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EC number: 219-145-8 | CAS number: 2372-82-9
- 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 25, 2002 to September 26, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- see 'Principles of method if other than guideline'
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Remarks:
- see 'Principles of method if other than guideline'
- Principles of method if other than guideline:
- The only deviation was that analytical quantification of the applied test concentrations was not possible due to the absence of a suitable analytical method. Therefore only the stock solution used to prepare the test concentrations were analyzed. However, based on the high water solubility and stability of the test substance it was considered reasonable to assume that the actual concentrations were identical to the nominal concentrations during the entire test.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Triamine content 85.3%, Total amine content 100%
- Analytical monitoring:
- yes
- Details on sampling:
- Quantification of the actual exposure concentrations in the test solutions was not possible due to the absence of suitable analytical method. Instead the concentrations in the stock solutions were quantified.
- Vehicle:
- yes
- Details on test solutions:
- STOCK AND TEST SOLUTION AND THEIR PREPARATION:
- Dispersion: A stock solution was prepared by dissolving approximately 1 g of test substance in 120 mL deionized water at 50 °C under stirring. After cooling pH was adjusted to 8.5 and deionized water was added up to make up a volume of 1000 mL (at Day 2 a fresh solution was prepared to change the medium). The test solutions were prepared by addition of the required amounts of stock solution to the test medium (Dutch Standard Water). - Vehicle, solvent: deionized water
- Concentration of vehicle/ solvent: 1 g/L
STABILITY OF THE TEST CHEMICAL SOLUTIONS:
- Reference substance: Dilution water
- Source: Dutch Standard Water; Containing per liter of dionized water 100 mg Na HCO3, 20 mg KHCO3, 200 mg CaCl2.2H2O and 180 mg MgSO4.7H2O
- Aeration: test solutions were aerated with water-saturated air purified by an active coal filter and cotton filter.
- Hardness: 12°dH
- pH: 8.2
- Oxygen content: 8.2-8.7 mg/L
- Conductance: < 5uS/cm
- Holding water: Dutch Standard Water (DSW) - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISMS:
- Strain: Brachydanio rerio (Zebra fish)
- Supplier: Retailer (fish were accepted according to the quality control criteria of the guidelines and SOP)
- Wild caught: no
- Age/size/loading: Juvenile/<= 3 cm/1g/L (wet weight)
- Feeding: Commercially available dry or deep-frozen food
- Pretreatment: 1-3 times a day
- Feeding during test: No; feeding stopped 24 h before study - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
- Hardness:
- Hardness: 12°dH
- Test temperature:
- 19.4-21.4°C
- pH:
- 8.2
- Dissolved oxygen:
- Oxygen content: 8.2-8.7 mg/L
- Salinity:
- Dutch Standard Water was used which is a freshwater
- Nominal and measured concentrations:
- Concentrations: 0.1, 0.18, 0.32, 0.58 and 1.05 mg/L
- Details on test conditions:
- TEST SYSTEM:
- Test type: Semi static
- Concentrations: 0.1, 0.18, 0.32, 0.58 and 1.05 mg/L
- Renewal of test solution: day 2
- Exposure vessel type: 5 L aquaria containing 3 L of test solution
- Number of replicates, fish per replicate: one aquarium per dose with 7 fish
- Test temperature: 19.4-21.4°C
- Dissolved oxygen: 8.2-8.7 mg/L
- pH: 7.6-8.2
- Adjustment of pH: The pH of the stock solution (1.0031 g in 120 mL and 1.0004 g in 120 mL) of the chemical prepared in deionized water of approximately 50°C after cooling down the pH was adjusted to 8.5. Deionized water was added up to a volume of 1000 mL.
- Intensity of irradiation: Ambient light provided by fluorescent tubes
- Photoperiod: 16 h photoperiod daily
DURATION OF THE TEST: 96 h
TEST PARAMETER: The fish were considered dead when a lack of opercular movement was observed and touching of the caudal peduncle produced no reaction. Dead fish were removed from the test vessels directly after being observed, which was checked at least twice each day. In addition to death, sub-lethal effects such as erratic swimming, loss of reflex, increased excitability, lethargy, changes in physiology, discoloration, pigmentation, excessive mucous production, hyperventilation, opaque eyes, curved spine or hemorrhaging were recorded. Fish that were convulsing or showing other severe forms of distress not considered transient in nature and likely to become more severe before the exposure is terminated, were sacrificed for humane reasons. These fish were treated as having died in the test. - Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.431 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (0.346 - 0.538)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 1.05 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: observed after 29 h
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.18 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - The LC50 (96 h) was calculated to be 0.431 mg/L with 95 % confidence limits of 0.346 and 0.538 m/L.
- The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 h amounted to 0.18 mg/L whereas 0.32 m/L was the lowest tested concentration (LOEC,96 h) at which lethality was observed as compared to the control.
- The LC100 was 1.05 mg/L, which was observed after 29 h. - Reported statistics and error estimates:
- The LC50 was calculated using the computer program Toxcalc v 5.0 applying the trimmed Spearman-Karber method
- Sublethal observations / clinical signs:
RESULTS: EXPOSED
- Nominal/measured concentrations: 0, 0.1, 0.18, 0.32, 0.58,1.05 mg/L (nominal)
Table 1
Survival of fish
Nominal
Hours of test duration
Concentration
0
2
5
21
24
29
45
48
53
54
69
72
77
96
(mg/l)
Number of living fish
Control
7
7
7
7
7
7
7
7
7
7
7
7
7
7
0.1
7
7
7
7
7
7
7
7
7
7
7
7
7
7
0.18
7
7
7
7
7
7
7
7
7
7
7
7
7
7
0.32
7
7
7
7
7
7
7
7
7
7
7
7
6
6
0.58
7
7
7a
7a
7a
7a
7a
6a
4a*
4a
3
2
1
1
1.05
7
7a
7b
1b
1b
0
a= reduced activity
b= very reduced activity
* = For ethical reasons two fish were euthanised at the concentration of 0.58 mL/L after 53 h.
Table 2
Data evaluation
Hours of test
LC50-values
95%-confidence intervals
duration
(mg/l)
(mg/l)
24
0.82
0.7369
0.9124
48
0.7169
0.6126
0.8389
72
0.5105
0.4168
0.6253
96
0.4314
0.3460
0.5378
- The LC50 (96 h) was calculated to be 0.431 mg/L with 95 % confidence limits of 0.346 and 0.538 m/L. - The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 h amounted to 0.18 mg/L whereas 0.32 mg/L was the lowest tested concentration (LOEC,96 h) at which lethality was observed as compared to the control. - The LC100 was 1.05 m/L, which was observed after 29 hours.
RESULTS: CONTROL
- Number/percentage of animals showing adverse effects: NoneBased on the following observations, the validity criteria was considered as fulfilled: - Mortality of control animals was <10 %;- The concentration of dissolved oxygen in all test vessels was > 60 % saturation and - The concentration of test substance >= 80 % of initial concentration during test. Although quantification of the applied concentrations was not possible due to the absence of a suitable analytical method it was possible to analyze the two stock solutions used to prepare the test concentrations. These analyses showed that the stock solutions were stable even after storage for almost 7 months in the refrigerator. Considering the high water solubility of the test substance and its stability it is reasonable to assume that the actual concentrations were identical to the nominal concentrations during the entire test. A dose-response related increase in mortality was observed.
Table 3
Oxygen measurements
Nominal
Days of measurements
concentration
0
1
2
old medium
2
fresh medium
3
4
(mg/l)
O2(mg/l)
Control
8.6
8.8
8.3
8.3
8.5
8.8
0.1
8.7
8.8
8.7
8.2
8.6
8.1
0.18
8.7
8.8
8.7
8.2
8.6
8.8
0.32
8.7
8.8
8.7
8.3
8.7
8.7
0.58
8.7
8.9
8.5
8.3
8.6
8.3
1.05
8.7
8.9
Table 4
pH measurements
Nominal
Days of measurements
concentration
0
1
2
old medium
2
fresh medium
3
4
(mg/l)
pH
Control
8.0
7.8
8.0
8.2
8.0
7.8
0.1
8.1
7.8
8.0
8.2
8.0
7.6
0.18
8.2
7.8
8.0
8.2
8.0
7.9
0.32
8.2
7.8
8.1
8.2
8.0
7.9
0.58
8.2
7.8
8.0
8.2
8.0
7.8
1.05
8.2
7.8
Table 5
Results of the chemical analyses
Measured
Concentration in 10 times diluted stock solution (mg/l)
Average measured concentration
(mg/l)
Standard deviation
Concentration of undiluted stock solution
(mg/l)
First analyses stock 25022002
111.40
110.81
0.83
1108.10
Second analyses 25022002
110.22
First analyses stock 27022002
101.54
100.01
2.17
1000.10
Second analyses 27022002
98.47
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance were calculated to be 0.43 and 0.18 mg/L, respectively. The test substance was found to be toxic to Zebra fish after 96 h at concentration levels of 0.32 mg/L and higher.
- Executive summary:
A study was conducted to determine the acute toxicity of the test substance to Zebra fish (Danio rerio) according to the OECD Guideline 203 and EU Method C.1, in compliance with GLP. In this study, single replicate of seven fish per concentration were exposed to 0.1, 0.18, 0.32, 0.58 and 1.05 mg/L nominal test concentrations under semi-static conditions for 96 h. Mortality was observed at 24, 48, 72 and 96 h intervals. Although quantification of the applied concentrations was not possible due to the absence of a suitable analytical method, it was possible to analyze the two stock solutions used to prepare the test concentrations. These analyses showed that the stock solutions were stable even after storage for almost 7 months in the refrigerator. Considering the high water solubility and stability of the test substance, it was considered reasonable to assume that the actual concentrations would be identical to the nominal concentrations during the entire test. All the validity criteria were considered to be fulfilled. Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance were calculated to be 0.43 and 0.18 mg/L, respectively. The test substance was found to be toxic to Zebra fish after 96 h at concentration levels of 0.32 mg/L and higher (Company data, 2002).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Vehicle:
- no
- Test organisms (species):
- Lepomis macrochirus
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 22±2°C
- pH:
- 8.1 to 8.3
- Dissolved oxygen:
- > 7.5 mg/L (86% of saturation)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.45 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 1.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the study conditions, the mean measured 96 h LC50 and NOEC of the test substance were determined to be 0.45 and 0.3 mg/L, respectively.
- Executive summary:
A study was conducted to determine the toxicity of the test substance to bluegill sunfish (Lepomis macrochirus) according to EPA OPPTS Guideline 850.1075, in compliance with GLP. Toxicity, expressed a mortality and clinical signs, followed a positive dose-response relationship. Dose levels were verified analytically. All validity criteria for the study were fulfilled. Under the study conditions, the mean measured 96 h LC50 and NOEC of the test substance were determined to be 0.45 and 0.3 mg/L, respectively (Drottar, 2000).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No analytical dose verification
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 797.1400 (Fish Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- no analytical verification of test concentrations.
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.58 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Validity criteria fulfilled:
- no
- Remarks:
- no analytical veryfication
- Conclusions:
- Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance were determined to be 0.75 and 0.58 mg/L, respectively
- Executive summary:
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to EPA OTS Guideline 797.1400, in compliance with GLP. Toxicity, expressed a mortality and clinical signs, followed a positive dose-response relationship. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance were determined to be 0.75 and 0.58 mg/L, respectively (Holmes, 1992).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 797.1460 (Fish Acute Toxicity Test mitigated by humic acid)
- Deviations:
- yes
- Remarks:
- No analytical verification of test concentrations.
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Details on test conditions:
- Humic acid content: 10 mg humic acid/litre.
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Validity criteria fulfilled:
- no
- Remarks:
- no analytical verification
- Conclusions:
- Under the study conditions, the 96 h LC50 and NOEC of the test substance mitigated by dissolved organic carbon were determined to be 3.0 and 1.4 mg/L (nominal), respectively. This study demonstrates the mitigating effects of organic matter on the test substance.
- Executive summary:
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to EPA OTS 797.1460 (fish acute toxicity test mitigated by humic acid) under static conditions, in compliance with GLP. The applied humic acid content in this experimental setup was 10 mg/L. No analytical dose verification was conducted. The toxicity of the test substance to fish followed a positive dose-response relationship for mortality and clinical signs of toxicity. Under the study conditions, the 96 h LC50 and NOEC of the test substance mitigated by dissolved organic carbon were determined to be 3.0 and 1.4 mg/L (nominal), respectively (Holmes, 1992).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 797.1460 (Fish Acute Toxicity Test mitigated by humic acid)
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Details on test conditions:
- Humic acid content: 20 mg humic acid/litre
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Validity criteria fulfilled:
- no
- Remarks:
- no analytical veryfication
- Conclusions:
- Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance mitigated by dissolved organic carbon were determined to be 3.0 mg/L and 1.4 mg/L (nominal), respectively. This study shows the positive relationship between the concentration of organic matter and mitigating effect on the test substance.
- Executive summary:
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to EPA OTS 797.1460 (fish acute toxicity test mitigated by humic acid) under static conditions, in compliance with GLP. The applied humic acid content in this experimental setup was 20 mg/L. No analytical dose verification was conducted. The toxicity of the test substance to fish followed a positive dose-response relationship for mortality and clinical signs of toxicity. Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance mitigated by dissolved organic carbon were determined to be 3.0 mg/L and 1.4 mg/L (nominal), respectively (Holmes, 1992).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Not all validity criteria met
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Remarks:
- derivation and quantification by UV absorbance
- Vehicle:
- no
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.68 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.23 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 4.44 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Toxicity of the test substance to fish followed a positive dose-response relationship for mortality and clinical signs of toxicity.
- Results from analytical part:
Recovery of the test substance from the test medium was variable, with concentrations recovered at the lower test concentrations falling below 80% after 48 or 96 hours. At other time periods the recoveries were above 100% of nominal. No indication of the possible cause of the loss of test material is stated. However, the analytical methodology (derivation and quantification by UV absorbance) could account for the deviation as at the level of quantification it is not as specific as chromatographic analysis. Further, the method of analysis is not stability indicating.It is considered that although this validation criteria has not been fulfilled the performance of the study and the result are reliable. - Validity criteria fulfilled:
- no
- Remarks:
- It is considered that although this validation criteria has not been fulfilled the performance of the study and the result are reliable.
- Conclusions:
- Under the study conditions, the measured 96 h LC50 and NOEC were determined to be 0.68 and 0.23 mg/L, respectively.
- Executive summary:
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203, in compliance with GLP. Animals were exposed to the test substance for 96 h under static conditions. Toxicity, expressed a mortality and clinical signs, followed a positive dose-response relationship. Analytical dose verification was conducted. Recovery of the substance from the test medium was variable, with levels at the lower test concentrations falling below 80% after 48 or 96 h. At other time periods, the recoveries were above 100%. Although validity of the test method was not evaluated, performance of the study and the result were considered to be reliable. Under the study conditions, the measured 96 h LC50 and NOEC were determined to be 0.68 and 0.23 mg/L, respectively (Ritter, 1989).
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Description of key information
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 0.43 mg/L
Additional information
A study was conducted to determine the acute toxicity of the test substance to Zebra fish (Danio rerio) according to the OECD Guideline 203 and EU Method C.1, in compliance with GLP. In this study, single replicate of seven fish per concentration were exposed to 0.1, 0.18, 0.32, 0.58 and 1.05 mg/L nominal test concentrations under semi-static conditions for 96 h. Mortality was observed at 24, 48, 72 and 96 h intervals. Although quantification of the applied concentrations was not possible due to the absence of a suitable analytical method, it was possible to analyze the two stock solutions used to prepare the test concentrations. These analyses showed that the stock solutions were stable even after storage for almost 7 months in the refrigerator. Considering the high water solubility and stability of the test substance, it was considered reasonable to assume that the actual concentrations would be identical to the nominal concentrations during the entire test. All the validity criteria were considered to be fulfilled. Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance were calculated to be 0.43 and 0.18 mg/L, respectively. The test substance was found to be toxic to Zebra fish after 96 h at concentration levels of 0.32 mg/L and higher (Company data, 2002).
A study was conducted to determine the toxicity of the test substance to bluegill sunfish (Lepomis macrochirus) according to EPA OPPTS Guideline 850.1075, in compliance with GLP. Toxicity, expressed a mortality and clinical signs, followed a positive dose-response relationship. Dose levels were verified analytically. All validity criteria for the study were fulfilled. Under the study conditions, the mean measured 96 h LC50 and NOEC of the test substance were determined to be 0.45 and 0.3 mg/L, respectively (Drottar, 2000).
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203, in compliance with GLP. Animals were exposed to the test substance for 96 h under static conditions. Toxicity, expressed a mortality and clinical signs, followed a positive dose-response relationship. Analytical dose verification was conducted. Recovery of the substance from the test medium was variable, with levels at the lower test concentrations falling below 80% after 48 or 96 h. At other time periods, the recoveries were above 100%. Although validity of the test method was not evaluated, performance of the study and the result were considered to be reliable. Under the study conditions, the measured 96 h LC50 and NOEC were determined to be 0.68 and 0.23 mg/L, respectively (Ritter, 1989).
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to EPA OTS Guideline 797.1400, in compliance with GLP. Toxicity, expressed a mortality and clinical signs, followed a positive dose-response relationship. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance were determined to be 0.75 and 0.58 mg/L, respectively (Holmes, 1992a).
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to EPA OTS 797.1460 (fish acute toxicity test mitigated by humic acid) under static conditions, in compliance with GLP. The applied humic acid content in this experimental setup was 10 mg/L. No analytical dose verification was conducted. The toxicity of the test substance to fish followed a positive dose-response relationship for mortality and clinical signs of toxicity. Under the study conditions, the 96 h LC50 and NOEC of the test substance mitigated by dissolved organic carbon were determined to be 3.0 and 1.4 mg/L (nominal), respectively (Holmes, 1992b).
A study was conducted to determine the toxicity of the test substance to rainbow trout (Oncorhynchus mykiss) according to EPA OTS 797.1460 (fish acute toxicity test mitigated by humic acid) under static conditions, in compliance with GLP. The applied humic acid content in this experimental setup was 20 mg/L. No analytical dose verification was conducted. The toxicity of the test substance to fish followed a positive dose-response relationship for mortality and clinical signs of toxicity. Under the study conditions, the nominal 96 h LC50 and NOEC of the test substance mitigated by dissolved organic carbon were determined to be 3.0 mg/L and 1.4 mg/L (nominal), respectively (Holmes, 1992c).
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