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EC number: 485-320-2 | CAS number: 221667-31-8
- 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:
- 02 Feb - 09 Mar 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1400 (Fish Early-life Stage Toxicity Test)
- Version / remarks:
- (draft)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA72-4
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Interval of analytical verification of test material: At experimental start, weekly (± 2 days) thereafter including experimental finish.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution was prepared with 208 mg a.i./L in 120 L stainless steel drums. The stock solution was mixed for 30 - 93 hours. The stock solution was used to dose the test aquaria via a modified proportional diluter system (Mount and Brungs, 1967). The temperature was approximately 20°C (room temperature) during mixing and use.
- Controls: Yes - Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: Fathead Minnow
- Source: In-house fathead minnow breeding facility (Parental Lot Number: EG081104)
METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish: 2 males and 5 females per aquaria
- Number of Spawning Substrates per Aquaria: 3
- Method of collection of fertilised eggs: Eggs were removed fromsubstrates contained in breeding tanks on the morning of the experimental start with nonviable eggs being discarded.
POST-HATCH FEEDING
- Start date: Day 6
- Type/source of feed: Brine shrimp (Artemia salind) starting on Day 4
- Amount given: Equal distribution at 0.5 - 3.0 mL per feeding
- Frequency of feeding: At least once daily on weekends and two to three times daily on weekdays until approximately 24 hours prior to study termination. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 35 d
- Hardness:
- soft water: 40 to 60 mg/L as CaCO3
- Test temperature:
- 23.9 to 25.8 °C
- pH:
- 7.6 to 8.3
- Dissolved oxygen:
- 6.6 to 7.6 mg/L (80 to 92% saturation)
- Nominal and measured concentrations:
- Nominal Test Concentrations: Control, 0.63, 1.25, 2.50, 5.00 and 10.0 mg a.i./L
Measured Test Concentrations: Control (< 0.10), 0.70, 1.07, 2.58, 4.67 and 10.5 mg a.i./L - Details on test conditions:
- TEST SYSTEM
- Emybro cups: One oscillating egg cup per replicate placed in each replicate through the egg hatching phase
- Test vessel:
- Material, size, fill volume: All Glass, 8.4-L, 7-L (21.6x12.7x25.5 cm) fill volume
- Type of flow-through: Modified Mount-Brungs proportional diluter system
- Renewal rate of test solution: Volume turnover per vessel per 24 hours aprox. 5 to 10
- No. of fertilized eggs/embryos per vessel: 35 eggs at initiation (Thinned to 20 alevin after hatching phase)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 0.22 g /L static (mean wet weight based on controls), 0.09 g/L/day (mean biomass based on controls)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Process water (blended spring and reverse osmosis waters); according to guideline
- Culture medium different from test medium: No
- Intervals of water quality measurement: At experimental start, weekly (± 2 days) thereafter including experimental finish.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light, 8 hours dark (30 minutes light/dark transition period)
- Light intensity: 59.2 to 92.5 footcandles (637 to 996 lux)
EFFECT PARAMETERS MEASURED: Sublethal effects, fish hatchability, survival, and growth (length and dry weight- all surviving fish on Day 35)
POST-HATCH DETAILS
- Begin of post-hatch period: Day 6
- No. of hatched eggs (alevins)/treatment released to the test chamber: 20
- Release of alevins from incubation cups to test chamber on day no.: 5 - Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 10.5 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.67 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- length
- Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.67 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- weight
- Validity criteria fulfilled:
- yes
- Remarks:
- See Table 3 in "Any other information on results incl. tables".
Reference
Table 1: Fish early life stage toxicity test
Test Object |
Fathead Minnow |
|
Exposure |
35 Day, flow- through (ELS) |
|
|
NOEC |
LOEC |
Alevin Survival (Day 5): |
10.5mga.i./L |
>10.5mga.i./L |
Fry Survival (Day 35): |
10.5mga.i./L |
>10.5mga.i./L |
Percent Hatch: |
10.5mga.i./L |
>10.5mga.i./L |
Time to Hatch: |
10.5mga.i./L |
>10.5mga.i./L |
Growth (Length & Weight): |
4.67 mga.i./L |
10.5 mga.i./L |
Morphological & Behavioral |
10.5mga.i./L |
>10.5mga.i./L |
Observations: |
No morphological or behavioral dose effects were apparent at any treatment group relative to the control group. |
|
Conclusion: |
The 35-day exposure to AE 0001789 technical resulted in a NOEC of 4.67 mg a.i./L and a LOEC of 10.5 mg a.i./L based on growth (length and weight). |
Table 2: Measured Concentrations of AE 0001789 Technical During the Fathead Minnow Early Life Stage Toxicity Test
|
|
Measured Concentration (mg a.i./L) |
|
|||||||
Nominal Conc. (mg a.i./L) |
Replicate |
Day 0 |
Day 7 |
Day 15 |
Day 21 |
Day 28 |
Day 35 |
Mean |
Standard Deviation |
Percent of Nominal |
Control |
A |
<0.10 |
- |
<0.10 |
- |
<0.10 |
- |
NA |
NA |
NA |
B |
<0.10 |
- |
<0.10 |
- |
<0.10 |
- |
||||
C |
- |
<0.10 |
- |
<0.10 |
- |
<0.10 |
||||
D |
- |
<0.10 |
- |
<0.10 |
- |
<0.10 |
||||
0.63 |
A |
0.72 |
- |
0.73 |
- |
0.70 |
- |
0.70 |
0.03 |
110 |
B |
0.68 |
- |
0.70 |
- |
0.68 |
- |
||||
C |
- |
0.73 |
- |
0.72 |
- |
0.69 |
||||
D |
- |
0.66 |
- |
0.68 |
- |
0.66 |
||||
1.25 |
A |
1.01 |
- |
1.01 |
- |
0.99 |
- |
1.07 |
0.07 |
86 |
B |
1.03 |
- |
1.08 |
- |
1.06 |
- |
||||
C |
- |
1.07 |
- |
1.10 |
- |
1.04 |
||||
D |
- |
1.16 |
- |
1.20 |
- |
1.14 |
||||
2.50 |
A |
2.57 |
- |
2.59 |
- |
2.52 |
- |
2.58 |
0.03 |
103 |
B |
2.60 |
- |
2.56 |
- |
2.61 |
- |
||||
C |
- |
2.57 |
- |
2.61 |
- |
2.56 |
||||
D |
- |
2.58 |
- |
2.63 |
- |
2.58 |
||||
5.00 |
A |
4.64 |
- |
4.67 |
- |
4.66 |
- |
4.67 |
0.10 |
93 |
B |
4.59 |
- |
4.62 |
- |
4.68 |
- |
||||
C |
- |
4.78 |
- |
4.89 |
- |
4.78 |
||||
D |
- |
4.60 |
- |
4.60 |
- |
4.58 |
||||
10.0 |
A |
10.4 |
- |
10.4 |
- |
10.2 |
- |
10.5 |
0.16 |
105 |
B |
10.6 |
- |
10.4 |
- |
10.6 |
- |
||||
C |
- |
10.6 |
- |
10.7 |
- |
10.4 |
||||
D |
- |
10.7 |
- |
10.6 |
- |
10.7 |
NA = Not applicable
LOQ = 0.10 mg/L
- Sample not collected
Table 3: Validity criteria for OECD 210
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The dissolved oxygen concentration should be >60% of the air saturation value throughout the test. |
The dissolved oxygen concentration was with≥6.6 mg/L higher than 60% of the air saturation value throughout the test. |
yes |
The water temperature should not differ by more than ± 1.5 °C between test chambers or between successive days at any time during the test, and should be within the temperature ranges specified for the test species (Annex 2). |
The water temperature did not differ by more than ± 1.5 °C between test chambers or between successive days at any time during the test. |
yes |
The analytical measure of the test concentrations is compulsory. |
There is evidence that the concentration of the tested substance has been satisfactorily maintained, throughout the test (86 – 110% of nominal). |
yes |
Overall survival of fertilised eggs and post-hatch success in the controls and, where relevant, in the solvent controls should be greater than or equal to the limits defined in Annex 2. |
Overall survival of fertilised eggs and post-hatch success in the controls was≥89%. |
yes |
Description of key information
NOEC (35 d): 4.67 mg/L (arith. mean measured, length and weight, Pimephales promelas, freshwater, OECD 210)
NOEC (35 d): 10.5 mg/L (arith. mean measured, reproduction, Pimephales promelas, freshwater, OECD 210)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- NOEC
- Effect concentration:
- 4.67 mg/L
Additional information
A 35-day early life stage test according to OECD 210 was conducted with the test substance under flow-through conditions on Fathead Minnow (Pimephales promelas, M-254985-01-1).
Fish were exposed to nominal test concentrations of 0.63, 1.25, 2.50, 5.00 and 10.0 mg a.i./L (measured: 0.70, 1.07, 2.58, 4.67 and 10.5 mg a.i./L), alongside a negative control.
The reported NOEC was 4.67 mg a.i./L for the parameter growth (length and weight) and the NOEC 10.5 mg a.i./L for reproduction (based on arith. mean measured concentrations). No morphological or behavioral effects for the test substance were apparent at any treatment group relative to the control group.
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