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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 222-225-5 | CAS number: 3391-83-1
- 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:
- The study was conducted between 27 July 2017 and 3 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 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:
- 11-oxahexadecan-16-olide
- EC Number:
- 222-225-5
- EC Name:
- 11-oxahexadecan-16-olide
- Cas Number:
- 3391-83-1
- Molecular formula:
- C15H28O3
- IUPAC Name:
- 1,7-dioxacycloheptadecan-8-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot No.: VE00497116
Aspect: colourless liquid, may crystallize
Purity: 98.9%
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The test item concentration in the test samples was determined by high performance liquid chromatography with UV detection (HPLC/UV) using external calibration. The test item gave a chromatographic profile consisting of one peak.
Test solutions
- Vehicle:
- yes
- Remarks:
- Acetonitrile
- Details on test solutions:
- Due to the low water solubility of the test item, the test media were prepared as follows: The test item was mixed into the test water at a loading rate of 100 mg/L, and was intensively stirred for 24 hours. After stirring the suspension was filtered through a 0.45 μm membrane filter. The undiluted filtrate and the dilutions 1:2, 1:4, 1:8 and 1:16 of the filtrate were used as test media. Additionally, a control (test water without test item) was tested in parallel. The preparation of the test media was based on the OECD Guidance Document No. 23 on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test System
The study was performed with young daphnids of the species Daphnia magna Straus. A clone of this species (originally from the Daphnia Collection of the University of Basel/Switzerland in 2015) is successfully bred in IES Ltd Laboratories. The cultivation of the parental daphnids is performed in reconstituted water of the quality identical to the water quality used in the tests (with respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests (see below).
During breeding, daphnids were generally fed three times a week with an algal suspension of the green algae Desmodesmus subspicatus, supplied by the Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen, 37073 Göttingen/Germany) and cultivated at IES Ltd Laboratories under standardized conditions or a mixture of this algal suspension and a commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49324 Melle/Germany).
At the start of the test, the organisms used in the test were 6-24 hours old and were not first brood progeny.
For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in March 2017 (24-hour EC50: 1.2 mg/L, IES Laboratories Study 20170076) showed that the sensitivity of the test organisms was within the range given by the guideline (24-hour EC50:0.60-2.1 mg/L).
Study design
- Test type:
- semi-static
- Water media type:
- other: Reconstituted test water (ISO Test water) according to OECD Guideline No. 202 was used in the study.
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20-22 °C
- pH:
- 7.6 - 7.9
- Dissolved oxygen:
- At least 8.0 mg/L
- Nominal and measured concentrations:
- The concentrations determined in the freshly prepared test sample of day 0 were 7.61 mg/L (dilution 1:4), 12.9 mg/L (dilution 1:2) and 28.0 mg/L (undiluted). The concentrations determined in the freshly prepared test sample of day 1 were 7.27 mg/L (dilution 1:4), 12.8 mg/L (dilution 1:2) and 26.8 mg/L (undiluted). The measured concentrations reflect the dilution factors.
The concentrations determined in the test samples taken from the 24 hours aged test media of day 1 were 2.98 mg/L (dilution 1:4), 6.77 mg/L (dilution 1:2) and 10.2 mg/L (undiluted). The concentrations determined in the test samples taken from the 24 hours aged test media of day 2 were 4.59 mg/L (dilution 1:4) and 10.2 mg/L (dilution 1:2). It represents a decrease to 36 to 79 % of the corresponding starting concentration. - Details on test conditions:
- Study Design for Main Test.
Based on the results of the stirring experiment and the range-finding test and in agreement with the Sponsor, the following concentrations of MUSK R1 were selected for the main test: The undiluted filtrate with a loading rate of 100 mg/L and the dilutions 1:2, 1:4, 1:8 and 1:16. Additionally, a control (test water without test item) was tested in parallel. The main test was performed in a closed system. Based on the analytical results of the pre-experiment, a semi-static main test with test medium renewal after 24 hours was chosen to keep the concentration as constant as possible during the test period of 48 hours. After 24 hours, the test organisms were transferred by wide-bore pipette in to clean test vessels with freshly prepared test medium of the corresponding concentration.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI :10.4 - 16.9 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 10.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 16.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC0
- Effect conc.:
- 10.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- 16.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- For evaluation of the quality of the daphnia clone and the experimental conditions, potassium dichromate is tested as a positive control twice a year. The result of the latest positive control test in March 2017 (24-hour EC50: 1.2 mg/L, IES Laboratories Study 20170076) showed that the sensitivity of the test organisms was within the range given by the guideline (24-hour EC50: 0.60-2.1 mg/L).
Any other information on results incl. tables
Validity criteria:
The test is considered to be valid, as in the control no daphnids showed immobilization or other signs of disease or stress (e.g., discolouration or unusual behaviour such as trapping at the surface of water). Furthermore, the dissolved oxygen concentration at the end of the test was ≥3 mg/L in all test vessels.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the mean measured concentrations of the test item, the 24-hour and 48-hour EC50 for Daphnia magna was 13.3 mg/L (95% confidence limits: 10.4 - 16.9 mg/L).
- Executive summary:
The acute toxicity of the test item MUSK R1 to Daphnia magna was determined in a 48-hour test according to the OECD Guideline for Testing of Chemicals, No. 202 (2004) and the Commission Regulation (EC) No. 440/2008, Part C.2.
Based on the mean measured concentrations of the test item, the 24-hour and 48-hour EC50 for Daphnia magna was 13.3 mg/L (95% confidence limits: 10.4 - 16.9 mg/L).
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.