Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 608-477-2 | CAS number: 3041-16-5
- 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 November 2018 - 11 January 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-dioxan-2-one
- EC Number:
- 608-477-2
- Cas Number:
- 3041-16-5
- Molecular formula:
- C4H6O3
- IUPAC Name:
- 1,4-dioxan-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): 1,4-dioxan-2-one (PDO monomer)
- Physical state: solid (powder)
- Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: YRMC196
- Expiration date of the lot/batch: 24 January 2019
- Purity test date: 12 September 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in refrigerator, 2-8°C
- Solubility and stability of the test substance in the solvent/vehicle: test substance is completely soluble in test medium at the concentrations tested
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
10, 18, 32, 56, 100 mg/L + control
At the end of the exposure period, the replicates were not pooled at each concentration before sampling. Instead, samples were taken from one replicate per treatment.
- Sampling method:
Samples for possible analysis were taken from all test concentrations and the control according to the following schedule:
Frequency at t=0 h and t=48 h
Volume 4.0 mL from the approximate centre of the test vessel
- Sample storage conditions before analysis:
Not applicable, samples were transferred to the analytical laboratory at the Test Facility and analysed on the day of sampling.
Test solutions
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with the highest concentration of 100 mg/L. No other treatment than vigorous shaking was needed to completely dissolve the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.
- Eluate:
- Differential loading:
- Controls:
- Chemical name of vehicle (organic solvent, emulsifier or dispersant):
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
- Evidence of undissolved material (e.g. precipitate, surface film, etc.):
- Other relevant information:
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain/clone: at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions
- Source: in-house laboratory culture with a known history
- Age of parental stock (mean and range, SD): young daphnia with an age of < 24 hours from parental daphnids of more than two weeks old
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 liters of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during cultivation: fresh water algae, daily
- Feeding during test: no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L CaCO3
- Test temperature:
- 19-20°C
- pH:
- Start (t=0h): 8 (mean)
End (t=48h): 8.6 (mean) - Dissolved oxygen:
- Start (t=0h): 9.4 mg/L O2 (mean)
End (t=48h): 8.6 mg/L O2 (mean) - Salinity:
- not applicable
- Conductivity:
- not applicable
- Nominal and measured concentrations:
- Range-finding test:
Nominal concentrations: 0.1, 1.0, 10, 100 mg/L
Measure concentrations (t=0h): *, 0.36, 5.1, 76 mg/L
Measured concentrations (t=48h): *, *, *, 1.6 mg/L
* not detected
Final test:
Nominal concentrations: 10, 18, 32, 56, 100 mg/L
Measure concentrations (t=0h): 4.1, 9.9, 17, 36, 67 mg/L
Measured concentrations (t=48h): *, *, *, 0.18, 1.9 mg/L
* not detected - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass vessel
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass vessels
- Aeration: no aeration of the test solutions
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immoblity, defined as those animals not able to swim within 15 seconds after gentle agitation of the test vessel and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST SYSTEM
- Test vessel: glass vessel
- Type: closed
- Material, size, headspace, fill volume: 50 mL all glass airtight closed without headspace
- Volume of solution: 50 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 20
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
The following salts (analytical grade) were added to tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
CaCl2.2H2O 211.5 mg/L
MgSO4.7H2O 88.8 mg/L
NaHCO3 46.7 mg/L
KCl 4.2 mg/L
The hardness of test medium expressed as CaCO3: 180 mg/L with a pH between 6 and 9.
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: daily photoperiod of 16 hours
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence interval: 2.5-11 mg/L
- Details on results:
- - Mortality of control:
no
- Immobilisation of control: no
- Abnormal responses: none indicated
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
- Effect concentrations exceeding solubility of substance in test medium: no - Reported statistics and error estimates:
- The 24h-EC50 could not be determined because the observed effects were below 50%.
The 48h-EC50 could not be determined using a regression method. This was because there was no concentration between the highest concentration (A) at which 0% immobility and the lowest concentration (B) at which 100% immobility occurred. Instead, the EC50 was calculated as (AB)½, with A and B being limits of the 95% confidence interval.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of PDO monomer to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. the EC50-48h value with respect to immobilization is 5.3 mg PDO monomer per litre. The results of the test can be considered reliable without restriction.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.