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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
13/02/1996 - 08/03/1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test was not performed according to GLP. Actual test concentrations of the test substance were not measured. Strain and origin of test species are not reported. A polymer is reported to have been added to the test medium, but its purpose is not clear.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: USEPA (EPA 600/4-89/001)
Deviations:
yes
Remarks:
One organism in replicate 3 of the 1.9 mg/l treatment died due to a labaratory induced mortality. This organism was excluded from data analysis.
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not relevant
Analytical monitoring:
no
Details on sampling:
Daily samples were taken to monitor physical/chemical conditions. Samples were cold-stored between renewals.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Batches of 300 ml were prepared daily from a 1000 ppm stock solution using a pre-determined dilution plan.
- Controls: Yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No, test substance concentration was below maximum solubility
Test organisms (species):
Ceriodaphnia dubia
Details on test organisms:
TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Age of parental stock (mean and range, SD): Less than 24 hours, all released within 8 hour period of aech other
- Feeding during test
- Food type: YTC and algal suspension
- Amount: 0.1 ml / test chamber
- Frequency: daily
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
8 d
Remarks on exposure duration:
Test lasts until 60% of the control females have produced three broods
Post exposure observation period:
Not relevant
Hardness:
80 - 92 mg/l (not specified)
Test temperature:
24.5 - 25.5 degrees Celsius
pH:
7.8 - 8.2
Dissolved oxygen:
7.5 - 8.4 mg/l
Salinity:
Not relevant
Nominal and measured concentrations:
Nominal: 1.9, 3.8, 7.5, 15 and 31 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: size: 30ml; filled with 15-20 ml medium
- Aeration: none
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Moderately hard synthetic water (prepared using deionized water and reagent grade chemicals) or suitable natural water.
- Intervals of water quality measurement: daily


OTHER PARAMETERS
- Photoperiod: 16/8 hours light/dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : survival and reproduction were observed daily
Reference substance (positive control):
yes
Remarks:
Sodium chloride
Duration:
8 d
Dose descriptor:
NOEC
Effect conc.:
3.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
8 d
Dose descriptor:
other: MATC
Effect conc.:
5.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
8 d
Dose descriptor:
LOEC
Effect conc.:
7.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
8 d
Dose descriptor:
other: IC25
Effect conc.:
5.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Survival of parent animals: 80%, 89%, 100%, 90%, 80% and 100% at 0, 1.9, 3.8, 7.5, 15 and 31 mg/l respectively.
- No. of offspring produced per day per female: 15.1, 17.9, 17.2, 4.8, 3.3 and 1.2 at 0, 1.9, 3.8, 7.5, 15 and 31 mg/l respectively.
- Other biological observations: adults and neonates appeared to be healthy during the test
Results with reference substance (positive control):
- Results with reference substance valid?: yes, 48h-LC50 of 1.9 g/l is within range of 1.3 to 2.5 mg/l.
Reported statistics and error estimates:
Statistical analysis was done using Fisher exact tests and bootstrapping methods.

Conc substance (in mg/L)

% survival

Reproduction (average no. of neonates/female

Control

80

15.1

1.9

89

17.9

3.8

100

17.2

7.5

90

4.8*

15

80

3.3*

31

100

1.2*

Values marked with "*" are significantly different from control values (P<0.05)

Validity criteria fulfilled:
yes
Remarks:
minimum acceptable survival and reproduction criteria were met or exceeded in the control
Conclusions:
The chronic NOEC, MATC, LOEC and IC25 values of Sumalchlor towards Ceriodaphnia dubia are 3.8, 5.3, 7.5 and 5.1 mg/l respectively.
Executive summary:

The chronic toxicity of Sumalchlor towards Ceriodaphnia dubia was investigated according to USEPA guideline EPA 600/4 -89/001. Validity criteria for the test were met. The test was performed by Inchcape Testing Servives as ordered by Summit Research Labs. Sumalchlor was tested at concentrations of 1.9, 3.8, 7.5, 15 and 31 mg/l in moderately hard water. No relationship between test substance concentration and survival was observed. Actual concentrations of the test substance were not measured. The chronic NOEC, MATC, LOEC and IC25 were found to be 3.8, 5.3, 7.5 and 5.1 mg/l respectively.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
30/01/1996 - 08/03/1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test was not performed according to GLP. Actual test concentrations of the test substance were not measured. Strain and origin of test species are not reported. A polymer is reported to have been added to the test medium, but its purpose is not clear.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: USEPA (EPA 600/4-89/001)
Deviations:
yes
Remarks:
One organism in replicate 3 of the 1.9 mg/l treatment died due to a labaratory induced mortality. This organism was excluded from data analysis.
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not relevant
Analytical monitoring:
no
Details on sampling:
Daily samples were taken to monitor physical/chemical conditions. Samples were cold-stored between renewals.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Batches of 300 ml were prepared daily from a 1000 ppm stock solution using a pre-determined dilution plan.
- Controls: Yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No, test substance concentration was below maximum solubility
Test organisms (species):
Ceriodaphnia dubia
Details on test organisms:
TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Age of parental stock (mean and range, SD): Less than 24 hours, all released within 8 hour period of aech other
- Feeding during test
- Food type: YTC and algal suspension
- Amount: 0.1 ml / test chamber
- Frequency: daily
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
7 d
Remarks on exposure duration:
Test lasts until 60% of the control females have produced three broods
Post exposure observation period:
Not relevant
Hardness:
80 - 88 mg/l (not specified)
Test temperature:
24.6 - 25.7 degrees Celsius
pH:
7.2 - 8.2
Dissolved oxygen:
8.0 - 8.3 mg/l
Salinity:
Not relevant
Nominal and measured concentrations:
Nominal: 15, 31, 62, 125 and 250 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: size: 30ml; filled with 15-20 ml medium
- Aeration: none
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Moderately hard synthetic water (prepared using deionized water and reagent grade chemicals) or suitable natural water.
- Intervals of water quality measurement: daily


OTHER PARAMETERS
- Photoperiod: 16/8 hours light/dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : survival and reproduction were observed daily
Reference substance (positive control):
yes
Remarks:
Sodium chloride
Duration:
7 d
Dose descriptor:
NOEC
Effect conc.:
< 15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
7 d
Dose descriptor:
LOEC
Effect conc.:
15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
7 d
Dose descriptor:
other: IC25
Effect conc.:
3.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Survival of parent animals: 100%, 70%, 100%, 60%, 90% and 40% at 0, 15, 31, 62, 125 and 250 mg/l respectively.
- No. of offspring produced per day per female: 19.2, 0.0, 0.9, 0.3, 0.1 and 0.0 at 0, 15, 31, 62, 125 and 250 mg/l respectively.
- Other biological observations: adults and neonates appeared to be healthy during the test
Results with reference substance (positive control):
- Results with reference substance valid?: yes, 48h-LC50 of 1.9 g/l is within range of 1.3 to 2.5 mg/l.
Reported statistics and error estimates:
Statistical analysis was done using Fisher exact tests and bootstrapping methods.

Conc substance (in mg/L)

% survival

Reproduction (average no. of neonates/female

Control

100

19.2

15

70

0.0*

31

100

0.9*

62

60

0.3*

125

90

0.1*

250

40

0.0*

Values marked with "*" are significantly different from control values (P<0.05)

Validity criteria fulfilled:
yes
Remarks:
minimum acceptable survival and reproduction criteria were met or exceeded in the control
Conclusions:
The chronic NOEC, LOEC and IC25 values of Sumalchlor towards Ceriodaphnia dubia are <15, 15, and 3.8 mg/l respectively.
Executive summary:

The chronic toxicity of Sumalchlor towards Ceriodaphnia dubia was investigated according to USEPA guideline EPA 600/4 -89/001. Validity criteria for the test were met. The test was performed by Inchcape Testing Servives as ordered by Summit Research Labs. Sumalchlor was tested at concentrations of 15, 31, 62, 125 and 250 mg/l in moderately hard water. No relationship between test substance concentration and survival was observed. Actual concentrations of the test substance were not measured. The chronic NOEC, LOEC and IC25 were found to be <15, 15 and 3.8 mg/l respectively.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
13/02/1996 - 08/03/1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test was not performed according to GLP. Actual test concentrations of the test substance were not measured. Strain and origin of test species are not reported. A polymer is reported to have been added to the test medium, but its purpose is not clear.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: USEPA (EPA 600/4-89/001)
Deviations:
yes
Remarks:
One organism in replicate 3 of the 1.9 mg/l treatment died due to a labaratory induced mortality. This organism was excluded from data analysis.
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not relevant
Analytical monitoring:
no
Details on sampling:
Daily samples were taken to monitor physical/chemical conditions. Samples were cold-stored between renewals.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Batches of 300 ml were prepared daily from a 1000 ppm stock solution using a pre-determined dilution plan.
- Controls: Yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No, test substance concentration was below maximum solubility
Test organisms (species):
Ceriodaphnia dubia
Details on test organisms:
TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Age of parental stock (mean and range, SD): Less than 24 hours, all released within 8 hour period of aech other
- Feeding during test
- Food type: YTC and algal suspension
- Amount: 0.1 ml / test chamber
- Frequency: daily
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
8 d
Remarks on exposure duration:
Test lasts until 60% of the control females have produced three broods
Post exposure observation period:
Not relevant
Hardness:
80 - 92 mg/l (not specified)
Test temperature:
24.5 - 25.6 degrees Celsius
pH:
7.2 - 8.2
Dissolved oxygen:
7.6 - 8.3 mg/l
Salinity:
Not relevant
Nominal and measured concentrations:
Nominal: 15, 31, 62, 125 and 250 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: size: 30ml; filled with 15-20 ml medium
- Aeration: none
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Moderately hard synthetic water (prepared using deionized water and reagent grade chemicals) or suitable natural water.
- Intervals of water quality measurement: daily


OTHER PARAMETERS
- Photoperiod: 16/8 hours light/dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : survival and reproduction were observed daily
Reference substance (positive control):
yes
Remarks:
Sodium chloride
Duration:
8 d
Dose descriptor:
NOEC
Effect conc.:
< 15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
8 d
Dose descriptor:
LOEC
Effect conc.:
15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
8 d
Dose descriptor:
other: IC25
Effect conc.:
4.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Survival of parent animals: 80%, 100%, 90%, 100%, 70% and 80% at 0, 15, 31, 62, 125 and 250 mg/l respectively.
- No. of offspring produced per day per female: 17.1, 3.7, 2.5, 2.0, 1.0 and 1.0 at 0, 15, 31, 62, 125 and 250 mg/l respectively.
- Other biological observations: adults and neonates appeared to be healthy during the test
Results with reference substance (positive control):
- Results with reference substance valid?: yes, 48h-LC50 of 1.9 g/l is within range of 1.3 to 2.5 mg/l.
Reported statistics and error estimates:
Statistical analysis was done using Fisher exact tests and bootstrapping methods.

Conc substance (in mg/L)

% survival

Reproduction (average no. of neonates/female

Control

80

17.1

15

100

3.7*

31

90

2.5*

62

100

2.0*

125

70

1.0*

250

80

1.0*

Values marked with "*" are significantly different from control values (P<0.05)

Validity criteria fulfilled:
yes
Remarks:
minimum acceptable survival and reproduction criteria were met or exceeded in the control
Conclusions:
The chronic NOEC, LOEC and IC25 values of Sumalchlor towards Ceriodaphnia dubia are <15, 15, and 4.8 mg/l respectively.
Executive summary:

The chronic toxicity of Sumalchlor towards Ceriodaphnia dubia was investigated according to USEPA guideline EPA 600/4 -89/001. Validity criteria for the test were met. The test was performed by Inchcape Testing Servives as ordered by Summit Research Labs. Sumalchlor was tested at concentrations of 15, 31, 62, 125 and 250 mg/l in moderately hard water. No relationship between test substance concentration and survival was observed. Actual concentrations of the test substance were not measured. The chronic NOEC, LOEC and IC25 were found to be <15, 15 and 4.8 mg/l respectively.

Description of key information

USEPA 600/4 -89/001, key study, validity 2 (Williams, 1996):

NOEC < 15 mg/L, LOEC = 15 mg/L, IC25 = 3.8 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
15 mg/L

Additional information

Three read-across studies performed on Aluminium chloride hydroxide are available. The first referenced study is a key study while the two others are supporting studies.

1)    The chronic toxicity of Sumalchlor towards Ceriodaphnia dubia was investigated according to USEPA guideline EPA 600/4 -89/001. Validity criteria for the test were met. The test was performed by Inchcape Testing Servives as ordered by Summit Research Labs. Sumalchlor was tested at concentrations of 15, 31, 62, 125 and 250 mg/L in moderately hard water. No relationship between test substance concentration and survival was observed. Actual concentrations of the test substance were not measured. The chronic NOEC, LOEC and IC25 were found to be <15, 15 and 3.8 mg/L respectively.

2)    The chronic toxicity of Sumalchlor towards Ceriodaphnia dubia was investigated according to USEPA guideline EPA 600/4 -89/001. Validity criteria for the test were met. The test was performed by Inchcape Testing Servives as ordered by Summit Research Labs. Sumalchlor was tested at concentrations of 15, 31, 62, 125 and 250 mg/L in moderately hard water. No relationship between test substance concentration and survival was observed. Actual concentrations of the test substance were not measured. The chronic NOEC, LOEC and IC25 were found to be <15, 15 and 4.8 mg/L respectively.

3)    The chronic toxicity of Sumalchlor towards Ceriodaphnia dubia was investigated according to USEPA guideline EPA 600/4 -89/001. Validity criteria for the test were met. The test was performed by Inchcape Testing Servives as ordered by Summit Research Labs. Sumalchlor was tested at in moderately hard water. No relationship between test substance concentration and survival was observed. Actual concentrations of the test substance were not measured. The chronic NOEC, MATC, LOEC and IC25 were found to be 3.8, 5.3, 7.5 and 5.1 mg/L respectively.