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EC number: 932-164-2 | 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
Long-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14. November 2013 - 02. April 2014
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- yes
- Remarks:
- (1)Calculation error - three lowest test concentrations. Results not affected by deviation. (2)Light intensity was measured before and after the test. No influenece on integrity. (3)Temparture range above 22°C - no effect on integrity
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: yellowish-brown liquid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Concentrations:
Different concentrations were dissolved at the test medium according Elendt M4 given in the guideline OECD211.
The main test was performed using nominal concentrations of 0.020*), 0.047**), 0.113***), 0,39, and 0.90 mg/L.
*) instead of 0.03mg/L planned for geom. series (separation factor 2.3) modification due to calculation error
**) instead of 0.07mg/L planned for geom. series (separation factor 2.3) modification due to calculation error
***) instead of 0.17mg/L planned for geom. series (separation factor 2.3) modification due to calculation error
The modified concentration steps did not affect either the results of the test or the integrity of the study.
Sampling method:
The application method was performed according to the OECD guideline 211.
All treatments are renewed daily in order to assure that the animals were exposed to the test item at almost the same concentrations.
Preparation of a stock solution by using dilution water. The stock solutions with the macronutrients were individually prepared in ultrapure water (for each salt a separate solution). From these individual stock solution, the test solution was prepared using algal-supension, stock solution, and Elendt M4 medium in specific amounts to a total of 1500ml.
Sample storage conditions before analysis:
As the supporting analyse could not be performed on the same day the collection of the specimens. Therefore the specimen to be analysed were deep-frozen stored in glass flasks until the day of the analyses. Specimens were colected from freshly prepared test solutions and from those incubated with the daphnia for 24hr. Within the study, three pairs of specimens (freshly prepared and 24hr incubated) were analysed for each concentration.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation and solution of the test item
- The stock solution of the test item was prepared by solving the test item (10mg in 2000ml)
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test Organism
Daphnia magna STRAUS (clone 5)
Laboratory bred (derived from Dr. M. Bergtold, BASF, D-67117 Limburgerhof; the strain originally derived from the Institut National de Recherche Chimique Appliquee, France in 1978 and cultivated since then at BASF using medium M4 acc. Elendt)
The cultivation of the daphnia is performed in a way that the animals are transferred in new test medium (see below) at an interval of 1 to 3 days followed by feeding with Desmodesmus subspicatus- and/or Chlorella-cells. Daphnia used for the test are not older than 24 h. Therefore, in every case, daphnia are transferred into fresh medium one day before starting of the daphnia test in order to get daphnia for the test younger than 24 h.
Acclimation
The daphnia (parent animals) are held in the test medium (M4 according Elendt) and thus had not to be adapted to that standard medium.
The animals were fed daily with unicellular cells of Desmodesmus subspicatus.
The amount of the algae was calculated to refer to a content of 0.1-0.2 mg C / Daphnia (corresponding to 1-2 mg C/L).
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- no observation
Test conditions
- Hardness:
- see 8.3.1.1 ff
- Test temperature:
- see table 7
- pH:
- see table 7
- Dissolved oxygen:
- see table 7
- Nominal and measured concentrations:
- see table 8
- Details on test conditions:
- The objective of the test was to assess the effect of the test item on the reproductive output of Daphnia magna. For this purpose, young female Daphnia (the parent animals), aged less than 24 h at the start of the test, were exposed to 5 concentrations of the test item added to the test medium. The test duration was 21 days. At the end of the test, the total number of living offspring produced per parent animal alive at the end was assessed. This means, that juveniles produced by adults that died during the test were excluded from the calculations. The reproductive output of the animals exposed to the test item was compared to that of the control in order to determine the lowest observed effect concentration (LOEC) and hence the no observed effect concentration (NOEC). In addition, the EC10, EC20 and EC50 were calculated. Besides that, the survival of the parent animals and time to production of the first brood are reported. Furthermore, the size of the daphnia at the end of the test was determined in order to investigate side-effects on growth.
Daphnia magna STRAUS (clone 5) of laboratory bred (derived from Dr. M. Bergtold, BASF, D-67117 Limburgerhof; the strain originally derived from the Institut National de Recherche Chimique Appliquee, France in 1978 and cultivated since then at BASF using medium M4 acc. Elendt) were used for the test. In order to verify the sensitivity of the test system towards toxic items the effect of potassium dichromate towards different animals of this bred was tested prior to beginning of the test. The value of the EC50 (24 h) in this period of time was 1.06 mg/L potassium dichromate. This value is in accordance with the recommendations given in OECD Guideline 202 (Daphnia sp., Acute Immobilisation Test).
The cultivation of the daphnia is performed in a way that the animals are transferred in new test medium (see below) at an interval of 1 to 3 days followed by feeding with Desmodesmus subspicatus- and/or Chlorella-cells. Daphnia used for the test are not older than 24 h. Therefore, in every case, daphnia are transferred into fresh medium one day before starting of the daphnia test in order to get daphnia for the test younger than 24 h.
The daphnia (parent animals) are held in the test medium (M4 according Elendt) and thus had not to be adapted to that standard medium. At the beginning of the test, the new born daphnia being not older than 24 h were transferred individually into the different test vessels (beakers) containing approximately 90 mL of the treatments (one animal each vessel). The test item was introduced as a stock solution prepared in the medium according Elendt M4. The concentration range was fixed together with the Sponsor considering two acute daphnia toxicity tests with EC50 values (acute) being in the range of 5-9 mg/L. The following nominal concentrations were applied in the main test: 0.0 mg/L (control), of 0.020, 0.047, 0.113, 0.39, and 0.90 mg/L. For each concentration, 13 parallels were prepared. The animals were fed with unicellular cells of Desmodesmus subspicatus. The amount of the algae was calculated to refer to a content of 0.1-0.2 mg C / Daphnia (corresponding to 1-2 mg C/L). The test was performed semistatically; this means that the daphnia were transferred into freshly prepared treatments every day. As supporting analyses, pH and oxygen content of the test solutions were measured in the freshly prepared test solutions and in those being incubated for a period of 24 h. The incubation took place in beakers filled with 90 mL of the treatments, respectively. All values were documented in data sheets.The test duration was 21 days. The temperature range in the test room was shown to be at 20.1 – 23.1 °C but temperatures in thetreatments measured were in the range of 20.0 – 22.0. There was a day-night-period of 16hr/8hr. With the exception of one lamp, all lamps were switched off in the test room after daily manipulation in order to get a low light intensity. The mean light intensity in the test room was between 0.56 and 0.66 µmol*m2*s-1 (0.56 - 0.66 klx) corresponding to ≈ 9-10 µE/m2s (measured before and after the test period), and thus in accordance with OECD 211 not exceeding 15 - 20 µE/m2s. Daily the test solutions were investigated for appearance of offspring animals, and the numbers were recorded. The newborn offspring animals were eliminated daily from the treatments. For this purpose, the whole contents of test vessels were transferred into a large glass-petri dish which facilitated the manipulation. The daphnia could then be easily picked up and transferred into the new prepared test solutions, and newborne offspring daphnia could be counted.
During the study, the numbers of living offspring animals were determined with each parent animal, and the numbers from each concentration were set into relation with those of the control without any test item. The aim of the test is to determine the so-called LOEC („Lowest Observed Effect Concentration“), and the NOEC („No Observed Effect Concentration”). Additionally the EC10, EC20 and EC50 should be determined.
At the end of the test, the size of the parent daphnia was measured using a binocular microscope equipped with a digital camera. Using scales below the daphnia, the diameters of all daphnia of each the control and the treatments with the test item were determined. This parameter is used as an additional growth parameter for the evaluation of the toxicity effect. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.39 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: not apllicable
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.379 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: not applicable
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: not applicable
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.84 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: not applicable
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.604 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: (95% confidence level) - 0.604-0.604
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.574 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: (95% confidence level) - not given due to mathematical reasons
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 0.718 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: (95% confidence level) - 0.718 - 0.719
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 0.678 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: (95% confidence level) - not given due to mathematical reasons
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 1.001 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: (95% confidence level) - 1.001-1.001
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 0.93 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: (95% confidence level) - not given due to mathematical reasons
- Details on results:
- Mortality of parent animals after 7, 14, and 21 days:
see table 3 (report)
Number of offspring produced per day per female from day 9 to 21:
see table 6 (report)
Body length and weight of parent animals:
see tables 10.3ff (report) Additional Size-Measurements of the Daphnia after Incubation
Type and number of morphological abnormalities:
no abnormalties discovered
Type and number of behavioural abnormalities:
no abnormalties discovered
Number of females (parental):
72 femal animals for all groups (1 group 6 animals was arithmetically eliminated)
Time to first brood release or time to hatch
Control: 11.5 (day/mean)
Nominal concentration (0.02) : 10.8 (day/mean)
Nominal concentration (0.047): 11.0 (day/mean)
Nominal concentration (0.113): 10.7 (day/mean)
Nominal concentration (0.390): 10.8 (day/mean)
Nominal concentration (0.900): 13.4 (day/mean)
No relevant biochemical changes or biological observations - Results with reference substance (positive control):
- no reference substance used
- Reported statistics and error estimates:
- Parameters analysed:
- Mean cumulative offspring per survivor in daphnia magna
- Mobility
- Age of first reproduction
- Intrinsic rate
Statistical methods:
- Probit analysis (ToxRatPro version 2.10)
Probit slopes:
See tables 6 / 15 / 26 in apendices report for parameters of the probit analysis
Error estimates (confidence interval 95%)
Any other information on results incl. tables
Report
Table 3: Mortality [%] of the Adult Daphnids after 7, 14 and 21 Days of Exposure (n = 12)
Nominal Concentration |
Mortality [%] |
||
7 days |
14 days |
21 days |
|
0.020 |
0 |
0 |
0 |
0.047 |
0 |
0 |
1 |
0.113 |
0 |
0 |
2 |
0.390 |
0 |
0 |
0 |
0.900 |
1 |
4 |
5 |
Control |
0 |
0 |
0 |
EC50 adult mortality |
>0.9 mg/L |
Table 6: Detailed Results on Reproduction and Mortalities
Nominal Concentration:0 (Control) |
|
|||||||||||||
Day1) |
|
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
|
Vessel No. |
No. of offspring Animals |
Total alive |
||||||||||||
1 |
|
0 |
9 |
0 |
0 |
20 |
0 |
30 |
0 |
0 |
23 |
0 |
0 |
82 |
2 |
|
0 |
8 |
0 |
0 |
18 |
0 |
0 |
29 |
0 |
0 |
23 |
0 |
76 |
3 |
|
0 |
6 |
0 |
19 |
0 |
0 |
26 |
0 |
0 |
23 |
0 |
0 |
74 |
4 |
|
0 |
5 |
0 |
7 |
10 |
0 |
27 |
1 |
0 |
26 |
0 |
0 |
76 |
5 |
|
0 |
8 |
0 |
15 |
8 |
0 |
28 |
2 |
0 |
0 |
16 |
0 |
(77)*) |
6 |
|
0 |
9 |
0 |
0 |
21 |
0 |
0 |
27 |
1 |
0 |
26 |
0 |
84 |
7 |
|
0 |
6 |
0 |
0 |
19 |
0 |
0 |
29 |
0 |
0 |
23 |
0 |
77 |
8 |
|
0 |
8 |
0 |
24 |
0 |
0 |
32 |
0 |
0 |
12 |
11 |
0 |
87 |
9 |
|
0 |
9 |
0 |
0 |
19 |
0 |
0 |
28 |
0 |
0 |
22 |
0 |
78 |
10 |
|
0 |
6 |
0 |
0 |
18 |
0 |
0 |
33 |
0 |
0 |
30 |
0 |
87 |
11 |
|
0 |
0 |
12 |
0 |
0 |
22 |
0 |
0 |
25 |
0 |
0 |
20 |
79 |
12 |
|
0 |
7 |
0 |
0 |
18 |
0 |
0 |
27 |
0 |
0 |
22 |
0 |
74 |
13 |
|
12 |
0 |
0 |
18 |
0 |
0 |
26 |
1 |
0 |
19 |
0 |
0 |
76 |
Dead parent animal |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
1)Day 1-9 no offspring animals were observed
*)Results
with animal No. 5 was statistically eliminated as one animal had been
killed upon manipulation during the test within concentration step 0.02
mg/L representing immobilisation not due to effects of the test item.
Therefore, automatic routine analysis was not possible without special
measures. For this reason, using the random generator in EXCEL,
following twelve vessels were chosen for routine statistical analysis
with the ToxRat Program: No. 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, and
for all other test concentrations, also 12 animals are used for
statistical evaluation.
Other concentrations and tables (0.020 mg/L; 0.047 mg/L ; 0.113 mg/L; 0.39 mg/L; 0.900mg/L) to be found in the attached report.
10.3.1 Body Length
Replicate No. |
Nominal Concentration (mg/L) |
|||||
Control |
0.020 |
0.047 |
0.113 |
0.39 |
0.90 |
|
1 |
4.27 |
--*) |
4.58 |
4.53 |
4.12 |
3.74 |
2 |
4.12 |
4.17 |
4.22 |
4.40 |
4.45 |
3.92 |
3 |
4.12 |
4.19 |
4.40 |
4.25 |
4.12 |
3.97 |
4 |
4.12 |
4.45 |
4.25 |
M |
4.45 |
3.51 |
5 |
--*) |
4.40 |
M |
4.14 |
4.19 |
M |
6 |
4.47 |
4.45 |
4.45 |
4.53 |
4.55 |
M |
7 |
4.14 |
4.22 |
4.12 |
4.53 |
4.45 |
3.94 |
8 |
4.50 |
4.58 |
4.53 |
4.53 |
--*) |
4.02 |
9 |
4.47 |
4.22 |
4.25 |
M |
4.22 |
3.94 |
10 |
4.12 |
4.27 |
--*) |
4.12 |
4.25 |
3.84 |
11 |
4.42 |
4.30 |
4.17 |
4.32 |
4.07 |
--*) |
12 |
4.04 |
4.60 |
4.32 |
--*) |
4.45 |
M |
13 |
4.45 |
4.22 |
4.40 |
4.42 |
4.09 |
M |
No. of Replicates |
12 |
12 |
11 |
10 |
12 |
8 |
Mean |
4.27 |
4.34 |
4.34 |
4.38 |
4.28 |
3.86 |
Std.Dev |
0.18 |
0.15 |
0.15 |
0.16 |
0.17 |
0.17 |
CV% |
4.2 |
3.5 |
3.4 |
3.7 |
4.1 |
4.3 |
10.3.2 Body Width
Replicate No. |
Nominal Concentration (mg/L) |
|||||
Control |
0.020 |
0.047 |
0.113 |
0.39 |
0.90 |
|
1 |
2.80 |
--*) |
2.77 |
2.75 |
2.62 |
2.52 |
2 |
2.54 |
2.67 |
2.80 |
2.72 |
2.72 |
2.44 |
3 |
2.67 |
2.72 |
2.85 |
2.75 |
2.67 |
2.54 |
4 |
2.72 |
2.69 |
2.75 |
M |
2.69 |
2.34 |
5 |
--*) |
2.80 |
M |
2.62 |
2.72 |
M |
6 |
2.72 |
2.82 |
2.77 |
2.77 |
2.77 |
M |
7 |
2.69 |
2.64 |
2.75 |
2.67 |
2.72 |
2.34 |
8 |
2.75 |
2.75 |
2.77 |
2.77 |
--*) |
2.44 |
9 |
2.72 |
2.62 |
2.82 |
M |
2.54 |
2.42 |
10 |
2.75 |
2.72 |
--*) |
2.75 |
2.67 |
2.42 |
11 |
2.69 |
2.77 |
2.69 |
2.69 |
2.62 |
--*) |
12 |
2.72 |
2.75 |
2.64 |
--*) |
2.67 |
M |
13 |
2.69 |
2.64 |
2.67 |
2.75 |
2.59 |
M |
No. of Replicates |
12 |
12 |
11 |
10 |
12 |
8 |
Mean |
2.71 |
2.72 |
2.75 |
2.72 |
2.67 |
2.43 |
Std.Dev |
0.06 |
0.07 |
0.06 |
0.05 |
0.06 |
0.07 |
CV% |
2.3 |
2.4 |
2.3 |
1.8 |
2.4 |
3.0 |
--*)Replicate was statistically excluded from statistical treatments as one animal had been killed upon manipulation during the test within concentration step 0.02 mg/L representing immobilisation not due to effects of the test item. Therefore, automatic routine analysis was not possible without special measures. For this reason, using the random generator in EXCEL, the indicated twelve vessels were chosen for routine statistical analysis with the ToxRat Program.
Measured Concentration (Appendix)
Parameters of the probit analysis (Offspring per survivor)
Tab. 6: Parameters of the probit analysis: Results of the regression analysis
Parameter Value
Computation runs: 9
Slope b: 6,12452
Intercept a: 0,19324
Variance of b: 2.543,09619
Goodness of Fit
Chi²: 0,00000
Degrees of freedom: 3
p(Chi²): n.d.
Log EC50: -0,03155
SE Log EC50: 0,41021
g-Criterion: 0,00000
Residual Variance (Chi²/df): 0,00000
r²: 1,000
F: -5279104,000
p(F) (df: 1;3): n.d.
Chi² is a goodness of fit measure. If the probability, p(Chi²), is lower or equal than 0,100, data is much scattering round the computed dose/response function. In this case and with quantal data, confidence limits are corrected for heterogeneity (= are made wider; so, check whether these results are reasonable!). The coefficient of determination, r² (0 <= r² <= 1), gives the proportion of variance explained by the dose/response function.F-Test for regression: Ho: Slope = 0; hence, if p(F) <= alpha, the selected significance level, (e.g., alpha = 0.05) the regression revealed significant results (= slope is significantly different from zero).
Parameters of the probit analysis (Mobility)
Tab. 15: Parameters of the probit analysis: Results of the regression analysis
Parameter Value
Computation runs: 6
Slope b: 0,69515
Intercept a: -0,65965
Variance of b: 0,15630
Goodness of Fit
Chi²: 4,74704
Degrees of freedom: 3
p(Chi²): 0,19129
Log EC50: 0,94894
SE Log EC50: 0,98073
g-Criterion: 1,24255
F: 1,954
p(F) (df: 1;3): 0,257
Chi² is a goodness of fit measure. If the probability, p(Chi²), is lower or equal than 0,100, data is much scattering round the computed dose/response function. In this case and with quantal data, confidence limits are corrected for heterogeneity (= are made wider; so, check whether these results are reasonable!).
No meaningful concentration/response was found (p(F) > 0.05; i.e. slope of the relationship is not significant different from zero).
Due to the lacking concentration/response the shown ECx are not valid.
Parameters of the probit analysis (Age at first reproduction)
Tab. 26: Parameters of the probit analysis: Results of the regression analysis
Parameter Value
Computation runs: 13
Slope b: 11,86428
Intercept a: 0,30479
Variance of b: 1.704.233.984,00000
Goodness of Fit
Chi²: 0,00000
Degrees of freedom: 3
p(Chi²): 1,00000
Log EC50: -0,02569
SE Log EC50: 174,08523
g-Criterion: 0,65302
Residual Variance (Chi²/df): 0,00000
r²: 0,838
F: 15,505
p(F) (df: 1;3): 0,029
Chi² is a goodness of fit measure. If the probability, p(Chi²), is lower or equal than 0,100, data is much scattering round the computed dose/response function. In this case and with quantal data, confidence limits are corrected for heterogeneity (= are made wider; so, check whether these results are reasonable!). The coefficient of determination, r² (0 <= r² <= 1), gives the proportion of variance explained by the dose/response function.F-Test for regression: Ho: Slope = 0; hence, if p(F) <= alpha, the selected significance level, (e.g., alpha = 0.05) the regression revealed significant results (= slope is significantly different from zero).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- see executive summary
- Executive summary:
Product LE 097 was tested for its effects on the reproductive output of Daphnia magna according to OECD-Test Guideline 211. For this purpose, young female Daphnia (the parent animals) aged less than 24h at the start of the test were exposed to the test item at five concentrations. The test duration was 21 days. Within that time cumulative living offspring produced per parent animal was recorded for each concentration. The reproductive output of the animals exposed to the different concentrations of the test item was compared to that of the controls in order to determine the lowest observed effect concentration (LOEC) and the no observed effect concentration of the test item (NOEC). Besides these two parameters, the EC10, EC20and EC50were calculated. The following effect concentrations were found:
Mean Cumulative Offspring of Survivors
Basis: Nominal Concentrations
Basis: Measured Concentrations
NOEC
LOEC
EC10
EC20
EC50
=
=
=
=
=
0.390 mg/L
0.900 mg/L
0.604 mg/L
0.718 mg/L
1.001 mg/L
(0.604 - 0.604)1)
(0.718 - 0.719)1)
(1.001 - 1.001)1)
=
=
=
=
=
0.379 mg/L
0.840 mg/L
0.574 mg/L
0.678 mg/L
0.930 mg/L
[n.d.1)]2)
[n.d.1)]2)
[n.d.1)]2)
Age of first Reproduction
Basis: Nominal Concentrations
Basis: Measured Concentrations
NOEC
LOEC
=
=
0.390 mg/L
0.900 mg/L
=
=
0.379 mg/L
0.840 mg/L
Intrinsic Rate
NOEC
LOEC
EC10
EC20
EC50
=
=
=
=
=
0.390 mg/L
0.900 mg/L
0.783 mg/L
0.856 mg/L
1.015 mg/L
[(n.d.)1)]2)
[(n.d.)1)]2)
[(n.d.)1)]2)
=
=
=
=
=
0.379 mg/L
0.840 mg/L
0.735 mg/L
0.801 mg/L
0.943 mg/L
(0.419 - 0.780)1)
(0.654 - 0.818)1)
(0.895 - 1.531)1)
Mobility / Mortality
Basis: Nominal Concentrations
Basis: Measured Concentrations
NOEC
LOEC
EC10
EC20
EC50
≥
>
=
=
=
0.900 mg/L
0.900 mg/L 0.139 mg/L
0.563 mg/L
n.d.2)
[(n.d.)1)]2)
[(n.d.)1)]2)
(>0.9 mg/L)
≥
>
=
=
=
0.840 mg/L
0.840 mg/L
0.127 mg/L
0.547 mg/L
n.d.2)
[(n.d.)1)]2)
[(n.d.)1)]2)
(>0.840 mg/L)
1)Numbers in brackets indicate the lower and upper confidence limits at the 95% confidence level.
2)No values are given due to mathematical reasons.
Concerning “mobility/mortality” statistical calculations have to be regarded as follows: at the nominal concentration step 0.9 mg/L, 5 animals were immobilized. At the concentration step lower (0.39 mg/L) there wasnomortality, and therefore the immobilization at the lower concentrations than 0.39 mg/L are not considered as such (EC10and EC20values are calculated by the computer program – but these are obviously extrapolated values calculated from probit analyses and are not considered significant). Therefore, NOEC for “mobility / mortality” was considered to be 0.84 mg/L (basis: measured concentration).
Test item related effects were found for the additional endpoint size length and width of animals: There is statistical evidence between the control and the test item. A NOEC of 0.390 mg/L (nominal concentration) was calculated for body length as well as for the body width. The LOEC was recogniced as being 0.9 mg/L (nominal concentration) for both parameters body length and body width. EC50for body length was calculated to be 1.28 mg/L (nominal concentration) and >1.34 mg/L for body width (nominal concentration).
Within chemical analyses performed with the test solutions at the start of incubation (three times during the test) and after 24 hr, respectively, it could be shown that the test item remained always stable at the requested level of ≥ 80% in the aqueous phase.Nevertheless,the measured concentrations of Product LE 097 within the treatments deviated partially more than 20 % from the nominal values.For this reason, the results of this test should be based on the measured concentrations tested.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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