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EC number: 260-686-4 | CAS number: 57345-19-4
- 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 June 2017 to 29 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- The study was performed according to the guideline, the study plan and its amendment(s).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Reference substance name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Cas Number:
- 220432-47-3
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot No.: VE00484383
- Purity: 99.8% (major peak)
- Physical appearance: solid
- Color: whitish to pale yellow
- Water solubility: 0.63 mg/l at 20 °C
- Vapour Pressure: 0.0013 Pa at 20 °C
- Log kow: 5.9; method: OECD Test Guideline 117
- Density: not applicable
- Storage conditions: in a dry, well ventilated location at ambient temperature/10–30 °C, protected from light
- Stability under correct storage conditions (expiry date): August 23, 2017
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples of stock solution and test solutions were taken to determine the actual test item concentrations in comparison to the nominally applied concentrations. The duplicate samples were kept separately as a reserve. The nominal volume per sample was 10 mL. The volume of each sample was recorded. After sampling and before shipment, all samples were stored in amber glass bottles in the dark
at a temperature of ≤ -18°C. A record was kept for each sample. Samples of untreated test medium were provided to the analytical laboratory in order to determine the recovery of the analytical method with the specific test medium. Samples were transferred to the test site for chemical analysis (address see section 1.3 in study report) under the required storage conditions.
The sampling schedule for chemical analysis during the test period was:
- the start of exposure in fresh test solution (hour 0)
- 48 hours, Aged test solution
Test solutions
- Vehicle:
- no
- Details on test solutions:
- As the test item is poorly water-soluble, the following approach was used taking into account aspects of OECD 2000, Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment Number 23. ENV/JM/MONO(2000)6.
A saturated stock solution was prepared at a nominal loading rate of 100 mg/L by adding 200 mg of the test item to 2000 mL of the test medium. This stock solution (S1) was slowly stirred (250 rpm) for 139 hours at ambient temperature in the dark. Thereafter this stock solution was left to settle for half an hour. The stock solution was visually examined for undissolved/particulate matter in the free water column. There was still undissolved material visible in the water column.
Thereafter this stock solution was filtered (filter type: Macherey-Nagel MN GF-5; 0.4 μm pore size); the initial 0.5 L of filtrate were discarded. The remaining stock solution was filtered via the same filter. Visual inspection of the flask showed a clear solution without Tyndall effect.
The filtrate of the stock solution was used, immediately and undiluted, as the test concentration (100% of a filtrate of a saturated solution at a loading rate of 100 mg/L).
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Species: The test system used in this study was Daphnia magna STRAUS (clone M10), a water flea, cultured at ECT Oekotoxikologie GmbH since December 22, 2011.
- Origin: The organisms were originally supplied by KU Leuven, Belgium
- Food: algae (Desmodesmus subspicatus), instant baker’s yeast suspension, TetraMin® suspension
- Feeding frequency: 4 times per week
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 14.2 °dH
- Test temperature:
- 21.2 °C
- pH:
- 7.9
- Dissolved oxygen:
- 8.7 mg/L
- Conductivity:
- 659 μS/cm
- Nominal and measured concentrations:
- Nominal concentration: 100% of a saturated solution at a loading rate of 100 mg/L.
Measured concentrations (test period: 0 h) : 1.18 mg test item/L
Measured concentrations (test period: 48 h) : 0.978 mg test item/L - Details on test conditions:
- - Test duration: 48 h
- Test units: 60-mL glass beakers, closed by screw-caps
- Volume of test solution per test vessel: 50-60 mL
- Number of daphnids per test vessel: 5
- Target temperature: 18 - 22°C
- Photoperiod: 16 h light / 8 h dark
- Aeration: none
- Feeding during exposure: none
- Test concentrations (nominal): Control; 100% of a saturated solution at a loading rate of 100 mg/L
- Number of replicates per concentration: 4
- Number of replicates in the controls: 4
- Renewal of test solution during exposure: Static, no renewal
- Chemical analysis of test concentrations: At start and at end of exposure - Reference substance (positive control):
- no
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.07 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- saturated solution at a loading rate of 100 mg test item/L.
- Basis for effect:
- mobility
- Remarks on result:
- other: no effects at solubility limit of the test media
- Details on results:
- In this limit test no immobilities were observed in control or in the undiluted filtrate of a saturated solution at a loading rate of 100 mg test item/L.
It is therefore concluded that the EC50 of the test item at the water saturation level under the conditions of this test is higher than the limit concentration tested (saturated solution at a loading rate of 100 mg test item/L). This corresponds to a geometric mean measured Amberketal concentration of 1.07 mg/L.
The test item concentration was stable during the test period, with 83% of the initially measured concentration found in the aged solution.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this limit test no immobilities were observed in control or in the undiluted filtrate of a saturated solution at a loading rate of 100 mg test item/L.
It is therefore concluded that the test item exhibits no acute toxicity to daphnia at the solubility limit under the conditions of this test (saturated solution at a loading rate of 100 mg test item/L). This corresponds to a geometric mean measured Amberketal concentration of 1.07 mg/L. - Executive summary:
Acute Toxicity Study in Daphnia magna with AMBERKETAL was determined according to OECD guideline No. 202.
The Batch of AMBERKETAL tested was a whitish to pale yellow solid.
As the test item is poorly water-soluble, the following approach was used taking into account aspects of OECD 2000, Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment Number 23. ENV/JM/MONO(2000)6.
A saturated stock solution was prepared at a nominal loading rate of 100 mg/L as described below by adding 200 mg of the test item to 2000 mL of the test medium (section 13.4). This stock solution (S1) was slowly stirred (250 rpm) for 139 hours at ambient temperature in the dark. Thereafter this stock solution was left to settle for half an hour. The stock solution was visually examined for undissolved/particulate matter in the free water column. There was still undissolved material visible in the water column. Thereafter this stock solution was filtered (filter type: Macherey-Nagel MN GF-5; 0.4 μm pore size); the initial 0.5 L of filtrate were discarded. The remaining stock solution was filtered via the same filter. Visual inspection of the flask showed a clear solution without Tyndall effect. The filtrate of the stock solution was used, immediately and undiluted, as the test concentration (100% of a filtrate of a saturated solution at a loading rate of 100 mg/L).
Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to a saturated solution at a loading rate of 100 mg/L. This corresponds to a geometric mean measured Amberketal concentration of 1.07 mg/L. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test ( Day 0 and Day 2).The test item concentration was stable during the test period, with 83% of the initially measured concentration found in the aged solution.The study met the acceptability criteria prescribed by the study plan and was considered valid.
In this limit test no immobilities were observed in control or in the undiluted filtrate of a saturated solution at a loading rate of 100 mg test item/L.
It is therefore concluded that the EC50 of the test item at the water saturation level under the conditions of this test is higher than the limit concentration tested (saturated solution at a loading rate of 100 mg test item/L). This corresponds to a geometric mean measured Amberketal concentration of 1.07 mg/L.
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