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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 606-524-1 | CAS number: 203313-47-7
- 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:
- Apr 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- adopted April 13,2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate
- EC Number:
- 606-524-1
- Cas Number:
- 203313-47-7
- Molecular formula:
- C19H27NO4
- IUPAC Name:
- methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate
- Test material form:
- solid: bulk
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- 42.6 mg of the test item were dissolved in Acetonitrile and made up with Acetonitrile to the mark in a 100 mL volumetric flask to prepare a stock solution of 426 mg/L. Defined volumes of this stock solution were diluted with Milliporewater to obtain standard solutions in the range of 0.004 to 4.26 mg/L.
Although the overall method sensitivity would have been better, the concentration of the lowest used calibration solution was employed as the limit of quantification.
These solutions were used to calibrate the HPLC-system.
Sample storage conditions before analysis:
Routinely, the samples were analysed immediately. Only in exceptional cases, they were stored overnight deep frozen and protected from light
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Culture and dilution water
Reconstituted water (so-called 'M4 medium') was used for the maintenance of the test animals and the preparation of stock and test solutions of the test item.
Pre-treatment of the test item
A stock solution was prepared to give the desired series of test concentrations.
To achieve this 120.3 mg of the test item were added to 1 litre of dilution water and treated for 1 h in an ultrasonic bath and afterwards stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using a folded filter of pore size 7-12 μm.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Common name: water flea
Source: Strain of Bundesgesundheitsamt Berlin
Maintenance and Acclimatisation:
A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture water (so-called 'M4 medium') was partly renewed once a week.
The Daphnia were exclusively fed with unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semiquantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 341 mg/L CaCo3
- Test temperature:
- 20.1-20.6 °C
- pH:
- 7.8-7.9
- Dissolved oxygen:
- 8.7-8.8 mg/L
- Nominal and measured concentrations:
- Nominal: control, 25, 50, 100 mg/L
Measured (48 h): < 0.004, 25.433, not measured, 100.911 mg/L - Details on test conditions:
- Test vessels: 50 mL glass beakers holding 10 neonates in 20 mL of test medium
Experimental design:
3 test concentrations plus 1 control
10 neonates per vessel, 2 replicates per concentration/control
no feeding during the exposure period
Photoperiod: 16 h light : 8 h dark
Aeration: none
Criteria of effects: The criterion of adverse effects used in this study was the item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 hours.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
Any other information on results incl. tables
No toxic effects were observed at the highest concentration.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- No toxic effects were observed at the highest concentration. The results are expressed in terms of nominal concentrations at 24 h and 48 h. Recovery rates ranged from 97.8 – 98.7% of nominal values at 0 hours, and from 100.9 – 101.7% of nominal values at 48 hours, respectively.
- Executive summary:
Analysis of the immobilisation rates (by probit analysis) gave the following results:
Time [h]
EC 50 [mg/L]
24
> 100
48
> 100
No toxic effects were observed at the highest concentration.
The results are expressed in terms of nominal concentrations at 24 h and 48 h.
Recovery rates ranged from 97.8 – 98.7% of nominal values at 0 hours, and from 100.9 – 101.7% of nominal values at 48 hours, respectively.
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.