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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 627-199-2 | CAS number: 120728-10-1
- 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:
- 27 Oct 2020 to 18 Dec 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid
- EC Number:
- 627-199-2
- Cas Number:
- 120728-10-1
- Molecular formula:
- C10H17NO4
- IUPAC Name:
- 1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical state: powder
Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: AC07N1912008
- Expiry date: 02 January 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 98.9%
- Purity correction factor: not required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: not indicated
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 2.0 mL of volume was taken from the approximate centre of the test vessels. Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility. At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with the highest concentration of 100 mg/L applying a twenty-five-minute period of ultrasonic waves to accelerate dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All test solutions were clear and colorless at the end of the preparation procedure. Any residual volumes were discarded.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- 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
ACCLIMATION
- Acclimation period: not relevant
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- The hardness of test medium expressed as CaCO3: 180 mg/L
- Test temperature:
- 20-21°C
- pH:
- At t=0h: 6.4* - 7.7
At t=48h: 7.7 - 8.0
*The pH 6.4, measured at the start of the test for test concentration 100 mg/L, was within the range of 6 to 9. There was not more than 1.5 units difference with the pH of test concentration 100 mg/L measured at the end of the test and also not between all test concentrations at the start of the test. There was 1.6 units difference between this pH 6.4 and the pH measured at the end of the test for the control and test concentration 0.10 mg/L. However, as no immobility was observed in the control and at any of the test concentrations throughout the exposure period, this variance in pH was assumed to have no effect on the validity and integrity of the test. - Dissolved oxygen:
- At t-0h: 8.4 - 8.8
At t-48h: 7.7 - 8.0 - Salinity:
- Not relevant
- Nominal and measured concentrations:
- nominal: 0.10, 1.0, 10 and 100 mg/L
Samples taken from the control and the highest test concentration were analysed. The analysed concentrations of the first batch of samples were considered not reliable, since the mean recovery of the high QC sample was outside the criterion of 70-110%, i.e. 123%.
The measured concentration in the reserve sample of the highest test concentration taken at the start of the test was 107 mg/L. At the end of the exposure period, the measured concentration was at 97% relative to the initial concentration.
Based on these results, effect parameters were expressed as analytically confirmed nominal concentrations.
Please refer to the tables below under 'Any other information on materials and methods incl. tables' - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 60 mL, glass beaker filled with 50 mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 for highest concentration, 2 for intermediate concentrations
- No. of vessels per control (replicates): 4
- Test medium: adjusted ISO medium
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Range finding study
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L (setup: combined range finder/limit test)
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Details on results:
- - Immobility of control: none
- Other adverse effects control: no
- Abnormal responses: none
- 24h-EC50: > 100 mg/L - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- The batch of Daphnia magna tested, showed expected sensitivity to Potassium dichromate based on the range specified in ISO International Standard 6341, October 2012 - Reported statistics and error estimates:
- No EC50 could be calculated because the test item proved to be non-toxic (EC50 > maximum concentration tested)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Toxicity of T003661 to Daphnia magna was tested according to OECD 202 guideline using test concentrations of 0.10, 1.0, 10 and 100 mg/L during 48 hours. In conclusion, the 48h-EC50 for Daphnia magna exposed to JNJ-63543883-AAA (T003661) was beyond the range of concentrations tested, i.e. EC50 > 100 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.