Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 243-797-2 | CAS number: 20407-84-5
- 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:
- 17-09-2014 to 30-10-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Definitive test: Nominal test concentrations: 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L
Arithmetic Mean Measured concentrations: 0 (ND), 0.1032, 0.2149, 0.3587, 0.5374, 1.070 mg/L
Spacing factor (1.77) determined from range-finding test
Controls: test water without test item but treated in the same way as the test item solutions.
- Sampling method: Triplicate samples for analysis were taken from the mid-layer of each control and all test concentrations at the start of the test and every 24 hours thereafter in old and new solutions until the end of the test (t=96h)
- Sample storage conditions before analysis: Samples were used on day of sampling and analysed as soon as possible after their preparation. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock preparation: The required amount of the test substance was weighed and mixed with breeding water and the bottle was filled completely and tightly closed. This preparation was sonicated by sonication for 15 minutes with intense stirring using a magnetic stirrer for 3 hours in the dark and then, it was filtered through a 0.7 μm glass fibre filter. The additional concentrations were prepared by serial dilution of the saturated solution. Five litres of the test solution were prepared for each treatment group and the control group was prepared only with breeding water. The control and test solutions were prepared on the day of exposure.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable.
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): Range Finding Test: Nominal Concentrations: 0 (control), 1 (1:100), 10 (1:10) and 100 mg/L (saturated solution) ; Definitive Test: Nominal test concentrations: 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None. Turbidity testing indicated absence of undissolved test item. - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Rice fish (Oryzias latipes)
- Strain: Not reported
- Source: Recognised supplier (listed in full study report)
- Age at study initiation (mean and range, SD): Not reported.
- Length at study initiation (length definition, mean, range and SD): Range Finder: mean: 1.97 ± 0.05 cm (SD) ; range: 1.91 to 2.03 cm and Definitive: mean: 2.03 ± 0.07 cm (SD) ; range: 1.91 to 2.12 cm
- Weight at study initiation (mean and range, SD): Range Finder: mean: 0.18 ± 0.01 g (SD) ; range: 0.173 to 0.190 g and Definitive: mean: 0.19 ± 0.01 g (SD) ; range: 0.181 to 0.201 g
- Method of breeding: Suitable male and female fish, at a ratio of 3 to 2 without any visible abnormalities and of similar size were selected and placed in breeding water of 50 L. Approximately 25 fish (±10%) were bred. Eggs were harvested in breeding chambers and placed in hatching chambers. After hatching, the fry were placed in breeding chambers maintained at 23±1°C and bred.
- Maintenance of the brood fish: 30% of holding water was replaced once a week. The holding room was artificially illuminated; 16-hour light and 8-hour dark. Fish were fed Brine Shrimp in the morning and Top meal in the afternoon. Quantity was ca. 3% bodyweight daily except for weekends when fasted.
ACCLIMATION
- Acclimation period: > 7 days (Actual: 10 days)
- Acclimation conditions (same as test or not): Yes (Temperature: 22.0 to 22.5°C ; dissolved oxygen concentration was maintained at 96.1–98.8% of the saturation value in the range finding study and at 95.7–97.6% of the saturation value in the definitive study).
- Type and amount of food during acclimation: Flaked food or live food (such as brine shrimp nauplii).
- Feeding frequency during acclimation: Daily (with fasting at weekends) ; feeding ceased 24 hours before test initiation.
- Health during acclimation (any mortality observed): Seven days prior to exposure, the mortality of a batch of fish was less than 5% of the population
QUARANTINE (wild caught)
- Duration: Internal quarantine at least 7 days after delivery.
- Health/mortality: None.
FEEDING DURING TEST
- Food type: No.
- Amount: Not applicable.
- Frequency: Not applicable. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- none.
- Hardness:
- Between 10 and 240 mg/L (expressed as CaCO3) ; actual 70 mg/L
- Test temperature:
- 23 ± 1 ºC (actual 22.0–22.8 ºC)
- pH:
- 7.79-8.00 (fresh media); 7.48-7.72 (expired media)
- Dissolved oxygen:
- 8.38-9.11 mg/L (fresh media); 5.11-8.09 mg/L (or 60.9 to 96.4% ASV) (expired media)
- Salinity:
- not applicable.
- Nominal and measured concentrations:
- Range Finding Test:
Nominal Concentrations: 0 (control), 1 (1:100), 10 (1:10) and 100 mg/L (saturated solution)
Definitive Test:
Nominal test concentrations: 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L
Arithmetic Mean Measured concentrations: 0 (ND), 0.1032, 0.2149, 0.3587, 0.5374, 1.070 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 5L glass.
- Type (delete if not applicable): closed (aluminium foil)
- Material, size, headspace, fill volume: 600W×300D×400H (mm) dimensions ; ca. 5 L fill volume test media per test vessel (minimum headspace)
- Aeration: no
- Renewal rate of test solution (frequency): 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: < 1.0 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Drinking water (certified; filtered and irradiated by UV light)
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported (see certificate of analysis in full study report)
- Pesticides: Not reported (see certificate of analysis in full study report)
- Chlorine: Not reported (see certificate of analysis in full study report)
- Alkalinity: Not reported
- Ca/mg ratio: Not reported
- Conductivity: Not reported.
- Culture medium different from test medium: No.
- Intervals of water quality measurement: Water temperature, dissolved oxygen concentration and pH of the test solutions were recorded for the treatment groups and control group prior to initiation of exposure and at 24, 48, 72 (before and after renewal of each test solution) and 96 hours after exposure.
OTHER TEST CONDITIONS
- Adjustment of pH: No.
- Photoperiod: 16 h light / 8 h darkness
- Light intensity: white fluorescent lamp, intensity not reported
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and visible abnormality recorded at least the following: 24 h, 48 h, 72 h and 96 h.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.77 (Definitive)
- Range finding study: yes (semi-static)
- Test concentrations: Range Finder: Nominal Concentrations: 0 (control), 1 (1:100), 10 (1:10) and 100 mg/L (saturated solution)
- Results used to determine the conditions for the definitive study: Yes. - Reference substance (positive control):
- yes
- Remarks:
- copper (II) sulfate (non-concurrent ; documented in full study report)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.718 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% CL: 0.6473-0.7964 mg/L)
- Details on results:
- - Behavioural abnormalities: See table 1 and 2
- Observations on body length and weight: Not reported
- Other biological observations: Not reported
- Mortality of control: 0%
- Other adverse effects control: No abnormalities observed in the control.
- Abnormal responses: Sub lethal responses are reported in table 1 and 2
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None. Turbidity measurements indicated the absence of any undissolved test item (transparent)
- Effect concentrations exceeding solubility of substance in test medium: Not applicable. See above. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes (non-concurrent ; reliability check documented in the full study report).
- Mortality: Not reported
- LC50: 0.30 mg/L (95% CL 0.25-0.35 mg/L) in 96 h
- Other: In agreement with laboratory historical database - Reported statistics and error estimates:
- Statistical analysis was performed using the U.S. EPA authorized program. During the exposure period, a concentration-mortality curve was generated and the LC50 and its 95% confidence limits for mortality at 24, 48, 72 and 96 hours after exposure were analyzed using Probit method and Trimmed Spearman-Karber method.
However, only three decimal points are displayed in the Probit method, therefore, statistical analysis was performed by multiplying the measured values by 10 and the statistical values (LC50) were divided by 10.
The test result is expressed in the same way as significant digits of analytical result. However, only two decimal points are displayed in the Trimmed spearman-Karber method, therefore, statistical analysis was performed by multiplying the measured values by 100 and the statistical values (LC50) were divided by 100. - Sublethal observations / clinical signs:
Table 1.0 – Cumulative mortality
Diluted test item solution [nominal concentration / mg/L]
Arithmetic mean measured concentration
[/ mg/L]
Number of fish
Cumulative Mortality (Mortality %)
1 hr
3 hr
6 hr
24 hr
48 hr
72 hr
96 hr
0 (control)
N.D.
10
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1.02
0.1032
10
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1.80
0.2149
10
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
3.19
0.3587
10
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
5.65
0.5374
10
0 (0)
0 (0)
0 (0)
1 (10)
1 (10)
1 (10)
1 (10)
10.00
1.070
10
0 (0)
0 (0)
0 (0)
8 (80)
8 (80)
10 (100)
10 (100)
N.D. : Not detected
Table 2.0 – Behavioural observations
Diluted test item solution [nominal concentration / mg/L]
Arithmetic mean measured concentration
[/ mg/L]
Number of fish
General symptoms (number of fish)
1 hr
3 hr
6 hr
24 hr
48 hr
72 hr
96 hr
0 (control)
N.D.
10
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
1.02
0.1032
10
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
1.80
0.2149
10
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
3.19
0.3587
10
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
NOR
(10)
5.65
0.5374
10
NOR
(10)
NOR
(10)
NOR
(10)
NOR (9)
DEA (1)
NOR (9)
NOR (9)
NOR (9)
10.00
1.070
10
NOR
(10)
NOR
(10)
SWI (1)
RES (3)
HYO (6)
HYO (2)
DEA (8)
HYO (2)
DEA (2)
-
NOR: Normal
SWI: Swimming on the water surface
RES: Respiration at the water surface
HYO: Hypoactivity
DEA: Death
N.D.: Not detected
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 hour LC50 for the test item to Oryzias latipes was determined to be 0.7180 (C.I. 0.6473 – 0.7964) mg/L based on arithmetic mean measured concentrations.
- Executive summary:
The acute toxicity of the test item to Rice fish (Oryzias latipes) was determined in a 96 hour closed semi-static test according to OECD TG 203 under GLP. Based on the results of preliminary range finding testing, the nominal concentrations of 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L with a geometric series factor of 1.77 and minimal headspace were selected for exposure to groups of ten fish. One control containing no test item was also performed. The test total duration was 96 hours and test solutions were renewed on a daily basis. The mortality of the fish was determined by visual observation after 1, 3, 6 24, 48, 72 and 96 hours. Samples taken from the control and all test concentrations were analysed at the start of the test and every 24 hours thereafter in old and new solutions. The test item was renewed at 24 hour intervals within a 96-hour semi-static test system. The actual concentrations were verified by measurement of the test item in the nominal loading rates of 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L at 0h, 96h and 24h,48h, 72h of new and old solutions (after and before the renewal). The 24 h aged test media were maintained in the range of ±20% when compared to the initially measured concentrations of the freshly prepared media at 0, 24, 48 and 72 hours. Nevertheless, all test results were calculated based on the arithmetic mean measured concentration. The reason for using the arithmetic mean is the possibility that the concentration in the preparation of the test solutions may vary in this study with replacement of the test solution at 24, 48 and 72-hour intervals. Therefore, the evaluation of the effects was based on the arithmetic mean measured concentrations: 0 (ND), 0.1032, 0.2149, 0.3587, 0.5374, 1.070 mg/L .After the 96-hours exposure, mortality was 0% at 0 to 0.3587 mg/L concentration and 10% and 100% at 0.5374 and 1.070 mg/L concentrations, respectively. Measurements were performed by Gas Chromatography (GC-FID). All relevant validity criteria were fulfilled for the test. The relevant LC50 were: 24h: 0.8181 (C.I. 0.6439 – 1.083) mg/L, 48h: 0.8181 (C.I. 0.6439 – 1.083) mg/L, 72h: 0.7180 (C.I. 0.6473 – 0.7964) mg/L based on arithmetic mean measured concentrations. The 96 hour LC50 was 0.7180 (C.I. 0.6473 – 0.7964) mg/L based on arithmetic mean measured concentrations.
Reference
Description of key information
96-h LC50 (fish) = 0.7180 mg/L (C.I. 0.6473 – 0.7964 mg/L) based arithmetic mean measured concentrations, 96-hour, freshwater, OECD TG 203, 2014
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 0.718 mg/L
Additional information
Key data : OECD TG 203, 2014 : The acute toxicity of the test item to Rice fish (Oryzias latipes) was determined in a 96 hour closed semi-static test according to OECD TG 203 under GLP. Based on the results of preliminary range finding testing, the nominal concentrations of 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L with a geometric series factor of 1.77 and minimal headspace were selected for exposure to groups of ten fish. One control containing no test item was also performed. The test total duration was 96 hours and test solutions were renewed on a daily basis. The mortality of the fish was determined by visual observation after 1, 3, 6 24, 48, 72 and 96 hours. Samples taken from the control and all test concentrations were analysed at the start of the test and every 24 hours thereafter in old and new solutions. The test item was renewed at 24 hour intervals within a 96-hour semi-static test system. The actual concentrations were verified by measurement of the test item in the nominal loading rates of 0 (control), 1.02, 1.80, 3.19, 5.65, 10.00 mg/L at 0h, 96h and 24h,48h, 72h of new and old solutions (after and before the renewal). The 24 h aged test media were maintained in the range of ±20% when compared to the initially measured concentrations of the freshly prepared media at 0, 24, 48 and 72 hours. Nevertheless, all test results were calculated based on the arithmetic mean measured concentration. The reason for using the arithmetic mean is the possibility that the concentration in the preparation of the test solutions may vary in this study with replacement of the test solution at 24, 48 and 72-hour intervals. Therefore, the evaluation of the effects was based on the arithmetic mean measured concentrations: 0 (ND), 0.1032, 0.2149, 0.3587, 0.5374, 1.070 mg/L .After the 96-hours exposure, mortality was 0% at 0 to 0.3587 mg/L concentration and 10% and 100% at 0.5374 and 1.070 mg/L concentrations, respectively. Measurements were performed by Gas Chromatography (GC-FID). All relevant validity criteria were fulfilled for the test. The relevant LC50 were: 24h: 0.8181 (C.I. 0.6439 – 1.083) mg/L, 48h: 0.8181 (C.I. 0.6439 – 1.083) mg/L, 72h: 0.7180 (C.I. 0.6473 – 0.7964) mg/L based on arithmetic mean measured concentrations. The 96 hour LC50 was 0.7180 (C.I. 0.6473 – 0.7964) mg/L based on arithmetic mean measured concentrations.
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.
