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EC number: 468-890-7 | 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
- 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:
- 2004-10-08 to 2004-12-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 29 December 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Remarks:
- Because of the low water solubility (<0.03 mg/L) and the fact that the study was performed as a limit test, the test material concentration was not analyzed during the course of the study.
- Vehicle:
- no
- Details on test solutions:
- Before exposure of the fish, the test medium (reconstituted water and test material) was freshly prepared: The calibrated flask with test material and reconstituted water was treated in an ultrasonic device for 1 hour. Subsequently the preparation was aerated, and stirred with a magnetic stirrer for further 23 hours. After 24 hours the formulation was given through a nutsch filter (pore size >10 - <16 µm). The filtrate was used for the study.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Selection and adaptation
The fish were acclimatized to the conditions of the laboratory for more than 14 days and were held in reconstituted water for at least for 7 days before testing. During the acclimatization, until one day before the experimental part, the fish were fed with flakes (Tetra Min® diet; Tetra GmbH, Melle). During the week before testing, the mortality of the test fish batch was lower than 5%.
At the start of the test, 10 fish per group were randomly introduced into aquaria filled with test medium or reconstituted water, respectively.
Assignment
Numbers of zebra fish
Pretest: 4 zebra fish
Control group: 10 fish;
Test material group: 10 fish.
A total of 24 zebra fish were used in this study. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- about 267 mg CaCO3
- Test temperature:
- 23-25 °C
- pH:
- 7.16 - 7.93
- Dissolved oxygen:
- The dissolved oxygen concentration was > 60 % oxygen saturation throughout the study.
- Nominal and measured concentrations:
- nominal 100 mg/l
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquarium
- Type: open
- Material, size, fill volume: glass, 30cm x 20cm x 15cm, 9 liter
- Aeration: open conditions
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: fully demineralized water
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours light - 12 hours dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Lethality, behaviour and general conditions, Twice at the first day and then daily
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: limit test based on results of a prestudy
- Range finding study: yes
- Test concentrations: 100 mg/L (nominal
- Results used to determine the conditions for the definitive study: no toxicity observed
Environmental conditions
During the study, the zebra fish were kept in all-glass aquaria. The study was located in an air-conditioned room. Lighting was controlled by a timer provide a 12 hours light - 12 hours dark regime. The fish were not fed during the study.
Preparation
Before exposure of the fish, the test medium (reconstituted water and test material) was freshly prepared: The calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently the preparation was stirred with a magnetic stirrer for further 23 hours. Thereafter the formulation was given in a separating funnel for 6 hours. To remove small test material droplets the formulation was subsequently given through a nutsch filter (pore size >10 - <16 µm). The filtrate was used for the study.
Administration
At the start of the experimental phase, 10 zebra fish per group were inserted into an aquarium (all-glass) with about 9 liters of reconstituted water (control group) or test medium (test material group). The aquaria were labeled to assure an unequivocal identification.
Observation schedule
The behavior and general condition of all fish were checked immediately after the introduction into the test medium or reconstituted water, after three hours, and then daily.
Laboratory tests
Dissolved oxygen (O2) concentration in percent and pH values were measured in the control and test material groups at the beginning and at the end of the exposure period.
During the experimental part, the temperature was registered in the control vessel with an electronic thermometer containing a maximum and minimum memory display. - Reference substance (positive control):
- no
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Clinical findings
No clinical findings were observed in the control and the test material group during the experimental part. All fish survived the observation period.
LC50 value
A dose group with nominal 100 mglL of the test item (maximal solubility <0.03 mg/L analytically) revealed no aquatic toxicity in this test system. The analytical 24, 48, 72, and 96 h LC50 values exceed the maximum solubility of the test material.
No remarkable observations were made concerning the appearance of the test material solution. The test medium was a clear preparation and stayed unchanged throughout the study.
Laboratory Tests
Analysis
The solubility in water was examined using a HPLC method. The solubility of the test material could not be determined but was < 0.03 mg/L. The same low solubility can be expected for reconstituted water for fish.
Temperature
The temperature during the main study was 22 to 23 °C.
pH and oxygen
The dissolved oxygen concentrations were > 60 % oxygen saturation throughout the study. The pH values (~7.7) during the final study were inconspicuous. - Validity criteria fulfilled:
- yes
- Conclusions:
- An aqueous solution of the test substance, of a nominal concentration of 100 mg/L, revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebra fish exceeded the maximal solubility of < 0.03 mg/L (as established analytically) of the test material in reconstituted water and, thus, could not be determined in this test.
- Executive summary:
Purpose
The objective of this aquatic toxicity study in zebra fish (Danio rerio) was to provide information on environmental hazards likely to arise from exposure of the test material and to serve as a basis for classification and labeling purposes.
Study DesignFor this purpose, 10 fish (test material group) were exposed to the test material over 96 hours, under defined conditions in a limit test. Further, 10 fish were used as a control group. The fish were observed for signs of toxicity or death for 96 hours. Zebra fish of the test material group were exposed to a saturated aqueous test material solution of nominal 100 mg/L (limit test) in an open static system. The study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guidelines for the Testing of Chemicals, No. 203 Fish Acute Toxicity Test.
Results
The following results were obtained:
Mortality 24h 48h 72h 96 hControl Group 0/10 0/10 0/10 0/10
Test item 100 mg/L nominal 0/10 0/10 0/10 0/10
Zebra fish exposed to an aqueous preparation of the test item, with a nominal concentration of 100 mg/L were not affected.
The solubility of the test item in reconstituted water for daphnia was established as < 0.03 mg/L (separate study) . Due to this low water solubility and the fact that the study was performed as a limit test, the test material concentrations in the aqueous medium at the start and the end of this study were not quantified.
For the test material, the following LC50 values for zebra fish were determined.
24 h LC50 > 100 mg/L (nominal)
48 h LC50 > 100 mg/L (nominal)
72 h LC50 > 100 mg/L (nominal)
96 h LC50 > 100 mg/L (nominal)
ConclusionAn aqueous solution of the test substance, of a nominal concentration of 100 mg/L, revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebra fish exceeded the maximal solubility of < 0.03 mg/L (as established with reconstituted water for daphnia, separate study) of the test material in reconstituted water and, thus, could not be determined in this test.
Reference
Description of key information
In an acute toxicity test in fish, no mortality or adverse effects have been observed in zebrafish exposed to test medium with nominal 100 mg/L test material for a time period of 96 hours. The 96 h LC50 value exceeds the maximum solubility of the test material in the test medium. The study was performed according to international accepted guidelines and under GLP regulation, i.e. of very high quality.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
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