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EC number: 606-790-9 | CAS number: 215247-95-3
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study according to OECD Guideline 211 and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Details on sampling:
- - Concentrations: 2.50 mg/L stock solution
No analytical determinations were carried out, because no chromatography compatible solvent is suitable for dissolving the test item in a defined and reproducible concentration - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution (2.50 mg/L test item was weighed out) was prepared with dilution water two days prior to application
- Eluate: Dilution water
- Controls: 10 replicates of dilution water without test item - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Clone 5
- Justification for species other than prescribed by test guideline: Daphnia magna STRAUS is recommended in the guideline
- Source: Own breeding (Origin: Institut fuer Wasser- Boden- und Lufthygiene)
- Age of parental stock (mean and range, SD): > 14 days
- Feeding during test
- Food type: Mix of Pseudokirchneriella subcapitata and Desmodesmus subspicatus
- Amount: 0.2 mg C/daphnia per day
- Frequency: daily
ACCLIMATION
- Acclimation period: 2 h in dilution water
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: During acclimation the daphnids were not fed
- Feeding frequency: None
- Health during acclimation (any mortality observed): Healthy
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: The parent animals were removed from the culture medium and the juveniles collected over a sieve and flushed into fresh medium - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Post exposure observation period:
- Not observed
- Hardness:
- Total Hardness [mg/L] as CaCO3
Nominal Loading
of the Test Item
[mg/L] I F I F I F
Day 0 Day 2 Day 7 Day 9 Day 14 Day 16
February 18th February 20th February 25th February 27th March 4th March 6th
2.50 182 164 176 174 166 173
Control 174 165 164 163 178 182 - Test temperature:
- Temperature [°C]
Nominal Loading
of the Test Item
[mg/L] I F I F I F
Day 0 Day 2 Day 7 Day 9 Day 14 Day 16
February 18th February 20th February 25th February 27th March 4th March 6th
2.50 21.5 20.5 21.7 21.8 21.4 21.1
Control 21.0 20.6 22.0 21.3 21.7 21.3 - pH:
- Nominal Loading
of the Test Item
[mg/L] I F I F I F
Day 0 Day 2 Day 7 Day 9 Day 14 Day 16
February 18th February 20th February 25th February 27th March 4th March 6th
2.50 7.63 7.94 7.82 7.96 7.36 7.48
Control 7.75 7.97 7.74 8.06 7.92 7.46 - Dissolved oxygen:
- Dissolved Oxygen Concentration [mg/L]
Nominal Loading
of the Test Item
[mg/L] I F I F I F
Day 0 Day 2 Day 7 Day 9 Day 14 Day 16
February 18th February 20th February 25th February 27th March 4th March 6th
2.50 8.09 9.76 8.30 8.81 7.71 8.25
Control 8.13 9.87 8.28 9.16 8.18 8.09 - Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- Nominal: 2.50 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: 100 mL glass beaker, filled with 50 mL test solution
- Aeration: No
- Renewal rate of test solution (frequency): 3 x per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4, according to ELENDT (1990), modified to a total hardness of > 140 mg CaCO3/L.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light : 8 h dark per day
- Light intensity: Max. 20 µE*m-2*s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Adult mortality: daily
- Number of juveniles: daily
- Stillborn juveniles and aborted eggs: daily
- Appearance of first brood
- Intrinsic rate of natural increase: test end
- Growth (total length and dry weight): test end
RANGE-FINDING STUDY
- Test concentrations: No range-finding study - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality of parent animals: All parent animals at the control group and the limit loading level survived until the end of the test. There was also no immobilization of the parent animals at the limit loading level and the control determined
- No. of offspring produced per day per female: The mean number of offspring alive produced per parent animal surviving at the end of the test was 106 juveniles at the control group and 102 juveniles at the limit loading level. The reduction of the reproductive output was calculated to be 4 %. There was no statistically significant reduction of the reproductive output (unpaired t-test, p = 0.05,
- Body length and weight of parent animals: please refer to the respective table
- Type and number of morphological abnormalities: No abnormalities
- Type and number of behavioural abnormalities: No abnormalities
- Time to first brood release or time to hatch: The first day of appearance of juveniles at the test and control group was day 8 - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: EC50 (24 h) = 1.53 (CI 1.43 - 1.65) - Reported statistics and error estimates:
- The NOEL and LOEL were determined directly from the results.
Significant deviations were determined in comparison to the control group using statistical standard procedures as Normality Test, Equal Variance Test, Analysis of Variance and t-test.
Unpaired t-test, p = 0.05 was used for the determination of significant deviations for the reproduction rates, the intrinsic rates of natural increase and the body length. Statistical evaluation of the age of first reproduction and the occurrence of stillborn juveniles and aborted eggs could not be carried out because normality test failed. The coefficients of variation around the mean number of living offspring produced per parent in the control group and the limit loading level were evaluated. - Validity criteria fulfilled:
- yes
- Conclusions:
- At the supersaturated solution of the test item with a nominal loading of 2.50 mg/L no significant effects were determined. The No Observed Effect Loading Level (NOEL) and the Lowest Observed Effect Loading Level (LOEL) were assessed at:
NOEL: 2.50 mg/L
LOEL: > 2.50 mg/L
All effect values are given based on the nominal loading level of 2.50 mg Pigment Violet 23/L of the supersaturated solution of the test item. - Executive summary:
The Daphnia magna Reproduction Test (Semi-Static, 21 d) of the test item(batch number: DEB 2060256) was conducted as a limit test with a supersaturated solution of the test item with the nominal loading of 2.50 mg/L according to OECD 211 (1998) from 2009-02-18 to 2009-03-11 at Dr.U.Noack-Laboratorien, Käthe-Paulus-Str. 1, D-31157 Sarstedt, Germany.
Test system was Daphnia magna STRAUS (Clone 5). 10 test organisms, individually held were used for the limit loading level and the control. At test start they were 2 to 24 hours old. The test method was semi-static. The test solutions were renewed 3 times per week. Aim of the Daphnia Reproduction Test over 21 days was to assess effects on the reproduction capacity and other test item-related effects on parameters such as occurrence of aborted eggs and stillborn juveniles, time of production of first brood, adult mortality, intrinsic rate of natural increase, dry body weight and length of the parent animals.
A specific analytic of the test item was not possible, because the test item is insoluble in water and organic solvents. Therefore, the results given are based on the nominal loading of 2.50 mg test item/L.· The average number of juveniles per parentat the control group was 106 and 102 at the limit loading level after 21 days. There was no statistically significant reduction of the reproductive output (unpaired t-test).
· The coefficient of variation of the mean number of living offspring produced per parent at the control group was 9 % and 16 % at the limit loading level.
· The intrinsic rates of natural increase (IR) of the surviving parent animals accounting for generation time and number of offspring were used for calculation of population growth and maintenance. The mean IR of the surviving daphnids of the limit loading level was comparable to the control group (unpaired t-test, p = 0.05).
· No immobilization or adult mortality of parent animals occurred at the control group and at the limit loading level.
· No stillborn juveniles and aborted eggs were produced by the control group. Related to the total number of produced juveniles (dead + alive) the percentage of dead juveniles was 1 % at the limit loading level.
· The first brood occurred between day 8 and 9 at each parent animal of the control and the limit loading level. In the control and test group 5 broods were released during the test period by all daphnids.
· The mean dry body weight of the parent daphnids was 0.56 mg per daphnid at the control group and 0.60 mg per daphnid at the limit loading level. The total length of the parent daphnids of the test group was comparable to the control. The mean value of the total body length at the limit loading level was 4.85 mm per daphnid and 5.03 mm per daphnid at the control group.
· No males and ephippia (winter eggs) occurred in control or test groups.
A summary of all test item related effects is presented in Table 1. There was no statistically significant effect determined at the supersaturated solution of the test item with a nominal loading of 2.50 mg/L.
Table 1: Summary of all Test Item Related Effects
Based on the limit loading level of nominal 2.50 mg test item/L
Effects
Test item
Significance
Control
Nominal Loading of the supersaturated solution 2.50 mg/L
Mean Number of Juveniles per Producing Parent (Reproduction Rate ± SD)
106 ± 10
102 ± 17
no1)
Intrinsic Rate of Natural Increase
0.47
0.47
no1)
Appearance of First Brood [Mean Day]
8.2
8.0
no
Number of Broods
5
5
no
Stillborn Juveniles and Aborted Eggs
0
6
no
Adult Mortality after 21 Days [%]
0
0
no
Parent Animals: Mean Dry Weight [mg]
0.56
0.60
no
Parent Animals: Mean Body Length [mm]
5.03
4.85
no1)
NOELReproduction
2.50 mg/L
LOELReproduction
> 2.50 mg/L
SD = Standard deviation
no = No biological significance
1) = Statistical significance (unpaired t-test, p = 0.05)
· Water quality parameters as pH-value, dissolved oxygen, water hardness and temperature were determined to be within the acceptable limits.
· In order to prove the validity of the test system and test conditions at the test facility, an acute immobilization test according to DIN 38412 L 11 was carried out with potassium dichromateas reference item once per month.
The EC50 of the reference item, determined to be 1.53 mg/L after 24 hours, was within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item was also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.
Reference
Number of Juveniles in the Control and Test Group after 21 Days
Nominal [mg/L] |
No. |
Mean No. of Juveniles |
Compared |
|||||||||||||
Number of Juveniles in Replicate No. |
Total |
of |
CV |
versus |
||||||||||||
No. |
Parents |
per Parent |
Control |
|||||||||||||
prod. Juv. |
producing Juveniles |
Red. |
||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
å |
N |
MV ± SD |
[%] |
[%] |
||
2.50 |
110 |
96 |
94 |
98 |
68 |
104 |
104 |
96 |
121 |
129 |
1020 |
10 |
102 ± |
17 |
16 |
4 |
Control |
106 |
107 |
98 |
107 |
99 |
101 |
109 |
91 |
121 |
122 |
1061 |
10 |
106 ± |
10 |
9 |
— |
Immobilization and Mortality [%] of the Adult Daphnids after 7, 14 and 21 Days of Exposure
(n = 10)
Nominal Loading [mg/L] |
Immobilization / Mortality [%] |
||
7 days |
14 days |
21 days |
|
2.50 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
Stillborn Juveniles and Aborted Eggs after 21 Days
Nominal Loading [mg/L] |
Number of |
Total No. |
Mean Stillborn Juveniles and Aborted Eggs per Parent alive |
||
Stillborn |
Aborted |
||||
Juveniles |
Eggs |
å |
N |
MV ± SD |
|
2.50 |
0 |
6 |
6 |
10 |
0.60 ± 1.07 |
Control |
0 |
0 |
0 |
10 |
0 ± 0 |
First Appearance of Living Juveniles in the Individual Groups
Nominal Loading [mg/L] |
Day of First Appearance of Living Juveniles |
First |
|||||||||
in Replicate No. |
Appearance |
||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
Mean Day |
|
2.50 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
8.0 |
Control |
9 |
8 |
8 |
8 |
8 |
8 |
9 |
8 |
8 |
8 |
8.2 |
Total Length and Dry Weight of the Parent Animals
Nominal Loading [mg/L] |
Total Length of the Parent Animals [mm] |
MV |
N |
Dry Weight [mg] |
||||||||||
Replicate No. |
||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
[mm] |
S |
MV |
||
2.50 |
5.00 |
4.50 |
4.25 |
4.75 |
4.50 |
5.25 |
5.00 |
5.25 |
5.00 |
5.00 |
4.85 |
10 |
6.00 |
0.60 |
Control |
5.00 |
4.75 |
5.00 |
5.00 |
5.25 |
5.00 |
5.00 |
5.00 |
5.00 |
5.25 |
5.03 |
10 |
5.60 |
0.56 |
Description of key information
At the supersaturated solution of the test item (Pigment violet 23) with a nominal loading of 2.50 mg/L no significant effects were determined. The No Observed Effect Loading Level (NOEL) and the Lowest Observed Effect Loading Level (LOEL) were assessed at:
NOEL: 2.50 mg/L
LOEL: > 2.50 mg/L
All effect values are given based on the nominal loading level of 2.50 mg Pigment Violet 23/L of the supersaturated solution of the test item.
Key value for chemical safety assessment
Additional information
TheDaphnia magna Reproduction Test (Semi-Static, 21 d) of the test item was conducted as a limit test with a supersaturated solution of the test item with the nominal loading of 2.50 mg/Laccording to OECD 211 (1998). The test methodwas semi-static. The test solutions were renewed 3 times per week. Aim of the Daphnia Reproduction Test over 21 days was to assess effects on the reproduction capacity and other test item-related effects on parameters such as occurrence of aborted eggs and stillborn juveniles, time of production of first brood, adult mortality, intrinsic rate of natural increase, dry body weight and length of the parent animals.
At the supersaturated solution of the test item with a nominal loading of 2.50 mg/L no significant effects were determined. The No Observed Effect Loading Level (NOEL) and the Lowest Observed Effect Loading Level (LOEL) were assessed at: NOEL: 2.50 mg/L LOEL: > 2.50 mg/L
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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