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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Read-across from short-term toxicity study in daphnia on one closely structural and physicochemical related substance: OBSH (4,4'-Oxybis (benzenesulfonyl hydrazide)).
For further read-across justification se document attached in section 13.
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
15 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1.9 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Conclusions:
Based on read-across to OBSH (80-51-3), the EC50(daphnia, 48hrs) is derived at 2.9 mg/L
Executive summary:

Based on read-across to OBSH (80-51-3), the EC50(daphnia, 48 hrs) is derived at 2.9 mg/L

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
following GLP
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
no data
Analytical monitoring:
yes
Details on sampling:
NA
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: OECD M4 Medium
Hardness: 243 mg/L as CaCO3
Alkalinity: 33.1 mg/L as CaCO3
Test organisms (species):
Daphnia magna
Details on test organisms:
Test Organism
Age: Juveniles within 24 hrs old
Supplier: GSF Institute of Ecological Chemistry, Germany
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
no
Hardness:
243 mg/L as CaCO3
Test temperature:
20.1± 0.2 °C
pH:
7.43 ~ 7.92
Dissolved oxygen:
7.3 ~ 8.7 mg/L (80 ~ 96 % of the air saturation value)
Salinity:
NA
Nominal and measured concentrations:
Nominel concentrations:
Control; 0.3 mg/L; 0.6 mg/L; 1 mg/L; 3 mg/L; 5 mg/L; 10 mg/L; 20 mg/L; 40 mg/L
Meassured concentrations:
0.05, 0.07, 0.10, 0.20, 0.38, 0.52, 0.81, and 1.37 mg/L (3.43 % ~ 16.7 % of nominal concentration)
Details on test conditions:
Dilution water source: OECD M4 medium (Hardness: 243 mg/L as CaCO3, Alkalinity: 33.1 mg/L as CaCO3)
Water chemistry: DO = 7.3 ~ 8.7 mg/L (80 ~ 96 % of the air saturation value), pH = 7.43 ~ 7.92
Temperature: 20.1± 0.2 °C
Light: 750 ~ 860 Lux, Light periodicity: 16/8 (light/dark)

Replicates: 3 replicates
Loading: 10 daphnids/concentration
Reference substance (positive control):
not specified
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
23 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Result: 48 hr-EC50 (α=0.05) of OBSH to Daphnia magna was 15 mg/L (13 ~ 18 mg/L). The NOEC was estimated to be 5 mg/L at 48 hrs.

Control: No immobilisation and adverse effects were observed in the control.
At 24 hrs, 14 and 26 daphnids were immobilized with 20 and 40 mg/L of OBSH, respectively. At 48 hrs, 6, 20, and 30 daphnids were immobilized with 10, 20, and 40 mg/L of OBSH. Any abnormal behaviors of the daphnids was notobserved in each treatment group during the testing.

Precipitation of the test substance and formation of film at the surface were observed in more than 1 mg/L but immobilisation was observed in more than 10 mg/L. Therefore immobilization of daphnia and film formation are not related to each other.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
The EC50 value (α=0.05) were calculated by Probit Analysis method (EPA/600/4-85/013, 1985).

In the stability test, the concentration of OBSH was decreased by 50% ofthe initial level (1 mg/L) after 4 hrs in daphnia culture media The measured concentration of test substance was very low because of its low water solubility and high degradation of dissolved substance in aqueous solution.At 48 hrs (the end of the test), the mean measured concentrations of OBSH were 0.05, 0.07, 0.10, 0.20, 0.38, 0.52, 0.81, and 1.37 mg/L (3.43 %~16.7 % of nominal concentration). Although several peaks for degraded or transformed products were observed, identification and measurement of them were not performed. Therefore, all test results were expressed as nominal concentrations.

Validity criteria fulfilled:
not specified
Conclusions:
48 hr-EC50 (α=0.05) of OBSH to Daphnia magna was 15 mg/L (13 ~ 18 mg/L). The NOEC was estimated to be 5 mg/L at 48 hrs. (nominal concentrations)
Executive summary:

The Toxicity of OBSH towards Daphnia magna was tested applying the OECD Guideline no. 202. The study was conducted accoring to GLP. Test concentrations were measured at the beginning (0 hr) and the end (48 hrs) of the studyusing HPLC with C18 column and DAD G1315B detector. Based on the endpoint mobility a 48 hr-EC50 (α=0.05) of OBSH to Daphnia magna was 15 mg/L (13 ~ 18 mg/L). The NOEC was estimated to be 5 mg/L at 48 hrs. (nominal concentrations)

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Following GLP
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
no data
Analytical monitoring:
yes
Details on sampling:
Test concentrations were measured at the beginning (0 hr) of the study and 24 hrs after exposure (before renewal of test solution)
Details on test solutions:
Stock solution was prepared by diluting test chemical in dimethylformamide (200,000 mg/L). Test solutions were prepared by adding the corresponding amounts of stock solution into 500 mL of OECD M4 medium. The concentration of solvent was 100 µL/L.
Nominal concentration: Control, solvent control, 2.0, 3.6, 6.0, 11.2, 20.0 mg/L
Number of Replicate: 4
Daphnia per test concentration: 5
Test solutions were renewed after 24 hrs.
Test organisms (species):
Daphnia magna
Details on test organisms:
Age: Juveniles within 24 hrs old
Supplier: Independent Administrative Institution National Institute of Environmental Studies, Japan

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
Test concentrations were measured at the beginning (0 hr) of the study and 24 hrs after exposure (before renewal of test solution) using HPLC.
Post exposure observation period:
no
Hardness:
250 mg/L as CaCO3
Test temperature:
20 ± 1 °C
pH:
7.7 ~ 8.4
Dissolved oxygen:
8.0 ~ 8.8 mg/L (over 60 % of the air saturation value)
Nominal and measured concentrations:
Nominal Con. (mg/L) Measured Con. (mg/L) Geometric Mean Conc. During 24 hrs (mg/L)
0 hr (New*) % of Nominal 24 hrs (Old**) % of Nominal
Control < 0.02 – < 0.02 – –
Solvent Control < 0.02 – < 0.02 – –
2.00 1.73 87 0.78 39 1.16
3.60 2.93 81 1.24 34 1.91
6.40 5.29 83 2.17 34 3.39
11.20 9.12 81 3.80 34 5.89
20.0 16.2 81 6.50 33 10.3


Details on test conditions:
Dilution water source: OECD M4 medium (Hardness: 250 mg/L as CaCO3)
Water chemistry: DO = 8.0 ~ 8.8 mg/L (over 60 % of the air saturation value), pH = 7.7 ~ 8.4
Temperature: 20 ± 1 °C
Light: 800 Lux, Light periodicity: 16/8 (light/dark)
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
2.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
48 hr-EC50 (α=0.05) of OBSH to Daphnia magna was 2.9 mg/L (2.44 ~ 3.47 mg/L). No immobilisation and adverse effects were observed in the control and solvent control.
No immobilisation and adverse effects were observed in the control. At 24 hrs, 14 and 26 daphnids were immobilized with 20 and 40 mg/L of OBSH, respectively. At 48 hrs, 6, 20, and 30 daphnids were immobilized with 10, 20, and 40 mg/L of OBSH. Any abnormal behaviors of the daphnids was not observed in each treatment group during the testing.
Precipitation of the test substance and formation of film at the surface were observed in more than 1 mg/L but immobilisation was observed in more than 10 mg/L. Therefore immobilization of daphnia and film formation are not related to each other.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
Data Analysis: The EC50 value (α=0.05) was calculated by Probit Analysis method.

Measured concentration of the test substance in test water under the semi-static condition

Nominal Con. (mg/L)

Measured Con. (mg/L)

Geometric Mean Conc.

During 24 hrs (mg/L)

0 hr (New*)

% of Nominal

24 hrs (Old**)

% of Nominal

Control

< 0.02

< 0.02

Solvent Control

< 0.02

< 0.02

2.00

1.73

87

0.78

39

1.16

3.60

2.93

81

1.24

34

1.91

6.40

5.29

83

2.17

34

3.39

11.20

9.12

81

3.80

34

5.89

20.0

16.2

81

6.50

33

10.3

Results of acute toxicity test to Daphnia magna   (Unit mg/L)                                                           

Exposure time

24 hrs

48 hrs

EC50*

9.8

2.9

95% confidence limits

8.3~13.4

2.4~3.5

Highest test concentration resulting in 0% mortality

3.4

< 1.2

Lowest test concentration resulting in 100% mortality

> 10.3

10.3

The results of cumulative immobilization data for Daphnia magna

Nominal Conc.(mg/L)

Mean Measured Conc.(mg/L)a

Number of

Organisms tested

Cumulative Number of

Organisms Immobilized (%immobility)

24 hrs

48 hrs

Control

20

0

0

Solvent Control

20

0

0

2.00

1.16

20

0

1 (5)

3.60

1.91

20

0

3 (15)

6.40

3.39

20

0

12 (60)

11.20

5.89

20

2 (10)

19 (95)

20.0

10.3

20

11 (55)

20 (100)

Validity criteria fulfilled:
not specified
Conclusions:
48 hr-EC50 (α=0.05) of OBSH to Daphnia magna was 2.9 mg/L (2.44 ~ 3.47 mg/L). No immobilisation and adverse effects were observed in the control and solvent control.
Executive summary:

The acute toxicity of OBSH towards Daphnia magna was tested accoring to the OECD Guideline no. 202. The study was conducted according to GLP. Juvenile daphnids (> 24h) were exposed for 48 h under static conditions. The following concentrations were applied: Control,solvent control, 2.0, 3.6, 6.0, 11.2, 20.0mg/L. Based on the results the 48 hr-EC50 (α=0.05) of OBSH to Daphnia magna was 2.9 mg/L (2.44 ~ 3.47 mg/L). (meas. geom. mean)No immobilisation and adverse effects were observed in the control and solvent control during the study.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
no information on GLP
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: EPA Guideline 600/3-75-009 (1975)
Deviations:
no
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
NA
Analytical monitoring:
yes
Details on sampling:
no data
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method: Nominal hydrazine concentrations were prepared in soft reconstituted water. The reconstituted water used for the tests was prepared by adding the following quantities of salts to 1 L of deionized water: 48 mg NHCO3, 30 mg MgSO4, 30 mg CaSO4, and 2 mg KCl.
8 concentrations and a control tested in duplicate;

Renewal after 24 h.
Test organisms (species):
Daphnia pulex
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia pulex
- Age at study initiation (mean and range, SD): < 24 hours old
- Feeding during test: no

ACCLIMATION
Daphnids less than 24 h of age were applied. They were not feed before exposure.

Test type:
other: static renewal
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
no
Test temperature:
Test 1: 20 ± 0.3 °C
Test 2: 20 ± 0.4 °C
pH:
Test 1: 7.2
Test 2: 7.1
Dissolved oxygen:
Test 1: 8.2 ± 0.2 mg/L
Test 2: 8.2 ± 0.3 mg/L
Salinity:
NA
Nominal and measured concentrations:
- Test Design
8 concentrations and a control tested in duplicate; 10 animals per group; renewal after 24 h.
Highest nominal hydrazine concentration: Test 1: 5.00; Test 2: 4.00 mg/L
A dilution factor of 0.5 was used to prepare the remaining concentrations in both tests.
Details on test conditions:
- Test Condition
Photoperiod: 16 h/8 h(light/dark)
Test 1: Temperature 20 ± 0.3 °C; pH 7.2 dissolved oxygen 8.2 ± 0.2 mg/L; alkalinity 36.3 mg/L as CaCO3
Test 2: Temperature 20 ± 0.4 °C; pH 7.1 dissolved oxygen 8.2 ± 0.3mg/L; alkalinity 34.8 mg/L as CaCO3
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.19 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Test 1
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Test 2
Details on results:
The daphnids were observed at 3, 6, 12, 24, 36 and 48 h for immobilization.
Mean hydrazine loss was 2.7 % for 24 h periods
Test 1: EC50 0.19 (0.16 - 0.23) mg/L
Test 2: EC50 = 0.16 (0.13 ~ 0.19) mg/L
There was no significant difference (p < 0.05) between the 48-hr EC50 values determined from the two Daphnia tests.
24-hr EC50 values of test 1 and 2 were 1.01 (0.85 ~ 1.21) and 0.51 (0.39 ~ 0.71) mg/L, respectively.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
no data
Validity criteria fulfilled:
not specified
Conclusions:
Test 1: EC50 0.19 (0.16 - 0.23) mg/L
Test 2: EC50 = 0.16 (0.13 ~ 0.19) mg/L
There was no significant difference (p < 0.05) between the 48-hr EC50 values determined from the two Daphnia tests.
(nominal concentrations)
Executive summary:

Two seperate static renewal tests with Daphnia pulex were conducted according to the EPA Guideline 600/3 -75 -009.

Daphnids less than 24 hours were exposed for 48 h and the effect on mobility was observed.

Based on the results an EC50 = 0.19 (0.16 - 0.23) mg/L (Test)

and an EC50 = 0.16 (0.13 ~ 0.19) mg/L (Test 2) were determined. (nominal concentrations)

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
NA
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Reason / purpose:
reference to same study
Reference:
Composition 0
Principles of method if other than guideline:
Data from handbook. Reported as "Closed static bioassay"
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
NA
Analytical monitoring:
not specified
Details on sampling:
No data
Vehicle:
not specified
Details on test solutions:
No data
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnids 24 hours old were applied.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
24 h
Post exposure observation period:
no
Hardness:
16°(German)
Test temperature:
20 °C
pH:
7.8-8.1
Dissolved oxygen:
final oxygen concentration > 2 mg/L
Salinity:
NA
Nominal and measured concentrations:
No data
Details on test conditions:
No data
Reference substance (positive control):
not specified
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
0.9 mg/L
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
2.3 mg/L
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
15 mg/L
Details on results:
no data
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
no data
Validity criteria fulfilled:
not specified
Conclusions:
EC0, EC50 and EC100 were 0.9 mg/L, 2.3 mg/L and 15 mg/L respectively
Executive summary:

A closed static bioassay was conducted exposing Daphnia magna (24h) for 24 h to hydrazine hydrate (80%). Based on the results obtained

EC0, EC50 and EC100 were 0.9 mg/L, 2.3 mg/L and 15 mg/L respectively

Description of key information

Based on read-across to OBSH (80-51-3, (S1)), the EC50 (daphnia, 48 hrs) is derived at 2.9 mg/L TSH

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
6.6 mg/L

Additional information