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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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 mg/L
- Sampling method: test sample of 5 ml was taken from the test vessel at 5 different locations for the top mid and lower layers, on the day of anlytical determinations
- Sample storage conditions before analysis: sample was analysed soon after sampling - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Test chemical was prepared by dissolving 1000 mg of test chemical in 1000 ml of RO water to get the final concentration of 1000 mg/L. which was then analytically determine. The final solubility value obtained after analytical detection was 745.93 mg/l.
- 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)): Not applicable - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebra fish
- Strain: Tubingen
- Source: Centre for cellular and molecular biology, India
- Age at study initiation (mean and range, SD): less than 3 months
- Length at study initiation (length definition, mean, range and SD): 1.4 cm
ACCLIMATION
- Acclimation period: Fishes, to be used in this study, are kept in the test water forseven days immediately before testing
- Acclimation conditions (same as test or not): same tes conditions
Photoperiod: 16hour light and 8 hours dark
Temperature range 23.2 °C
pH range 7.7
DO range 7.6 mg/L
Feeding Daily once but not given atleast 48 hours before study
Aeration Continuous
Mortality (%)0 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 22
- pH:
- 7.6
- Dissolved oxygen:
- 7.5
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/l
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquarium
- Type (delete if not applicable): Loosley closed
- Material, size, headspace, fill volume: 4L
- Aeration : No aeration
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): one vessel per concentration
- No. of vessels per control (replicates): one vessel
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 7 fishes /4 L
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light & 8 hours dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable - Reference substance (positive control):
- not required
- 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:
- - Behavioural abnormalities: No abnormal behaviour was observed
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None - Reported statistics and error estimates:
- Not applicable
- Sublethal observations / clinical signs:
- 6.6 Standard graph for determining stock solubilitySr. NoConcentrations (mg/L)Wavelength (nm)AbsorbanceTemperature (°C)1Blank1990.00252
50 199 0.17 253100 199 0.42 254150 199 0.59 255200 199 0.80 256250 199 1.04 257300 199 1.27 258350 199 1.46 259400 199 1.62 2510450 199 1.78 25Measured Concentration After Analytical DeterminationSr. No
Nominal Conc.
0 Hr
96Hr
Absorbance(mean)
Measured conc.
Absorbance(mean)
Measured conc.
1.
Control
00
00
00
00
2.
100
0.43
88.65
0.42
88.10
MORTALITY AND VISIBLE SYMPTOMS
Sr. No Test concentrations(mg/L) 3 hr 6 hr 24 hr 48 hr 72 hr 96 hr Cumulative Mortality Percent Inhibition 1 control - - - - - - - - 2 100 - - - - - - - -
Sr. No Test concentrations(mg/L) 3 hr 6 hr 24 hr 48 hr 72 hr 96 hr 1 control NS7 NS7 NS7 NS7 NS7 NS7 2 100 NS7 NS7 NS7 NS7 NS7 NS7 Any other symptoms - - - - - - EXPLANATION OF SYMPTOMS:
Number behind symbol for symptom = number of affected fishA:apathy,NR:Narcotic-like state,C:Swimming near water surface,M:Slow movements compared to control,NS:No abnormal symptoms,SC:Schooling effect,L:Loss of equilibrium,SM:Shimming movement,H1:Hyperactivity,H2:Hypo activityB:Bending behavior,F:Fin rot,IS:Invert swimming,SB:Swimming behavior,RF:Respiratory Function, P:Pigmentation,E:Exophthalmos
TEMPERATURE, AND DISSOLVE OXYGEN
Test Concentration(mg/L) pH 24 Hours 48 Hours 72 Hours 96 Hours control 7.6 7.6 7.5 7.7 100 8.4 7.9 7.8 7.8
Test Concentration(mg/L) Temperature °C 24 Hours 48 Hours 72 Hours 96 Hours control 22 23 23 23 100 22 23 23 23
Test Concentration(mg/L) Dissolved Oxygen 24 Hours 48 Hours 72 Hours 96 Hours control 7.5 6.8 6.5 6.0 100 7.2 6.7 6.4 5.9 - Validity criteria fulfilled:
- yes
- Conclusions:
- The test concentrations were measured and found to be 88.65 mg\L and 88.10 mg/L for 0th hour and 96th hour respectively, whereas the nominal concentration was 100 mg/L. Hence, LC50 (> 100 mg/L ) was expressed based on nominal concentrations.
- Executive summary:
The objective of this study is to assess the Acute Toxicity of test chemical in Freshwater Fish (Danio rerio). The study was performed in compliance with OECD 203 Guideline for the testing of chemicals: Fish, Acute Toxicity Testing, (18th June 2019). Prior to performing study fishes of mean size 1.4 cm were acclimatised for at least for 7 days under similar conditions as used in main study. The acclimatisation conditions were 16:8 hours, 23.2°C, 7.7, and 7.6 mg/L of photoperiod, temperature, pH and dissolved oxygen respectively. Under acclimatisation feed was provided daily with continues aeration. Feeding was stopped prior 24 hours to initiation of main study. The test chemical was directly formulated dissolved in the RO water by weighing 1000 mg of test chemical in 1000 ml of water to obtain a final concentration of 1000 mg/L. the analytically determined solubility was 745.93mg/l , carried out using UV Visible spectrophotometer. Based on the available data, main study was conducted with limit concentration, of 100 mg/L under static conditions. Total of 7 fishes were exposed per each concentration and control. The exposure was done in 7 lit of Glass aquarium which was loosely closed to avoid cross over and to reduce chemical evaporation from vessel. The whole setup was maintained at temperature ranging form 22 -23°C and dissolved oxygen concentrations ranging form 6.0-8.3 mg/L. At regular intervals of 24 hours vessels were observed for any behavioural changes and mortality along with that the DO, pH and temperature was measured. Test chemical was sampled from test vessel for analytical determinations at 0 hour and 96 hours. For chemical analysis a linearity range of 20, 40, 60, 80, 100, 120, 140, 160, 180, and 200 mg/l was selected, absorbance was recorded at 199 lamda max. The analytically measured concentrations at 0hour were 88.43 mg/L and 88.10 mg/L at 96 hours, concludes that chemical is within the range of 100±20% of the exposed test concentrations. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 79.76% of the air saturation value. The evaluation study after 96 hours meets all the validity criteria as mentioned in the OECD 203 guidelines and the median lethal concentration was reported to be >100 mg/L Thus, chemical cannot be classified as per CLP classification criteria.
Reference
Description of key information
The short term toxicity to fresh water fish was calculated using ECOSAR of EPI suite, the outcome was 126.801 mg/l after 96 hours of exposure. Thus the chemical cannot be classified as per CLP classification criteria.
The objective of this study is to assess the Acute Toxicity of test chemical in Freshwater Fish (Danio rerio). The study was performed in compliance with OECD 203 Guideline for the testing of chemicals: Fish, Acute Toxicity Testing, (18th June 2019). Prior to performing study fishes of mean size 1.4 cm were acclimatised for at least for 7 days under similar conditions as used in main study. The acclimatisation conditions were 16:8 hours, 23.2°C, 7.7, and 7.6 mg/L of photoperiod, temperature, pH and dissolved oxygen respectively. Under acclimatisation feed was provided daily with continues aeration. Feeding was stopped prior 24 hours to initiation of main study. The test chemical was directly formulated dissolved in the RO water by weighing 1000 mg of test chemical in 1000 ml of water to obtain a final concentration of 1000 mg/L. the analytically determined solubility was 745.93mg/l , carried out using UV Visible spectrophotometer. Based on the available data, main study was conducted with limit concentration, of 100 mg/L under static conditions. Total of 7 fishes were exposed per each concentration and control. The exposure was done in 7 lit of Glass aquarium which was loosely closed to avoid cross over and to reduce chemical evaporation from vessel. The whole setup was maintained at temperature ranging form 22 -23°C and dissolved oxygen concentrations ranging form 6.0-8.3 mg/L. At regular intervals of 24 hours vessels were observed for any behavioural changes and mortality along with that the DO, pH and temperature was measured. Test chemical was sampled from test vessel for analytical determinations at 0 hour and 96 hours. For chemical analysis a linearity range of 20, 40, 60, 80, 100, 120, 140, 160, 180, and 200 mg/l was selected, absorbance was recorded at 199 lamda max. The analytically measured concentrations at 0hour were 88.43 mg/L and 88.10 mg/L at 96 hours, concludes that chemical is within the range of 100±20% of the exposed test concentrations. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 79.76% of the air saturation value. The evaluation study after 96 hours meets all the validity criteria as mentioned in the OECD 203 guidelines and the median lethal concentration was reported to be >100 mg/L Thus, chemical cannot be classified as per CLP classification criteria.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
The short term toxicity to fresh water fish was calculated using ECOSAR of EPI suite, the outcome was 126.801 mg/l after 96 hours of exposure. Thus the chemical cannot be classified as per CLP classification criteria.
The objective of this study is to assess the Acute Toxicity of test chemical in Freshwater Fish (Danio rerio). The study was performed in compliance with OECD 203 Guideline for the testing of chemicals: Fish, Acute Toxicity Testing, (18th June 2019). Prior to performing study fishes of mean size 1.4 cm were acclimatised for at least for 7 days under similar conditions as used in main study. The acclimatisation conditions were 16:8 hours, 23.2°C, 7.7, and 7.6 mg/L of photoperiod, temperature, pH and dissolved oxygen respectively. Under acclimatisation feed was provided daily with continues aeration. Feeding was stopped prior 24 hours to initiation of main study. The test chemical was directly formulated dissolved in the RO water by weighing 1000 mg of test chemical in 1000 ml of water to obtain a final concentration of 1000 mg/L. the analytically determined solubility was 745.93mg/l , carried out using UV Visible spectrophotometer. Based on the available data, main study was conducted with limit concentration, of 100 mg/L under static conditions. Total of 7 fishes were exposed per each concentration and control. The exposure was done in 7 lit of Glass aquarium which was loosely closed to avoid cross over and to reduce chemical evaporation from vessel. The whole setup was maintained at temperature ranging form 22 -23°C and dissolved oxygen concentrations ranging form 6.0-8.3 mg/L. At regular intervals of 24 hours vessels were observed for any behavioural changes and mortality along with that the DO, pH and temperature was measured. Test chemical was sampled from test vessel for analytical determinations at 0 hour and 96 hours. For chemical analysis a linearity range of 20, 40, 60, 80, 100, 120, 140, 160, 180, and 200 mg/l was selected, absorbance was recorded at 199 lamda max. The analytically measured concentrations at 0hour were 88.43 mg/L and 88.10 mg/L at 96 hours, concludes that chemical is within the range of 100±20% of the exposed test concentrations. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 79.76% of the air saturation value. The evaluation study after 96 hours meets all the validity criteria as mentioned in the OECD 203 guidelines and the median lethal concentration was reported to be >100 mg/L Thus, chemical cannot be classified as per CLP classification criteria.
To evaluate the acute toxicity of the test item on Zebrafish (Danio rerio) a static 96-hour test according to OECD TG 203, was carried out in compliance with the GLP principles. Based on the results of a preliminary study 10 animals were exposed to a single limit concentration of 100 mg/L (nominal). A negative control with ISO Medium but without the test item was performed in parallel. The test item concentration was analytically verfied by using HPLC-UV and found to be 103 –104 % of the nominal at the start, and 100 % of the nominal at the end of the test. Therefore, all biological results are based on nominal concentrations. Fish were observed at approximately 2, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. All validity criteria of the test guidelines were fulfilled. As a result, no toxic effect on fish was observed at the limit concentration of 100 mg/L. Accordingly, the 96-hour LC50 value was determined to be > 100 mg/L. The 96-hour NOEC was determined to be 100 mg/L. Based on the outcomes the test chemical cannot be classified as per CLP classification criteria.
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