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EC number: 610-565-0 | CAS number: 50717-99-2
- 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:
- 28 April - 26 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (17alpha)-3-ethoxy-19-norpregna-3,5-dien-20-yn-17-ol
- EC Number:
- 619-217-2
- Cas Number:
- 96487-85-3
- Molecular formula:
- C22H30O2
- IUPAC Name:
- (17alpha)-3-ethoxy-19-norpregna-3,5-dien-20-yn-17-ol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: off-white powder
Test item storage: at room temperature
Constituent 1
- Specific details on test material used for the study:
- Solubility in water: not indicated in the report; please refer to section 4.8 of this dossier
Stability in water: yes
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all test concentrations and control.
- Frequency: at t=0 h and t=48 h
- Sampling method: 2.0 mL from the approximate center of the test vessels. At the end of the exposure period, replicates were pooled at each concentration before sampling.
- Sample storage conditions before analysis: samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Direct addition of the test item, highest loading rate of 100 mg/L, applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in medium. The aqueous Saturated Solution (SS) was collected by filtration through a 0.45 μm membrane filter (RC55, Whatman) and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Controls: Test medium without test item or other additives.
- All test solutions were clear and colorless at the end of the preparation procedure.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: Daphnia magna (Straus, 1820)
- Source: In-house laboratory culture with a known history.
- Age of parental stock: >2 weeks old
- 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.
- Age of test organisms at start of test: <24 h
BREEDING:
- Start of each batch: 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.
- Maximum age of the cultures: 4 weeks
- Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
- Temperature of the medium: 18-22 °C
- Feeding: Daily, a suspension of fresh water algae
- Medium: M7 medium
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:
- During test period: 20-21°C
- pH:
- Start: 7.8-7.9
End: 8.0-8.1 - Dissolved oxygen:
- Start: 8.5-8.9
End: 8.4-8.5 - Nominal and measured concentrations:
- Nominal loading rate: 100 mg/L (saturated solution)
Nominal loading rate during Final Test: Control, 10, 18, 32, 56, 100% SS.
Measured concentrations during Final Test: 100% SS: 0.081 mg/L at start, 0.051 mg/L at 48 h.
Based on the observed decrease in concentration during the exposure period, the geometric mean measured concentration was calculated to be 0.064 mg/L. The effect parameters are expressed based on the geometric mean of the measured concentration. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL, all-glass, containing 50 mL of test solution
- Aeration: no aeration
- No. of organisms per vessel: 5 daphnids per vessel
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO Medium, made by dissolving in Reverse-Osmosis purified tap water the following Macro salts: CaCl2.2H2O (211.5 mg/L), MgSO4.7H2O (88.8 mg/L), NaHCO3 (46.7 mg/L) and KCL (4.2 mg/L).
- Culture medium different from test medium: Yes.
- Intervals of water quality measurement: pH and dissolved oxygen were measured at the beginning and at the end of the Final Test, for all concentrations and the control. Temperature of the medium was continuously monitored in a temperature control vessel, beginning at the start of the test.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (including mortality) at 24 h and at 48 h.
RANGE-FINDING STUDY
- Test concentrations: Control, 1, 10, 100% SS. - Reference substance (positive control):
- yes
- Remarks:
- Potassium Dichromate (performed Feb 2017)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.064 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None observed in Control; not reported for test substance concentrations.
- Other biological observations: No signs of disease or stress, for example discoloration, were observed in Control; not reported for test substance concentrations.
- Mortality of control: None
- Other adverse effects control: None
- Effect concentrations exceeding solubility of substance in test medium: Yes
- Analysis of the 100% SS sample at the start of the Final Test showed a measured concentration of 0.081 mg/L, decreasing to 0.051 mg/L at the end of the test. The average exposure concentration (geometric mean) was calculated to be 0.064 mg/L. No precipitation was observed at any of the replicates, therefore 0.064 mg/L was considered the solubility limit of Norethyl in test medium. No immobility was observed at any of the test concentrations and the control during the exposure period of the Final Test. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes.
- The actual response was within the ranges of the expected responses (48h-EC50 between 0.3 and 1.0 mg/L). The sensitivity of this batch of D. magna was in agreement with the historical data collected at the Test Facility.
- Relevant effect levels:
24h-EC50: 0.64 mg/L with a 95% confidence interval 0.56-0.73 mg/L
48h-EC50: 0.48 mg/L with a 95% confidence interval 0.43-0.53 mg/L - Reported statistics and error estimates:
- No statistics reported.
Any other information on results incl. tables
Number of Introduced Daphnids and
Incidence of Immobility in the Final Test
Time (h) |
Replicate |
Norethyl, %SS prepared at 100 mg/L |
|||||
Control |
10
|
18
|
32
|
56
|
100 (0.064) |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
|
24 |
A |
0 |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
0 |
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
0 |
0 |
|
Effect % |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
0 |
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
0 |
0 |
|
Effect % |
0 |
0 |
0 |
0 |
0 |
0 |
( ): Average exposure concentration
Final Test: Test Samples
Time of sampling |
Date of sampling |
Date of |
Percentage of ss2 |
Analyzed concentration |
Relative to |
0 |
20 June 2017 |
26 June 2017 |
0 |
n.d. |
|
|
|
|
100 |
0.0810 |
|
48 |
22 June 2017 |
26 June 2017 |
0 |
n.d. |
n.a. |
|
|
|
100 |
0.0507 |
63 |
1 Samples were stored in the freezer (≤ -15°C) until the day of analysis.
2 Percentage of a saturated solution (ss) prepared at a loading rate of 100 mg/L.
n.d. Not detected.
n.a.Not applicable.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For details on validity criteria see 'Overall remarks' section.
- Conclusions:
- The 48h-EC50 of the test substance for Daphnia magna was above the solubility limit in test medium, i.e. >0.064 mg/L based on the geometric mean measured concentration in the highest treatment group tested.
- Executive summary:
In a 48h acute toxicity study conducted according to OECD guideline 202, Daphnia magna were exposed to Norethyl under static conditions at the following nominal concentrations: 0 (Control), 10, 18, 32, 56, and 100% of the Saturated Solution prepared at a loading rate of 100 mg/L. The geometric mean measured concentration in the SS was calculated to be 0.064 mg/L, which was considered the solubility limit in test medium. No immobility was observed at any of the test concentrations and the control during the exposure period. Therefore, the 48h-EC50 was above the solubility limit, i.e. >0.064 mg/L. The study is considered to be reliable without restrictions.
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