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EC number: 243-175-0 | CAS number: 19592-55-3
- 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 microorganisms
Administrative data
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 March 2013 to 18 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordance with OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
- Qualifier:
- according to guideline
- Guideline:
- ISO 8192 (Water quality - Test for inhibition of oxygen consumption by activated sludge for carbonaceous and ammonium oxidation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- EC Number:
- 243-175-0
- EC Name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- Cas Number:
- 19592-55-3
- Molecular formula:
- C25H36O4
- IUPAC Name:
- (1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
- Test material form:
- solid: crystalline
- Details on test material:
- Slightly yellow crystalline powder
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Batch: HX-1212088-716
Purity/Composition: 95.6%
Expiry date: 23 September 2013 (Retest date)
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Details on test solutions:
- Since the water solubility of Proketal was very low (<0.01 mg/L), nominal loading rates were prepared for the test. 1-Litre test bottles were filled with 200 mL of test substance mixtures in Milli-RO water (tap water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) with initial loading rates of 2.5 times the final loading rate. The test substance was transferred into the test medium after a 10 minute treatment with ultrasonic waves to pre dissolve the test substance in 10-20 mL of Milli-RO. These mixtures were stirred in closed dark brown bottles for approximately 24 hours except for the abiotic control which was stirred for approximately 27 hours. Subsequently, 16 mL synthetic medium, 250 mL sludge and Milli-RO water up to 500 mL were added resulting in the required loading rates. Optimal contact between the test substance and test organisms was ensured applying continuous aeration and stirring.
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- Micro-organisms in activated sludge from a Municipal sewage treatment plant: 'Waterschap Aaen Maas', Heeswijk-Dinther, The Netherlands, receiving predominantly domestic sewage.
The number of micro-organisms was determined as the amount of Mixed Liquor Suspended
Solids (MLSS) per litre test medium.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 3 h
- Post exposure observation period:
- After the 3-hour contact time, the oxygen consumption was recorded for a period of 10-15 minutes. During measurement, the sample was not aerated but continuously stirred on a magnetic stirrer with the exception of a short period
Test conditions
- Test temperature:
- The test was conducted under normal laboratory lighting in a temperature controlled room at 20 ± 2 ºC.
18.0-20.1 ºC. - pH:
- The pH in all test series, before the addition of sludge was between 7.3 and 7.6
- Dissolved oxygen:
- The dissolved oxygen concentration at the start was above 60-70% saturation (60% of air saturation is > 5 mg/L at 20°C)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass
- Type (delete if not applicable): open
- Aeration: yes - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol, which showed normal sensitivity.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 3 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth inhibition
- Details on results:
- In the combined limit/range-finding test no inhibition of the respiration rate of the sludge was recorded in two replicates at a loading rate of 1000 mg per litre. Since, the inhibition of the respiration rate in one replicate at a loading rate of 1000 mg/L could not be reliably determined, an additional limit test was performed.
Furthermore, there was no oxygen uptake from abiotic processes and 1000 mg/L with a nitrification inhibitor showed no heterotrophic inhibition of the respiration rate. Therefore, N-allylthiourea was not used in the limit test.
- Results with reference substance (positive control):
- The batch of activated sludge was checked for sensitivity by testing the reference substance 3,5-dichlorophenol, which showed normal sensitivity.
- Reported statistics and error estimates:
- In the additional limit test no statistically significant inhibition of the respiration rate of the sludge was recorded at a loading rate of 1000 mg Proketal / litre (Bonferroni t-Test: α=0.05 Toxstat). The effects observed were in agreement with the results of the combined limit/range-finding test. The results of this test allowed for reliable determination of a NOEC.
Any other information on results incl. tables
The study met the acceptability criteria prescribed by the protocol and was considered valid.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this present test Proketal was not toxic to waste water (activated sludge) bacteria at or below a nominal loading rate of 1000 mg/L (NOEC). The EC50 exceeded a nominal loading rate of 1000 mg/L. This loading rate was far above the very low
water solubility of Proketal (<0.01 mg/L).
This loading rate was far above the very low water solubility of Proketal (<0.01 mg/L).
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