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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
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 fish 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
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 6.6 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
74 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Conclusions:
Based on a read-across to OBSH, the LC50 (fish, 96hr) is derived at >6.6 mg/L.
Executive summary:

Based on a read-across to OBSH, the LC50 (fish, 96hr) is derived at >6.6 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity 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:
4,4’-oxybis(benzenesulfonyl hydrazide) (Sigma-Aldrich Co., Purity: 97.6 %, Lot No.: 08929DR)
Analytical monitoring:
no
Details on sampling:
not available
Vehicle:
yes
Details on test solutions:
Dilution water source: Tap water passed through activated carbon and membrane filter (1 mm)
solvent: DMSO
Test organisms (species):
Oryzias latipes
Details on test organisms:
- Test Organism
Age: 5 ~ 8 months
Length: 3.0 ± 0.1 cm
Weight: 0.21 ± 0.03 g
Loading: 8.7 L aquarium per 7 fish
Pretreatment: 55 fish were acclimated to the test condition for 7 days before the test. Feed was supplied to fish until 24 hrs before the test but notduring the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
44 mg/L as CaCO3
Test temperature:
23.0 ~ 24.5 °C
pH:
6.38 ~ 7.71
Dissolved oxygen:
5.1 ~ 8.8 mg/L
Salinity:
NA
Nominal and measured concentrations:
Nominal concentrations (mg/L):
Control
Solvent control
6.3 mg/L
12.5 mg/L
25.0 mg/L
50.0 mg/L
100.0 mg/L
Details on test conditions:
Test Organism
Age: 5 ~ 8 months
Length: 3.0 ± 0.1 cm
Weight: 0.21 ± 0.03 g
Loading: 8.7 L aquarium per 7 fish
Pretreatment: 55 fish were acclimated to the test condition for 7 days before the test. Feed was supplied to fish until 24 hrs before the test but not during the test.

- Test Condition
Dilution water source: Tap water passed through activated carbon and membrane filter (1 mm) (Hardness: 44 mg/L as CaCO3)
Water chemistry: DO = 5.1 ~ 8.8 mg/L, pH = 6.38 ~ 7.71
Temperature: 23.0 ~ 24.5 °C
Light periocity: 16/8 (light/dark)

- Test Substance Preparation
Stock solution was prepared by diluting test chemical in DMSO. Test solutions of the chosen concentrations were prepared by dilution of a stock solution (100-fold dilution). The concentration of solvent was 1,000 mg/L.

- Test Design
Nominal concentration: control, solvent control, 12.5, 25.0, 50.0, and 100.0 mg/L
Number of Replicate: 1
Number of Fish per concentration: 7
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
74 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Details on results:
The 96 hr-LC50 (α=0.05) of OBSH to Oryzias latipes was 74 mg/L (65.6 ~ 87.3 mg/L).
The NOEC was estimated to be 50 mg/L.
At 100 mg/L, 1, 5, 7, and 7 fish were dead after 24, 48, 72, and 96 hrs, respectively.
At 100 mg/L, there were 2 fish mainly at the surface and 6 fish at the bottom.
At 50.0 and 100.0 mg/L, floating of the test substance and formation of film at the surface of the test solution were observed.

- Mortality of control: No toxic symptom and dead fish were observed in the control and solvent control.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
The LC50 and the NOEC were calculated by Moving-Average Angle program (EPA/600/4-85/013, 1985).The 96 hr-LC50 (α=0.05) of OBSH to Oryzias latipes was 74 mg/L (65.6 ~ 87.3 mg/L). The NOEC was estimated to be 50 mg/L

Cumulative mortality of Oryzias latipes

Nominal concentrations (mg/L)

Number of

organisms tested

Cumulative number of dead fish

24 hrs

48 hrs

72 hrs

96 hrs

Control

7

0

0

0

0

Solvent control

7

0

0

0

0

 6.3

7

0

0

0

0

12.5

7

0

0

0

0

25.0

7

0

0

0

0

50.0

7

0

0

0

0

100.0

7

1

5

7

7

Results of acute toxicity test to Oryzias latipes  (unit mg/L)                                                             

Exposure time

96hrs

LC50

74

95% confidence limits

65.63~87.3

Highest test concentration resulting in 0% mortality

50

Lowest test concentration resulting in 100% mortality

100

No-observed effectconcentration (NOEC)

50

Validity criteria fulfilled:
not specified
Conclusions:
LC50 = 74 mg/L (96 hours)
Executive summary:

The study on the acute toxicity to Fish was conducted according to the OECD Guideline 203 and according to GLP

Oryzias latipes (Age: 5~8 months) were acclimatised for 7 days and exposed to the testsubstance under semi-static conditions (renewal every 24 hours) for 96 h. 7 fish were exposed per test concetration (control, solvent control, 12.5, 25.0, 50.0, and 100.0 mg/L

Fish were not feed during the study

The 96 hr-LC50(α=0.05) of OBSH to Oryzias latipes was 74 mg/L (65.6~87.3 mg/L) (nominal concentration)

The NOEC was estimated to be 50 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity 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:
No details
Analytical monitoring:
yes
Details on sampling:
no data
Vehicle:
yes
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 5 L of dilution water. The final concentration of solvent was 100 µL/L.
Test organisms (species):
Oryzias latipes
Details on test organisms:
Age: about 1 year
Length: 2.29 cm (2.19 ~ 2.40 cm)
Weight: 0.197 g (0.161 ~ 0.229 g)
Loading: 5.0 L aquarium per 10 fish

Acclimation
Acclimation period: Fish were acclimated to the test condition for 14 days before the test.
Type and amount of food: Feed was supplied to fish until 24 hrs before the test but not during the test.
Supplier: Tsunashima Fishing Ltd.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
NA
Test temperature:
24 ± 1 °C
pH:
7.4-7.7
Dissolved oxygen:
6.7-8.5 mg/L
Salinity:
NA
Nominal and measured concentrations:
please refer to results
Details on test conditions:
Dilution water source: Dechlorinated and air-saturated tap water passed through activated carbon
Water chemistry: DO = 6.7 ~ 8.5 mg/L, pH = 7.4 ~ 7.7
Temperature: 24 ± 1 °C
Light dark cycle: 16/8 (light/dark)
Test solution was renewed every 24 hrs.
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 6.6 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: no mortality was observed in the control groups
Results with reference substance (positive control):
not reported

Meassured test concentrations compared to nominal concentrations during the semistatic test

Nominal Concentration

(mg/L)

Measured Concentration

Mean Measured Concentration*

0 hr (New)

24 hrs (Old)

(mg/L)

(% of Nominal)

(mg/L)

(% of Nominal)

(mg/L)

(% of Nominal)

Control

< 0.02

< 0.02

Solvent Control

< 0.02

< 0.02

20.0

18.9

95

2.29

11

6.6

33

Results on acute toxicity to Oryzias latipes

Exposure time

24 hrs

48 hrs

72 hrs

96hrs

LC50

> 6.6

> 6.6

> 6.6

> 6.6

95% confidence limits

Highest test concentration resulting in 0% mortality

> 6.6

> 6.6

> 6.6

> 6.6

Lowest test concentration resulting in 100% mortality

> 6.6

> 6.6

> 6.6

> 6.6

Cumulative mortality of Oryzias latipes

Nominal

Concentration (mg/L)

Mean Measured Concentration (mg/L)

Number of Organisms tested

Cumulative Number of DeadFish

24 hrs

48 hrs

72 hrs

96 hrs

Control

10

0

0

0

0

Solvent control

10

0

0

0

0

20.0

6.6

10

0

0

0

0

Validity criteria fulfilled:
not specified
Conclusions:
The 96 hr-LC50 of OBSH to Oryzias latipes was > 6.6 mg/L (measured concentration).
No toxic symptom and dead fish were observed in the control and solvent control.
Executive summary:

The acute toxicity of OBSH to fish was tested applying the OECD Guideline no. 203. The test was conducted with the fish Oryzias latipes under semi static conditions. Test media was renewed every 24 hours and fish were not fed during the study. No toxic symptom and dead fish were observed in the control and solvent control during teh study. The 96 hr-LC50(α=0.05) could not be determined by statistical method because the mortality at the maximum concentration was less than 50 %. LC50 is therefore reported as >6.6 mg/L (Meassured concentration, HPLC method)

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reason / purpose:
reference to same study
Reference:
Composition 0
Principles of method if other than guideline:
other
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):
Based on the structure of OBSH, the reactive component of OBSH could be the hydrazide portion of the molecule.
Analytical monitoring:
yes
Details on sampling:
no data
Vehicle:
no
Test organisms (species):
Lepomis macrochirus
Details on test organisms:
TEST ORGANISM
- Common name: Lepomis macrochirus
- Length at study initiation (length definition, mean, range and SD): 6.3 ± 0.6 cm
- Weight at study initiation (mean and range, SD): 2.3 ± 0.2 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: 2 weeks
- Acclimation conditions (same as test or not): NA
- Type and amount of food: tetramin (feeding until 2 days before the test)
- Feeding frequency: NA
- Health during acclimation (any mortality observed): not stated

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
164 mg/L as CaCO3
Test temperature:
23-24 °C
pH:
7.8-7.9
Dissolved oxygen:
5.9-8.3 mg/L at t = 0 h
Salinity:
NA
Nominal and measured concentrations:
Toxicant analysis every 24h but concentrations not reported
Details on test conditions:
10 Fish per concentration; duplicate test
Photoperiod: 14 h/10 h (light/dark)
Temperature: 23 ~ 24 °C;
Dissolved oxygen 5.9 ~ 8.3 mg/L at 0 h

Acute threshold test:
Fish: Length 6.0 ± 0.5 cm; weight 3.0 ± 0.9 g
Sample size: trial 1 15; trial 2 10
pH: 7.8 - 7.9
Hardness 164 mg CaCO3/L

Acute toxicity test:
Fish: Length 6.3 ± 0.6 cm; weight 2.3 ± 0.2 g
Sample size: each trial 20
Trial 1: pH 7.2 - 7.3; hardness 292 mg CaCO3/L
Trial 2: pH 8.0 - 8.4; hardness 240 mg CaCO3/L
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.08 mg/L
Nominal / measured:
not specified
Conc. based on:
other: Hydrazine
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.43 mg/L
Nominal / measured:
not specified
Conc. based on:
other: Hydrazine
Basis for effect:
mortality
Details on results:
Behavior test:
Dorsal light responses
Aggressiveness: observing the number of bluegills that attacked the exposed prey. “Attack” was defined as the contact of the bluegill’s pre-maxillary or mandible with prey.
Aggressiveness, as measured by the number of attacks on prey, was increased in a dose related manner. Control fish made no attacks, but attacks increased as the hydrazine concentrations increased.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
Statistical analysis: All dorsal light response data were compared at the 5 % significance level. Mean tilt with and without prey in each test aquarium was compared by Student’s two-tailed t-test and an F-test to insure homogeneity of variances. Mean tilt of the fish in the various hydrazine concentrations was compared to the mean tilt of the control by one-way analysis of variance, and Bartlett’s test inured homogeneity of variances.
Validity criteria fulfilled:
not specified
Conclusions:
LC50 = 1.08 mg/L
NOEC = 0.43 mg/L
Executive summary:

A flow through test was conducted with fish lepomis macrochirus (96h).

The acute toxicity of hydrazine was tested and a resulting LC50 = 1.08 mg/L and NOEC = 0.43 mg/L was found.

Endpoint:
short-term toxicity to fish
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 with acceptable restrictions
Remarks:
Guideline study not following GLP
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
Details on sampling:
no data
Vehicle:
no
Details on test solutions:
Nominal exposure concentration: 1.12, 2.25, 4.50, 9.00, and 18.0 mg hydrazine/L. The actual exposure concentrations were measured at 0, 48 and 96 hr during the test.
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: pimeales promelas
- Source:Sea Plantations, Inc.
- Age at study initiation (mean and range, SD): 8 weeks
- Length at study initiation (length definition, mean, range and SD):2.6 ± 0.3 cm
- Weight at study initiation (mean and range, SD): 0.14 ± 0.07 g
- Feeding during test no


ACCLIMATION
- Acclimation period:
- Type and amount of food: A dry, finely ground commercial fish food was given ad libitum
- Feeding frequency: twice per day during the acclimation period
- Health during acclimation (any mortality observed): no data

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Post exposure observation period:
no
Hardness:
31.2 mg CaCo3/L
Test temperature:
20+/-0.4 °C
pH:
6.95
Dissolved oxygen:
7.9-8.3 mg/L
Nominal and measured concentrations:
Nominal exposure concentration: 1.12, 2.25, 4.50, 9.00, and 18.0 mg hydrazine/L.
Details on test conditions:
- Test Organism
Age: 8 week old
Supplier: Sea Plantations, Inc.
Length 2.6 ± 0.3 cm; weight 0.14 ± 0.07 g
Pretreatment: A dry, finely ground commercial fish food was given ad libitum twice per day during the acclimation period. The fathead minnows (Pimephales promelas) were not fed for 48 h before, or during, the test.

- Test Condition
5 concentrations plus control tested in duplicate; 10 juvenile animals per group
Temperature 20 ± 0.4 °C; pH 6.95; dissolved oxygen 7.9 ~ 8.3 mg/L; alkalinity; 31.2 mg/L as CaCO3
Photoperiod: 16h/8hr (light/dark)

Nominal exposure concentration: 1.12, 2.25, 4.50, 9.00, and 18.0 mg hydrazine/L. The actual exposure concentrations were measured at 0, 48 and 96 hr during the test.

The test fish were observed at 3, 6, 18, 24, 48, 71, and 96 hr and dead fathead minnows were removed and recorded.
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
5.98 mg/L
Nominal / measured:
nominal
Details on results:
LC50 = 5.98 and 95 % confidence limits: 4.83 ~ 7.40 mg/L
LC50 after 18, 24, 48, and 72 hr exposure; 8.98, 7.63, 6.19, and 5.98 mg/L
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
NA
Validity criteria fulfilled:
not specified
Conclusions:
LC50 = 5.98 and 95 % confidence limits: 4.83 ~ 7.40 mg/L
LC50 after 18, 24, 48, and 72 hrs exposure; 8.98, 7.63, 6.19, and 5.98 mg/L
Executive summary:

The toxicity of hydrazine hydrate (54%) was tested according to EPA guideline 600/3-75-009 (1975). Thes tudy was conducted exposing the fish pimeales promelas to the nominal concentrations: 1.12, 2.25, 4.50, 9.00, and 18.0 mg hydrazine/L for 72 hours. Concentrations were tested in duplicate with 10 juvenile animals per group. Based on the mortality observed LC50 (72h) = 5.98 and 95 % confidence limits: 4.83 ~ 7.40 mg/L wer reported

Description of key information

2 short-term (96 hrs) toxicity studies with fish have been carried out (OECD 203), showing a LC50 between >6.6 mg/L and 74 mg/L for the source substance (S1). These data are used for LC50 for the target substance as well. 

Key value for chemical safety assessment

LC50 for freshwater fish:
6.6 mg/L

Additional information

2 short-term (96 hrs) toxicity studies with fish have been carried out (OECD 203), showing a LC50 between >6.6 mg/L and 74 mg/L for the source substance (S1). Based on read-across, these data are used for LC50 for the target substance as well.