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EC number: 619-264-9 | CAS number: 972-46-3
- 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:
- 28 April - 30 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 March 2017 - 25 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- column elution method
- Key result
- Water solubility:
- 22.8 µg/L
- Conc. based on:
- test mat.
- Temp.:
- 19.9 °C
- pH:
- >= 8 - <= 8.1
- Remarks on result:
- other: average of two runs (maximum difference= 27%)
- Details on results:
- Mean concentration in the water samples (n=10) obtained at the flowrate of 25 mL/h was 25.8 μg/L. CV= 5.9%.
Mean concentration in the water samples (n=10) obtained at the flowrate of 12 mL/h was 19.7 μg/L. CV= 6.0%.
The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was in equilibrium at all flow rates.
The maximum difference on the mean values at both flow rates was ≤ 30%. - Conclusions:
- The water solubility at 19.9°C was determined to be 22.8 μg/L.
- Executive summary:
The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.
Quantification was performed by UPLC-MS/MS. The water solubility at 19.9°C was determined to be 22.8 μg/L. The pH of the aqueous samples was 8.0 -8.1.
No test substance was detected in the samples from the blank column.
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:
- 3-ethoxyandrosta-3,5-dien-17-one
- EC Number:
- 619-264-9
- Cas Number:
- 972-46-3
- Molecular formula:
- C21H30O2
- IUPAC Name:
- 3-ethoxyandrosta-3,5-dien-17-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical appearance: white crystalline powder
Test item storage: In refrigerator (2-8°C)
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:
- - Nominal concentrations: Control, WAFs prepared at 1.0, 10, and 100 mg/L
- Sampling method: 2.0 mL from the approximate centre of the test vessels, at t=0 h and t=48 h.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
- At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: direct addition of test item to test medium - loading rates were individually prepared at 1.0, 10 and 100 mg/L. A two-day period of magnetic stirring was applied to ensure maximum dissolution of the test item in medium. Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by filtration through a 0.45 µm membrane filter (RC55, Whatman) and used as test concentrations.
- Controls: Test medium without test item or other additives
- 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 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:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L expressed as CaCO3
- Test temperature:
- 20°C
- pH:
- Start: 7.9
End: 7.8 - Dissolved oxygen:
- Start: 8.4-8.8
End: 8.7-9.0 - Nominal and measured concentrations:
- - Nominal loading: Control and WAF prepared at a nominal loading rate of 100 mg/L
- Measured concentrations: WAF at 100 mg/L at start: 0.0368 mg/L; at 48 h: 0.00708 mg/L
Based on the observed decrease in concentration during the exposure period, the geometric mean measured concentration was calculated as 0.016 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL, all-glass, containing 80 mL of test solution
- Aeration: No aeration
- No. of organisms per vessel: 5 per vessel
- No. of vessels per concentration (replicates): 4 for WAF at 100 mg/L, 2 for WAFs at 1.0 and 10 mg/L
- 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 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, M7
- Intervals of water quality measurement: pH and dissolved oxygen were measured at the beginning and at the end of the test, for the control and the WAF at 100 mg/L. Temperature of medium was continuously measured 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 24h and at 48 h.
RANGE-FINDING STUDY
- Test concentrations: Control, WAFs prepared at 1.0, 10, and 100 mg/L
- Results used to determine the conditions for the definitive study: not applicable; the range-finding study was combined with a limit test and the results are used to draw final conclusions.
- Reference substance (positive control):
- yes
- Remarks:
- Potassium Dichromate (performed February 2017)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.016 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Details on results:
- - No immobility of daphnids was observed at any of the test concentrations and the control during the test period.
- Behavioural abnormalities: At 24 h, two daphnids in two separate replicates of Control were observed trapped at the surface of the test solution. These organisms were reimmersed into the respective solutions before recording of mobility.
- Mortality of control: None observed.
- Other adverse effects control: No signs of disease or stress, for example discoloration, were observed.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: After 24 and 48 hours of exposure unknown brown particles were observed on the bottom of the control vessels. These particles, however, did not affect the daphnids and therefore the test was accepted.
- Effect concentration exceeding solubility limit in test medium: yes. The sample of WAF at 100 mg/L at the start of the test showed a measured concentration of 0.037 mg/L, which decreased during the exposure period to 0.0071 mg/L. Based on this result, the average exposure concentration was calculated to be 0.016 mg/L, which was considered the solubility limit of the test item in test medium. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes.
Actual responses are within the ranges of the expected responses at the different concentrations (i.e., the 48h-EC50 was between 0.3 and 1.0 mg/L). Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at the Test Facility.
- Relevant effect levels:
The 24h-EC50 was 0.64 mg/L with a 95% confidence interval between 0.56 and 0.73 mg/L.
The 48h-EC50 was 0.48 mg/L with a 95% confidence interval between 0.43 and 0.53 mg/L. - Reported statistics and error estimates:
- No statistics were reported.
Any other information on results incl. tables
Number of Introduced Daphnids and
Incidence of Immobility
Time (h) |
Replicate |
Diona-R, WAF prepared at x mg/L |
|||
Control |
1.0
|
10
|
100 |
||
0 |
A |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
|||
D |
5 |
5 |
|||
Total introduced |
20 |
10 |
10 |
20 |
|
24 |
A |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
|
C |
0 [1] |
|
|
0 |
|
D |
0 [1] |
|
|
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
|
Effect % |
0 |
0 |
0 |
0 |
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
|
C |
0 |
|
|
0 |
|
D |
0 |
|
|
0 |
|
Total immobilised |
0 |
0 |
0 |
0 |
|
Effect % |
0 |
0 |
0 |
0 |
[ ]: number of daphnids observed trapped at the surface of the test solutions. These organisms were reimmersed into the respective solutions before recording of mobility.
( ): Average exposure concentration
Analysis results Combined Limit/Range-finding Test: Reserve test Samples
Time of sampling |
Date of sampling |
Date of |
Loading rate2 |
Concentration |
Relative to |
0 |
02 May 2017 |
30 May 2017 |
0 |
n.d. |
|
|
|
|
100 |
0.0368 |
|
48 |
04 May 2017 |
30 May 2017 |
0 |
n.d. |
n.a. |
|
|
|
100 |
0.00708 |
19 |
1 Samples were stored in the freezer (≤ -15°C) until the day of analysis.
2 A water accommodated fraction (WAF) prepared at the loading rate.
n.d.Not detected.
n.a.Not applicable.
In the initial analysis of the samples from this Daphnia magna test the low accuracy samples fel ouside the acceptability criterion range (70 -110%) and therefore the analysis was repeated with reseve samples.
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. >0.016 mg/L based on the geometric mean measured concentration in the highest treatment group tested.
- Executive summary:
In a 48 h acute toxicity test conducted according to OECD guideline 202, Daphnia magna were exposed to Water Accomodated Fractions (WAF) in a combined limit/range-finding study at the following nominal loading rates: 0 (Control), 1.0, 10, and 100 mg/L. The geometric mean measured concentration in the WAF prepared at 100 mg/L was calculated to be 0.016 mg/L, which was considered the solubility limit of the test item in test medium. No immobility was observed at any of the test concentrations and the control during the exposure period. The 48h-EC50 for Daphnia magna exposed to the test subtance was above the solubility limit, i.e. >0.016 mg/L. The study is considered to be reliable without restrictions.
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