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EC number: 247-063-2 | CAS number: 25513-64-8
- 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-06-18 to 2015-07-24
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Version / remarks:
- adopted July 26, 2013
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Nominal concentrations of 0.256- 0.64 - 1.60 - 4.0 - 10.0 mg/L (factor: 2.5)
- Arithmetical mean measured concentrations of 0.322 - 0.817 - 1.75 - 4.40 - 10.9 mg/L
- Samples of test media including the control group were taken from alternating test replicates on days -1, 0 and weekly thereafter until the end of
exposure.
- Stock solutions were sampled and analysed from freshly prepared and aged solutions of one application interval.
- To prove the stability over at least three days, the old stock solutions (age: 3 days) were analysed after exchange of the syringes - Vehicle:
- no
- Details on test solutions:
- - No organic solvent was used. The stock solutions were prepared in demineralised water.
- A flow-through exposure design was carried out.
- Membrane piston pumps provided the water flow-through in two consecutively subsequent orders.
- The first order of membrane piston pumps delivered the dilution water in 5 separate streams. A tubing pump was used for the application of stock
solutions with different concentrations.
- The stock solutions and the dilution water were mixed in a mixing chamber (approx. Vol. 1.5 L) by magnetic stirring.
- A second row of membrane piston pumps provided the test solutions from these mixing chambers to the test aquaria (approx. Vol. 7.6 L;
four replicates per test concentration and control), where the fish were exposed.
- The accuracy of the water flow-through was checked prior to the start of exposure and daily on working days after test start.
- Water exchange in the mixing chamber was about 230 times per day (14.375 L/h) and about 10 times per day in the test aquaria (3.17 L/h),
respectively. An equilibration period of 7 days was carried out prior to exposure. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Danio rerio (zebrafish), Gnathostoma, Pisces, Osteichthyes, Teleostei, Cypriniformes, Cyprinidae
- Source: All fish used in the test were gained at DR.U.NOACK-LABORATORIEN from a single brood stock (supplier: Umweltbundesamt,
Schichauweg 58, D-12307 Berlin, Germany)
- Age at study initiation (mean and range, SD): eggs
- Method of breeding: unexposed, mature zebrafish with an age of 10 months was used for the egg production
- Maintenance of brood fish:Spawners were maintained in aquaria with a loading capacity of a minimum of 1 L water per fish.
- Temperature: 25 ± 2 °C
- Dissolved oxygen concentration > 60 % of air saturation value
- pH value: 6 – 8.5
- Photoperiod: 16 h light / 8 h dark cycle
(2 transition periods, 30 minutes each)
- Diffuse light (0.1 - 10 µmol photons · m-2 · s-1 on water surface)
- Food: Artemia salina nauplii, 48 hours old, ad libitum; Daphnia magna, juvenile and adult daphnids, ad libitum;
dry food sera vipan SERA, ad libitum.
- No disease treatments were administered.
- Feeding of test fish: Feeding started 2 days after hatch (on post-hatch day 1).
Larvae were first fed with starter food (e. g. TetraMin Baby Hauptfutter, TETRA GMBH, D-49304 MELLE, Germany).
ACCLIMATION
- Acclimation period: eggs were taken, washed in dilution water and transferred immediately into vessels containing the respective exposure
solutions, - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 30 d
- Post exposure observation period:
- none
- Hardness:
- Total hardness: 10 - 250 mg CaCO3/L
- Test temperature:
- Water temperature: 26 ± 1.5 °C
- pH:
- pH-value: 6.0 - 8.5
- Dissolved oxygen:
- Not less than 60 % of air saturation value
- Salinity:
- not measured
- Nominal and measured concentrations:
- - Nominal concentrations of 0.256- 0.64 - 1.60 - 4.0 - 10.0 mg/L (factor: 2.5)
- Arithmetical mean measured concentrations of 0.322 - 0.817 - 1.75 - 4.40 - 10.9 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria of 8.7 L provided with mesh coated fittings allowing flow-through of test media (dimensions: 22/22/18 cm) were used.
The volume of the test media was approximately 7.6 L. A randomised block design with each treatment being present in each block was established.
- Aeration: No additional aeration of the test vessels was provided. The dilution water supply tank was aerated.
- Type of flow-through (e.g. peristaltic or proportional diluter): Membrane piston pumps provided the water flow-through in two consecutively
subsequent orders. The first order of membrane piston pumps delivered the dilution water in 5 separate streams. A tubing pump was used for the application of stock solutions with different concentrations.
- Renewal rate of test solution (frequency/flow rate):The accuracy of the water flow-through was checked prior to the start of exposure and daily on working days after test start. Water exchange in the mixing chamber was about 230 times per day (14.375 L/h) and about 10 times per day in the
test aquaria (3.17 L/h), respectively. An equilibration period of 7 days was carried out prior to exposure.
- No. of fertilized eggs/embryos per vessel: 20
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): not required
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: A loading rate not exceeding 0.5 g/L wet weight fish per 24 hours and not exceeding 5 g/L of solution at any time was
maintained.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding. The water was filtered on activated charcoal and aerated for at
least 24 h to remove chlorine.
- Total organic carbon: 10 - 250 mg CaCO3/L
- Metals: filtered on activated charcoal
- Pesticides: filtered on activated charcoal
- Chlorine: filtered on activated charcoal
- Alkalinity: filtered on activated charcoal
- Ca/mg ratio:
- Conductivity:
- Salinity:
- Intervals of water quality measurement:
Continuously: - Temperature in the dilution water (once per hour).
At least 3 times per week: - Dissolved oxygen and temperature in one replicate of each test group
- Check of flow rates of the test media (variation < 10 % throughout exposure)
Weekly: - pH-value in alternate replicates of each test group
- TOC and Chlorine from dilution water
- Total hardness in one replicate of the control and the highest test item concentration
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: A daily 16 / 8 h photoperiod (light / dark) was maintained throughout exposure.
- Light intensity: 0.1 - 10 µmol photons · m-2 · s-1 (corresponding to approximately 7 – 750 Lux).
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality: Criteria for mortality vary according to life stage:
For eggs/embryos: If fungus growth on eggs was observed, these eggs were removed and counted. Mortality as discerned by a distinct change in
coloration or a marked loss of translucency and change in coloration, caused by coagulation and/or precipitation of protein, leading to a white
opaque appearance and change in coloration was checked daily. Mortality caused by absence of heartbeat was checked, if applicable. Dead
eggs/embryos were discarded.
For larvae and juvenile fish: Immobility and/or lack of reaction to mechanical stimulus. Dead larvae or juvenile fish were discarded.
- Further effects:
Abnormal appearance and behaviour were also recorded at adequate intervals.
The number of larvae or fish showing abnormality of body form was recorded. Abnormal animals were only removed from the test vessels on death. Abnormalities, e.g. hyperventilation, uncoordinated swimming, swim-up behaviour, atypical quiescence and atypical feeding behaviour were
recorded by visually inspecting each replicate.
- Measurement of fish size:
At the end of exposure (post-hatch day 30) the fish were euthanized in a Benzocaine solution and the individual total length of all survivors was
measured to the nearest 0.5 mm.
- Measurement of fish wet weight:
At the end of exposure (post-hatch day 30) all surviving fish were weighed on replicate basis. Fish were blotted on paper towels to remove excess
moisture prior to weighing. The mean wet weight per animal was calculated from the number of surviving fish.
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- Preliminary range finding test was conducted over 6 days under flow-through conditions (n = 40 per treatment group with 4 replicates and 10 eggs each under flow-through conditions)
- Test concentrations: 1 mg/L, 10 mg/L
- Results used to determine the conditions for the definitive study: yes
POST-HATCH DETAILS
- Begin of post-hatch period: Per definition the post-hatch period begun when at least 90 % (better 95 %) of all fertilized and living embryos in the
control groups had hatched (about day 5 ± 2 of the study). On study day 4, 96 % of the control larvae had hatched. Therefore, study day 4 was
defined as post-hatch day 0 (= PHD 0).
- No. of hatched eggs (alevins)/treatment released to the test chamber: The number of hatched larvae was determined daily until post-hatch day 1.
FERTILIZATION SUCCESS STUDY
- Number of eggs used:
- Removal of eggs to check the embryonic development on day no.: - Reference substance (positive control):
- not required
- Duration:
- 30 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 10.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 30 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 10.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Mortality/survival at embryo, larval, juvenile, and adult stages: The post-hatch survival in the control replicates met the validity criteria of the
guideline (required: > 75 %). The fry survival (post-hatch survival) at the end of the study was 89 % in the control group. The post-hatch survival in
the arithmetic mean calculated test concentrations 0.322 to 10.9 mg/L was 77 to 85 %
- Days to hatch or time to release of young: Hatch began on study day 3 in the control and all test item concentrations and continued until study day 6. Study day 4 was determined to be post hatch day 0 (PHD 0) with a control hatching rate of 96 %.
- Numbers hatched, Numbers of offspring produced, or Number of offspring per live female per day: The egg fertilization rate, determined on study
day 0 (start of the exposure) was 98 %.
- Number of fish in swim-up stage at one or more time periods (e.g., day x1, x2): Swim-up was observed for a 4-day period from study days 4 to 7
(see Table 6). Newly hatched fry began to swim up on study day 4 (PHD 0). On study day 5 (PHD 1), all surviving larvae had swum up.
No statistical analysis of swim-up data was carried out.
- Observations on body length and weight of young and/or exposed parents at one or more time periods: Fry growth, expressed as length and wet
weight, was measured on study day 34 (PHD 30) from all survivors. The statistical analysis of the data of all arithmetic mean calculated test
concentrations showed no significant differences for any parameter
- Number of healthy fish at end of test: see above
- Type of and number with morphological abnormalities: No biologically significant morphological effects were observed in any treatment.
- Type of and number with behavioural abnormalities: none
- Type and number of developmental effects: none
- Other biological observations: none
- Effect concentrations exceeding solubility of substance in test medium: none
- Incidents in the course of the test which might have influenced the results: none
Tables see below " Overall remarks, attachments" - Results with reference substance (positive control):
- - Results with reference substance valid? not required
- Relevant effect levels:
- Other: - Validity criteria fulfilled:
- yes
- Conclusions:
- The test item caused no significant effects on Zebrafish in an early life stage test, 30 days post hatch.
Based on the parameters hatch, growth (expressed as length and dry weight) and post-hatch survival (mortality) the overall NOEC (nominal,
post hatch day 0 – 30) was ≥ 10.0 mg/L, corresponding to 10.9 mg/L (arithmetical mean). The overall LOEC (nominal, post hatch day 0 – 30) was
> 10.0 mg/L, corresponding to > 10.9 mg/L (arithmetical mean).
For further NOEC and LOEC values. All effect values are given based on the arithmetical mean calculated concentrations of test item. - Executive summary:
Purpose of the study was, determination of the toxicity of test item to the early-life stages of the zebrafish acc. to OECD 210. The test was started by placing fertilised eggs into the test vessels and it lasted 34 days (30 days post-hatch). Lethal and sublethal effects (hatch, fry growth (expressed as length and weight) and post-hatch survival) were assessed and compared with control values to determine the LOEC, the NOEC and the ECx-values.
A test was conducted under flow-through conditions with the nominal test item concentrations of 0.256 - 0.64 - 1.60 - 4.0 - 10.0 mg/L, corresponding to arithmetical mean measured concentrations of 0.322 - 0.817 - 1.75 - 4.40 - 10.9 mg/L.The test was started by placing fertilized eggs into the test vessels and it lasted 34 days (30 days post-hatch). 80 eggs of Danio rerio were exposed to each test concentration and the control (4 replicates with 20 eggs each).
Different toxicological endpoints were determined: hatch, time to hatch, fry growth (expressed as length and fresh weight), morphological and behavioural effects and post-hatch survival. Specific analysis of various concentrations of test item in the test media and the control was carried out via LC-MS/MS. The test media were sampled and analysed prior to exposure on day -1 and during the exposure on study days 0, 6, 13, 19, 27 and 35. The measured concentrations of the test media during the exposure were in the range of 82 % to 198 % of the nominal values.
The test substance caused no significant effects on Zebrafish in an early life stage test, 30 days post hatch.
Based on the parameters hatch, growth (expressed as length and dry weight) and post-hatch survival (mortality) the overall NOEC (nominal, post hatch day 0 – 30) was≥10.0 mg/L, corresponding to 10.9 mg/L (arithmetical mean). The overall LOEC (nominal, post hatch day 0 – 30) was > 10.0 mg/L, corresponding to > 10.9 mg/L (arithmetical mean).
Reference
Measured Concentrations in the Test Vessels during Exposure
Measured Concentrations, Percent of Nominal Concentrations and Arithmetical Mean of test item in the Test Vessels during Exposure
(Control, 0.256 and 0.640 mg/L)
Nominal |
Control |
0.256 |
0.640 |
|||
Sampling day [d] |
Sampling date / Start of Analysis |
|||||
Meas. conc. [mg/L] |
Meas. conc. [mg/L] |
%
|
Meas. conc. [mg/L] |
%
|
||
0 |
2015-06-18 |
< LOQ |
0.309 |
121 |
0.716 |
112 |
6 |
2015-06-24 |
< LOQ |
0.304 |
119 |
0.750 |
117 |
13 |
2015-07-01 |
< LOQ |
0.4451) |
174 |
1.271) |
198 |
19 |
2015-07-07 |
< LOQ |
0.289 |
113 |
0.730 |
114 |
27 |
2015-07-15 |
< LOQ |
0.305 |
119 |
0.724 |
113 |
33 |
2015-07-21 |
< LOQ |
0.282 |
110 |
0.711 |
111 |
Arithmetical mean |
< LOQ |
0.322 |
0.817 |
Measured Concentrations, Percent of Nominal Concentrations and Arithmetical Mean of test item in the Test Vessels during Exposure
(1.60, 4.00 and 10.0 mg/L)
Nominal |
1.60 |
4.00 |
10.0 |
||||
Sampling [d] |
Sampling date / Start of Analysis |
||||||
Meas. conc. [mg/L] |
%
|
Meas. conc. [mg/L] |
%
|
Meas. conc. [mg/L] |
%
|
||
0 |
2015-06-18 |
1.31 |
82 |
3.33 |
83 |
8.68 |
87 |
6 |
2015-06-24 |
1.79 |
112 |
4.78 |
120 |
11.6 |
116 |
13 |
2015-07-01 |
1.76 |
110 |
4.36 |
109 |
11.0 |
110 |
19 |
2015-07-07 |
1.89 |
118 |
4.77 |
119 |
11.5 |
115 |
27 |
2015-07-15 |
1.88 |
118 |
4.56 |
114 |
11.3 |
113 |
33 |
2015-07-21 |
1.86 |
116 |
4.59 |
115 |
11.6 |
116 |
Arithmetical mean |
1.75 |
4.40 |
10.9 |
Meas. Conc. = Measured concentration (dilution factor taken into account)
% = Percent of nominal concentration of the test item
LOQ = Limit of quantification of theanalytical method(0.025 mg/L of the test item)
Description of key information
The long-term effects on Danio rerio were studied in a fish early life stage test according to OECD 210. The test substance caused no significant effects on Zebrafish, 30 days post hatch. Based on the parameters hatch, growth (expressed as length and dry weight) and post-hatch survival (mortality) the overall NOEC (nominal, post hatch day 0 30) was 10.0 mg/L, corresponding to 10.9 mg/L (arithmetical mean). The overall LOEC (nominal, post hatch day 0 30) was > 10.0 mg/L, corresponding to > 10.9 mg/L (arithmetical mean).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- NOEC
- Effect concentration:
- 10 mg/L
Additional information
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