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EC number: 240-642-0 | CAS number: 16587-71-6
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from a guideline study
- Justification for type of information:
- The acute Daphnia toxicity of Orivone is based on read-across from p-tert-butyl-trans-cyclohexanol. The documentation is presented in the Endpoint summary of Aquatic toxicity.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 43.2 mg/L
- Basis for effect:
- mobility
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 May 2012 to 17 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This information is used for read across to Orivone.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The test item was analytically verified in the fresh media (0 and 24 h) and old media (after 24 h) of all concentration levels and controls. After 48 h, samples of the old media, only of the concentration levels 6.25 and 50 mg/L and the control were analytical verified, because 100% adult mortality was observed at the highest concentration level of 100 mg/L. Sampling from freshly prepared media was carried out immediately after homogenisation. Samples of the old media were taken directly from the vessels.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The test item was completely melted at temperatures up to 70-90 °C before weighing out. The stock solution (100 mg/L test item was weighed out) was prepared with dilution water one day before star of the exposure phase (0 hours) and water renewal (24 hours). The stock solution was stirred with approcimately 1100 rpm for 24 hours at room temperature. The stock solution was further diluted to obtain the respective test concentrations. A solvent control was prepared from dilution water without test item under the same conditions as the test group. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: STRAUS (clone 5)
- Source: Institut für Wasser-, Boden und Lufthygiene (WaBoLu)
- Breeder: DR.U.Noack-Laboratorien, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
- Feeding during test: no
ACCLIMATION
- Acclimation period: at least 2 h in dilution water
STOCK CULTURE MAINTENANCE CONDITIONS
- Culture conditions: in glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2 °C, in an incubator, 16 h illumination (max 20 µE·m-2·s-1)
- Culture medium: Elendt M4, according to Elendt (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Food type: a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata, Desmodesmus subspicatus and Chlorella vulgaris, with an algal density of >10E+06 cells/mL
- Frequency: at least 5 times per week
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 160 - 180 mg/L (as CaCO3)
- Test temperature:
- 18 - 22 ± 1°C
- pH:
- 7.57 - 8.20
- Dissolved oxygen:
- 8.02 - 8.64 mg/L
- Conductivity:
- 641 µS/cm
- Nominal and measured concentrations:
- - Nominal concentrations: 0 (control), 6.25, 12.5, 25.0, 50.0 and 100.0 mg/L (based on a range-finding test)
- Measured concentrations (t=0h; new):- Measured concentrations (t=24h; old): - Measured concentrations (t=24h; new): - Measured concentrations (t=48h; old): - Details on test conditions:
- TEST SYSTEM
- Age of the daphnids at experimental starting: 2 to 24 h old daphnids were used for the reference test. They were obtained by removing the mother animals twice within 22 h.
- Culture medium: Elendt M4
- Test vessel/volume: With regard to the volatility of the test item sealed glass flasks (4.5 (ID) x 9.5 (H) cm, ca. 130 mL) filled up with the test solution having nearly no headspace to reduce losses of the test item.
- Renewal rate of test solution: Daily. For this purpose, the freshly prepared test solutions were filled into a second set of test vessels and the daphnids were transferred afterwards by a pipette.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Application: The test vessels were filled up with the test solutions. The daphnids were transferred with a small amount of dilution water (start of the exposure) or test solution (water renewal) by a pipette. The test vessels were closed thereafter immediately to reduce losses of the test item.
TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: ISO Test water
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24h
OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: diffuse light, light intensity of max. 20 µE·m -² · s -¹
EFFECT PARAMETERS MEASURED
At the beginning of the exposure phase (0 h) and water renewal after 24 hours, the water quality parameters (pH value, dissolved oxygen concentration, temperature, conductivity and total hardness) of the dilution water were measured, respectively. At the beginning of the exposure phase (0 h) and after 24 h, the water quality parameters of the fresh media (pH value, oxygen concentration) were measured in one additional replicate per concentration level and control. After 24 h and 48 h, the water parameters of the old media were measured in all replicates per concentration level and control. The incubator temperature was recorded throughout the test with a hygrothermograph. Immobility was determined in all groups after 24 and 48 h. An animal was considered to be immobile, if it was not able to swim within 15 seconds after gentle agitation of the test vessel.
RANGE-FINDING STUDY: yes
- Test concentrations (nominal): 0 (control), 1.0, 10.0 and 100.0 mg/L
- Results used to determine the conditions for the definitive study: all daphnids were immobile at 100 mg/L; no immobility was observed at the other concentrations- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 43.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% C.L.: 41.3 - 45.1 mg/L
- Details on results:
- - Mobility: no immobility was observed in the negative control group and up to a concentration of 25.0 mg/L throughout the test. At 50 and 100 mg/L, 90 and 100% daphnia were immobile after 48 h, respectively. See 'Any other information on results incl. tables'. The 48-h NOEC was 25.0 mg/L.
- Mortality of control: no
- Test item solubility: all test item solutions were visually clear throughout exposure- Results with reference substance (positive control):
- The 24-h EC50 value of the reference substance was determined to be 1.76 mg/L (Cl 1.50 - 2.01 mg/L) (a reference test is conducted once per month at the test facility).
- Reported statistics and error estimates:
- EC10 and EC50 values were calculated by sigmoidal dose-response regression. The confidence intervals were calculated from the best-fit values, the standard error and the t-distribution with the software GraphPad prism5. Calculations were using the following software: GraphPad prism5 and Microsoft Excel.
Table: Immobilization Rates after 24 and 48 h of exposure
Nominal Test Item Concentration [mg/L]
Immobilization [%]
24 h
48 h
Replicates
Replicates
1
2
3
4
MV
1
2
3
4
MV
100
100
100
100
100
100
100
100
100
100
100
50
60
60
80
80
70
100
80
100
80
90
25
0
0
0
0
0
0
0
0
0
0
12.5
0
0
0
0
0
0
0
0
0
0
6.25
0
0
0
0
0
0
0
0
0
0
Control
0
0
0
0
0
0
0
0
0
0
MV = Mean value
- Validity criteria fulfilled:
- yes
- Remarks:
- see 'Any other information on materials and methods incl tables'.
- Conclusions:
- The 48-h EC50 is 43.2 mg/L in freshwater invertebrates (D. magna).
- Executive summary:
The acute toxicity to aquatic invertebrates was determined in a study according to OECD TG 202 and in compliance with GLP criteria. In this study daphnids (D. magna, 20 per concentration) were exposed to nominal concentrations of 0 (control), 6.25, 12.5, 25.0, 50.0 and 100 mg/L for 48 hours under semi-static conditions. Analytical confirmation of nominal test concentrations showed that all test concentrations remained within ±20% of nominal concentrations throughout the test. Therefore, the effect values are based on nominal concentrations. Immobilization was recorded after 24 and 48 hours exposure. The water quality parameters measured at 24 and 48 h, were determined to be within the acceptable limits. The validity criteria of the test guidelines were fulfilled. After 48 hours, immobility was determined to be 90 and 100% in the two highest test concentrations, whereas at the other (lower) test concentrations no effects were observed. Based on these findings the 48-h EC50 value was estimated to be 43.2 mg/L (95% C.L.: 41.3 - 45.1 mg/L).
Referenceopen allclose all
Description of key information
No data is available for Orivone. Therefore read-across is performed to the close structural analogue p-tert butyl-trans-cyclohexanol (CAS 98-52-2). Its acute toxicity to aquatic invertebrates was determined in a study according to OECD TG 202 and in compliance with GLP criteria. In this study daphnids (D. magna, 20 per concentration) were exposed to nominal concentrations of 0 (control), 6.25, 12.5, 25.0, 50.0 and 100 mg/L for 48 hours under semi-static conditions. Analytical confirmation of nominal test concentrations showed that all test concentrations remained within ±20% of nominal concentrations throughout the test. Therefore, the effect values are based on nominal concentrations. Immobilization was recorded after 24 and 48 hours exposure. The water quality parameters measured at 24 and 48 h, were determined to be within the acceptable limits. The validity criteria of the test guidelines were fulfilled.After 48 hours, immobility was determined to be 90 and 100% in the two highest test concentrations, whereas at the other (lower) test concentrations no effects were observed.Based on these findings the 48-h EC50 value was estimated to be 43.2 mg/L (95% C.L.: 41.3 - 45.1 mg/L). There is no need to convert the toxicity of the source chemical data towards Orivone, because of the comparable properties of the substances.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 43.2 mg/L
Additional information
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