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EC number: 944-482-9 | 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August - 15 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- (2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from all test concentrations and the control according to the schedule below.
Frequency: At the start and the end of both 24-hour renewal periods.
Volume: 3.0 mL from the approximate centre of the test vessels
Storage: Samples were stored in a freezer until analysis.
At the end of each refreshment period, samples were taken from one replicate of each test concentration and the control. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The batch of GALBASCONE tested was a clear colourless liquid and not completely soluble in test medium at loading rates above 3.2 mg/L. No correction was made for the composition of the test item.
All test solutions were prepared separately applying one day of magnetic stirring in a closed vessel followed by a stabilization period of one day in order to reach the maximum solubility of the test item in the test medium. The resulting clear and colourless solutions (concentrations up to and including 3.2 mg/L) and the aqueous mixtures (concentrations above 3.2 mg/L) were siphoned off. The final test solutions were all referred to as Water Accommodated Fractions (WAFs). Note that during the preparation of test solutions for the range-finding test the test item was not completely dissolved at a loading rate of 1.0 mg/L after stirring and stabilization. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (Straus, 1820)
- Source: In-house laboratory culture with a known history, at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions. 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.
- Age at study initiation: young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.
- Method of 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 (M7) in an all-glass culture vessel. Renewal of the cultures: after 7 days of cultivation half of the medium twice a week.
- Feeding during test: no
ACCLIMATION
- Acclimation period: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
- Hardness:
- 180 mg CaCO3/L
- Test temperature:
- 20 °C
- pH:
- 7.6 - 8.1
- Dissolved oxygen:
- 8.5 - 9.3 mg O2/L
- Nominal and measured concentrations:
- Based on the results of the combined limit/range-finding test, EC50 was expected to range between WAFs prepared at loading rates of 1.0 and 10 mg/L, thus the following test concentrations were assigned to the definitive test:
Test concentrations: WAFs separately prepared at loading rates of 1.0, 1.8, 3.2, 5.6 and 10 mg/L
Mean measured test concentrations: 1.4, 1.7, 3.1, 5.6 and 11 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL, all-glass, air-tight closed; fill-volume: 60 mL
- Aeration: None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium
- Culture medium different from test medium: Yes, M7
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h daily
EFFECT PARAMETERS MEASURED: mobility at 24 and 48 hours ; pH and dissolved oxygen at the start and the end of both renewal periods, for all concentrations and the control. Temperature continuously. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (September 2015)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 4.2 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI: 3.1 - 5.6 mg/L
- Details on results:
- Recovery: Measured concentrations ranged from 84 -111% of initial loading rates, except for the highest and the lowest concentration prepared for the first renewal period, where the concentrations were above the initial loading rates (127 and 170%, respectively)
Relative to initial [%] ranged from 90 - 109% (see table 3 below)
Individual pH, temperature and dissolved oxygen values remained within acceptable limits throughout the duration of the study. - Results with reference substance (positive control):
- 48h-EC50: 0.39 mg/L.
- Validity criteria fulfilled:
- yes
- Remarks:
- 1) In the control, no daphnids became immobilised or showed other signs of disease or stress. 2) The oxygen concentration at the end of the test was ≥3 mg/L in control and test vessels.
- Conclusions:
- The 48h-EC50 value to Daphnia magna was 4.2 mg/L based on mean measured concentrations.
- Executive summary:
A study was performed to assess the acute toxicity of the substance to Daphnia magna. The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202 and GLP under semi-static conditions.
Based on the results of a combined limit/range-finding test, the following nominal concentrations were tested in the definitive test: WAFs prepared separately at loading rates of 1.0, 1.8, 3.2, 5.6 and 10 mg/L.
For each concentration and a control group, twenty Daphnia magna (less than 24 hours old) were exposed for 48 hours in air-tight closed vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. Samples taken from all concentrations at the start and the end of both 24-hour renewal periods were analysed with a validated GC-FID method.
Measured concentrations ranged from 84 -111% of initial loading rates, except for the highest and the lowest concentration prepared for the first renewal period, where the concentrations were above the initial loading rates (127 and 170%, respectively). All test concentrations remained stable during the 24 -hour renewal periods (90 -109% of initial). Based on these results, the mean measured concentrations were calculated. The range tested based on mean measured concentrations was 1.4, 1.7, 3.1, 5.6 and 11 mg/L.
The 48h-EC50 value to Daphnia magna was 4.2 mg/L based on mean measured concentrations.
Reference
Table 1: Measured concentrations
Time of sampling |
Loading rate1 |
Concentration |
Relative to |
Relative to |
|
|
|
|
|
0 |
0 |
n.d. |
|
|
|
1.0 |
1.70 |
|
170 |
|
1.8 |
1.73 |
|
96 |
|
3.2 |
3.49 |
|
109 |
|
5.6 |
6.21 |
|
111 |
|
10 |
12.7 |
|
127 |
|
|
|
|
|
24 |
0 |
n.d. |
|
|
(Old) |
1.0 |
1.81 |
107 |
|
|
1.8 |
1.89 |
109 |
|
|
3.2 |
3.35 |
96 |
|
|
5.6 |
6.04 |
97 |
|
|
10 |
12.3 |
96 |
|
|
|
|
|
|
24 |
0 |
n.d. |
|
|
(Fresh) |
1.0 |
1.08 |
|
108 |
|
1.8 |
1.51 |
|
84 |
|
3.2 |
2.78 |
|
87 |
|
5.6 |
4.92 |
|
88 |
|
10 |
10.7 |
|
107 |
|
|
|
|
|
48 |
0 |
n.d. |
|
|
(Old) |
1.0 |
0.970 |
90 |
|
|
1.8 |
1.53 |
101 |
|
|
3.2 |
2.81 |
101 |
|
|
5.6 |
5.16 |
105 |
|
|
10 |
10.1 |
95 |
|
|
|
|
|
|
|
|
|
|
|
1 A water accommodated fraction (WAF) prepared at the loading rate.
2 Calculated by reviewer
n.d. Not detected
Table 2: Mean concentrations
GALBASCONE WAF prepared at x mg/L |
Mean concentration (mg/L) |
Mean concentration 0-48 h (mg/L) |
|
t=0-24 h |
t=24-48 h |
||
1.0 |
1.8 |
1.0 |
1.4 |
1.8 |
1.8 |
1.5 |
1.7 |
3.2 |
3.4 |
2.8 |
3.1 |
5.6 |
6.1 |
5.0 |
5.6 |
10 |
12 |
10 |
11 |
Table 3: Number of introduced daphnids and incidence of immobilityin the final test
Mean conc. GALBASCONE (mg/L) |
Vessel number
|
Number Daphnia exposed |
Response at 24 h |
Response at 48 h |
||
number |
Total % |
number |
Total % |
|||
Control |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
1.4 |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
1.7 |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
3.1 |
A B C D |
5 5 5 5 |
1 1 1 0 |
15 |
0 0 0 0 |
0 |
5.6 |
A B C D |
5 5 5 5 |
0 1 2 2 |
25 |
4 5 5 5 |
95 |
11 |
A B C D |
5 5 5 5 |
5 5 5 5 |
100 |
5 4 5 5 |
95 |
Vessel number A, B, C, D = replicate 1, 2, 3, 4
Description of key information
A study was performed to assess the acute toxicity of the substance to Daphnia magna. The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202 and GLP under semi-static conditions.
Based on the results of a combined limit/range-finding test, the following nominal concentrations were tested in the definitive test: WAFs prepared separately at loading rates of 1.0, 1.8, 3.2, 5.6 and 10 mg/L.
For each concentration and a control group, twenty Daphnia magna (less than 24 hours old) were exposed for 48 hours in air-tight closed vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. Samples taken from all concentrations at the start and the end of both 24-hour renewal periods were analysed with a validated GC-FID method.
Measured concentrations ranged from 84 -111% of initial loading rates, except for the highest and the lowest concentration prepared for the first renewal period, where the concentrations were above the initial loading rates (127 and 170%, respectively). All test concentrations remained stable during the 24 -hour renewal periods (90 -109% of initial). Based on these results, the mean measured concentrations were calculated. The range tested based on mean measured concentrations was 1.4, 1.7, 3.1, 5.6 and 11 mg/L.
The 48h-EC50 value to Daphnia magna was 4.2 mg/L based on mean measured concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 4.2 mg/L
Additional information
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