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EC number: 444-960-2 | CAS number: 39148-16-8
- 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, juvenile growth test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Aug - 22 Sep 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 215 (Fish, Juvenile Growth Test)
- Version / remarks:
- 2000
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 10, and 100 mg/L
- Sampling method: The highest and lowest test concentration were analysed when freshly prepared and immediately prior to renewal at the start of the study (day 0) and weekly thereafter (days 3, 9, 18, 28)
- Sample storage conditions before analysis: On each occasion, one sample was analysed after certain pre-treatment and the remaining samples were retained in case further analysis would be required - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions were prepared by directly adding the appropriate amount of Fosetyl-Na in dilution water and stirring for 30 min. For the test concentrations of 10, 20, 40, 80, and 100 mg/L amounts of 0.0307, 0.0614, 0.1230, 0.2456, and 0.3074 g, respectively, were added to 3 L of dilution water.
- Controls: Negative Control (dilution water) - Test organisms (species):
- other: Gobiocypris rarus
- Details on test organisms:
- TEST ORGANISM
- Common name: rare minnow
- Strain: batch no.: JF20140615
- Source: bred in the lab
- Age at study initiation (mean and range, SD): juvenile fish in exponential growth phase (hatch date: 15 Jun 2014 )
- Weight at study initiation (mean and range, SD): mean weight of 10 fish in each concentration tested were 0.0665, 0.0622, 0.0591, 0.0607, 0.0588, and 0.0557 g in control, 10, 20, 40, 80, and 100 mg/L, respectively
- Feeding during test : yes
- Amount: 4% dry weight related to the initial fish weight (about 0.15 g)
- Frequency: daily
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): feeding fry were maintained in holding tanks supplied with a continous flow of aerated water (90% of the air saturation) at 22 - 23 °C and 16 hours light/ 8 hours darkness photoperiod (1000-1500 lux)
- Type and amount of food: live food (Artemia) 4% dry weight related to the initial fish weight (about 0.15 g)
- Feeding frequency during acclimation: daily until 24 h prior to test
- Health during acclimation (any mortality observed): no mortality was observed in 7 days following a 48 h settling-in period
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 28 d
- Test temperature:
- 22.5 - 23.5 °C
- pH:
- 7.66 - 8.06
- Dissolved oxygen:
- 71 - 90% of the air saturation value
- Nominal and measured concentrations:
- - Nominal concentrations: control, 10, 20, 40, 80, 100 mg/L
- Measured concentrations: see results - Details on test conditions:
- TEST SYSTEM
- Test vessel: tanks made of chemically inert material with a sealable inert lid
- Size of vessel: 5 L
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 3 L
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): every 72 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.2 to 0.4 g of fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: good quality tap water hich has been dechlorinated for at least 12 hours
- Total organic carbon: 1.91 mg/L
- Metals: < 0.001 mg/L (As, Cd, Pb, Co, Ag); < 0.0002 mg/L (Hg); 0.001 mg/L Ni; 0.002 mg/L Cu; < 0.004 mg/L Cr6+; < 0.03 mg/L Fe; 0.25 mg/L Zn
- Pesticides: < 0.001mg/L (malathion, methyl parathion, and parathion)
- Alkalinity: pH = 7.55
- Culture medium different from test medium: no
- Intervals of water quality measurement: the characteristics of the dilution water are measured at least twice a year by Jiangsu Provincial Center for Disease Prevention and Control
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: 1000 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and any abnormal behaviour and external abnormalities (e.g. hemorrhage, discoloration) were recorded daily. Fish were considered dead if there was no visible movement and if touching of the caudal peduncle produced no reaction. Dead fish were removed as soon as possible. Dissolved oxygen, pH, and temperature were measured out in the beginning of the test and weekly thereafter (3, 9, 18, 28 d). Highest and lowest test concentration were analysed when freshly prepared and immediately prior to renewal at the start of the study (0 d) and weekly thereafter (3, 9, 18, 28 d).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2, unless for the second highest concentration to the highest concentration (factor of 1.25)
RANGE-FINDING STUDY
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: No deaths and normal behaviour up to 100 mg/L in an 96-hour exposure period - Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: based on mortality and growth
- Duration:
- 28 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: based on mortality and growth
- Reported statistics and error estimates:
- For the estimation of the lowest observed effect concentration (LOEC), and the no observed effect concentration (NOEC), for the effects of the target substance on growth rate, the mean growth rate for each concentration were compared with the control mean using a multiple comparison method of Bartlett's tests (ANOVA, STATA 10.0).
- Validity criteria fulfilled:
- yes
- Remarks:
- see Table 4 in 'any other information on results incl. tables'
Reference
Table 1. Measured concentrations of Fosetyl-Na in test medium
Nominal concentration (mg/L) |
Analyzed concentration (mg/L) |
Mean analyzed concentration (mg/L) |
|||||||||
|
Day 0 |
Day 3 |
Day 9 |
Day 18 |
Day 28 |
|
|||||
|
fresh |
aged |
fresh |
aged |
fresh |
aged |
fresh |
aged |
|
||
Control |
< LOD |
< LOD |
< LOD |
< LOD |
< LOD |
< LOD |
< LOD |
< LOD |
- |
||
10 |
10.2 |
9.98 |
10.0 |
10.3 |
10.3 |
10.2 |
10.2 |
10.3 |
10.2 |
||
100 |
99.8 |
99.5 |
99.8 |
99.9 |
99.6 |
99.8 |
100 |
99.9 |
99.8 |
||
Table 2. Summary of mortality and abnormal behaviour data in a 28 day juvenile growth test with Gobiocypris rarus
Nominal concentration (mg/L) |
Initial number of fish |
Number of dead fish |
Abnormal behaviour |
Mean weight on day 0 (g) |
Control |
10 |
0 |
NB |
0.0665 |
10 |
10 |
0 |
NB |
0.0622 |
20 |
10 |
0 |
NB |
0.0591 |
40 |
10 |
0 |
NB |
0.0607 |
80 |
10 |
0 |
NB |
0.0588 |
100 |
10 |
0 |
NB |
0.0557 |
NB = normalbehaviour
Table 3. Individual weights at day 28 of a juvenile growth test with Gobiocypris rarus
|
Control |
10 mg/L |
20 mg/L |
40 mg/L |
80 mg/L |
100 mg/L |
||||||
|
Weights (g) |
Rates (%) |
Weights (g) |
Rates (%) |
Weights (g) |
Rates (%) |
Weights (g) |
Rates (%) |
Weights (g) |
Rates (%) |
Weights (g) |
Rates (%) |
1 |
0.163 |
3.22 |
0.152 |
3.21 |
0.163 |
3.67 |
0.144 |
3.10 |
0.139 |
3.08 |
0.148 |
3.53 |
2 |
0.157 |
3.10 |
0.167 |
3.55 |
0.150 |
3.38 |
0.157 |
3.42 |
0.132 |
2.92 |
0.133 |
3.13 |
3 |
0.147 |
2.85 |
0.166 |
3.53 |
0.154 |
3.47 |
0.143 |
3.06 |
0.142 |
3.17 |
0.141 |
3.35 |
4 |
0.153 |
3.01 |
0.149 |
3.14 |
0.161 |
3.62 |
0.138 |
2.93 |
0.137 |
3.04 |
0.137 |
3.26 |
5 |
0.161 |
3.19 |
0.157 |
3.33 |
0.154 |
3.48 |
0.149 |
3.23 |
0.153 |
3.43 |
0.156 |
3.71 |
6 |
0.157 |
3.10 |
0.170 |
3.61 |
0.167 |
3.77 |
0.146 |
3.15 |
0.145 |
3.25 |
0.144 |
3.41 |
7 |
0.144 |
2.79 |
0.151 |
3.20 |
0.152 |
3.42 |
0.139 |
2.97 |
0.136 |
3.01 |
0.134 |
3.17 |
8 |
0.153 |
3.00 |
0.148 |
3.11 |
0.153 |
3.44 |
0.143 |
3.07 |
0.151 |
3.40 |
0.129 |
3.03 |
9 |
0.173 |
3.43 |
0.164 |
3.49 |
0.148 |
3.34 |
0.158 |
3.43 |
0.130 |
2.87 |
0.139 |
3.30 |
10 |
0.157 |
3.09 |
0.155 |
3.29 |
0.152 |
3.42 |
0.141 |
3.03 |
0.148 |
3.31 |
0.146 |
3.46 |
Rates = pseudo specific growth rates for the periods from day 0 to day 28
Table 4. Validity criteria OECD 215
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The mortality in the control(s) must not exceed 10 per cent at the end of the test. |
Mortality was 0% |
Yes |
The mean weight of fish in the control(s) must have increased enough to permit the detection of the minimum variation of growth rate considered as significant. |
Mean weight in the beginning was 0.0605 g and increased by more than 50% in the control. |
Yes |
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value (ASV) throughout the test. |
71 – 90% |
Yes |
The water temperature must not differ by more than ± 1 °C between test chambers at any one time during the test and should be maintained within a range of 2°C within the temperature ranges specified for the test species. |
22.5 – 23.5 °C |
Yes |
Description of key information
NOEC (28 d) ≥ 100 mg/L, nominal, for Gobiocypris rarus (OECD 215, ≥ 99.8 mean measured concentration)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- NOEC
- Effect concentration:
- >= 100 mg/L
Additional information
A 28 day GLP long-term toxicity study to fish is available for Fosetyl-Sodium. The study was performed according to OECD guideline 215 on the chronic toxicity to the rare minnow (Gobiocypris rarus) under semi-static conditions. Fish were exposed to the nominal concentrations of 10, 20, 40, 80, and 100 mg/L and an untreated control at 22.5 - 23.5 °C. The test item was dissolved in test water. No additional solvent was used. The test water was not aerated during the time of testing. Chemical analysis was performed for the highest and lowest test concentration when freshly prepared and immediately prior to renewal at the start of the study (day 0) and weekly thereafter (days 3, 9, 18, 28) using HPLC-MS/MS.
Analysis of the test solutions (fresh media and old media) showed that the measured concentrations were within +/- 20% of nominal values. Therefore, results were based on nominal concentrations. No mortality and no sub-lethal effects, as well as no effects on the growth were observed in the study. Thus, the NOEC (28 d) for rare minnow was determined to be ≥ 100 mg/L, nominal.
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