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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August 2015 - 15 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23, December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Test concentrations were verified by chemical analysis. Samples for analysis were taken from all test concentrations with surviving fish and the control according to the schedule below:
Frequency At the start and the end of all 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. - 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 10 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 10 mg/L) and the aqueous mixtures (concentrations above 10 mg/L) were siphoned off. The final test solutions were all referred to as Water Accommodated Fractions (WAFs). - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp (Cyprinus carpio)
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Age at study initiation: not reported; F1 from a single parent-pair bred in UV-treated water
- Length at study initiation (final test, mean): 2.2 ± 0.2 cm
- Weight at study initiation (final test, mean): 0.38 ± 0.13 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period.
ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions: same as test, i.e. adjusted ISO medium
- Type of food: pelleted fish food (Cyprico Crumble Excellent (300-500 µm))
- Feeding frequency: daily
- Health during acclimation: <5% mortality observed during the seven days prior to the start of the test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 180 mg CaCO3/L
- Test temperature:
- 21.0 - 21.7°C
- pH:
- 7.0 - 7.9
- Dissolved oxygen:
- fresh solutions: 8.6-9.3 mgO2/L
used solutions: 3.0-6.4 mgO2/L - Nominal and measured concentrations:
- Based on the results of the range-finding test (biological effects observed between 1.0 and 10 mg/L) the following test concentrations were assigned to the final test: WAFs prepared at loading rates of 1.0, 2.2, 4.6, 10 and 22 mg/L.
Measured test concentrations: see Tables 1 and 2 in field 'Any other information on results'
The effect concentrations are based on the arithmetic mean of geometric mean measured concentrations since the average measured concentrations derived from the 24 h intervals decreased to 44-71% of initial at the end of the various 24-hour renewal periods. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3.2 litres, all-glass
- Type: closed (air-tight)
- Fill volume: 3.2 litres of test solution
- Aeration: no
- Renewal rate of test solution: 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.83 g fish/litre, i.e.7 fish per 3.2 litres of test medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Mortality (after 3.5, 24, 48, 72 and 96 hours following the start of exposure)
- Other effects: dead or severely distressed fish - daily
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.1- 2.2
- Range finding study
- Test concentrations: WAFs prepared at loading rates of 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- pentachlorophenol (January 2015)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 5 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 3.3-7.7 mg/L (based on the arithmetic mean of the geometric mean measured concentrations)
- Details on results:
- The effect, i.e. 50% mortality, was reached already after 48 hours of exposure.
No mortality was observed in the control throughout the test.
pH and temperature remained within the recommended guideline ranges (pH: 6.0-8.5, constant within 1 unit; temperature 20-24°C, constant within 2°C).
The oxygen concentrations remained within the recommended guideline ranges (oxygen > 60% of air saturation), except for the old medium of the 10 mg/L test item concentration on day 1. In that test solution the oxygen concentration had decreased to 3.0 mg/L. Since the test item was treated as volatile the test solutions could not be aerated. Based on experience, fish are not affected by temporarily lower oxygen concentrations. Therefore, the fish mortality observed after 48 hours of exposure cannot be directly related to this temporarily lower oxygen concentration. Moreover, fish mortality was expected at this concentration level, based on the results of the range-finding test where the oxygen concentrations were at least 60% of air saturation at all times. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Mortality: 100% at 0.46 mg/L
- LC50: 0.32 mg/L
- Other: effect (i.e. 50% mortality) reached already within 48 h of exposure - Reported statistics and error estimates:
- LC50 determination
The LC50 could not be determined using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations. This was because there was no concentration between the highest concentration (A) at which 0% mortality and the lowest concentration (B) at which 100% mortality occurred. Instead, the LC50 was calculated as (AB)^½, with A and B being limits of the 95% confidence interval. - Sublethal observations / clinical signs:
Range-finding test (static)
All fish exposed to the highest test concentration died within 4 hours of exposure. The actual test concentration was 45 mg/L at the start of the test and this concentration remained stable during the 4 hours of exposure (95% of initial).
Two out of three fish exposed to the middle test concentration also died within 4 hours of exposure. The actual test concentration was 8.7 mg/L at the start of the test and this concentration remained stable for at least 28 hours (85% of initial). The surviving fish after the 96 -hour test period was observed to be discoloured and stopped swimming from time to time. At the end of the test period the concentration had decreased to 62% of initial.
No mortality or clinical effects were observed in the lowest test concentration during the test period. The actual test concentration was 1.2 mg/L at the start of the test and this concentration decreased to 24% of initial at the end of the test.
The expected LC50was between concentrations obtained in WAFs prepared at loading rates of 1.0 and 10 mg/L.
Table 1: Concentrations of the test item in test medium - final test
Time of sampling
[hours]Loading rate1
[mg/L]Concentration
analysed
[mg/L]Relative to
initial
[%]0
0
n.d.
1.0
1.12
2.2
2.25
4.6
4.27
10
9.16
22
21.0
24 (Old)
0
n.d.
1.0
0.563
50
2.2
0.995
44
4.6
2.52
59
10
5.45
59
24 (Fresh)
0
n.d.
1.0
1.10
2.2
2.09
4.6
4.45
10
10.4
48 (Old)
0
n.d.
1.0
0.596
54
2.2
1.49
71
4.6
2.77
62
10
6.78
65
48 (Fresh)
0
n.d.
1.0
1.14
2.2
1.96
4.6
4.22
10
8.64
72 (Old)
0
n.d.
1.0
0.572
50
2.2
1.19
61
4.6
2.86
68
72 (Fresh)
0
n.d.
1.0
0.979
2.2
1.89
4.6
3.72
96 (Old)
0
n.d.
1.0
0.587
60
2.2
1.14
60
4.6
2.63
71
1 A water accommodated fraction (WAF) prepared at the loading rate.
n.d. Not detected.
Table 2: Mean measured concentrations
GALBASCONE
WAF prepared at
x mg/L
Geometric mean concentration (mg/L)
Mean concentration
0-96 h (mg/L)
t=0-24 h
t=24-48 h
t=48-72 h
t=72-96 h
1.0
0.79
0.81
0.81
0.76
0.79
2.2
1.5
1.8
1.5
1.5
1.6
4.6
3.3
3.5
3.5
3.1
3.3
10
7.1
8.4
7.7
22
211
211
1Initial concentration
Mean conc.
GALBASCONE (mg/L)
Initial
number
of fish
Cumulative mortality
Total
Mortality
(%)
3½h
24h
48h
72h
96h
control
7
0
0
0
0
0
0
0.79
7
0
0
0
0
0
0
1.6
7
0
0
0
0
0
0
3.3
7
0
0
0
0
0
0
7.7
7
0
0
7
7
7
100
21
7
7
7
7
7
7
100
Table 4: Clinical effects observed during the final test
Mean conc.
GALBASCONE (mg/L)
Time of
recording
(hours)
Specification of effects
Relative
number
Control, 0.79, 1.6
3.3
7.7
0-96
3½
24
48-96
3½
24
No abnormalities
Discoloured and hypoactive
Snapping at the surface
No abnormalities
Discoloured
No abnormalities
Immobile
Loss of equilibrium
Immobile
7/7
7/7
6/7
1/7
1/7
6/7
4/7
3/7
7/7
- Validity criteria fulfilled:
- yes
- Remarks:
- no mortality in controls; test conditions were maintained constant throughout the test; for dissolved oxygen criterion and concentrations please refer to 'Overall remarks'
- Conclusions:
- The 96 h LC50 value in fish (Cyprinus carpio) is 5.0 mg/L.
- Executive summary:
A study was performed to assess the acute toxicity of the substance to fish (Cyprinus carpio). The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 203 and GLP. In a semi-static test set-up in air-tight closed 3.2-L vessels, seven fish per concentration were exposed to 5 concentrations of the substance in test water (water accommodated fractions prepared separately at loading rates of 1.0, 2.2, 4.6, 10 and 22 mg/L) and a control. Throughout the test, test solutions were refreshed in intervals of 24 hours. After 3.5 hours all fish in the highest treatment group, and after 48 hours all fish in the second highest treatment group had died. Clinical effects (such as discolouration, hypoactive swimming, loss of equilibrium or immobility) and incidences of mortality were recorded for the control and each test group at all timepoints and the following effect value was determined: 96-h LC50 = 5.0 mg/L.
All results are expressed in terms of mean measured concentrations. Measured concentrations were in agreement with initial loading rates in fresh solutions (81 -114%) but decreased to 44 -71 % of initial during the refreshment periods of 24 hours (in used solutions). Therefore, geometric mean measured concentrations were calculated for each time interval and concentration, and these values were used to calculate the 0 -96 h (arithmetic) mean measured concentrations.
Reference
Description of key information
A study was performed to assess the acute toxicity of the substance to fish (Cyprinus carpio). The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 203 and GLP. In a semi-static test set-up in air-tight closed 3.2-L vessels, seven fish per concentration were exposed to 5 concentrations of the substance in test water (water accommodated fractions prepared separately at loading rates of 1.0, 2.2, 4.6, 10 and 22 mg/L) and a control. Throughout the test, test solutions were refreshed in intervals of 24 hours. After 3.5 hours all fish in the highest treatment group, and after 48 hours all fish in the second highest treatment group had died. Clinical effects (such as discolouration, hypoactive swimming, loss of equilibrium or immobility) and incidences of mortality were recorded for the control and each test group at all timepoints and the following effect value was determined: 96-h LC50 = 5.0 mg/L.
All results are expressed in terms of mean measured concentrations. Measured concentrations were in agreement with initial loading rates in fresh solutions (81 -114%) but decreased to 44 -71 % of initial during the refreshment periods of 24 hours (in used solutions). Therefore, geometric mean measured concentrations were calculated for each time interval and concentration, and these values were used to calculate the 0-96 h (arithmetic) mean measured concentrations.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 5 mg/L
Additional information
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