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EC number: 282-001-8 | CAS number: 84082-55-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lupinus albus, Leguminosae.
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 September 2016 to 27 September 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- yes
- Remarks:
- For the concentration 10 mg/L in the abiotic conditions (test item only, without algae), the deviation between T0 and T72 hours is higher than 20% unlike the stability test performed. The deviation was still higher than 20 % with additional analysis.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 14 January 2016
- Analytical monitoring:
- yes
- Details on sampling:
- Chemical analyses of the test item were performed in the test solutions (biotic and abiotic). In order to verify the nominal or initial concentrations of the test item and maintenance of the exposure concentrations of the test item during the ecotoxicological testing, chemical analysis of the test item in algae test solutions were performed in samples containing the test item from algae ecotoxicology solutions by a Total Organic Carbon analyzer and the following protocol:
- at the beginning of the test (T = 0 h)
- at the end of the test (T = 72 h)
- for the control (i.e. algae test medium filtered), the highest and the lowest concentrations and a concentration around expected EC50 (filtered solutions)
A total of 8 analyses were performed at the start of the test (T 0 h).
A total of 8 analyses were performed at the end of the test (T 72 h).
Schedule analysis at initial time (T0h):
Control Abiotic: 10 mg/l Abiotic; 328 mg/L Abiotic; 1050 mg/L Abiotic.
Schedule analysis at final time (T72h):
Control Biotic: 10 mg/l Biotic; 328 mg/L Biotic; 1050 mg/L Biotic.
Control Abiotic: 10 mg/l Abiotic; 328 mg/L Abiotic; 1050 mg/L Abiotic.
The measured concentrations of the test item should not vary more than ± 20 % of nominal or initial measured concentration during the test. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The test item is soluble in the test medium.
The test medium and the test solutions were filtered through a membrane filter (cellulose acetate) with a mesh size of 0.22 µm to sterilizing and all the manipulations have been done under sterile conditions to prevent contamination.
Five test item concentrations in algae test medium (OECD medium) were performed, plus a control. - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: Strain no. CCAP 278.4
- Method of cultivation: Algae cultures are stored in the laboratory on a solid medium (LC/agar Petri plates) and in a liquid medium with regular sub-culturing (every week). - Test type:
- not specified
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- None
- Hardness:
- No data
- Test temperature:
- 22.6–23.4 °C shaking at 120 rpm
- pH:
- pH at the start: 7.2 - 8.0
pH after 72 h: 7.6 - 7.8 - Dissolved oxygen:
- No data
- Salinity:
- No data
- Conductivity:
- No data
- Nominal and measured concentrations:
- 10, 32, 102, 328 and 1050 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Initial cells density: 10000 cells/mL at the start of the test
- No. of vessels per concentration (replicates): 3 biotic replicates + 1 abiotic replicate per concentration
- Control: 6 biotic replicates + 2 abiotic replicates
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Algae test medium (OECD medium); Algae dilution water
OTHER TEST CONDITIONS
- Light intensity and quality: 6378 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: The algae growth inhibition in relation to the control was evaluated over a period of 72 h. The algae cells per unit volume were measured during the test at 24, 48 and 72 h with a particle counter (Beckman Coulter Z2) and under a microscope with a Malassez counting cell.
- pH: pH of each test concentration was measured at the start and at the end of the test. The pH of the control medium had not increased by more than 1.5 units during the test.
TEST CONCENTRATIONS
- Range finding study: 10, 100 and 200 mg/L
- Results used to determine the conditions for the definitive study: Algae concentrations (x 10^4 per mL of test solution) i.e., 222.1, 160.3, 69.3 and 25.7 at 0, 10, 100 and 200 mg/L, respectively at 72 h. Based on the results of the preliminary test, the following test concentrations 10, 32, 102, 328 and 1050 mg/L were proposed for the definitive test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 10 - < 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 050 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- < 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 10 - < 1 050 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- See "any other information on results incl. tables"
- Results with reference substance (positive control):
- The last algae growth inhibition test performed with the reference item potassium dichromate (August 23, 2016) gave an ErC50 (0-72h) = 0.75 mg/L (0.66 - 0.85), indicating that the algae sensitivity is correct (within the accepted interval of 0.65 to 1.73 mg/L fixed by the International Standard NF EN ISO 8692 from May 2012 as mentioned in the OECD Guideline) and in accordance with previous data obtained by the laboratory.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the 72 h ErC10, ErC50, EyC10 and EyC50 of the test item was determined to be between 10 and 32 mg/L, > 1050 mg/L, < 10 mg/L and between 10 and 1050 mg/L, respectively.
- Executive summary:
Introduction
In an algal growth inhibition study performed according to OECD Guideline 201 and in compliance with GLP, freshwater green algae species Pseudokirchneriella subcapitata was exposed to test item at 10, 32, 102, 328 and 1050 mg/L over an exposure period of 72 h. The algae growth inhibition in relation to the control was evaluated over a period of 72 h. The algae cells per unit volume were measured during the test at 24, 48 and 72 h with a particle counter (Beckman Coulter Z2) and under a microscope with a Malassez counting cell.
Chemical analysis
In order to verify the nominal or initial concentrations of the test item and maintenance of the concentratrations during the ecotoxicological testing, TOC analysis were performed in test solutions. Under test conditions (with algae), the test item is considered to be stable for the nominal concentrations 328 and 1050 mg/L because the measured concentrations of the test item did not vary by more than ± 20% of the initial concentrations during the test. At 10 mg/L and in Control, the increase of Total Carbon during the test was explained by the growth of algae due to lack of inhibition effect.
Results
A concentration effect relationship was observed and statistically analyzed to obtain effect concentrations.Under the test conditions, the 72 h ErC10, ErC50, EyC10 and EyC50 of the test item was determined to be between 10 and 32 mg/L, > 1050 mg/L, < 10 and between 10 and 1050 mg/L, respectively.
Validity criteria
Regarding the validity criteria of the study, the increase of the biomass during 72 h was determined to be higher than a factor of 16 in the Control. The coefficients of variation of daily section-by-section specific growth rate and of average specific growth rate were determined respectively to be less than 35 % and 7% in the control. Therefore, the validity criteria were fulfilled.
Reference
Table 6.1.5/1: Algae growth inhibition
Nominal test item concentration |
[algae] *104/mL at 24 hours |
[algae] *104/mL at 48 hours |
[algae] *104/mL at 72 hours |
|||||||
Count. |
Average |
cv |
Count. |
Average |
cv |
Count. |
Average |
cv |
||
Control |
a |
6,1 |
6,2 |
4,9 |
30,3 |
31,9 |
5,5 |
177,8 |
171,6 |
3.5 |
b |
6,2 |
32,9 |
179,3 |
|||||||
c |
6,4 |
31,0 |
166,3 |
|||||||
d |
5,8 |
34,9 |
165,0 |
|||||||
e |
5,9 |
30,5 |
168,4 |
|||||||
f |
6,6 |
32,0 |
172,6 |
|||||||
10 mg/L |
a |
6,8 |
6,6 |
5,7 |
32,3 |
29,5 |
11,8 |
152,5 |
149,5 |
5.9 |
b |
6,2 |
25,6 |
139,5 |
|||||||
c |
6,9 |
30,5 |
156,4 |
|||||||
32 mg/L |
a |
6,0 |
6,2 |
3,3 |
30,5 |
31,6 |
3,2 |
84,2 |
83,8 |
5.1 |
b |
6,4 |
31,7 |
79,4 |
|||||||
c |
6,3 |
32,5 |
87,9 |
|||||||
102 mg/L |
a |
6,3 |
6,2 |
3,3 |
32,8 |
33,6 |
5,1 |
81,5 |
87,2 |
5.6 |
b |
6,4 |
35,6 |
90,2 |
|||||||
c |
6,0 |
32,5 |
89,8 |
|||||||
328 mg/L |
a |
6,1 |
6,0 |
5,1 |
24,3 |
27,5 |
15,1 |
88,0 |
93,6 |
5.4 |
b |
6,3 |
32,2 |
97,8 |
|||||||
c |
5,7 |
26,0 |
95,1 |
|||||||
1050 mg/L |
a |
3,5 |
3,5 |
5,7 |
22,8 |
21,7 |
5,6 |
42,2 |
45,8 |
7.2 |
b |
3,7 |
20,4 |
48,7 |
|||||||
c |
3,3 |
21,9 |
46,5 |
CV = Coefficient of variation.
Table 6.1.5/2: Specific growth rate
Control replicates |
Specific growth rate |
|||||||||||||
0-24h |
Average |
CV (%) |
24 -48h |
Average |
CV (%) |
48 -72h |
Average |
CV (%) |
0 - 72h |
Average |
CV per replicate (%) |
Average CV |
||
Control |
a |
1.808 |
1.818 |
2.7 |
1.603 |
1.644 |
5.0 |
1.770 |
1.682 |
4.2 |
1.727 |
1.715 |
6.3 |
6.7% |
b |
1.825 |
1.669 |
1.696 |
1.730 |
4.8 |
|||||||||
c |
1.856 |
1.578 |
1.680 |
1.705 |
8.3 |
|||||||||
d |
1.758 |
1.795 |
1.553 |
1.702 |
7.6 |
|||||||||
e |
1.775 |
1.643 |
1.709 |
1.709 |
3.9 |
|||||||||
f |
1.887 |
1.579 |
1.685 |
1.717 |
9.1 |
CV: Coefficient of variation (%)
Table 6.1.5/3: Calculation of the ErC50(0-72h)
Nominal test item concentration |
Algae *104/mL at 0hour |
Average growth rate µ0-72h |
Inhibition growth rate (% Ir) |
Average inhibition of growth rate (%) |
Coefficient of variation |
Significance |
|
Control |
a |
1 |
1,727 |
Not applicable |
0.7 |
- |
|
b |
1,730 |
||||||
c |
1,705 |
||||||
d |
1,702 |
||||||
e |
1,709 |
||||||
f |
1,717 |
||||||
10 mg/L |
a |
1 |
1,676 |
2,3 |
2,7 |
Not required |
* |
b |
1,646 |
4,0 |
|||||
c |
1,684 |
1,8 |
|||||
32 mg/L |
a |
1 |
1,478 |
13,8 |
14,0 |
Not required |
* |
b |
1,458 |
15,0 |
|||||
c |
1,492 |
13,2 |
|||||
102 mg/L |
a |
1 |
1,467 |
14,5 |
13,2 |
Not required |
* |
b |
1,501 |
12,5 |
|||||
c |
1,499 |
12,6 |
|||||
328 mg/L |
a |
1 |
1,492 |
13,0 |
11,8 |
Not required |
* |
b |
1,528 |
10,9 |
|||||
c |
1,518 |
11,5 |
|||||
1 050 mg/L |
a |
1 |
1,247 |
27,3 |
25,7 |
Not required |
* |
b |
1,295 |
24,5 |
|||||
c |
1,280 |
25,4 |
The average specific growth rate (µ) was determined according to the OECD guideline.
Statistical significance was determined with the Dunnett test (α=5%) from raw data with the scientific software Minitab 17.2.1. Therefore, it was not possible to determine a NOEC because a significant difference between the control was observed at the lowest concentration 10 mg/L.
The results did not permit to calculate a regression because the inhibition of growth rate at 1050 mg/L is only 25.7%.
The raw data did not permit to determined ErC10-(0-72h) with reliability, for information the ErC10-(0-72h could be between 10 and 32 mg/L.
The results obtained for the test item on the toxicological endpoint “inhibition of growth rate” indicate an ErC50-(0-72h) higher than 1050 mg/L (highest tested concentration) value expressed in nominal test item concentration
Calculation of the EyC50(0-72h)
The results did not permit to calculate a regression because the Yield inhibition were too close between 32 and 328 mg/L.
The results obtained for the test item on the toxicological endpoint “Yield inhibition” indicate anEyC10-(0-72h) is inferior 10 mg/L(lowest tested concentration), value expressed in nominal test item concentration.
The results obtained for the test item on the toxicological endpoint “Yield inhibition” indicate anEyC50-(0-72h)betwwen 10 and 1050 mg/L,value expressed in nominal test item concentration.
Table 6.1.5/3: Results of TOC analysis measured in test solutions
Nominal test item concentration |
mg “test item”/L in algae solutions |
Variation between T0 and T72 hrs (%) |
|
Results at T0 hour(deviation/nominal value) |
Results at T72 hours |
||
Control |
< 5 |
48.8 |
NA |
10 mg/L |
8.4 (+ 16.0%) |
55.5 |
+ 560 |
328 mg/L |
315 (+ 4.1%) |
315 |
0 |
1050 mg/L |
1011 (+ 3.7%) |
950 |
6 |
TOC = Total Organic Carbon
Under test conditions (with algae), the test item is considered to be stable for the nominal concentrations 328 and 1050 mg/L, except 10 mg/L, because the measured concentrations of the test item did not vary by more than ± 20% of the initial concentrations during the test. At 10 mg/L and in Control, the increase of Total Carbon during the testing was explained by the growth of algae due to lack of inhibition effect at 10 mg/L.
Validity criteria
In the control, the increase of the biomass during 72 h was determined to be higher than a factor of 16.
The coefficients of variation of daily section-by-section specific growth rate and of average specific growth rate were determined respectively to be less than 35 % and 7% in the control.
The validity criteria were successfully fulfilled.
Description of key information
Under the test conditions, the 72 h ErC50 of the test item to the algae Pseudokirchneriella subcapitata was determined to be > 1050 mg/L.
Under the test conditions, the 72 h ErC10 of the test item to the algae Pseudokirchneriella subcapitata was determined to be between 10 and 32 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1 050 mg/L
- EC10 or NOEC for freshwater algae:
- 10 mg/L
Additional information
An algal growth inhibition study was available and it was performed according to OECD Guideline 201 and in compliance with GLP. In this study, the freshwater green algae species Pseudokirchneriella subcapitata was exposed to the test item at 10, 32, 102, 328 and 1050 mg/L over an exposure period of 72 h. The algae growth inhibition in relation to the control was evaluated over a period of 72 h.
The validity criteria were fulfilled and a concentration effect relationship was observed and statistically analyzed to obtain effect concentrations.
Under the test conditions, the 72 h ErC10, ErC50, EyC10 and EyC50 of the test item was determined to be between 10 and 32 mg/L, > 1050 mg/L, < 10 and between 10 and 1050 mg/L, respectively.
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