Registration Dossier
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EC number: 216-407-3 | CAS number: 1576-35-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- 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 for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- 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 for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- 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).
- 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 for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- 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.
- 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 for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline 600/3-75-009 (1975)
- Deviations:
- no
- GLP compliance:
- not specified
- 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 for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Data from handbook. Reported as "Closed static bioassay"
- GLP compliance:
- not specified
- 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
Referenceopen allclose all
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.
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) |
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
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 6.6 mg/L
Additional information
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