposed to sediment spiked with Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics for 10 days. Fourteen studies were available and give LC50 values. 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).

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

Long-term studies:

No data is available for long-term sediment toxicity.

In accordance with Annex IX column 2, testing does not need to be conducted as the hazard is adequately assessed by equilibrium partitioning.  Substance is a hydrocarbon UVCB: The hydrocarbon block method is used for environmental risk assessment (see REACH guidance, R7, app.13-1). PNECs for hydrocarbon blocks have been derived using aquatic PNECs and the equilibrium partitioning method (EqP) using representative structures. Justification for this approach is provided in Redman et al., 2014. Extension and validation of the target lipid model for deriving predicted no-effect concentrations for soils and sediments. ET&C, Vol. 33, No. 12, pp. 2679–2687. See Product Library tab in “assessment report. PetroRisk information excel” spreadsheet attached to Section 13 for PNEC values.

 

The aquatic PNECs have been derived using the HC5 statistical extrapolation method and the target lipid model using representative structures. Given the large database of organisms included in the target lipid model, an assessment factor of one has been applied to the HC5.