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EC number: 876-151-9 | CAS number: 2292123-68-1
- 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
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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
- 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:
- July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Fish, Acute Toxicity Test stipulated in Testing Method for New Chemical Substances of Japanese Chemical Substances Control Law
- Version / remarks:
- July 1, 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidance Document No. 23
- Version / remarks:
- February 2019
Guidance Document on Aqueous-phase Aquatic Toxicity Testing of Difficult Test Chemicals - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: single concentration (nominal concentration: 100 mg/L)
- Sampling method: Solution sampled separately from the preparation container (at start of exposure); mixed solution was taken out with equal volumes from the middle layer of the test solution in the test vessels in each test level (at the end of exposure)
- Sample storage conditions before analysis: samples were analysed straightaway after collection. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A saturated solution was prepared. 0.28g test item and 2800mL dilution water were mixed to produce the test concentration 100 mg/L and stirred by a magnetic stirrer for 48h to prepare the test solution. The test solution was divided into each test vessel.
- Controls: Dilution water (negative control) prepared using the same method as the test solution but no test item added
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): No used; not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): not applicable
- Test concentration separation factor: not applicable (limit test)
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): yes: white suspension, precipitation and insoluble matter were observed.
- Other relevant information: undissolved test item had no physical effect on the test organisms - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Japaese Medaka
- Source: in-house
- Age at study initiation (mean and range, SD): 3 months
- Length at study initiation (length definition, mean, range and SD): 2.0 cm +/- 1cm
ACCLIMATION
- Acclimation period: 59 days
- Acclimation conditions (same as test or not): Flow-through
- Type and amount of food during acclimation: KYORIN, amount corresponding to 3% of body weight
- Feeding frequency during acclimation: daily. withdrawn 24 hours before start of exposure
- Health during acclimation (any mortality observed): 0% mortality observed 7 days before start of exposure
FEEDING DURING TEST (as applicable): not fed during test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- As recommended in the guideline
- Post exposure observation period:
- Not applicable
- Test temperature:
- 24 +/1 °C
- pH:
- 7.8 - 8.0
- Dissolved oxygen:
- 8.0 - 8.2 mg/L at start of exposure
8.3 mg/L at end of exposure - Nominal and measured concentrations:
- Nominal: 100 mg/L
Measured: 0.000618 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3L glass tank, transparent plastic lid
- Type (delete if not applicable): open
- Material, size, headspace, fill volume:
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): not renewed
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water, aerated sufficiently and temperature controlled
- Total organic carbon: <0.5 mg/L
- Particulate matter: <1 mg/L
- Metals:- Pesticides: - Chlorine: <0.02 mg/L
- Alkalinity: 39 mg/L
- Ca/mg ratio: 44 mg/L
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Room light, 16-hour light, 8 hours dark
- Light intensity: not reported
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and visible abnormality were observed at 3, 24, 48, 72 and 96 hours after exposure. A fish was considered dead when the observable motion (motion of the month or opercula, etc.) was not observed and touching of the caudal peduncle with a glass rod caused no reaction.
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: yes - no mortality - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks on result:
- other: No mortality or abnormal behaviour was observed during the test.
- Details on results:
- - Other abnormalities: None
- Observations on body length and weight: No abnormal findings
- Mortality of control: None
- Other adverse effects control: None
- Effect concentrations exceeding solubility of substance in test medium: No effects observed in study. - Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- None.
- Sublethal observations / clinical signs:
Table 1: Cumulative mortality
Measured concentrationa (mg/L)
Cumulative mortality (%)
3 hours
24 hours
48 hours
72 hours
96 hours
Control
0
0
0
0
0
0.000618
0
0
0
0
0
aTime-weighted mean of the measured concentrations (also expressed as measured concentration in the following tables)
Table 2: Observed abnormal response
Measured concentrationa (mg/L)
Result of observation
3 hours
24 hours
48 hours
72 hours
96 hours
Control
N
N
N
N
N
0.000618
N
N
N
N
N
N: Normal (no abnormal response) – all fish 7/7
Table 3: EC50 values to Medaka
Exposure duration
LC50 (mg/L)
24 hours
>0.000618
48 hours
>0.000618
72 hours
>0.000618
96 hours
>0.000618
Table 4: Measured concentration of the test item in test solution
Nominal concentration (mg/L)
Measured concentration (mg/L)
(percentage of measured concentration versus that at the start %)
At the start
At the end
Time-weighted average mean
Control
<LOQ
<LOQ
-
100
0.0000698
0.00220 (3160)
0.000618
LOQ = 0.0002 mg/L
The time weighted mean is calculated by the following calculation:
[96 (C0-C96)/(lnC0-lnC96]/96
Cn: the measured concentration at n hours
lnCn: the natural logarithm of Cn
- Validity criteria fulfilled:
- yes
- Remarks:
- No mortality within control Dissolved oxygen concentration was >60% of air saturation value at the water temperature throughout the exposure duration
- Conclusions:
- No mortality or abnormal behaviour was observed during the limit test. The 96h LC50 was calculated as >0.000618 mg/L greater than the solubility of the test item in the test water.
Reference
Description of key information
In a study conducted in accordance with OECD Guideline 203 on Japanese Medeka, the 96h LC50 >100 mg/L (nominal) was reported. Based on measured concentrations, no mortality or abnormal behaviour was observed up to the limit of solubility of the test item (TWA measured with analytical verification at 0.000618 mg/L).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- > 100 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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