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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
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:
- 25 February 2013 to 27 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordance with GLP and OECD methods. Substance is well characterised.
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 202 (Daphnia sp. Acute Immobilisation Test)
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- GLP compliance:
- yes
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:
- Proketal; pregna-5,7-diene-3,20-dione, cyclic 3,20-bis(1,2-ethanediyl acetal)
-Molecular weight 400.5
-Purity/composition correction No factor required
-Hygroscopic Not indicated
-Volatile No
-Stability in water Not indicated
-Solubility in water <0.01 mg/L
- Substance type:
- Physical state: Slightly yellow crystalline powder
Stability under test conditions: Stable
- Storage condition of test material: At room temperature (<25C) in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for analytical confirmation of actual exposure concentrations were taken at the start and after 48-hours of exposure.
Volume 2 mL from the approximate center of the test vessels
Storage Samples were stored in a freezer until analysis.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Additionally, singular reserve samples of 2 mL were taken for possible analysis. If not used,these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.
Test solutions
- Details on test solutions:
- Stock and spiking solutions
Stock solutions of the test substance were prepared in acetonitrile at concentrations of 584 and 976 mg/l. In order to dissolve the test substance the solutions were ultrasonicated for 10 minutes.
Spiking solutions were prepared in tetrahydrofuran. In order to dissolve the test substance the solutions were ultrasonicated for 5 minutes.
Calibration solutions
Calibration solutions in the concentration range of 0.04 – 60 mg/l were prepared from two stock solutions. The end solution of the calibration solutions was 50/50 (v/v) acetonitrile/water.
Procedural recovery samples
2 ml blank medium was spiked with the test substance at a target concentration of 0.1 or
100 mg/l. The accuracy samples were treated similarly as the test samples (see paragraph 4.2 ‘Samples’).
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Crustacea, Cladocera
- Source: Straus, 1820
Daphnids of at least the third generation and obtained by acyclical parthenogenesis under specified breeding conditions were used.
The batch was considered valid if the daphnids originated from a healthy stock; being the 2nd to 5th brood of the parental batch which showed 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 was observed. For the test young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old were selected.
ACCLIMATION
A new batch was started with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel. The maximum age of the culture was 4 weeks and half of the medium (M7) was renewed after the first seven days of cultivation. After this renewal, half of the medium was renewed twice a week. The temperature of the medium was 18-22°C. Daphnids were fed daily with a suspension of fresh water algae.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Methods: A static combined limit/range-finding test was performed.
- Post exposure observation period:
- Immobility was recorded after 24 and 48 hours of exposure. Further clinical signs, e.g. daphnids trapped on the surface on the surface, were recorded at the same time.
Test conditions
- Test temperature:
- The temperature of the medium was continuously measured in a temperature control vessel, beginning at the start of the test.
The temperature of the test medium was between 19.8 and 20.1°C at the start of the test. The
temperature continuously measured in a temperature control vessel varied between 19.4 and
20.0
ºC during the test, and complied with the requirements as laid down in the protocol (18-22°C, constant within 2°C).
- pH:
- The pH was measured at the beginning of the test for all test solutions and the control. At the end of the test only measurements were performed in the control and the undiluted filtrate.
These test conditions remained within the limits prescribed by the protocol (pH: 6.0-8.5, not
varying by more than 1.5 unit
- Dissolved oxygen:
- The dissolved oxygen concentration was measured at the beginning and at the end of the test, for the control and the undiluted filtrate.
These test conditions remained within the limits prescribed by the protocol; oxygen: >= 3 mg/L at the end of the test).
- Salinity:
- n/a
- Nominal and measured concentrations:
- Analysis of the samples taken from the filtrate prepared at 100 mg/L showed an estimated concentration of 4 and 7 μg/L at the start and at the end of the test, respectively. This resulted in an estimated average exposure concentration of 5 μg/L. On the filter used to prepare the test concentrations the test substance was identified, which is indicative of the use and removal of Proketal during the test solution preparation.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: All glass culture vessel
- fill volume: 5 litres
- Renewal rate of test solution (frequency/flow rate): renewed after 7 days of cultivation and half of the medium was renewed twice a week
- No. of organisms per vessel: approx 250
Composition of medium in table below - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 5 µg/L
- Nominal / measured:
- estimated
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: Due to the very low solubility of Proketal in the test medium, concentration levels that might be toxic for daphnids could not be reached.
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 5 µg/L
- Nominal / measured:
- estimated
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- Under the conditions of the present study Proketal did not induce acute immobilisation of Daphnia magna at an estimated average concentration of 5 μg/L after 48 hours of exposure (NOEC).
- Results with reference substance (positive control):
- Calculation of EC50:
No EC50 could be calculated because the test substance proved to be non-toxic (EC50 > maximum soluble concentration).
Statistical analysis of the data was not needed as the effects recorded were not significant (<10%). Therefore, the NOEC was considered to be the highest concentration tested.
Acceptability of the test
1. In the control, no daphnids became immobilized.
2. The oxygen concentration at the end of the test was ≥ 3 mg/L in control and test vessels. - Reported statistics and error estimates:
- Statistical analysis of the data was not needed as the effects recorded were not significant (<10%).
Therefore, the NOEC was considered to be the highest concentration tested.
Determination of the average exposure concentrations: The average exposure concentrations were calculated as the geometric means of the concentrations of Proketal measured in the samples taken at the start (C t=0) and the end of the test (C t=48).
Any other information on results incl. tables
Table 1Acute immobilization of daphnids after 24 and 48 hours
Proketal % filtrate prepared at 100 mg/L |
Vessel number |
Number Daphnia exposed |
Response at 24 h |
Response at 48 h |
||
number |
Total % |
number |
Total % |
|||
Control |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 [1] 0 0 0 |
0 |
1.0 |
A B |
5 5 |
0 0 |
0 |
0 0 |
0 |
10 |
A B |
5 5 |
0 0 |
0 |
0 0 |
0 |
100 (5) |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
[ ] number of daphnia observed trapped at the surface of the test solutions. This organism was reimmersed into the respective solution before the recording of mobility.
( ) measured concentration and expressed as the estimated average concentration (μg/L)
Table 2 Effectparameters
Parameter |
Concentration Proketal (μg/L)1 |
NOEC |
5 |
24 and48h-EC50 |
>5 |
1: Estimated average exposureconcentration
Table 3 pH and oxygenconcentrations
Proketal % filtrate preparedat 100mg/L |
Start (t=0h) |
End (t=48h) |
||
pH |
O2 |
pH |
O2 |
|
Control |
8.0 |
9.5 |
8.0 |
9.2 |
1.0 |
8.0 |
|
|
|
10 |
8.0 |
|
|
|
100(5) |
8.0 |
8.6 |
8.0 |
9.2 |
( ) measured concentration and expressed as the estimated average exposure concentration(μg/L)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the present study Proketal did not induce acute immobilisation of DapThis concentration of the undiluted filtrate was considered the maximum soluble concentration in the test medium.
The 48h-EC50 was above the range tested, i.e. exceeded an estimated average concentration of 5 μg/L.
Due to the very low solubility of Proketal in the test medium, concentration levels that might be toxic for daphnids could not be reached.
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