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Endpoint:
sediment toxicity: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June to July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This robust summary has a reliability rating of 1 because the study followed a standard guideline, followed GLP, and was conducted without deviations that would invalidate the study.
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: Oslo and Paris Commission Guidelines, A Sediment Bioassay Using an Amphipod Corophium Sp. (PARCOM, 1995)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on sediment and application:
Sediment collected with the test organisms was allowed to settle in a container overnight after which the overlying water was decanted and the container and its contents weighed. The sediment was then used to set up tests. A sample of the sediment was weighed and dried at 60 degrees C for 72 hours to determine its water content (33%) as the test concentrations are based upon dry weight.
Test organisms (species):
Corophium volutator
Details on test organisms:
The test organisms were collected with the top few centimeters of sediment from a clean intertidal shore. The organisms were separated from the sediment by wet sieving (0.5 mm) in a container containing seawater that was collected from the same site as the organisms and transferred to aquaria together with 1 cm deep sediment removed by the sieving where they were held until used in the test. The organisms were held at 15 degrees C under a photoperiod of 16 hours light and 8 hours dark. The test organism size ranged from approximately 5 to 10 mm.
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:
None
Test temperature:
15.2 to 17.1 degrees C
pH:
8.2 to 8.9
Dissolved oxygen:
5.4 to 8.1 mg/L
Salinity:
35 to 39‰ (3.1 to 3.3%)
Nominal and measured concentrations:
Nominal concentrations were: 0 (control), 10, 132, 100, 320, 1000, 3200, and 10000 mg/kg sediment (dw). Analysis of spiked sediments was not conducted.
Details on test conditions:
The test substance was dissolved in 25 mg of Analar grade acetone to prepare the final test loadings. The control was treated similarly but without test substance. All sediments were left to air dry of acetone. Once dry, the spiked sediment was added to wet sediment to derive sediment loadings of 10, 132, 100, 320, 1000, 3200, and 10000 mg/kg sediment (dw). 1 L beaker test systems were used to contain the control and treatment sediments. Seawater was added to each beaker to bring the combined sediment and overlying seawater layer up to 850 ml. Sixty test organisms judged to be between 5 to 10 mm in length were selected from the stock and randomly allocated to each beaker. Water lost to evaporation during the study was added back on days 2,5, and 6. Test vessels were maintained under artificial light with a 16-hour light and 8-hour dark photoperiod.
Reference substance (positive control):
no
Key result
Duration:
10 d
Dose descriptor:
other: LL50
Effect conc.:
1 100 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL = 910 to 1200 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: NOELR
Effect conc.:
32 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
10 d
Dose descriptor:
other: EL50
Effect conc.:
770 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality and behavior
Remarks on result:
other: 95% CL = 650 to 900 mg/Kg sediment dw; behavior was identified as on the surface of the sediment
Details on results:
The mortality results are as follows:

Nominal
Conc. Mortality
(mg/kg sed. dw) (%)
Control 3
Acetone Control 0
10 0
32 0
100 2
320 5
1000 42
3200 95
10000 100
Reported statistics and error estimates:
Statistical analyses were performed using Probit analysis.
Validity criteria fulfilled:
yes
Remarks:
The validation criteria, including oxygen concentration, control mortality, and temperature were in accordance with the guidelines.
Conclusions:
Marine sediment dosed with the test substance at loadings between 10 and 10000 mg/kg (dw) produced a 10-day LL50 value of 1100 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The 10-day no-observed effect loading rate value based on mortality was 32 mg/kg sediment (dw). The 10-day EL50 value based on mortality and behavior was 770 mg/kg sediment (dw).
Executive summary:

Marine sediment dosed with the test substance at loadings between 10 and 10000 mg/kg (dw) produced a 10-day LL50 value of 1100 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The 10-day no-observed effect loading rate value based on mortality was 32 mg/kg sediment (dw). The 10-day EL50 value based on mortality and behavior was 770 mg/kg sediment (dw).

Endpoint:
sediment toxicity: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
December 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This robust summary has a reliability rating of 1 because the study followed a standard guideline, followed GLP, and was conducted without deviations that would invalidate the study.
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: Oslo and Paris Commission Guidelines, A Sediment Bioassay Using an Amphipod Corophium Sp. (PARCOM, 1995)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on sediment and application:
Sediment collected with the test organisms was allowed to settle in a container for 24 hours after which the overlying water was decanted and the container and its contents weighed. Previous analyses showed this sediment to be very fine, so a predominantely fine-sand sediment was added through a 0.5 mm sieve to approximately 35% of the total weight. The sediment was then thoroughly mixed under seawater and again allowed to settle for 24 hours before decanting. The sediment was then used to set up tests. Periodic analyses of the sediment have shown that it contains a silt/clay fraction at <20%, a median grain size between 0.09 and 0.125 mm, and an organic content no greater than 4%. Immediately prior to the test, a small sample of the sediment was weighed and dried at 60 degrees C for 24 hours to determine its water content (40%) as the test concentrations are based upon dry weight.
Test organisms (species):
Corophium volutator
Details on test organisms:
The test organisms were collected with the top 50 mm of sediment from a clean intertidal shore. The organisms were separated from the sediment by wet sieving (0.5 mm) in a container containing seawater that was collected from the same site as the organisms and transferred to aquaria together with some of the detritus removed by the sieving where they were held until used in the test. The organisms were held under a photoperiod of 16 hours light and 8 hours dark.
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:
None
Test temperature:
14.4 to 15.2 degrees C
pH:
7.8 to 8.0
Dissolved oxygen:
95 to 99%
Salinity:
32.2 to 33.5‰ (3.2 to 3.4%)
Nominal and measured concentrations:
Nominal concentrations were: 0 (control), 64, 160, 400, and 1000 mg/kg sediment. Analysis of spiked sediments was not conducted.
Details on test conditions:
1 L beaker test systems were used to contain the control and treatment sediments, each at a depth of approximately 15 mm. Seawater was added to each beaker to bring the combined sediment and overlying seawater layer up to 900 ml. Test organisms judged to be at least 5 mm in length were selected from the stock and randomly allocated to specimen tubes until there were 10 organisms per tube. One tube of organisms was then added to the control and each treatment level once the sediment had settled. Control and treatment levels were evaluated in duplicate with a total of 20 organisms per control and treatment. Water quality measurements were taken twice through the study and at test termination.
Reference substance (positive control):
no
Key result
Duration:
10 d
Dose descriptor:
other: LL50
Effect conc.:
340.6 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
10 d
Dose descriptor:
other: LL100
Effect conc.:
> 1 000 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
19 d
Dose descriptor:
other: NOELR
Effect conc.:
< 64 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The mortality results are as follows:

Nominal
Conc. Mortality
(mg/kg sed. dw) (%)
Control 10
64 15
160 50
400 35
1000 95

The lowest sediment loading rate producing 100% mortality was not determined as there was 5% survival at the highest loading tested. The No-observed effect loading rate was not determined as there was 15% mortality at the lowest loading tested.
Reported statistics and error estimates:
Although statistical analyses were performed, the test type was not described. Confidence limits could not be determined due to the trend in the data set.
Validity criteria fulfilled:
yes
Remarks:
The validation criteria, including oxygen concentration, control mortality, and temperature were in accordance with the guidelines.
Conclusions:
Marine sediment dosed with the test substance at loadings between 64 and 1000 mg/kg (dw) produced a 10-day LL50 value of 341 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The lowest sediment loading rate producing 100% mortality was not determined as there was 5% survival at the highest loading tested, 1000 mg/kg sediment (dw). The no-observed effect loading rate was not determined as there was 15% mortality at the lowest loading tested, 64 mg/kg sediment (dw).
Executive summary:

Marine sediment dosed with the test substance at loadings between 64 and 1000 mg/kg (dw) produced a 10-day LL50 value of 341 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The lowest sediment loading rate producing 100% mortality was not determined as there was 5% survival at the highest loading tested, 1000 mg/kg sediment (dw). The no-observed effect loading rate was not determined as there was 15% mortality at the lowest loading tested, 64 mg/kg sediment (dw). There was 10% mortality in the control.

Endpoint:
sediment toxicity: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June to July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This robust summary has a reliability rating of 1 because the study followed a standard guideline, followed GLP, and was conducted without deviations that would invalidate the study.
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: Oslo and Paris Commission Guidelines, A Sediment Bioassay Using an Amphipod Corophium Sp. (PARCOM, 1995)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on sediment and application:
Sediment collected with the test organisms was allowed to settle in a container overnight after which the overlying water was decanted and the container and its contents weighed. The sediment was then used to set up tests. A sample of the sediment was weighed and dried at 60 degrees C for 72 hours to determine its water content (33%) as the test concentrations are based upon dry weight.
Test organisms (species):
Corophium volutator
Details on test organisms:
The test organisms were collected with the top few centimeters of sediment from a clean intertidal shore. The organisms were separated from the sediment by wet sieving (0.5 mm) in a container containing seawater that was collected from the same site as the organisms and transferred to aquaria together with 1 cm deep sediment removed by the sieving where they were held until used in the test. The organisms were held at 15 degrees C under a photoperiod of 16 hours light and 8 hours dark. The test organism size ranged from approximately 5 to 10 mm.
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:
None
Test temperature:
Temperature on days 0 to 4 ranged from 14.6 to 19.2 degrees C. The higher temperature, an excursion from the guideline, was the result of a faulty chiller which was repaired and teperatures during the remainder of the study ranged from 14.2 to 16.9 degrees C. The relevant regulatory authority (the Centre for Environment Fisheries and Aquaculture Science, Burnham, Essex, UK) was contacted and agreed that the study should not be invalidated.
pH:
8.0 to 8.9
Dissolved oxygen:
5.5 to 8.1 mg/L
Salinity:
33 to 38‰ (3.1 to 3.3%)
Nominal and measured concentrations:
Nominal concentrations were: 0 (control), 10, 132, 100, 320, 1000, 3200, and 10000 mg/kg sediment (dw). Analysis of spiked sediments was not conducted.
Details on test conditions:
The test substance was dissolved in 25 mg of Analar grade acetone to prepare the final test loadings. The control was treated similarly but without test substance. All sediments were left to air dry of acetone. Once dry, the spiked sediment was added to wet sediment to derive sediment loadings of 10, 132, 100, 320, 1000, 3200, and 10000 mg/kg sediment (dw). 1 L beaker test systems were used to contain the control and treatment sediments. Seawater was added to each beaker to bring the combined sediment and overlying seawater layer up to 850 ml. Sixty test organisms judged to be between 5 to 10 mm in length were selected from the stock and randomly allocated to each beaker. Water lost to evaporation during the study was added back on days 2,5, and 6. Test vessels were maintained under artificial light with a 16-hour light and 8-hour dark photoperiod.
Reference substance (positive control):
no
Key result
Duration:
10 d
Dose descriptor:
other: LL50
Effect conc.:
490 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL = 400 to 580 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: NOELR
Effect conc.:
< 10 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
10 d
Dose descriptor:
other: EL50
Effect conc.:
340 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality and behavior
Remarks on result:
other: 95% CL = 290 to 400 mg/Kg sediment dw; behavior was identified as on the surface of the sediment
Details on results:
The mortality results are as follows:

Nominal
Conc. Mortality
(mg/kg sed. dw) (%)
Control 3
Acetone Control 0
10 2
32 5
100 5
320 30
1000 75
3200 93
10000 100
Reported statistics and error estimates:
Statistical analyses were performed using Probit analysis.
Validity criteria fulfilled:
yes
Remarks:
The validation criteria, including oxygen concentration, control mortality, and temperature were in accordance with the guidelines.
Conclusions:
Marine sediment dosed with the test substance at loadings between 10 and 10000 mg/kg (dw) produced a 10-day LL50 value of 490 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The 10-day no-observed effect loading rate value based on mortality was <10 mg/kg sediment (dw), the lowest dose tested. The 10-day EL50 value based on mortality and behavior was 340 mg/kg sediment (dw).
Executive summary:

Marine sediment dosed with the test substance at loadings between 10 and 10000 mg/kg (dw) produced a 10-day LL50 value of 490 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The 10-day no-observed effect loading rate value based on mortality was <10 mg/kg sediment (dw), the lowest dose tested. The 10-day EL50 value based on mortality and behavior was 340 mg/kg sediment (dw).

Endpoint:
sediment toxicity: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This robust summary has a reliability rating of 1 because the study followed a standard guideline, followed GLP, and was conducted without deviations that would invalidate the study.
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: Oslo and Paris Commission Guidelines, A Sediment Bioassay Using an Amphipod Corophium Sp. (PARCOM, 1995)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on sediment and application:
Sediment collected with the test organisms was allowed to settle in a container for 24 hours after which the overlying water was decanted and the container and its contents weighed. Previous analyses showed this sediment to be very fine, so a predominantely fine-sand sediment was added through a 0.5 mm sieve to approximately 35% of the total weight. The sediment was then thoroughly mixed under seawater and again allowed to settle for 24 hours before decanting. The sediment was then used to set up tests. Periodic analyses of the sediment have shown that it contains a silt/clay fraction at <20%, a median grain size between 0.09 and 0.125 mm, and an organic content no greater than 4%. Immediately prior to the test, a small sample of the sediment was weighed and dried at 60 degrees C for 24 hours to determine its water content (36%) as the test concentrations are based upon dry weight.
Test organisms (species):
Corophium volutator
Details on test organisms:
The test organisms were collected with the top 50 mm of sediment from a clean intertidal shore. The organisms were separated from the sediment by wet sieving (0.5 mm) in a container containing seawater that was collected from the same site as the organisms and transferred to aquaria together with some of the detritus removed by the sieving where they were held until used in the test. The organisms were held under a photoperiod of 16 hours light and 8 hours dark.
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:
None
Test temperature:
14.4 to 15.3 degrees C
pH:
7.7 to 8.0
Dissolved oxygen:
6.7 to 7.3 mg/L
Salinity:
30.6 to 33.0‰ (3.1 to 3.3%)
Nominal and measured concentrations:
Nominal concentrations were: 0 (control), 80, 160, 320, 638, and 1267 mg/kg sediment. Analysis of spiked sediments was not conducted.
Details on test conditions:
1 L beaker test systems were used to contain the control and treatment sediments, each at a depth of approximately 15 mm. Seawater was added to each beaker to bring the combined sediment and overlying seawater layer up to 900 ml. Test organisms judged to be at least 5 mm in length were selected from the stock and randomly allocated to specimen tubes until there were 10 organisms per tube. One tube of organisms was then added to the control and each treatment level once the sediment had settled. Control and treatment levels were evaluated in duplicate with a total of 20 organisms per control and treatment. Water quality measurements were taken twice through the study and at test termination.
Reference substance (positive control):
no
Key result
Duration:
10 d
Dose descriptor:
other: LL50
Effect conc.:
398 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL = 284 to 558 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: LL100
Effect conc.:
> 1 267 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
10 d
Dose descriptor:
other: NOELR
Effect conc.:
< 80 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The mortality results are as follows:

Nominal
Conc. Mortality
(mg/kg sed. dw) (%)
Control 5
80 15
160 25
320 50
638 55
1267 90

The lowest sediment loading rate producing 100% mortality was not determined as there was 10% survival at the highest loading tested. The no-observed effect loading rate was not determined as there was 15% mortality at the lowest loading tested.
Reported statistics and error estimates:
Although statistical analyses were performed, the test type was not described.
Validity criteria fulfilled:
yes
Remarks:
The validation criteria, including oxygen concentration, control mortality, and temperature were in accordance with the guidelines.
Conclusions:
Marine sediment dosed with the test substance at loadings between 80 and 1267 mg/kg (dw) produced a 10-day LL50 value of 398 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The lowest sediment loading rate producing 100% mortality was not determined as there was 10% survival at the highest loading tested, 1267 mg/kg sediment (dw). The no-observed effect loading rate was not determined as there was 15% mortality at the lowest loading tested, 80 mg/kg sediment (dw).
Executive summary:

Marine sediment dosed with the test substance at loadings between 80 and 1267 mg/kg (dw) produced a 10-day LL50 value of 398 mg/kg sediment (dw) with the marine amphipod, Corophium volutator. The lowest sediment loading rate producing 100% mortality was not determined as there was 10% survival at the highest loading tested, 1267 mg/kg sediment (dw). The no-observed effect loading rate was not determined as there was 15% mortality at the lowest loading tested, 80 mg/kg sediment (dw). There was 5% mortality in the control.

Endpoint:
sediment toxicity: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
February 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This robust summary has a reliability rating of 1 because the study followed a standard guideline and was conducted without deviations that would invalidate the study, but was not conducted under GLP.
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: Oslo and Paris Commission Guidelines, A Sediment Bioassay Using an Amphipod Corophium Sp. (PARCOM, 1995)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on sediment and application:
Sediment was collected with the test organisms from a site in mid Norway considered free of contaminants. Sieved sediment used in the test was that fraction less than 500 um in size. Test substance was spiked to sediment at each loading level.
Test organisms (species):
Corophium sp.
Details on test organisms:
The test organisms were collected from a site in mid Norway considered free of contaminants. The organisms were collected from the top 5 cm layer of sediment from an inter tidal mud flat. Sediment was collected in HD polyethylene trays and seawater from the site added to the trays. The test organisms were >5 mm in size. Collected organisms were acclimated in the lab in an aquarium.
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:
None
Test temperature:
14.9 to 15.6 degrees C
pH:
8.01 to 8.07
Dissolved oxygen:
93 to 98% of saturation
Salinity:
5.3 uS x 10+4
Nominal and measured concentrations:
Nominal concentrations were: 0 (control), 39, 102, 184, 401, 753, 1506, and 3096 mg/kg sediment (dw). Analysis of spiked sediments was not conducted.
Details on test conditions:
Sediment loadings were 39, 102, 184, 401, 753, 1506, and 3096 mg/kg sediment (dw). 1 L beaker test systems were used to contain the control and treatment sediments. Approximately 200 ml of spiked sediment was added to each beaker together with approximately 650 ml of seawater. twenty-two test organisms greater than 5 mm in length were selected for each treatment solution and the control.
Reference substance (positive control):
no
Key result
Duration:
10 d
Dose descriptor:
other: EL10
Effect conc.:
65 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Remarks on result:
other: 95% CI = 28 to 102 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: EL50
Effect conc.:
596 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Remarks on result:
other: 95% CI = 341 to 851 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: EL90
Effect conc.:
2 374 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Remarks on result:
other: 95% CI = 1823 to 2925 mg/kg sediment dw
Details on results:
The Immobility results are as follows:

Nominal
Conc. Immobilzation
(mg/kg sed. dw) (%)
Control 5
39 9
102 18
184 32
401 36
753 64
1506 77
3096 100
Reported statistics and error estimates:
Calculation of effect loading values was based on the non-linear model: Y = aX + b( logX) +C.
Validity criteria fulfilled:
yes
Remarks:
The validation criteria, including oxygen concentration, control mortality, and temperature were in accordance with the guidelines.
Conclusions:
Marine sediment dosed with the test substance at loadings between 39 and 3096 mg/kg (dw) produced 10-day EL10, EL50, and EL90 values of 65, 596, and 2374 mg/kg sediment (dw), based on immobility, with the marine amphipod, Corophium volutator.
Executive summary:

Marine sediment dosed with the test substance at loadings between 39 and 3096 mg/kg (dw) produced 10-day EL10, EL50, and EL90 values of 65, 596, and 2374 mg/kg sediment (dw), based on immobility, with the marine amphipod, Corophium volutator.

Endpoint:
sediment toxicity: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
October 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This robust summary has a reliability rating of 1 because the study followed a standard guideline and was conducted without deviations that would invalidate the study, but was not conducted under GLP.
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: Oslo and Paris Commission Guidelines, A Sediment Bioassay Using an Amphipod Corophium Sp. (PARCOM, 1995)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on sediment and application:
Sediment was collected with the test organisms from a site in mid Norway considered free of contaminants. Sieved sediment used in the test was that fraction less than 500 um in size. Test substance was spiked to sediment at each loading level.
Test organisms (species):
Corophium sp.
Details on test organisms:
The test organisms were collected from a site in mid Norway considered free of contaminants. The organisms were collected from the top 5 cm layer of sediment from an inter tidal mud flat. Sediment was collected in HD polyethylene trays and seawater from the site added to the trays. The test organisms were >5 mm in size. Collected organisms were acclimated in the lab in an aquarium.
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:
None
Test temperature:
14.6 to 15.4 degrees C
Dissolved oxygen:
Samples showed that dissolved oxygen was at a saturated level.
Salinity:
32 to 34‰
Nominal and measured concentrations:
Nominal concentrations were: 0 (control), 78, 160, 266, 530, 1006, 1929, and 4039 mg/kg sediment (dw). Analysis of spiked sediments was not conducted.
Details on test conditions:
Sediment loadings were 78, 160, 266, 530, 1006, 1929, and 4039 mg/kg sediment (dw). 1 L beaker test systems were used to contain the control and treatment sediments. Approximately 200 ml of spiked sediment was added to each beaker together with approximately 650 ml of seawater. twenty-two test organisms greater than 5 mm in length were selected for each treatment solution and the control.
Reference substance (positive control):
no
Key result
Duration:
10 d
Dose descriptor:
other: EL10
Effect conc.:
92 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Remarks on result:
other: 95% CI = 83 to 101 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: EL50
Effect conc.:
273 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Remarks on result:
other: 95% CI = 244 to 302 mg/kg sediment dw
Key result
Duration:
10 d
Dose descriptor:
other: EL90
Effect conc.:
1 116 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: immobility
Remarks on result:
other: 95% CI = 895 to 1337 mg/kg sediment dw
Details on results:
The immobility results are as follows:

Nominal
Conc. Immobilzation
(mg/kg sed. dw) (%)
Control 9
78 9
160 36
266 54
530 86
1006 86
1929 86
4039 91
Reported statistics and error estimates:
Calculation of effect loading values was based on the non-linear model: Y = aX + b( logX) +C.
Validity criteria fulfilled:
yes
Remarks:
The validation criteria, including oxygen concentration, control mortality, and temperature were in accordance with the guidelines.
Conclusions:
Marine sediment dosed with the test substance at loadings between 78 and 4039 mg/kg (dw) produced 10-day EL10, EL50, and EL90 values of 92, 273, and 1116 mg/kg sediment (dw), based on immobility, with the marine amphipod, Corophium volutator.
Executive summary:

Marine sediment dosed with the test substance at loadings between 78 and 4039 mg/kg (dw) produced 10-day EL10, EL50, and EL90 values of 92, 273, and 1116 mg/kg sediment (dw), based on immobility, with the marine amphipod, Corophium volutator.

Endpoint:
sediment toxicity: long-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
OECD Guideline 225 (Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment)
Version / remarks:
2007
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0017649794
- Expiration date of the lot/batch: 07 Feb 2019
- Purity: 97.5%


Analytical monitoring:
yes
Details on sampling:
SEDIMENT
- Concentrations: in additional replicates
- Sampling interval: on day 0, 7 and 28

PORE WATER
- Concentrations:
- Sampling interval:
- Sample storage before analysis:

OVERLYING WATER
- Concentrations:
- Sampling interval:
- Sample storage before analysis:
Vehicle:
yes
Details on sediment and application:
PREPARATION OF SPIKED SEDIMENT
- Method of mixing: The test item amount was weighed out for a stock solution and dissolved in acetone. The stock solution was further diluted with acetone to receive the respective application solution.
- Details of spiking: The appropriate amount of spiking solution (2.5 mL per replicate) was thouroughly mixed with a sub-quantity of the artificial sediment (10 g). After complete evaporation of the solvent, the spiked portion of artificial sediment was thoroughly mixed with the remaining sediment.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Evaporation of vehicle before use: yes
Test organisms (species):
Lumbriculus variegatus
Details on test organisms:
TEST ORGANISM
- Source: Bundesanstalt für Gewässerkunde, Koblenz, Germany
- Breeding conditions: at 20 °C and diffuse light (100-500 lx, 16h light); 6.2 mg/L O2,
- Feeding during test
- Food type: TetraMin flake food
- Amount: ad librium
- Frequency: twice per week
Study type:
laboratory study
Test type:
static
Water media type:
freshwater
Type of sediment:
artificial sediment
Limit test:
no
Duration:
28 d
Exposure phase:
total exposure duration
Hardness:
288 - 428 mg/L as CaCO3
Test temperature:
18.6 - 20.9 °C
pH:
7.37 - 8.31
Dissolved oxygen:
6.65 - 9.12 mg/L
Ammonia:
control: 0.09 - 0.54 mg/L
solvent control: 0.04 - 0.54 mg/L
treatments: 0.04 - 0.63 mg/L
Nominal and measured concentrations:
Nominal: 10, 31.6, 100, 316 and 1000 mg/kg sediment dw
Measured (geom. mean): 2.69, 5.85, 29.4, 75.8 and 371 mg/kg sediment dw
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 250 mL glass beakers
- Overlying water volume: 150 mL
- Depth of sediment and overlying water: 1-3 cm from the ground
- Aeration: yes
- Aeration frequency and intensity: gentle aeration via Pasteur pipettes
- Replacement of evaporated test water, if any: water levels were topped up with demineralised water at least each working day during the study

EXPOSURE REGIME
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control / vehicle control: 6
- Feeding regime:
- Type and preparation of food: powder of Urtica dioica was mixed into the sediment at the day of application
- Amount of food: 0.4% of the sediment dry weight

CHARACTERIZATION OF SEDIMENT
- Composition (if artificial substrate): 5% peat, 20% laolin, 75% quartz sand; 0.4% calcium carbonate
- Method of preparation (if artificial substrate):
- Organic compounds: OC = 1.85%

OTHER TEST CONDITIONS
- Light: 293 +- 93.9 lx
- Photoperiod: 16h light

EFFECT PARAMETERS MEASURED: Number of surviving worms and total dry biomass of worms were recorded throughout the study.

VEHICLE CONTROL PERFORMED: yes
Reference substance (positive control):
yes
Remarks:
Potassium chloride
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
75.8 mg/kg sediment dw
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
371 mg/kg sediment dw
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 371 mg/kg sediment dw
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Details on results:
- Mortality of test animals at end of exposure period: none
- Morphological abnormalities: none
- Behavioural abnormalities: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Dose-response test: EC50 = 3.04 mg/L

The measured concentrations of the test item in the sediment were in the range of 25 - 35% at day 0, 24 -41% at day 7 and 7 -36% of nominal concentrations at day 28. Minor recoveries of the test item in the aqueous phase and pore water could be determined. Control and solvent control samples were < LOQ.

By independent and repeated sampling and analytics it was confirmed that the application procedure is the main reason for losses of the test item at start of the test. While this initial decrease of the test item concentrations appears to be unavoidable, exposure levels stay remarkably constant over the whole expsoure period, thus allowing for expression of test results on the basis of geometric mean measured concentrations.

Validity criteria fulfilled:
yes
Conclusions:
The test substance showed to be toxic to sediment organisms at long-term exposure with a 28d-NOEC value of 75.8 mg/kg sediment dw.
Executive summary:

The test substance showed to be toxic to sediment organisms at long-term exposure with a 28d-NOEC value of 75.8 mg/kg sediment dw.

Description of key information

There is no data available for this substance. However, key data for short-term studies is available for structural analogues Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, <2% aromatics; Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics; and Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics. 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 information is summarised below:

Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d LL50 for Corophium volutator of 1,100 mg/kg sediment dry weight, a 10-d EL50 for Corophium volutator of 770 mg/kg sediment dry weight (based on mortality and behaviour), and a 10-d NOELR for Corophium volutator of 32 mg/kg sediment dry weight (based on mortality).

 

Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d LL50 for Corophium volutator of 341 mg/kg sediment dry weight, and a 10-d NOELR for Corophium volutator of < 64 mg/kg sediment dry weight.

 

Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d LL50 for Corophium volutator of 490 mg/kg sediment dry weight, a 10-d EL50 for Corophium volutator of 340 mg/kg sediment dry weight (based on mortality and behaviour), and a 10-d NOELR for Corophium volutator of < 10 mg/kg sediment dry weight (based on mortality).

 

Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d LL50 for Corophium volutator of 398 mg/kg sediment dry weight, and a 10-d NOELR for Corophium volutator of < 80 mg/kg sediment dry weight (based on mortality).

 

Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d EL50 for Corophium volutator of 596 mg/kg sediment dry weight (based on immobility), and a 10-d EL10 for Corophium volutator of 65 mg/kg sediment dry weight (based on immobility).

 

Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, <2% aromatics presented a 10-d EL50 for Corophium volutator of 273 mg/kg sediment dry weight (based on immobility), and a 10-d EL10 for Corophium volutator of 92 mg/kg sediment dry weight (based on immobility).

 

In a long-term study, Hydrocarbons, C11-C13 (odd number), n-alkanes,<2% aromatics presented a 28-d NOEC for Lumbriculus variegatus of 75.8 mg/kg sediment dw (based on reproduction).

Key value for chemical safety assessment

Additional information

In short-term studies, substances identified as C10-13 hydrocarbons, C11-14 hydrocarbons, and C12-C16 hydrocarbons, each containing n-alkanes, isoalkanes, and cyclics, with <2% aromatics are expected to demonstrate toxicity to sediment invertebrates based on results of studies with a marine water sediment invertebrate, Corophium sp. These substances have been shown to demonstrate a range of effects, as measured by immobility and mortality in 10-day EL50 and LL50 studies. The 10-day EL50 and LL50 values ranged from 273 to 1,100 mg/kg sediment (dw).

A long-term study is available investigating the toxicity of Hydrocarbons, C11-C13 (odd numbered), n-alkanes, <2% aromatics to sediment organisms. The study was performed according to GLP and OECD guideline 225 using Lumbriculus variegatus as test organism. Test substance concentrations between 10 and 1000 mg/kg sediment dw were tested by spiking the artificial sediment. The measured concentrations of the test item in the sediment were in the range of 25-35% at day 0, 24-41% at day 7 and 7-36% of nominal concentrations at day 28. Minor recoveries of the test item in the aqueous phase and pore water could be determined. By independent and repeated sampling and analytics it was confirmed that the application procedure is the main reason for losses of the test item at start of the test. While this initial decrease of the test item concentrations appears to be unavoidable, exposure levels stay remarkably constant over the whole expsoure period, thus allowing for expression of test results on the basis of geometric mean measured concentrations. No mortalities or behavioural changes were observed in control and treatments throughout ther exposure period. A 28d-NOEC value for reproduction was determined to be 75.8 mg/kg sediment dw based on geometric mean measured concentrations.