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EC number: 500-276-7 | CAS number: 89800-10-2
- 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:
- 27 Nov 2017 - 14 Mar 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
- EC Number:
- 500-276-7
- EC Name:
- ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
- Cas Number:
- 89800-10-2
- Molecular formula:
- {(C10H16O7).(C3H3O)b.[(C6H10O2)m.(C3H3O)a]} (i.e., UVCB substance)
- IUPAC Name:
- ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Samples were taken from the control and each test group; Samples were analysed at the NOEL test item concentration and above
- Sampling method: Samples were taken from the freshly prepared bulk test preparation at 0 and 24 hours and from the old or expired pooled replicates (R1 to R4) at 24 and 48 h.
- Sample storage conditions before analysis: Samples were stored frozen prior to analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Differential loading: 5.0, 16, 50, 160 and 500 mg were each separately added to the surface of 5 L of test water to give the 1.0, 3.2, 10, 32 and 100 mg/L loading rates respectively. The test solutions were stirred by magnetic stirrer for 23 h and was allowed to stand for 1 h. Subsequently the WAFs were filtered through a glass wool plug (2 to 4 cm in length). A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75 to 100 mL discarded) to give the 1.0, 3.2, 10, 32 and 100 mg/L loading rate WAFs.
- Controls: Yes, Medium only
- Evidence of undissolved material: Microscopic observations of the WAFs were performed after filtering and showed no micro-dispersions of test item were present.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Source: In-house laboratory cultures
- Feeding during test: No feeding during the test
ACCLIMATION
- Acclimation conditions: Same
- Type and amount of food: Mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension.
- Feeding frequency: Each culture was fed daily
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20 - 21 °C (Control and Test item concentrations)
- pH:
- 7.9 - 8.0 (Control)
7.9 - 8.1 (Test Item Concentrations) - Dissolved oxygen:
- 8.7 - 8.8 mg O2/L (Control)
8.3 - 8.8 mg O2/L (Test Item Concentrations) - Nominal and measured concentrations:
- Control, 1.0, 3.2, 10, 32 and 100 mg/L (nominal loading rate, WAF)
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open (covered to reduce evaporation)
- Material, size, headspace, fill volume: 150 mL glass beakers containing 100 mL Elendt M7 medium and 50 mL headspace
- Aeration: No aeration
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 according to OECD 202
- pH: 7.9 ±0.3
- Culture medium different from test medium: Same
- Intervals of water quality measurement: The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test.
OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness cycle with 20 min dawn and dusk transition periods
- Light intensity: between 806 and 903 lux
EFFECT PARAMETERS MEASURED: Any immobilization or adverse reactions to exposure were recorded at 24 and 48 h after the start of exposure.
RANGE-FINDING STUDY
- Test concentrations: Control, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed at 1.0 mg/L loading rate WAF, however, immobilization was observed at 10 and 100 mg/L loading rate WAF. See detailed information in section "Any other information on results incl tables". - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 93 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: water accomodated fraction
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: Water accomodated fraction
- Duration:
- 48 h
- Dose descriptor:
- LOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: Water accomodated fraction
- Details on results:
- - Observations on body length and weight: at 32 and 100 mg/L decrease of body length and pale
- Mortality of control: No mortality - Results with reference substance (positive control):
- The EC50 after 24 h was determined to be at 0.79 mg/L (95% confidential limits: 0.73 - 0.86 mg/L). The results from the positive control with potassium dichromate were within the normal range for this reference item (within the range 0.6 mg/L to 2.1 mg/L).
- Reported statistics and error estimates:
- The EL50 value at 48 h and the slope of the response curve and its standard error were calculated by Probit analysis using Linear Maximum-Likelihood regression. The LOEL and the NOEL at 24 and 48 h were calculated using the Fisher’s Exact Binomial Test with Bonferroni correction. All results were calculated using the ToxRat Professional computer software package (TOXRAT).
Any other information on results incl. tables
Table 1: Biological Results of the Range finding test: Cumulative Immobilization Data and Observations
Nominal Loading rate |
Observations (Initial Population: 5 Per Replicate) |
|||||||
24 Hours |
48 Hours |
|||||||
Cumulative Immobilized Daphnia |
Observations |
Cumulative Immobilized Daphnia |
Observations |
|||||
[mg/L] |
Rep1 |
Rep2 |
Rep1 |
Rep2 |
Rep1 |
Rep2 |
Rep1 |
Rep2 |
Control |
0 |
0 |
5 N |
5 N |
0 |
0 |
5 N |
5 N |
1.0 |
0 |
0 |
5 N |
5 N |
0 |
0 |
5 N |
5 N |
10 |
1 |
1 |
4 N |
4 N |
4 |
5 |
1 N |
AI |
100 |
1 |
0 |
4 N |
4 N 1 R |
5 |
5 |
AI |
AI |
Rep=Replicate; N=normal; R=Reduced mobility; AI=All daphnids immobilized
Table 2: Biological Results of Definitive test: Cumulative Immobilization Data and Observations
Nominal Loading Rate |
48 Hours |
|||||||||
[mg/L] |
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
||||||||
|
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Total |
% |
Rep1 |
Rep2 |
Rep3 |
Rep4 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
1.0 |
1 |
0 |
0 |
0 |
1 |
5 |
4 N |
5 N |
5 N |
5 N |
3.2 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
32 |
0 |
0 |
0 |
0 |
0 |
0 |
4 N 1 S |
5 N |
4 N 1 P |
5 N |
100 |
4 |
2 |
3 |
4 |
13 |
65 |
1 R |
3 P |
2 P |
1 S |
Rep=Replicate; N=normal; R=Reduced mobility; AI=All daphnids immobilized
Table 3: Validity criteria
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
0% |
Yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
>8.5 mg/L |
Yes |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For detailed information see table 3 in section "Any other information on results incl tables".
- Conclusions:
- The effect of the test item on aquatic invertebrates has been investigated and gave EL50 values of 93 mg/L loading rate WAF. The NOEL was 32 mg/L loading rate WAF.
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