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EC number: 831-109-9 | CAS number: 5837-73-0
- 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:
- 2021-11-08 to 2021-11-12
- 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 18 June 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Version / remarks:
- October 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidance document No. 23 (ENV/JM/MONO(2000)6/REV1)
- Version / remarks:
- 8 February 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: For determination of the test item concentrations, samples were taken from the test concentration and from the concurrent vehicle control at the start and at the end of each water renewal period.
- Sample storage conditions before analysis: no - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion without using any
solubilising agent, as the substance is well water soluble. An appropriate amount of test item was dissolved in the dilution water (ISO medium) in order to obtain the nominal concentration of 6 mg/L at each water renewal period. The limit concentration was chosen based on experimental results for aquatic invertebrates and algae (please see IUCLID sections 6.1.3 and 6.1.5). After the formulation procedure the test animals were immediately introduced into the test solutions at each water renewal period.
- Eluate: no
- Controls: negative control (without test item)
- Test concentration separation factor: not applicable (limit test)
- Evidence of undissolved material: no - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: not specified
- Source: Toma István e.v., 2146 Mogyoród, Gödöllői u. 41/B, Hungary
- Age at study initiation: juvenile
- Length at study initiation (length definition, mean, range and SD): 1-2 cm
- Loading: 0.8 g fish/L test medium
ACCLIMATION
- Acclimation period: held for at least 9 days before test initiation in the fish laboratory
- Acclimation conditions: same as test
- Type and amount of food during acclimation: bred in a well-known fish farm, disease- and parasite-controlled conditions
- Feeding frequency during acclimation: fed with appropriate, commercial diet for fish at least three times per week until 24-48 hours before the test start
- Health during acclimation: apparently healthy - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- post exposure observation not performed
- Hardness:
- 249 mg/L (as CaCO3)
- Test temperature:
- 21.7 – 22.6 °C
- pH:
- 6.87 – 7.35
- Dissolved oxygen:
- 69.7 – 90.9 % of air saturation
- Salinity:
- not applicable
- Conductivity:
- not specified
- Nominal and measured concentrations:
- nominal: 0 (control), 6 mg/L (limit concentration); measured: < LOQ, 5.6 mg/L (geometric mean measured); considering the concentration decline observed during that Daphnia test, the
initial test concentration was set higher in order to meet the exposure concentration
(geometric mean) of at least 2.84 mg/L. Accordingly, a limit test was performed at the nominal concentration of 6 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquariums
- Type: open
- Material, size, headspace, fill volume: glass, appropriate size for holding the fish up to the loading of 0.8 g fish/L
- Aeration: not necessary during the experiment
- Renewal rate of test solution: 1 exchange per 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: loading did not exceed 0.8 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Fish were held prior to and during the test in reconstituted water (ISO medium, prepared according to the recommendation of OECD guideline 203). Separate stock solutions of individual substances were first prepared in deionised water (BWT Christ Ministil water purification system)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 to 16 hours light daily
EFFECT PARAMETERS MEASURED: Fish were observed twice a day (in the morning and afternoon) during the exposure at approx. 2-3, 5-6, 24, 30, 48, 54, 72, 78 and 96 hours after start of the test for signs of intoxication and mortality.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study: Yes. Based on the threshold concentration derived from the alga and daphnia studies a non-GLP preliminary test was conducted at 6 mg/L nominal concentration (plus a concurrent control) in order to investigate whether the test item has toxic effect on fish up to at least this concentration level. About twice the concentration of the lowest EC50 value (2.84 mg/L in Daphnia) was chosen to cover a potential decomposition of the test item during the test, so resulting in a measured concentration clearly above 2.84 mg/L. Three fish were exposed for 96 hours in a semi-static test (with 24-h renewal periods) in the treatment and control group respectively. The test solution was prepared by dissolving an appropriate amount of test item in ISO medium (without using of any solubilising agent) resulting a test concentration of 6 mg/L for each water renewal period. The test item is assumed to be volatile, therefore the test was performed in a closed system without headspace (i.e. sealed test aquarium, filled up fully with test medium) in order to minimise the loss of test item from the test solution during the exposure period. No mortality or any sublethal effects were observed in the treatment group or in the control during the 96-h exposure period.
- Test concentrations: 6 mg/L nominal concentration
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 5.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 5.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 5.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Other abnormalities: no
- Observations on body length and weight:
At the start of the test (on day 0) 10 fish were introduced into each aquarium, each containing ~2.3 litre testing solution. Before introduction of test animals, the total body weight of fish was measured and recorded: first the weight of a vessel filled with water was determined. Then the ten fish were selected randomly and placed into this vessel. The weight of the group of fish was registered and the average body weight calculated. On the basis of the above, the loading of the test-aquariums was calculated and was 0.29 g/L in the control and 0.27 g/L in the test item treated group. The test solutions were renewed daily. At these water renewal periods a second series of test vessels were prepared (including the fresh test medium) and fish were transferred to them. The test item is assumed to be volatile, therefore a modified exposure system according to the recommendation of OECD 23 guidance document was used in order to minimise the loss of test item from the test solution during the exposure period. In this exposure system the test aquariums were sealed by glass plates and filled up fully, thus allowing no headspace during the exposure. Water film between the cover plate and the upper edge of aquarium (filled up fully) ensured the sealing.
Total length of fish were measured prior to the initiation of the exposure in a subsample of at least 10 fish from the stock used for the test in order to check their compliance with the size range recommended for the species by the test guideline (OECD No. 203). These fish were not used in the test. Total length of each fish was measured and recorded at the end of the test. The measured values were within the range of 1.75 – 1.95 cm.
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Hatching rate control and treatment groups (embryo): no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: because of the high volatility of the substance aquaria were sealed in order to minimize evaporation
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- A limit test was carried out and no toxic effects were observed, therefore statistical analysis was not necessary.
- Sublethal observations / clinical signs:
Table 1: Oxygen concentration
Test group Dissolved Oxygen Concentration [%] 1st renewal period 2nd renewal period 3rd renewal period 4th renewal period 0 h 24 h 24 h 48 h 48 h 72 h 72 h 96 h Control 90.9 71.2 89.6 73.2 88.4 73.0 89.5 69.7 5.6 mg/L
(exposure concentration)89.9 73.6 89.6 74.2 89.1 74.0 88.9 72.3 Table 2: Cumulative mortality data in the definitive test
Test group Cumulative mortality
(initial population = 10 fish / test group)2-3 h 5-6 h 24 h 30 h 48 h 54 h 72 h 78 h 96 h Control 0 0 0 0 0 0 0 0 0 5.6 mg/L 0 0 0 0 0 0 0 0 0 VALIDITY OF TEST
- No mortality was observed in the control or in the treatment group during the test.
- The dissolved oxygen concentration did not fall below 60 % of air saturation value in any of the test vessels during the test.
- Test concentrations were analytically determined at the start and at the end of each water renewal period.
All validity criteria were met and therefore the study was considered to be valid.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an acute toxicity test according to OECD TG 203 with Danio rerio the 96-hour LC50 of the test item was determined to be higher than 5.6 mg/L.
- Executive summary:
The acute toxicity of the test item towards fish was assessed in a study according to OECD TG 203, EU Method C.1 and US EPA OCSPP 850.1075. Fish were exposed to aqueous test media containing the test item for 96 hours in a semi-static test (24-h water renewal periods). Ten fish were exposed to limit test item concentration of 6 mg/L in nominal and control (no replicates were used). The limit concentration was chosen based on experimental results for aquatic invertebrates and algae (please see IUCLID sections 6.1.3 and 6.1.5). For determination of the test item concentrations, samples were taken from the treatment and the control group at the start and at the end of each water renewal period. The corresponding calculated exposure concentration (based on analytical measurements using a HPLC-UV method) was 5.6 mg/L. Fish were observed twice a day (in the morning and afternoon) during the exposure at approx. 2-3, 5-6, 24, 30, 48, 54, 72, 78 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen concentration and water temperature were carried out daily (at the start and end of each water renewal period). All validity criteria of the guidelines were met. No mortality or any sub-lethal effects were observed during the 96-h test period either in the exposure concentration of 5.6 mg/L or in the concurrent negative control. Accordingly, the 96-h NOEC was determined to be 5.6 mg/L. The 96-h LC50 and LOEC were determined to be higher than 5.6 mg/L.
Reference
Description of key information
In an acute toxicity test according to OECD TG 203 with Danio rerio the 96-hour LC50 of the test item was determined to be higher than 5.6 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- > 5.6 mg/L
Additional information
The acute toxicity of the test item towards fish was assessed in a study according to OECD TG 203, EU Method C.1 and US EPA OCSPP 850.1075. Fish were exposed to aqueous test media containing the test item for 96 hours in a semi-static test (24-h water renewal periods). Ten fish were exposed to limit test item concentration of 6 mg/L in nominal and control (no replicates were used). The limit concentration was chosen based on experimental results for aquatic invertebrates and algae (please see IUCLID sections 6.1.3 and 6.1.5). For determination of the test item concentrations, samples were taken from the treatment and the control group at the start and at the end of each water renewal period. The corresponding calculated exposure concentration (based on analytical measurements using a HPLC-UV method) was 5.6 mg/L. Fish were observed twice a day (in the morning and afternoon) during the exposure at approx. 2-3, 5-6, 24, 30, 48, 54, 72, 78 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen concentration and water temperature were carried out daily (at the start and end of each water renewal period). All validity criteria of the guidelines were met. No mortality or any sub-lethal effects were observed during the 96-h test period either in the exposure concentration of 5.6 mg/L or in the concurrent negative control. Accordingly, the 96-h NOEC was determined to be 5.6 mg/L. The 96-h LC50 and LOEC were determined to be higher than 5.6 mg/L.
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