Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- 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:
- Toxicity of Orivone to algae is based on read-across from p-tert-butylcyclohexanon. The documentation is presented in the Endpoint summary of Aquatic toxicity.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 60 mg/L
- Nominal / measured:
- meas. (TWA)
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 26 mg/L
- Nominal / measured:
- meas. (TWA)
- Basis for effect:
- growth rate
- Validity criteria fulfilled:
- yes
- Remarks:
- The information is based on read across and presented with adequate and reliable documentation.
- Conclusions:
- The EC50 and EC10 are 60 and 26 mg/l, respectively based on read across from p-tert-butyl cyclohexanone which is tested acciording to OECD TG 201.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Jun 2002 to 28 Jun 2002
- 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:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 1992
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 and 72 hours. Analysis was also performed on the stock solution at 0 hours.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
A stock solution was prepared to give the desired series of test concentrations. To achieve this, 125.2 mg of the test substance were added to 1 litre of dilution water and treated for 1 h in an ultrasonic bath and afterwards stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test substance were removed by filtration using a folded filter of pore size 7-12 µm. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Strain: non-axenic strain
- Source: 'The Collection of Algal Cultures' of the Institute of Plant Physiology at the University of Göttingen (Germany)
- Maintenance of stock cultures: Exponentially-growing stock cultures are maintained in the test facility under constant temperature conditions (23 ± 2 °C) at a light intensity in the range 60 - 120 µE·m-2·s-1 (measured in the range 400 to 700 nm using a spherical quantum flux meter). The nutrient medium (according to BRINGMANN & KUHN (1977) is renewed once a week. Cell density measurements are made using a microcell counter.
- Preparation of pre-cultures: Pre-cultures are set up three days before the start of a test. They are grown under identical exposure conditions as the stock cultures, except from the use of a different nutrient medium - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 21 - 25 °C
- pH:
- - Test start (0h): 7.8 - 7.9
- Test termination (72h): 10.2 - 10.3 - Nominal and measured concentrations:
- - Nominal concentrations: 0 (control), 3.2, 6.3, 13, 25, 50 and 100 mg/L
- Measured concentrations at t=0:- Measured concentrations at t=72: - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks with stoppers
- Fill volume: 300 mL
- Initial cells density: approximately 1.0E+04 cells per mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- Culturing apparatus: light chamber that control temperature and provide continuous illumination
TEST MEDIUM / WATER PARAMETERS
- Composition: see 'Any other information on materials and methods incl. tables'
- Other: Solid NaHCO3 is added to the nutrient media to make up a final concentration of 50 mg/L in the solutions of the pre-cultures and test cultures.
OTHER TEST CONDITIONS
- Light intensity: in the range of 60 to 120 µE·m-2·s-1 (equivalent to 4000 to 8000 lux)
EFFECT PARAMETERS MEASURED:
- Algal cell densities: The cell densities were measured at 24 hour intervals. Cell density measurements were made using a microcell counter.
- Inhihibition: Inhibition of the algal population was measured as reduction in growth and growth rate, relative to control cultures grown under identical conditions.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2- Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 60 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 26 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 45 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% C.L.: 40 - 50 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% C.L.: 20 - 30 mg/L
- Details on results:
- Inhibition of growth rate was observed from approximately 25 mg/L (3%) and increased in a dose-dependent manner up to 58.6% inhibition at 100 mg/L. See 'Any other information on results'.
- Results with reference substance (positive control):
- No positive control was used.
- Reported statistics and error estimates:
- Probit analysis and Dunnett's test.
Table: Mean cell density during the test
Nominal concentration [mg/L]
Cell density [cells/mL]
(initial cell density of 10E+04 cells/mL)
24 h
48 h
72 h
Control
38889
174444
345000
3.2
37778
185556
342222
6.3
40000
176667
345444
13
40000
185556
341111
25
34444
181111
301111
50
34444
128889
183333
100
3333
42222
43333
Table: Mean growth rate (r)
Nominal concentration [mg/L]
Growth rate
[1/d]
Inhibition (+) / Increase (-)
[%]
Control
1.18
0.0
3.2
1.18
0.2
6.3
1.19
-0.8
13
1.18
0.3
25
1.13
3.8
50
0.97
17.9
100
0.49
58.6
Table: Mean growth (b) [integral of biomass]
Nominal concentration [mg/L]
Area under growth curve
Inhibition (+) / Increase (-)
[%]
Control
360833
0.0
3.2
369444
-2.4
6.3
368889
-2.2
13
371111
-2.8
25
341111
5.5
50
230000
36.3
100
72222
80.0
ADDITIONAL TEST RESULTS
Growth rate:
- NOErC: 12.1 mg/L
- ErC05: 21 mg/L
- ErC90: 136 mg/L
- ErC95: 171 mg/L
Biomass:
- NOEbC: 21.1 mg/L
- EbC05: 22 mg/L
- EbC90: 78 mg/L
- EbC95: 92 mg/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 72-h ErC50 and ErC10 values are 60 and 26 mg/L, respectively, in freshwater algae (D. subspicatus).
- Executive summary:
The toxicity towards freshwater algae was determined in a study according to OECD TG 201 and in compliance with GLP criteria. In this study, exponentially growing freshwater algae (Desmodesmus subspicatus) were exposed to nominal test substance concentrations of 0 (control), 3.2, 6.3, 13, 25, 50 and 100 mg/L for 72 hours under static conditions. Analytical confirmation showed that measured concentrations ranged from 68 - 108% of nominal values at 0 hours, and from 58 - 85% of nominal values at 72 hours, respectively. Therefore, all results are expressed in terms of mean measured concentrations. The cell densities were measured at 24 h intervals. Inhibition of the algal population was measured as growth rate (index r) and reduction in growth (index b), relative to control cultures under identical conditions. Inhibition of growth rate was observed from approximately 25 mg/L (3%) and increased in a dose-dependent manner up to 58.6% inhibition at 100 mg/L. Biomass was also inhibited from approximately 25 mg/L (5.5%), and increased in a dose-dependent manner up to 80% at 100 mg/L. Based on these results, the 72-h ErC50 and 72-h EbC50 were determined at 60 and 45.0 mg/L. The 72-h ErC10 and 72 -h EbC10 were 26 and 25 mg/L, respectively.
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-butylcyclohexanone (CAS 98-53-3). Its toxicity towards freshwater algae was determined in a study according to OECD TG 201 and in compliance with GLP criteria. In this study, exponentially growing freshwater algae (Desmodesmus subspicatus) were exposed to nominal test substance concentrations of 0 (control), 3.2, 6.3, 13, 25, 50 and 100 mg/L for 72 hours under static conditions.Analytical confirmation showed that measured concentrations ranged from 68 - 108% of nominal values at 0 hours, and from 58 - 85% of nominal values at 72 hours, respectively. Therefore, all results are expressed in terms of mean measured concentrations. The cell densities were measured at 24 h intervals. Inhibition of the algal population was measured as growth rate (index r) and reduction in growth (index b), relative to control cultures under identical conditions. Inhibition of growth rate was observed from approximately 25 mg/L (3%) and increased in a dose-dependent manner up to 58.6% inhibition at 100 mg/L. Biomass was also inhibited from approximately 25 mg/L (5.5%), and increased in a dose-dependent manner up to 80% at 100 mg/L. Based on these results, The 72-h ErC50and 72-h EbC50 were determined at 60 and 45.0 mg/L. The 72-h ErC10 and 72 -h EbC10 were 26 and 25 mg/L, respectively. 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
- EC50 for freshwater algae:
- 60 mg/L
- EC10 or NOEC for freshwater algae:
- 26 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.