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EC number: 431-480-3 | 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:
- 27 May 2019 - 15 Aug 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 23: Guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals
- Version / remarks:
- Feb 2019
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- UPLC-FLR
- Details on sampling:
- Samples for analysis were taken from all test concentrations and the controls and stock solutions.
Sampling:
Frequency One day before the start of exposure to check the functioning of the system. At the start, after 7, 14 and 21 days of exposure.
Volume: 2.0 mL
Storage: If not analysed on the day of sampling samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
Additionally, reserve samples of 2.0 mL were taken from test solutions, controls and stocks for possible analysis. If not already used, these samples were stored in a freezer (≤-15°C) for this a maximum of three months after delivery of the draft report, pending the decision of the sponsor for additional analysis.
Test solutions
- Vehicle:
- yes
- Remarks:
- DMSO
- Details on test solutions:
- The batch of test subsatnce tested was a slightly yellow powder with a purity of 98%.
No correction was made for the purity/composition of the test substance.
Stock solutions were prepared in Dimethyl sulfoxide (DMSO, Merck, Darmstadt, Germany) at a concentration of 100 mg/L.
No other treatment than vigorous shaking was needed in order to completely dissolve the test item in solvent.
Due to the possible photosensitivity of the test item, preparation of test solutions during the reproduction test was performed under dimmed light conditions and amber glassware was used in the reproduction test.
Any residual volumes were discarded.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna (Crustacea, Cladocera) (Straus,1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Reason for selection This system has been selected as an internationally accepted invertebrate species.
Validity of batch Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: To initiate the test, young daphnids < 24 hours bold were selected, from parental daphnids greater than two weeks old.
Breeding
Start of each batch: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
Maximum age of the cultures: 4 weeks
Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
Temperature of medium: 18-22°C
Feeding: Daily, a suspension of fresh water algae
Validity of the cultures: Historical data on the reproductive capacity are based on the numbers of living young counted three times a week in the individual cultures and tested to meet the validity criteria for survival and reproduction.
Medium: M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Remarks on exposure duration:
- As per the test guideline.
- Post exposure observation period:
- No post exposure observation period specified in the study report.
Test conditions
- Hardness:
- 180 mg/L expressed as CaCO3 and the pH between 6 and 9. Total hardness complied with the requirements as laid down in the study plan (>140 mg CaCO3 per liter).
Hardness (mg CaCO3) range: 179-196 - Test temperature:
- The temperatures generally complied with the requirements as laid down in the study plan (18-22°C, constant within 2°C). The temperature measured in control vessel slightly exceeded the range (max. 23°C)
Temperature measured continuously in control vessel (°C) range: 20-23 - pH:
- The pH was maintained within the limits prescribed by the study plan (6.0-9.0, constant within 1.5 units).
pH range: 7.9-8.1 - Dissolved oxygen:
- The oxygen concentration complied with the requirements as laid down in the study plan (> 3 mg/L).
Dissolved oxygen concentration (mg O2/L) range: 8.3-9.2 - Salinity:
- not specified
- Conductivity:
- not specified
- Nominal and measured concentrations:
- Measured Concentrations: The concentration measured at the start of the test was 10 μg/L. Concentrations measured at weekly intervals decreased with the time of exposure (i.e. were 8.1, 6.5 and 6.6 μg/L at day 7, 14 and 21 of the exposure, respectively). This decrease can be associated with the growth of daphnids, presence of offspring in test medium and accumulation of the algal biomass.
The average exposure concentration was calculated to be 7.8 μg/L which is 78% of the target concentration. All measured concentrations were above the water solubility limit of the test item as determined in Test Facility Study No. 20218324. This was because of the DMSO used in the stock treatment solutions, which would increase the solubility of the test substance relative to pure water solution. - Details on test conditions:
- Test item: 10 μg/L1
Controls: Test medium without test item or other additives (blank control) and one control containing test medium with the additives used in the treatment of the stock solutions (solvent control).
Test Procedure and Conditions
Test duration: 21 days
Test type: Flow-through, with continuous renewal of test media
Test vessels: Stainless steel with a medium volume of 1.7 L containing four mesh containers. Covered with a Perspex plate.
Medium: M7
Experimental design:
At the start of the experiment (nominal day 0) twenty neonate daphnids, less than one day old, per group were divided over four stainless steel mesh containers (five daphnids per mesh).
Light: 16 h photoperiod daily, with intensity ~400 lux.
Feeding: Daily, a quantity of a Chlorella sp. suspension3 is added as feed for the daphnids providing a ration of ca. 0.4 mg C/daphnid/day.
Sampling for Analysis of Test Concentrations
Samples for analysis were taken from all test concentrations and the controls and stock solutions. The method of analysis is described in the appended Analytical Report
Sampling:
Frequency: One day before the start of exposure to check the functioning of the system. At the start, after 7, 14 and 21 days of exposure.
Volume: 2.0 mL
Storage: If not analysed on the day of sampling samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
Additionally, reserve samples of 2.0 mL were taken from test solutions, controls and stocks for possible analysis. If not already used, these samples were stored in a freezer (≤-15°C) for a maximum of three months after delivery of the draft report, pending the decision of the sponsor for additional analysis.
Measurements and Recordings
Parental daphnids
Condition: Every day, the number of living, immobile and dead parental daphnids was recorded. Dead daphnids were removed when observed.
Presence of eggs in the brood pouch: Every day.
Body length: At the end of the test.
Offspring
Appearance first brood: When observed.
Newborn daphnids: Every day, the number of new-born young was counted and the condition of the young recorded. Thereafter the young were removed.
Presence of unhatched eggs When observed.
Incidence of immobility: When observed.
Test medium
Temperature and pH: Once a week in all test solutions. Additionally, the temperature was continuously monitored in a temperature-control vessel.
Dissolved oxygen: Twice a week
Hardness: Once a week in both control groups and the highest test concentration.
Light: At the start and the end of the test.
INTERPRETATION
Acceptability of the Test
The mortality of the parent animals (female Daphnia) in the control did not exceed 20% at the end of the test.
The average cumulative number of young per female in the controls after 21 days was ≥ 60.
Data Handling
All results presented in the tables of the report are calculated using values as per the raw data rounding procedure and may not be exactly reproduced from the individual data presented.
The values for reproduction observed at various concentrations of the test item were expressed as mean number of living young per introduced parent4. The cumulative values for reproduction at each concentration were compared to those recorded in the control (day 21 of exposure). Further, the lengths of the parental daphnids (day 21) exposed to the test item were compared with the control.
ANALYSIS
Exposure concentrations: The exposure concentrations were calculated as an arithmetic mean of all values.
Statistical analysis: Differences between control treatments were analysed with Student t-test for homogenous variances.
As there was a significant difference in reproduction between both control treatments, the comparison of reproduction in the limit concentration was done with the solvent control. For consistency, all other comparisons were performed with solvent control.
The following statistical procedures were used to determine the NOEC for reproduction and
growth:
• Data distribution: Shapiro-Wilk´s Test
• Homogeneity of variance: Levene´s Test (with Residuals)
• Differences between treatments and the control: Two-sample t-test procedure.
Mortality of parental daphnids:
• Both the differences between control treatments and the difference between limit concentration and control were analysed with Fisher`s Exact Binomial Test.
All analyses were performed with ToxRat Professional 3.2.1 (ToxRat Solutions® GmbH,Germany). - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 7.8 µg/L
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 7.8 µg/L
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 7.8 µg/L
- Basis for effect:
- growth
- Details on results:
- Stability test
The concentration measured in freshly prepared solution was higher than the target concentration, i.e. was 14 instead of 10 μg/L. The measured concentrations in both vessels (with daphnia and algae (biotic) and without organisms (abiotic)) decreased significantly in time. The decrease in abiotic vessel was stronger than in the biotic vessel. The exact reason is unknown but possibly, some portion of light was absorbed by algae in the biotic vessel providing shielding for the test item. As the test item is possibly sensitive to light it was decided to keep light intensity as low as possible during the reproduction test.
As a decrease of 56-67% was observed after the first 24 hour of incubation, it was decided to perform the reproduction test under flow-through instead of semi-static conditions.
Reproduction Test
Measured Concentrations
The concentration measured at the start of the test was 10 μg/L. Concentrations measured at weekly intervals decreased with the time of exposure (i.e. were 8.1, 6.5 and 6.6 μg/L at day 7, 14 and 21 of the exposure, respectively). This decrease can be associated with the growth of daphnids, presence of offspring in test medium and accumulation of the algal biomass.
The average exposure concentration was calculated to be 7.8 μg/L which is 78% of the target concentration. All measured concentrations were above the water solubility limit of the test item as determined in Test Facility Study No. 20218324. This was because of the DMSO used in the stock treatment solutions, which would increase the solubility of test item relative to pure water solution.
Time to First Reproduction
First offspring were observed in all groups at day 7, therefore, the test item did not affect the onset of reproduction
Reproduction
On average 175 offspring were produced per parental daphnid in the blank and 136 in then solvent control. Hence, the validity criterion of at least 60 offspring per parental daphnid was
met. As the difference in reproduction between the blank and solvent control was statistically significant, the latter was used for statistical analysis of effects in the test item treated group.
A stimulation of reproduction was observed in the test item treated group when compared with solvent treatment (14% increase5). As only a reduction of reproduction is considered a relevant effect, the NOEC for reproduction was 7.8 μg/L
Six immobile offspring were observed in the blank control treatment, while none were recorded in the solvent control or in the test item treated group. Five aborted eggs were observed in the test item treated group.
Body Length
No statistically significant differences were found between controls. For consistency, the effect in the limit group was compared to the solvent control; no statistically significant effects were found . Therefore, the NOEC for growth was 7.8 μg/L.
In each of the control treatments 2 of the 20 exposed daphnids did not survive exposure, hence the mortality of parental daphnids did not exceed 20% and complied with the validity criteria of the study.
At day 1 of exposure, 5 daphnids were observed to be trapped at the surface of test solution in the limit concentration (3 in replicate B and 2 in replicate D). These daphnids were subsequently submerged in test solution. On the following day, one daphnid was still observed to float at the surface (replicate B) and was scored as immobile. Next day (day 3) one daphnid in this replicate was observed to be dead. It was considered the same daphnid as the immobilised one on day 2 and therefore, its mortality was counted as occurred on day 2.
The mortality observed at day 2 of exposure was considered insignificant (i.e. <20%).
Further, mortality increased to 10, 20, 25, 30, 45 and 50% at day 10, 12, 14, 18, 19 and 20 of exposure, respectively. The reason for the observed effect is unknown and it is considered as an inadvertent mortality. F
Discussion
During a chronic study, reproduction and growth are considered to be the most sensitive endpoints. Reproduction, when calculated as a number of offspring per introduced parent, was stimulated rather than inhibited by the presence of the test item in this study. Also, no negative effect on growth of exposed daphnids was observed. However, unexpectedly high mortality rate was observed in the limit concentration. The exact reason is unknown, however, it is believed not to be caused by toxicity of the test item, because: 1) no toxic effects were observed with respect to the typically more sensitive parameters growth and reproduction, and 2) a separate acute test of Daphnia toxicity showed no mortality at the maximum water solubility concentration (loading concentration of 100 mg/L). It is possible that observed mortality was caused by mechanical effect, i.e. by undissolved test material blocking filtering apparatus of the exposed daphnids. Although there is no direct proof for
this speculation, it can be supported by the fact that a number of daphnids exposed to the test item treated solution were trapped at the surface of the test solution at the start of the test.
Therefore, the observed mortality is considered inadvertent. For this reason the NOEC for survival cannot be set based on results obtained in this study.
Experimental Conditions
The individual results are presented in:
• pH: The pH was maintained within the limits prescribed by the study plan (6.0-9.0, constant within 1.5 units).
• Dissolved oxygen concentrations: The oxygen concentration complied with the requirements as laid down in the study plan (> 3 mg/L).
• Temperature: The temperatures generally complied with the requirements as laid down in the study plan (18-22°C, constant within 2°C). The temperature measured in control vessel slightly exceeded the range (max. 23°C, .
• Total hardness: Total hardness complied with the requirements as laid down in the study plan (>140 mg CaCO3 per liter).
• The concentration of TOC in sample taken from the M7-medium was below the detection limit of the device and as such complied with the value recommended by the guideline (i.e. <2 mg TOC/L).
• The light intensity during the 16-hour daily light period was close to 400 lux, as prescribed by the study plan.
During a chronic study, reproduction and growth are considered to be the most sensitive endpoints. Reproduction, when calculated as a number of offspring per introduced parent,
was stimulated rather than inhibited by the presence of the test item in this study. Also, no - Results with reference substance (positive control):
- N/A
Any other information on results incl. tables
Group Mean Cumulative Number of Juveniles per Introduced Parent and Reduction of Reproduction at the End of the Test |
||||
Test item Average exposure conc. (μg/L) |
Mean | s | n | % Change1, 2 |
Blank control | 175.0 | 16.07 | 4 | |
Solvent control | 135.6 | 26.45 | 4 | |
7.8 | 154.9 | 31.34 | 4 | -14.3 |
1 Change in reproduction when compared to the solvent control | ||||
2 Negative numbers indicate a stimulation |
Group Mean Body Lengths (mm) and Reduction of Growth of Parental Daphnids at the End of the Test |
||||
Test item Average exposure conc. (μg/L) |
Mean | s | n | % Change1, 2 |
Blank control | 4.07 | 0.120 | 18 | |
Solvent control | 4.01 | 0.053 | 18 | |
7.8 | 4.09 | 0.093 | 10 | -2,1 |
1 Change in length when compared to the solvent control | ||||
2 Negative numbers indicate a stimulation |
Exposure parameters | |
Condition | Range |
pH | 7.9-8.1 |
Dissolved oxygen concentration (mg O2/L) | 8.3-9.2 |
Temperature measured in test vessels (°C) | 20-21 |
Temperature measured continuously in control vessel (°C) | 20-231 |
Hardness (mg CaCO3) | 179-196 |
Total Dissolved Organic Carbon content (mg/L) | n.d. |
Light intensity (Lux) | |
Start test | 412-415 |
End test | 400-404 |
n.d.: not detectable; concentration was below the detection limit of the method, 1 see study plan deviation in |
|
Effect Parameters | |
Parameter | Concentration (μg/L) |
NOEC for reproduction | 7.8 |
EC10 for reproduction | >7.8* |
NOEC for mortality | n.d. |
NOEC for growth | 7.8 |
* – 95% confidence intervals could not be given, n.d. – not determined |
Number of Living Newborn per Replicate per Day | ||||
Nominal | Replicate | Test item - Average exposure conc. (μg/L) | ||
day | Blank control | Solvent control | 7.8 | |
0 | A | 0 | 0 | 0 |
B | 0 | 0 | 0 | |
C | 0 | 0 | 0 | |
D | 0 | 0 | 0 | |
Mean | 0 | 0 | 0 | |
7* | A | 13 | 9 | 4 |
B | 28 | 24 | 15 | |
C | 26 | 18 | 27 | |
D | 19 | 5 | 19 | |
Mean | 22 | 14 | 16 | |
8 | A | 29 | 91 | 85 |
B | 42 | 64 | 60 | |
C | 28 | 59 | 41 | |
D | 18 | 78 | 30 | |
Mean | 29 | 73 | 54 | |
9 | A | 93 | 1 | 6 |
B | 41 | 10 | 29 | |
C | 42 | 1 | 3 | |
D | 0 | 11 | 41 | |
Mean | 44 | 6 | 20 | |
10 | A | 139 | 197 | 201 |
B | 191 | 202 | 115 | |
C | 184 | 206 | 149 | |
D | 223 | 199 | 157 | |
Mean | 184 | 201 | 156 | |
11 | A | 7 | 21 | 5 |
B | 12 | 17 | 56 | |
C | 10 | 19 | 12 | |
D | 9 | 12 | 82 | |
Mean | 10 | 17 | 39 | |
12 | A | 134 | 2 | 0 |
B | 45 | 2 | 88 | |
C | 97 | 0 | 0 | |
D | 59 | 0 | 22 | |
Mean | 84 | 1 | 28 | |
13 | A | 159 | 105 | 288 |
B | 147 | 169 | 142 | |
C | 157 | 49 | 160 | |
D | 108 | 52 | 186 | |
Mean | 143 | 94 | 194 | |
14 | A | 3 | 33 | 3 |
B | 6 | 1 | 47 | |
C | 1 | 18 | 4 | |
D | 14 | 32 | 4 | |
Mean | 6 | 21 | 15 | |
15 | A | 94 | 0 | 0 |
B | 34 | 1 | 58 | |
C | 58 | 0 | 9 | |
D | 31 | 2 | 74 | |
Mean | 54 | 1 | 35 | |
16 | A | 35 | 96 | 115 |
B | 66 | 118 | 47 | |
C | 56 | 32 | 51 | |
D | 84 | 68 | 24 | |
Mean | 60 | 79 | 59 | |
17 | A | 0 | 0 | 0 |
B | 0 | 2 | 25 | |
C | 0 | 11 | 0 | |
D | 0 | 59 | 0 | |
Mean | 0 | 18 | 6 | |
18 | A | 95 | 0 | 0 |
B | 29 | 27 | 80 | |
C | 74 | 6 | 19 | |
D | 71 | 4 | 61 | |
Mean | 67 | 9 | 40 | |
19 | A | 76, 3i | 171 | 167 |
B | 145 | 170 | 30 | |
C | 107 | 75 | 41 | |
D | 108 | 11 | 39, 5e | |
Mean | 109 | 132 | 69 | |
20 | A | 0, 2i | 0 | 3 |
B | 12 | 3 | 44 | |
C | 0 | 3 | 0 | |
D | 0 | 46 | 7 | |
Mean | 3 | 13 | 14 | |
21 | A | 84 | 0 | 1 |
B | 23 | 0 | 45 | |
C | 85 | 0 | 32 | |
D | 50, 1i | 1 | 46 | |
Mean | 61 | 0 | 31 | |
i – number of immobile offspring, e – number of aborted eggs | ||||
* - no reproduction was observed on days 1-6 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, under the conditions of the present study test item did not negatively affect reproduction and growth of Daphnia magna at an average exposure concentration of 7.8 μg/L after 21 days of exposure (NOEC).
- Executive summary:
The objective of the test was to evaluate the effects of test item on the mobility, the growth and the reproductive capacity of Daphnia magna. For this purpose, test organisms were exposed to aqueous solutions containing the test item at a nominal concentration of 10 μg/L. The time of the first production of young, the number of young born, immobility and other signs of intoxication observed were compared with corresponding parameters in the controls. A limit test was conducted due to the very low water solubility of test item. In addition, the nominal test concentration of 10 ug/L was selected because this was close to the previously determined water solubility limit of for test item of <8 ug/L. It should be noted that later on, the water solubility was determined to be <1.6 μg/L (Test Facility Study No. 20218324).
The study procedures described in this report were based on the OECD guideline for Testing of Chemicals: Guideline No. 211, 2012. In addition, the procedures were designed to meet the OECD guidance document number 23, 2019.
The batch of test item was a slight yellow powder with a purity of 98%. Weighing of test item and preparation of stock solutions was performed under dimmed light and stock solutions were kept in amber vessels as the test item possibly reacts with light. The test was performed in a flow-through system with target concentration of 10 μg/L. Stock solutions were prepared in Dimethyl sulfoxide (DMSO). A blank- and a solvent control were included.
The test was performed with four replicates per group, each replicate contained 5 daphnids. Exposure duration was 21 days. The condition of the parental daphnids was recorded daily.
During the reproduction phase the number of living offspring, immobile young and appearance of unhatched (aborted) eggs was recorded daily. At the end of the test the length of the surviving parental daphnids was measured. Light intensity was kept as low as possible during the exposure.
Samples for analysis of exposure concentrations were taken at the start of the test and weekly thereafter. The average exposure concentration was calculated to be 7.8 μg/L.
Mortality in each of the control treatments reached 10% at the end of the exposure, hence complied with the validity criteria of the study (i.e. was ≤20%). Mortality in the limit concentration reached 50% at the end of the test. The observed mortality was considered inadvertent because: 1) no toxic effects were observed with respect to the typically more sensitive parameters growth and reproduction, and 2) a separate acute test of Daphnia toxicity showed no mortality at the maximum water solubility concentration (loading concentration of 100 mg/L).
On average 175 offspring were produced in the blank and 136 in the solvent control. Hence, the validity criterion of at least 60 offspring per parental daphnid was met.
A stimulation of reproduction was observed in the test item treated group when compared with solvent treatment (14% increase). Therefore, the NOEC for reproduction was 7.8 μg/L.
The growth of surviving daphnids (measured as the total length) was not affected by the presence of test item. Therefore, the NOEC for growth was 7.8 μg/L.
Effect parameters (μg/L) obtained in this study are summarized in the table below.
Parameter Concentration (μg/L)
NOEC for reproduction 7.8
EC10 for reproduction >7.8*
NOEC for mortality n.d.
NOEC for growth 7.8
* – 95% confidence intervals could not be given, n.d. – not determined
In conclusion, under the conditions of the present study for the test item did not negatively affect reproduction and growth of Daphnia magna at an average exposure concentration of 7.8 μg/L after 21 days of exposure (NOEC).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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