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EC number: 246-788-1 | CAS number: 25279-09-8
- 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 February 2018 - 23 July 2018
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Remarks:
- HPLC - UV method.
- Details on sampling:
- - Concentrations: 26.0, 36.4, 51.0, 71.3 and 100.0% w/v saturated test item solutions.
- Sampling method: Samples were taken from the test solutions at the applied concentration levels and from the control solution at 0, 24 and 48h. 310 mL of test sample from additional replicate of each group was drawn and divided into equal portion (155 mL in each portion) at 0, 24 and 48 h. One portion was sent for test concentration analysis and the second portion was stored at -20 ± 5 ºC temperature till the study completion. Active ingredient concentration in water was determined using a validated analytical method.
- Sample storage conditions before analysis: not required. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 8000 mL of 100% w/v saturated concentration prepared by mixing 100 mg of test item with 1L of reconstituted water individually in 1 L of 8 glass bottle (Stock solution A, B, C, D, E, F, G, and H). After mixing the test item, it was stirred on magnetic stirrer for 180 min, transferred to separating funnel having capacity of 1L and allowed to equilibrate for 30 min. After 30 min, 100% saturated solution collected and used for study. Volumes of 80.6, 112.84, 158.1, 221.0 and 310.0 mL from 100% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L and diphnids with 0.5 mL reconstituted water and diluted to 310 mL with reconstituted water in screw capped 250 mL glass bottles to obtain the nominal test concentrations of 26.0, 36.4, 51.0, 71.3 and 100.0% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain: Daphnia magna
- Source: MicroBio Test Inc, Kleimoer 15, 9030 Mariakerke (Gent), Belgium
- Age of the animals: less than 24 h old at the beginning of the test.
- Feeding during test: No
ACCLIMATION
- Acclimation period: 48h
- Acclimation conditions (same as test or not): yes
- Type and amount of food: live algal cells (Pseudokirchneriella subcapitata) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 179.2 mg/L (as CaCO3)
- Test temperature:
- 18.6 – 20.3ºC
- pH:
- 6.36 – 7.39
- Dissolved oxygen:
- 8.04 – 8.41 mg/L.
- Nominal and measured concentrations:
- Nominal concentrations: 0 (control), 26.0, 36.4, 51.0, 71.3 and 100.0% w/v saturated test item solutions.
Measured concentrations: 0, 12.76, 18.50, 22.22, 33.84 and 46.95 mg/L (geometric mean, measured). - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL screw capped glass bottles
- Material, size, headspace, fill volume: glass, 250 mL (metric capacity), fill volume 310 mL.
- Aeration: No
- 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: Reconstituted water (ISO medium, according to OECD 202)
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16-hour light and 8-hour dark cycle
- Light intensity: 1300 – 1320 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
RANGE-FINDING STUDY
- Test concentrations: Non GLP research trial study was conducted with test concentrations of 0.0 (control), 0.1, 1.0, 10.0, 25.0, 50.0 and 100.0% w/v saturated concentration prepared at 100 mg/L.
- Results used to determine the conditions for the definitive study: The percent immobility observed were 0, 0, 0, 0, 0, 20 and 100% at the test concentrations of 0.0 (control), 0.1, 1.0, 10.0, 25.0, 50.0 and 100.0% w/v saturated concentration prepared at 100 mg/L, respectively. Based on the results of non-GLP research study, the test concentrations selected for the main study were 26.0, 36.4, 51.0, 71.3 and 100.0% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L (geometric factor 1.4). - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate, last test 01/02/2018, ref: 502-3-07-19120)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 29.93 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.76 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 18.5 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: No abnormal behaviour, appearance or any other effect on test animals were detected. At 24 and 48h, lethargy was observed in G3 (36.4% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L), G4 (51.0% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L) and G5 (71.3% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L. 100% immobility was observed in G6 (100% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L). No immobility and behavioural symptoms was observed in G2 (26% w/v saturated concentration prepared at 100 mg dihydromyrcenyl formate/L) and G1 (control) groups. No sign of disease or stress, e.g., discolouration or unusual behaviour such as trapping at the surface of water was observed in any replicate of the control group.
- Mortality of control: 0/20 - Results with reference substance (positive control):
- - Results with reference substance valid? Yes.
Potassium dichromate is tested to demonstrate satisfactory test conditions; last test 01/02/2018, Study No.: 502-3-07-19120. - Validity criteria fulfilled:
- yes
- Remarks:
- There was no immobilization in the control group and the dissolved oxygen concentration at the end of the test in control and test vessels was ≥ 8.04 mg/L.
- Conclusions:
- The test item has a 48h-EC50 = 29.93 mg/L (measured, geom. mean), a NOEC = 12.76 mg/L, and a LOEC = 18.50 mg/L, based on mobility.
- Executive summary:
An acute immobilisation test on Daphnia magna was performed in accordance with OECD Guideline 202, following GLP. Twenty animals, divided into four groups of 5 daphnids each, were exposed to the test item or the control for 48 h. Based on the results obtained in a non-GLP preliminary range-finding test, the animals were exposed to 0 (control), 26.0, 36.4, 51.0, 71.3 and 100.0% w/v saturated test item solutions in a static system, since the test item was not soluble in water. As the test item was found to be volatile, all tests were performed in 250 mL (metric capacity) screw-capped glass bottles with 310 mL of medium to reduce the headspace and thus avoid substance loss from the test media. Test concentrations were analytically determined at every 24h interval by a validated HPLC-UV method. As the deviation from the initial values was greater than 20% from the nominal, measured concentrations are reported: 0, 12.76, 18.50, 22.22, 33.84 and 46.95 mg/L (geometric mean). A positive control (potassium dichromate) was performed to ensure the quality of the results. All validity criteria were met. The test item has a 48h-EC50 = 29.93 mg/L (measured, geom. mean), a NOEC = 12.76 mg/L, and a LOEC = 18.50 mg/L, based on mobility.
Reference
Table 1. Immobility Data
Group |
Nominal Concentration (% w/v saturated concentration prepared at 100 mg/L) |
Geometric mean measured concentration (mg a.i./L) |
N° of Replicates |
N° of Daphnids/ group |
Immobility N° and % at |
|||||
0 h |
24 h |
48 h |
||||||||
N° |
% |
N° |
% |
N° |
% |
|||||
G1 |
0.0 (Control) |
- |
4 |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
G2 |
26.0 |
12.76 |
4 |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
G3 |
36.4 |
18.50 |
4 |
20 |
0 |
0 |
0 |
0 |
1 |
5 |
G4 |
51.0 |
22.22 |
4 |
20 |
0 |
0 |
0 |
0 |
6 |
30 |
G5 |
71.3 |
33.84 |
4 |
20 |
0 |
0 |
0 |
0 |
12 |
60 |
G6 |
100.0 |
46.95 |
4 |
20 |
0 |
0 |
20 |
100 |
20 |
100 |
Key: h = Hour, - = Not Applicable
Table 2. Mean Values of Physico-Chemical Parameters of Test Media
Groups |
Nominal Concentration (% w/v saturated concentration prepared at 100 mg/L) |
pH |
Temperature (°C) |
Dissolved Oxygen (%) |
Total Hardness (as CaCO3) mg/L water |
|||||||||
Initial |
Final |
Initial |
Final |
Initial |
Final |
|||||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
179.2 |
||
G1 |
0.0 (Control) |
7.05 |
0.039 |
6.90 |
0.178 |
20.0 |
0.13 |
18.9 |
0.05 |
8.33 |
0.057 |
8.25 |
0.053 |
|
G2 |
26.0 |
7.16 |
0.017 |
7.06 |
0.123 |
20.0 |
0.26 |
18.8 |
0.17 |
8.28 |
0.100 |
8.16 |
0.110 |
|
G3 |
36.4 |
7.21 |
0.013 |
7.10 |
0.084 |
20.1 |
0.13 |
18.8 |
0.10 |
8.28 |
0.050 |
8.20 |
0.038 |
|
G4 |
51.0 |
7.25 |
0.008 |
7.19 |
0.166 |
19.9 |
0.13 |
18.8 |
0.10 |
8.28 |
0.054 |
8.22 |
0.048 |
|
G5 |
71.3 |
7.36 |
0.018 |
7.17 |
0.114 |
20.0 |
0.21 |
18.7 |
0.15 |
8.28 |
0.073 |
8.21 |
0.108 |
|
G6 |
100.0 |
7.37 |
0.021 |
6.85 |
0.363 |
20.0 |
0.10 |
18.9 |
0.06 |
8.27 |
0.087 |
8.15 |
0.088 |
Key: SD = Standard Deviation
Table 3. Geometric Mean of Dihydromyrcenyl Formate
Groups |
Nominal Concentration (% w/v saturated concentration prepared at 100 mg/L) |
Measured Concentration ofDihydromyrcenyl Formate (mg a.i./L) |
Geometric Mean |
Geometric Mean |
||
0 h |
24 h |
48 h |
||||
G1 |
0.0 (Control) |
- |
- |
- |
- |
- |
G2 |
26.0 |
14.3526300 |
12.9876800 |
11.1409000 |
13.65 |
12.76 |
G3 |
36.4 |
20.7413300 |
18.5342600 |
16.4639100 |
19.61 |
18.50 |
G4 |
51.0 |
24.2240400 |
21.9960300 |
20.5892300 |
23.08 |
22.22 |
G5 |
71.3 |
36.9503500 |
33.8285700 |
31.0012300 |
35.36 |
33.84 |
G6 |
100.0 |
49.9790900 |
45.4520300 |
45.5502300 |
47.66 |
46.95 |
Key: h = Hour, GM = Geometric mean
Formula for Calculating Geometric Mean Exposure Concentration
Table 4. Relationship between Percent Immobility and Concentration ofDihydromyrcenyl Formate
Exposure Time (h) |
EC50Value (% w/v saturated concentration prepared at 100 mg/L) |
95% Confidence Interval (mg/L) |
Regression Equation (y = a + bx) |
|
Lower Limit |
Upper Limit |
|||
48 |
63.9 |
54.7 |
76.4 |
y = -6.7 + 6.5x |
Calculation based on Geometric Mean Concentration
Exposure Time (h) |
EC50Value (mg a.i./L) |
95% Confidence Interval (mg a.i./L) |
Regression Equation (y = a + bx) |
|
Lower Limit |
Upper Limit |
|||
48 |
29.93 |
25.34 |
35.35 |
y = -4.92 + 6.72x |
Key: h = Hour, y = Probit of immobility, x = Log concentration of Dihydromyrcenyl Formate, a = Intercept, b = Slope
Description of key information
Key study: Method according to OECD 202. GLP study. The 48h-EC50 of the test item in Daphnia magna was found to be 29.93 mg/L (measured, geom. mean), the NOEC = 12.76 mg/L, and the LOEC = 18.50 mg/L, based on mobility.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 29.93 mg/L
Additional information
Key study. Acute immobilisation test on Daphnia magna according to OECD 202, GLP study. Based on the results obtained in a preliminary range-finding test, 4 groups of 5 daphnids each were exposed to 0 (control), 26.0, 36.4, 51.0, 71.3 and 100.0% w/v saturated test item solutions in a static system for 48 h. As the test item was found to be volatile, all tests were performed in screw-capped glass bottles and reduced headspace to avoid substance loss from the test media. Test concentrations were analytically determined at 24h intervals by a validated HPLC-UV method. As the deviation from the initial values was greater than 20% from the nominal, results are based on measured concentrations (geometric mean). A positive control (potassium dichromate) was performed to ensure the quality of the results. All validity criteria were met. The test item has a 48h-EC50 = 29.93 mg/L (measured, geom. mean), a NOEC = 12.76 mg/L, and a LOEC = 18.50 mg/L, based on mobility.
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