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EC number: - | CAS number: -
- 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
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- 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:
- 14-18 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 203. All validity criteria were fulfilled
- Justification for type of information:
- Information as to the availability of the in vivo study is provided in 'attached justification'.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Netherlands GLP Compliance Programme (inspected on 28 February - 7 March 2014 / signed on 30 April 2014)
- Specific details on test material used for the study:
- Phys-Chem Properties:
Water Solubility: Well soluble in water (481 mg/L in 2 days experiment; 875 mg/L in 3 days experiment)
Partition Coefficient: log Pow=3.8
Vapour Pressure: 5.8 Pa at 20 °C, 11 Pa at 25 °C - Analytical monitoring:
- yes
- Details on sampling:
- The concentrations of test substance of test media were determined by GC; samples were taken for analysis from the freshly prepared solutions at 0 and 72 hours, and the spent solutions at 24 and 96 hours.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: According to the solubility in water of the test item, test item was added directly into test water to prepare the test solution. The weight of test item was calculated according to the volume of bottles, the test item of 0.03298-0.03488, 0.04949-0.05195, 0.07351-0.08319, 0.11006-0.12355 and 0.16519-0.18853 g were weighted and dissolved in 5 glass bottles (with a stopper) respectively. Test water of about 11 L was filled into the bottles respectively, and then be stirred by magnetic stirrer (400 - 450 rpm) for about 2 hours to get the test solution.
- Controls: A concurrent blank control was included in parallel. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebra fish
- Batch: Zebra fish 20141209
- Strain: AB strain.
- Source: Hunter Biotech
- Length at study initiatio: 2.0 ± 1.0 cm
- Weight at study initiation: Should meet the requirement that test loading is <1.0 g/L
ACCLIMATION
- Feeding frequency during acclimation: Brine shrimp twice on workday and once on weekend which was discontinued approximately 24 hours prior to the start of the definitive test.
- Health during acclimation: There were no any sign of disease or mortalities maintained in-house.
FEEDING DURING TEST: None - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 136 mg/L (as CaCO3) (met the criteria of 10-250 mg/L).
- Test temperature:
- 23 ± 2 °C (21.07-24.93 °C)
- pH:
- 6.89-8.35
- Dissolved oxygen:
- 77.1-106.3% of the air saturation value (ASV)
- Salinity:
- None
- Nominal and measured concentrations:
- Nominal concentrations: 3.0, 4.5, 6.7, 10 and 15 mg/L.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Test was conducted under a closed system using glass bottles (having a stopper made from an inert material, filled with water to reduce headspace (ca 11 liters volume)).
- Type: Closed
- Aeration: Test water was aerated for at least 24 hours to get the dissolved oxygen saturated.
- Renewal rate of test solution: Test was performed with renewal of the test solutions every 24 hours.
- No. of organisms per test group: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Loading: <1.0 g fish/L water
- Ten fish were put into freshly prepared solutions at the beginning of the test and then transferred to newly prepared solutions after 24 hours.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Test water used for the aquatic test was ground water treated with aquapro pure water system.
OTHER TEST CONDITIONS
- Photoperiod: 12 hours darkness: 12 hours light
EFFECT PARAMETERS MEASURED
Observations: The fish in the test and control groups were observed daily. Toxic signs and mortality were recorded at 2, 4, 24, 48, 72 and 96 hours during exposure. Fish was considered dead if there was no visible movement (e.g. gill movements) and no reaction when touching of the caudal peduncle. Dead fish were removed when observed, and mortalities were recorded. Any of the visible abnormalities (e.g. pigmentation, lethargy, loss of equilibrium, etc.) were recorded. During 96 hours test period, the dissolved oxygen and pH of fresh media and of expired media of test were determined daily. And the temperature was monitored by automated temperature monitoring system and recorded at 1 hour interval.
Euthanasia of tested fish: After 96 hours of exposure, all of the surviving fish were euthanized. The method of euthanasia was to put fish into a 0.5% water solution of ethylene glycol monophenyl ether.
TEST CONCENTRATIONS
- Range finding study: In a non-GLP preliminary test, the concentrations of 2, 3, 5, 10, 15 and 100 mg/L were conducted in the preliminary test. The test solution was prepared by adding test item into test water and stirring for 2 hours or 24 hours. 5 fish were used for each concentration.
- Results used to determine the conditions for the definitive study: The results of a preliminary test showed that the 96-hour LC50 was located between 3 - 15 mg/L (nominal concentration). Based on the results of preliminary test, the definitive test was carried out as a semi-static-exposure test with 5 test item concentrations of 3.0, 4.5, 6.7, 10 and 15 mg/L.A concurrent blank control was included in parallel. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 11.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% confidence limit of 10.20-12.51 mg/L
- Details on results:
- During the 96-hour exposure period, there was no death and visible toxic sign observed in the vessels of control group, 3.0 and 4.5 mg/L group.
There was lethargy observed in the vessel of 6.7 mg/L, but no death was observed. There were lethargies, discolorations, hemorrhaging, erratic-swimming and lying in the side observed in the vessels of 10 and 15 mg/L. There were only 2 deaths in 10 mg/L, but all test fish in 15 mg/L were dead before the end of the test. - Results with reference substance (positive control):
- The reference substance test of potassium dichromate for this batch fish is conducted from July 06, 2015 to July 07, 2015. The LC50 (24 hour) result of reference substance test to zebra fish is 321.19 mg/L, with 95% confidence limits of 283.55-363 .84 mg/L.
- Reported statistics and error estimates:
- Trimmed Spearman-Karber (TSK) method (EPA, Version 1.5) was used to derive the 96 h-LC50 value and the 95% confidence limit. And the LC50 was calculated with nominal concentrations.
- Sublethal observations / clinical signs:
Table 6.1.1/1: Cumulative Mortality in the Definitive Test
Nominal Concentration (mg/L)
Determined Concentration (mg/L)
Initial Population
Time (h)
Cumulative Mortality
Abnormalities
Control
-
10
2
0
10 No poisoning sign
4
0
10 No poisoning sign
24
0
10 No poisoning sign
48
0
10 No poisoning sign
72
0
10 No poisoning sign
96
0
10 No poisoning sign
3.0
2.79
10
2
0
10 No poisoning sign
4
0
10 No poisoning sign
24
0
10 No poisoning sign
48
0
10 No poisoning sign
72
0
10 No poisoning sign
96
0
10 No poisoning sign
4.5
4.42
10
2
0
10 No poisoning sign
4
0
10 No poisoning sign
24
0
10 No poisoning sign
48
0
10 No poisoning sign
72
0
10 No poisoning sign
96
0
10 No poisoning sign
6.7
6.68
10
2
0
10 No poisoning sign
4
0
10 No poisoning sign
24
0
10 No poisoning sign
48
0
10 No poisoning sign
72
0
10 No poisoning sign
96
0
10 lethargy
10
10.1
10
2
0
10 lethargy
4
0
10 lethargy
24
0
10 lethargy and 8 discoloration
48
0
2 erratic swimming, 8 discoloration and lethargy
72
0
2 erratic swimming, 8 discoloration and lethargy
96
2
8 discoloration and lethargy
15
15.4
10
2
0
2 erratic swimming and discoloration;
8 lethargy and discoloration
4
0
4 erratic swimming and discoloration; 5 lethargy and discoloration
1 hemorrhaging and discoloration
24
0
2 lethargy and discoloration
8 lying in the side
48
1
9 lying in the side
72
10
-
Calculation of LC50
Basing on the analytically confirmed nominal concentrations, the 96-hour mortality data of the test was calculated by Trimmed Spearman-Karber (TSK) method (EPA, Version 1.5) to derive the LC50 value and the 95% confidence limit. The 96-hour LC50 of test substance to zebra fish was 11.30 mg/L with the 95% confidence limits of 10.20-12.51 mg/L.
Verification of test concentration
The results showed that for the nominal concentrations of 3.0, 4.5, 6.7, 10 and 15 mg/L, the mean determined concentrations were 2.86, 4.45, 6.75, 10.0 and 15.3 mg/L in the fresh solutions and 2.72, 4.39,6.61,10.1 and 15.4 mg/L in the spent solutions. The overall determined concentrations were 2.79, 4.42, 6.68, 10.1 and 15.4 mg/L, which were 92.9, 98.3, 99.7, 101 and 102% of nominal concentrations, respectively.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the 96-hour LC50 of test substance to zebra fish was 11.30 mg/L with the 95% confidence limit of 10.20-12.51 mg/L and based on analytically confirmed nominal concentrations.
- Executive summary:
The acute toxicity of the test item to zebra fish (Danio rerio) was conducted according to OECD guideline 203 and in compliance with GLP.
The test was performed with a semi-static water renewal system (solutions were replaced every 24 hours) with the nominal test item concentrations of 3.0, 4.5, 6.7, 10 and 15 mg/L. Duration of the test was 96 hours. 10 fish were used in each of the test groups and the control group. Water quality parameters temperature, pH-value and oxygen-saturation measured were determined to be within the acceptable limits. The determination of the test concentrations of test item was carried out via GC-MS.
During the 96-hour exposure period, there was no death and visible toxic sign observed in the vessels of control group, 3.0 and 4.5 mg/L group. There was lethargy observed in the vessel of 6.7 mg/L, but no death was observed. There were lethargies, discolorations, hemorrhaging, erratic-swimming and lying in the side observed in the vessels of 10 and 15 mg/L. There were only 2 deaths in 10 mg/L, but all test fish in 15 mg/L were dead before the end of the test.
The results showed that for the nominal concentrations of 3.0, 4.5, 6.7, 10 and 15 mg/L, the mean determined concentrations were 2.86, 4.45, 6.75, 10.0 and 15.3 mg/L in the fresh solutions and 2.72, 4.39, 6.61, 10.1 and 15.4 mg/L in the spent solutions. The overall determined concentrations were 2.79, 4.42, 6.68, 10.1 and 15.4 mg/L, which were 92.9, 98.3, 99.7, 101 and 102% of nominal concentrations, respectively.
Based on the analytically confirmed nominal concentrations, the 96-hour mortality data of the test was calculated by Trimmed Spearman-Karber (TSK) method (EPA, Version 1.5) to derive the LC50 value and the 95% confidence limit.
Under the test conditions, the 96-hour LC50 of test substance to zebra fish was 11.30 mg/L with the 95% confidence limit of 10.20-12.51 mg/L and based on analytically confirmed nominal concentrations.
Reference
Description of key information
OECD Guideline 203, GLP, key study, validity 1:
96h-LC50 (Danio rerio) = 11.3 mg/L (95% CI: 10.2 -12.51 mg/L) based on analytically confirmed nominal concentrations
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 11.3 mg/L
Additional information
One key study is available (SYRICI, 2015) to assess the 96h acute toxicity of the registered substance to zebra fish (Danio rerio) under semi-static conditions according to OECD guideline 203 with GLP compliance.
The test was performed with a semi-static water renewal system (solutions were replaced every 24 hours) with the nominal test item concentrations of 3.0, 4.5, 6.7, 10 and 15 mg/L.
Duration of the test was 96 hours. 10 fish were used in each of the test groups and the control group. Water quality parameters temperature, pH-value and oxygen-saturation measured were determined to be within the acceptable limits. The determination of the test concentrations of test item was carried out via GC-MS. A semi-static test sytem was used and the test solutions were analyzed during the study. Samples were taken for analysis from the freshly prepared solutions at 0 and 72h, and the spent solutions at 24 and 96 hours.
The results showed that for the nominal concentrations of 3.0, 4.5, 6.7, 10 and 15 mg/L, the mean determined concentrations were 2.86, 4.45, 6.75, 10.0 and 15.3 mg/L in the fresh solutions and 2.72, 4.39, 6.61, 10.1 and 15.4 mg/L in the spent solutions. The overall determined concentrations were 2.79, 4.42, 6.68, 10.1 and 15.4 mg/L, which were 92.9, 98.3, 99.7, 101 and 102% of nominal concentrations, respectively.
Based on the analytically confirmed nominal concentrations, the 96-hour mortality data of the test was calculated by Trimmed Spearman-Karber (TSK) method (EPA, Version 1.5) to derive the LC50 value and the 95% confidence limit.
During the 96-hour exposure period, there was no death and visible toxic sign observed in the vessels of control group, 3.0 and 4.5 mg/L group. There was lethargy observed in the vessel of 6.7 mg/L, but no death was observed. There were lethargies, discolorations, hemorrhaging, erratic-swimming and lying in the side observed in the vessels of 10 and 15 mg/L. There were only 2 deaths in 10 mg/L, but all test fish in 15 mg/L were dead before the end of the test.
Under the test conditions, the 96-hour LC50 of test substance to zebra fish was 11.30 mg/L with the 95% confidence limit of 10.20-12.51 mg/L and based on analytically confirmed nominal concentrations.
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