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EC number: 271-867-2 | CAS number: 68610-51-5
- 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
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:
- 28 October 2014 to 20 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD test guidelines in compliance with GLP. Testing conducted in accordance with ECHA Decision number CCH-D-0000003873-68-05/F.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Deviations:
- yes
- Remarks:
- See Any other information
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
None specified - Analytical monitoring:
- yes
- Details on sampling:
- Samples for analysis were taken in triplicate from the test concentration and singular samples were taken from the control.
Sampling:
Frequency: At the start and the end of one interval of 72 hours (nominal days 0 and 3) and one interval of 48 hours (nominal days 8 and 10). After this day no more samples were taken.
Volume: A sample volume of 20 ml was taken and spiked into a separation funnel containing 20 ml dichloromethane.
Storage: Not applicable, samples were analysed on the day of sampling. - Vehicle:
- no
- Details on test solutions:
- The batch of LOWINOX® CPL tested was a UVCB and its appearance was described as a white to cream coloured powder. The substance was not completely soluble in test medium at the loading rates initially prepared. No correction was made for the purity/composition of the test substance.
All test concentrations were prepared separately and started with loading rates of 1.0, 10 and 100 mg/l for the range-finding test and with a loading rate of 1.0 mg/l for the Early Life Stage (ELS) test. Two days of magnetic stirring at room temperature in the dark was applied to reach the maximum solubility of the test substance in the test medium. The resulting aqueous mixtures were filtered through a 0.45 µm membrane filter (Whatman) where after the clear and colourless Water Accommodated Fractions (WAFs) were used as the test concentrations. - Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- Test system
Species: Fathead minnow (Pimephales promelas, Teleostei Cyprinidae) Rafinesque.
Reason for selection: This system has been selected as an internationally accepted species.
Source: In house culture.
Holding of the brood stock
Medium: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands) with the following composition:
CaCl2.2H2O 211.5 mg/l
MgSO4.7H2O 88.8 mg/l
NaHCO3 46.7 mg/l
KCl 4.2 mg/l
Measurements: Conductivity, pH, nitrate, nitrite and ammonia concentration: once a week. Temperature: continuous. In addition, temperature was measured before transferring the parental fish to the breeding system.
Water quality parameters: Will be kept within the optimum limits for the respective fish species.
Ratio male/female: 1:2
Spawning tank: The spawning tank is equipped with a substrate (pvc-tube), which enables collection of the fertilised eggs.
Feeding brood stock: Frozen brine shrimp Nauplii and pelleted fish food (Cyprico Crumble Excellent (300-500 um), Coppens International bv, Helmond, The Netherlands).
Time of fertilisation: Males and females are put together in spawning tanks and spawning starts the following day approximately 1 to 2 hours after lights have been switched on. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 34 d
- Post exposure observation period:
- No post exposure observation period specified in the study report.
- Hardness:
- Total hardness ranged between 214 and 268 mg calcium carbonate per litre. This was according to the value described in the protocol, i.e. >140 mg/L as CaCO3.
- Test temperature:
- The average temperature in the control and the test concentration varied between 22.8 and 25.8 °C. The temperature continuously measured in a temperature control vessel (nominal days 0-6) or in one of the replicates of the control (nominal days 6-34) ranged between 23.2 and 26.5 °C. This was not within the range described in the Protocol: 25 ± 1.5 °C.
- pH:
- The pH varied between 7.2 and 8.0 during the test period, which was within the range described in the Protocol (6.0-8.5).
- Dissolved oxygen:
- Oxygen concentrations varied between 5.2 and 10 mg/l during the test period, which is >60% of oxygen saturation at 25°C as prescribed by the Protocol.
- Nominal and measured concentrations:
- Measured concentrations
Concentrations in the test samples measured until day 10 of exposure were below or around the concentration of the lowest calibration solution, i.e. below 0.5 µg/l.
No more samples were taken and analyzed during the remainder of the test period based on the results of the samples taken until day 10 which, showed that the actual test concentration was either below or around the concentration of the lowest calibration solution. The effect parameters were therefore based on the loading rate rather than on the measured test concentration. - Details on test conditions:
- Test procedure and conditions
Test type: Semi-static
Frequency of renewal: Three times a week
Test duration: 34 days
Introduction egg: Before cleavage of the blastodisc commenced (approximately 2-4 hours after fertilisation).
Test vessels: Embryonic phase: Petri-dishes.
Early larval phase: stainless steel vessels of 1.7 litre, middle larval phase: all-glass vessels of 3 litres, late larval phase: all-glass vessels of 5 litres.
Test medium: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3.
Experimental design: The experiment (nominal day 0) started with 80 fresh and healthy fertilised fathead minnow eggs per test group. The fertilised eggs were randomly distributed and divided equally over four Petri-dishes. Each Petri-dish contained 20 eggs in 50 mL test medium and these dishes were incubated under gentle continuous shaking. On days 6, 24 and 27 the hatched larvae were transferred to increasingly larger vessels/volumes.
Light period: 16 h photo-period daily from 5 am until 9 pm; between 452 and 635 lux.
Feeding:
Embryonic phase: no feeding.
Newly hatched larvae: pelleted fish food (75 µm) and Brine shrimp Nauplii 24 hours old.
Juvenile stage: Brine shrimp Nauplii 24 or 48-hours old.
Food is supplied ad libitum.
Euthanasia: At the end of the test the surviving larvae were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water.
Measurements and recordings
Organisms
Stage of embryonic development: Daily, from the beginning of the exposure
Hatching and survival: Daily, numbers of hatched larvae and dead embryos, larvae and juvenile fish were recorded. Dead embryos, larvae and juvenile fish were removed directly after recording.
Criteria for death
Eggs: particularly in the early stages, a marked loss of translucency and change in coloration, caused by coagulation and/or precipitating of protein, characterised by a white opaque appearance;
Embryos: Absence of body movement and /or absence of heartbeat;
Larvae and juvenile fish: immobility and/or absence of respiratory movement and/or absence of heart-beat and/or white opaque coloration of the central nervous system and/or lack of reaction to mechanical stimulus.
Abnormal appearance: Daily, abnormalities were recorded, e.g. hyperventilating, uncoordinated swimming, atypical quiescence and typical swimming behaviour.
Body weight: At the end of the test, all surviving fish were weighed on a replicate basis (blotted dry weight).
Body length: At the end of the test, all surviving fish were individually measured.
Test media
Oxygen, pH and temperature: At the start and the end of the test and at each renewal in each test group. In the freshly prepared solutions measurements were performed before exposing the organisms and in the old solutions after pooling of the replicates per group. In addition, temperature was recorded continuously.
Hardness: At the first and the last renewal interval in fresh and old media from each test group. - Reference substance (positive control):
- no
- Duration:
- 34 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: WAF loading rate
- Basis for effect:
- other: embryonic survival, larval survival and larval growth
- Duration:
- 34 d
- Dose descriptor:
- LOELR
- Effect conc.:
- > 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: WAF loading rate
- Basis for effect:
- other: embryonic survival, larval survival and larval growth
- Details on results:
- Range-finding test
Hatching of embryo’s started at nominal day 3 and was finished at nominal day 5. Overall survival of fertilised eggs in the control was >70% until hatching was complete (90%). No significant effects on mortality of fish embryos and juvenile fish were observed at any of the test concentrations during the 7-day range-finding test.
All test conditions were maintained within the limits prescribed by the protocol.
Samples taken from the WAFs prepared at 10 and 100 mg/l were analysed but the analytical method used proved to be insufficient. It was however obvious that the actual concentrations in the WAFs were low, i.e. <0.01 mg/l.
After the performance of the range-finding test, the analytical method needed to be re-developed in order to measure lower test concentrations. It was decided to perform the ELS test with only one test concentration, i.e. a WAF prepared at a loading rate of 1.0 mg/l, since WAFs prepared at higher test concentrations would only introduce the risk of having undissolved test material in the test vessels. Preparation of WAFs below 1.0 mg/l is technically not feasible.
ELS test
Measured concentrations
Concentrations in the test samples measured until day 10 of exposure were below or around the concentration of the lowest calibration solution, i.e. below 0.5 µg/l.
No more samples were taken and analyzed during the remainder of the test period based on the results of the samples taken until day 10 which, showed that the actual test concentration was either below or around the concentration of the lowest calibration solution. The effect parameters were therefore based on the loading rate rather than on the measured test concentration.
Embryonic survival, development and hatching
Hatching of embryos started on the fourth day of exposure and was finished on the seventh day. Mean survival of the embryos in the control group was 96% and a similar percentage was reached in the test concentration (90%). Hatching in the test concentration started on the same day as in the control. Embryonic survival in the test concentrations was not statistically different from the control.
Larval survival and development
The mean post-hatch larval survival was 84% for the control. A similar percentage was reached for the test concentration (90%). Larval survival in the test concentration was not statistically different from the control. Some visible sub-lethal effects, i.e. malformation, no or less developed swim bladder, were recorded in the control.
Effects on larval growth
Both body length and body weight in the test concentrations were not statistically different from the control.
Experimental conditions
The pH varied between 7.2 and 8.0 during the test period, which was within the range described in the Protocol (6.0-8.5).
Oxygen concentrations varied between 5.2 and 10 mg/l during the test period, which is >60% of oxygen saturation at 25 °C as prescribed by the Protocol.
The average temperature in the control and the test concentration varied between 22.8 and 25.8 °C. The temperature continuously measured in a temperature control vessel (nominal days 0-6) or in one of the replicates of the control (nominal days 6-34) ranged between 23.2 and 26.5 °C. This was not within the range described in the Protocol: 25 ± 1.5 °C.
Total hardness ranged between 214 and 268 mg calcium carbonate per litre. This was according to the value described in the protocol, i.e. >140 mg/L as CaCO3.
T(D)OC measurement of a sample taken from the ISO-medium showed a value of 1.99 mg C/l, which was according to Protocol (<2 mg C/l). - Results with reference substance (positive control):
- Reference substances not required for the study.
- Reported statistics and error estimates:
- STATISTICAL ANALYSIS ON EMBRYONIC SURVIVAL
Threshold Concentrations (NOELR) for Hatchability at 7 d
Chi² 2x2 Table Test with Bonferroni Correction
STATISTICAL ANALYSIS ON LARVAL SURVIVAL
Threshold Concentrations (NOELR) for Post-hatch survival at 34 d
Chi² 2x2 Table Test with Bonferroni Correction
STATISTICAL ANALYSIS ON BODY LENGTH
Shapiro-Wilk´s Test on Normal Distribution
Levene´s Test on Variance Homogeneity (with Residuals)
STUDENT-t test for Homogeneous Variances
STATISTICAL ANALYSIS ON BODY WEIGHT
Shapiro-Wilk´s Test on Normal Distribution
Levene´s Test on Variance Homogeneity (with Residuals)
STUDENT-t test for Homogeneous Variances - Validity criteria fulfilled:
- yes
- Conclusions:
- Testing conducted in accordance with ECHA Decision number CCH-D-0000003873-68-05/F
According to the integrated testing strategy, the Daphnia study was to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.
As effects were noted within the Daphnia study, and refinement of the PNEC was required, this test was conducted subsequently in order to allow for accurate risk assessment.
The study assessed the possible lethal and sub-lethal effects of LOWINOX® CPL during the embryonic and early larval development of the fathead minnow. The results led to the following conclusions:
LOWINOX® CPL did not induce any statistically significant effects on embryonic survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for embryonic survival were 1.0 and >1.0 mg/l, respectively;
LOWINOX® CPL did not induce any statistically significant effects on larval survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval survival were 1.0 and >1.0 mg/l, respectively;
LOWINOX® CPL did not induce any statistically significant effects on larval growth at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval growth were 1.0 and >1.0 mg/l, respectively. - Executive summary:
Testing conducted in accordance with ECHA Decision number CCH-D-0000003873-68-05/F
According to the integrated testing strategy, the Daphnia study was to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.
As effects were noted within the Daphnia study, and refinement of the PNEC was required, this test was conducted subsequently in order to allow for accurate risk assessment.
Fish early-life stage toxicity test with LOWINOX® CPL (semi-static).
The study procedures described in this report were based on the OECD guidelines for Testing of Chemicals: Guideline No. 210, 2013. In addition, the procedures were designed to meet the test methods and validity criteria of the EPA Ecological Effects Test Guidelines, 'Public Draft', EPA 712-C 96-121, 1996 and the OECD series on testing and assessment number 23, 2000.
The batch of LOWINOX® CPL tested was a UVCB and its appearance was described as a white to cream coloured powder. The substance was not completely soluble in test medium at the loading rates initially prepared.
A 34-day early life stage (ELS) test was performed based on the results of a preceding 7-day range-finding test. Preparation of the test solution started with a loading rate of 1.0 mg/l. Two days of magnetic stirring at room temperature in the dark was applied to reach the maximum solubility of the test substance in the test medium. The resulting aqueous mixture was filtered through a 0.45 µm membrane filter where after the clear and colourless Water Accommodated Fraction (WAF) was used as the test concentration.
The ELS test was performed under semi-static conditions with renewal of test solutions three times per week. The test was performed with four replicates of a control group and four replicates for the WAF. Both test groups contained 20 embryos per replicate. The test started by placing the embryos in Petri-dishes. On days 6, 24 and 27 hatched larvae and/or juvenile fish were transferred to larger vessels/volumes. During the embryonic and larval phases, the fish were observed for effects on development, appearance and swimming behaviour. At the end of the test, the surviving fish were measured and weighed.
During the test, samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of two renewal intervals. Concentrations in the test samples measured until day 10 of exposure were below or around the concentration of the lowest calibration solution, i.e. below 0.5 µg/l.
No more samples were taken and analyzed during the remainder of the test period based on the results of the samples taken until day 10 which, showed that the actual test concentration was either below or around the concentration of the lowest calibration solution. The effect parameters were therefore based on the loading rate rather than on the measured test concentration.
The study generally met the acceptability criteria prescribed by the protocol and was considered valid.
The results of the ELS test led to the following conclusions:
LOWINOX® CPL did not induce any statistically significant effects on embryonic survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the No Observed Effect Loading Rate (NOELR) and the Lowest Observed Effect Loading Rate (LOELR) for embryonic survival were 1.0 and >1.0 mg/l, respectively;
LOWINOX® CPL did not induce any statistically significant effects on larval survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval survival were 1.0 and >1.0 mg/l, respectively;
LOWINOX® CPL did not induce any statistically significant effects on larval growth at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval growth were 1.0 and >1.0 mg/l, respectively.
Reference
Survival of fish embryos and larvae during the range-finding test
LOWINOX® CPL WAF prepared at the given loading rate (mg/l) |
No. of eggs |
Number of survival |
Total survival (%) |
||||||
Day 0 |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
Day 7 |
||
Control |
10 |
9 |
9 |
9 |
9 |
8 |
8 |
6 |
60 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
7 |
70 |
|
1.0 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
100 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
100 |
|
10 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
90 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
90 |
|
100 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
90 |
10 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
80 |
Embryonic survival and hatching success during the ELS test
LOWINOX® CPL WAF prepared at the given loading rate (mg/l) |
Rep.1 |
93 h |
118 h |
145 h |
165 h |
% Hatch Success |
||||
No. Hatch |
% Hatch |
No. Hatch |
% Hatch |
No. Hatch |
% Hatch |
No. Hatch |
% Hatch |
|||
Control |
A |
4 |
20 |
16 |
80 |
20 |
100 |
20 |
100 |
96 |
B |
7 |
35 |
16 |
80 |
19 |
95 |
19 |
95 |
||
C2 |
5 |
24 |
14 |
67 |
30 |
95 |
21 |
100 |
||
D |
7 |
35 |
17 |
85 |
18 |
90 |
18 |
90 |
||
1.0 |
A |
7 |
35 |
15 |
75 |
17 |
85 |
17 |
85 |
90 |
B |
8 |
40 |
17 |
85 |
18 |
90 |
18 |
90 |
||
C |
7 |
35 |
16 |
80 |
18 |
90 |
18 |
90 |
||
D |
3 |
15 |
14 |
70 |
19 |
95 |
19 |
95 |
1Twenty embryos were added to each vessel at the start of the test
2An additional embryo was found after two days of exposure
Effects on fish larvae of the control and the test concentration
Group (mg/l) |
Vessel code |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
Day |
5 |
6 |
7 |
8 |
9 |
10 |
11-15 |
16-17 |
18 |
19 |
20-21 |
22-24 |
25-34 |
||
Control |
A |
|
|
|
1p |
1p |
|
|
|
|
|
|
|
|
B |
|
|
1h |
1h |
|
2z |
2bz |
1bz, 1s |
1b |
|
1s |
1s |
1s |
|
C |
|
|
2h |
2h |
|
1b,4z |
1b,4z |
1pbz,3bz |
3b |
3b |
2s,1bs |
3s |
2s,1s |
|
D |
|
|
|
1m |
|
1z |
|
|
|
|
|
|
|
|
1.0 |
A |
1y |
1h |
|
|
|
|
|
|
|
|
|
|
|
B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
C |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D |
|
|
|
|
|
|
|
|
|
|
|
|
|
Legend of effect codes:
b |
Bended corps/tail |
p |
Less pigmented |
y |
Malformed yolk sack |
h |
Cardiac edema |
s |
Small |
m |
Body malformed |
z |
No or less developed swim bladder |
Individual body length (mm) of surviving larvae at the end of the test period
Code for larvae |
Control |
Loading rate 1.0 (mg/l) |
||||||
A |
B |
C |
D |
A |
B |
C |
D |
|
1 |
21.0 |
13.0 |
20.0 |
23.5 |
25.0 |
21.0 |
24.0 |
22.5 |
2 |
23.0 |
24.0 |
24.0 |
23.0 |
25.0 |
23.5 |
24.5 |
25.0 |
3 |
26.5 |
24.5 |
25.0 |
25.0 |
24.0 |
23.5 |
20.5 |
23.0 |
4 |
25.5 |
21.5 |
22.5 |
22.0 |
23.0 |
23.5 |
24.0 |
25.0 |
5 |
24.0 |
25.0 |
26.0 |
24.0 |
24.5 |
24.0 |
24.5 |
21.0 |
6 |
24.0 |
19.0 |
25.0 |
20.0 |
22.5 |
25.0 |
23.5 |
21.5 |
7 |
24.5 |
25.0 |
25.0 |
23.5 |
25.0 |
23.0 |
23.5 |
25.0 |
8 |
22.0 |
24.5 |
25.0 |
25.0 |
25.0 |
24.5 |
24.0 |
21.0 |
9 |
23.5 |
25.0 |
12.5 |
24.0 |
25.0 |
24.5 |
22.5 |
25.0 |
10 |
22.5 |
29.0 |
25.0 |
24.0 |
24.0 |
24.5 |
23.0 |
24.0 |
11 |
23.5 |
19.0 |
27.0 |
24.5 |
25.0 |
24.5 |
22.5 |
24.5 |
12 |
25.0 |
22.5 |
22.0 |
25.0 |
22.5 |
24.5 |
25.0 |
23.5 |
13 |
23.5 |
25.0 |
24.0 |
23.0 |
|
21.5 |
25.0 |
21.0 |
14 |
24.0 |
21.0 |
23.0 |
23.0 |
|
24.5 |
24.0 |
23.5 |
15 |
24.5 |
24.5 |
22.5 |
22.0 |
|
23.0 |
23.0 |
23.0 |
16 |
22.5 |
25.0 |
12.5 |
24.0 |
|
25.0 |
21.0 |
25.0 |
17 |
|
|
19.0 |
|
|
23.0 |
23.0 |
21.5 |
18 |
|
|
|
|
|
|
24.5 |
24.0 |
19 |
|
|
|
|
|
|
|
|
20 |
|
|
|
|
|
|
|
|
Minimum |
21.0 |
13.0 |
12.5 |
20.0 |
22.5 |
21.0 |
20.5 |
21.0 |
Maximum |
26.5 |
29.0 |
27.0 |
25.0 |
25.0 |
25.0 |
25.0 |
25.0 |
Average |
23.7 |
23.0 |
22.4 |
23.5 |
24.2 |
23.7 |
23.4 |
23.3 |
SD |
1.37 |
3.67 |
4.23 |
1.32 |
1.01 |
1.15 |
1.25 |
1.54 |
CV |
6% |
16% |
9% |
6% |
4% |
5% |
5% |
7% |
n |
16 |
16 |
17 |
16 |
12 |
17 |
18 |
18 |
SD=standard deviation, CV=coefficient of variation, n=number of surviving larvae
Individual body weight (mg wet weight) of surviving larvae at the end of the test period
Parameter |
Control |
Loading rate 1.0 (mg/l) |
||||||
A |
B |
C |
D |
A |
B |
C |
D |
|
All larvae |
1877.2 |
1853.1 |
1758.5 |
1759.9 |
1719.8 |
1980.8 |
2032.1 |
2016.6 |
Mean |
117.3 |
115.8 |
103.4 |
110.0 |
143.3 |
116.5 |
112.9 |
112.0 |
Mean per conc. |
111.6 |
121.2 |
||||||
SD |
6.3 |
14.9 |
||||||
CV |
6% |
12% |
||||||
n |
16 |
16 |
17 |
16 |
12 |
17 |
18 |
18 |
SD=standard deviation, CV=coefficient of variation, n=number of surviving larvae
Description of key information
Long term toxicity to fish.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1 mg/L
Additional information
Testing conducted in accordance with ECHA Decision number CCH-D-0000003873-68-05/F
According to the integrated testing strategy, the Daphnia study was to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.
As effects were noted within the Daphnia study (although these are doubtful), and refinement of the PNEC was required, this test was conducted subsequently in order to allow for accurate risk assessment.
The study assessed the possible lethal and sub-lethal effects of LOWINOX® CPL during the embryonic and early larval development of the fathead minnow. The results led to the following conclusions:
LOWINOX® CPL did not induce any statistically significant effects on embryonic survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for embryonic survival were 1.0 and >1.0 mg/l, respectively;
LOWINOX® CPL did not induce any statistically significant effects on larval survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval survival were 1.0 and >1.0 mg/l, respectively;
LOWINOX® CPL did not induce any statistically significant effects on larval growth at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval growth were 1.0 and >1.0 mg/l, respectively.
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