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EC number: 607-277-2 | CAS number: 23825-05-0
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 January 2018 till 07 Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- 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
- Version / remarks:
- December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[10-(acetyloxy)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate
- EC Number:
- 607-277-2
- Cas Number:
- 23825-05-0
- Molecular formula:
- C25H30O6
- IUPAC Name:
- 2-[10-(acetyloxy)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Off-white powder
- Storage condition of test material: At room temperature
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48 hours.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The batch of PREDIAC-Z tested was not completely soluble in test medium at the loading rate initially prepared. Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in medium. Thereafter, the aqueous Saturated Solution (SS) was collected by filtration through a 0.45 µm membrane filter and used as the highest test concentration. Lower test concentrations (1% and 10% of the SS) were prepared by subsequent dilutions of the SS in test medium. All test solutions were clear and colorless at the end of the preparation procedure. Hence tested concentrations were PREDIAC-Z Solutions containing 1.0, 10 and 100% of a Saturated Solution prepared at a loading rate of 100 mg/L. As controls test medium without test item or other additives was used.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: For the test selection of young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.
Feeding during test: none.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L expressed as CaCO3
- Test temperature:
- 20-21°C
- pH:
- Range at start and end in control and the test concentration of 1.7 mg/L: 7.9-8.1
- Dissolved oxygen:
- Range at start and end in control and the test concentration of 1.7 mg/L: 8.6-9.2 mg/L
- Nominal and measured concentrations:
- Nominal concentrations were PREDIAC-Z Solutions containing 1.0, 10 and 100% of a Saturated Solution (SS) prepared at a loading rate of 100 mg/L. Samples taken from the control and the highest test concentration were analysed. At the start of the test, a concentration of 1.67 mg/L (rounded to 2 significant figures: 1.7 mg/L) was measured in the undiluted SS. During the exposure period, this concentration remained stable, i.e. was 90% of the initially measured concentration at the end of the test (measured concentration 1.51 mg/L). Based on these results, the effect parameters were based on initially measured concentrations (i.e. 1.7 mg/L).
- Details on test conditions:
- Test vessels: 60 mL, all-glass;
Number of daphnids: 20 each in the control and the undiluted SS, 10 per intermediate test concentration;
Loading: 5 per vessel containing 50 mL of test solution;
Light: 16 hours photoperiod daily;
Feeding: No feeding;
Aeration: No aeration of the test solutions;
Introduction of daphnids: Within 15 minutes after preparation of the test solutions.
Immobility (including mortality): Recorded at 24 hours and at 48 hours.
Dissolved oxygen & pH: Measured at the beginning of the test, for the highest concentration and the control.
Temperature of medium: Measured continuously in a temperature control vessel, beginning at the start of the test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr2O7)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.7 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: See remark
- Remarks:
- The measured concentration of 1.7 mg/L represents the maximum soluble concentration of the test item in test medium at a loading rate of 100 mg/L.
- Details on results:
- In the control and in the PREDIAC-Z Solutions containing 1.0, 10 and 100% of a Saturated Solution prepared at a loading rate of 100 mg/L, 0% immobility was recorded after 24 and 48 hours. This etablishes the 48-h EC50 as >1.7 mg/L based on measured concentrations.
- Results with reference substance (positive control):
- Potassium dichromate (K2Cr2O7) was tested in a separate test on 02-04 January 2018. The 24h-EC50 was 0.87 mg/L with a 95% confidence interval between 0.80 and 0.95 mg/L. This is within the expected range according to OECD 202 (2012): 06-2.1 mg/L, confirming the sensitivity of the test organisms.
- Reported statistics and error estimates:
- Not applicable.
Any other information on results incl. tables
Small responses at the retention time of the test item were detected in the chromatograms of the blank QC samples. It was considered to derive from carry-over in the analytical system since similar responses were found in the analytical blanks. The maximum contribution to the QC samples at the lowest concentration level (0.001 mg/L) was 15%. It was considered that it has no significant impact on the results of the study.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- 1. In the control: 0% immobility, no signs of disease or stress. 2. The oxygen concentration at the end of the test was ≥3 mg/L in control and test vessels.
- Conclusions:
- The 48h-EC50 for Daphnia magna exposed to PREDIAC-Z was beyond the tested range, i.e. exceeded a measured concentration of 1.7 mg/L being considered to be the maximum soluble concentration of the test item in test medium at a loading rate of 100 mg/L.
- Executive summary:
The objective of the study was to evaluate PREDIAC-Z for its ability to generate acute toxic effects on the mobility of Daphnia magna during an exposure period of 48 hours and, if possible, to determine the EC50 at 24 and 48 hours of exposure.
The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, procedures were based on the test methods described in the OECD series on testing and assessment number 23, 2000.
A Saturated Solution (SS) was prepared at a loading rate of 100 mg/L and used as the highest concentration. Lower concentrations (1.0 and 10% of the SS) were prepared by diluting the highest concentration in test medium.
A combined limit/range-finding test was performed. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an untreated control and to an undiluted SS prepared at a loading rate of 100 mg/L, in a limit test. In addition ten daphnids per group (5 per replicate, duplicate) were exposed to solutions containing 1.0 and 10% of the SS prepared at a loading rate of 100 mg/L in the combined range-finding test. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test.
No immobility was observed in the control or at any of the test concentrations throughout the exposure period.
Samples taken from the control and the highest test concentration were analysed. At the start of the test, a concentration of 1.7 mg/L was measured in the undiluted SS. During the exposure period, this concentration remained stable, i.e. was 90% of the initially measured concentration at the end of the test.
The study met the acceptability criteria prescribed by the study plan and was considered valid.
In conclusion, the 48h-EC50 for Daphnia magna exposed to PREDIAC-Z was beyond the tested range, i.e. exceeded a measured concentration of 1.7 mg/L being considered to be the maximum soluble concentration of the test item in test medium at a loading rate of 100 mg/L.
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