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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-281-1 | CAS number: 17243-69-5
- 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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study in compliance with GLP-criteria.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl trans-(±)-2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate hydrochloride
- EC Number:
- 248-226-0
- EC Name:
- Ethyl trans-(±)-2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate hydrochloride
- Cas Number:
- 27107-79-5
- IUPAC Name:
- 27107-79-5
- Details on test material:
- - Substance name: Trans-Tilidin-HCl-Hemihydrate
- Physical state/appearance: Solid (powder)/white
- Homogeneity: Homogeneous
- Storage conditions: At room temperature, under nitrogen atmosphere, in the dark and closed tightly
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for analytical determination of the concentration were taken within the first hour after the start of exposure and at the end of the exposure after approx. 96 hours. Water samples were taken from the middle of the test vessel using a glass pipette and were transported to the analytical Iaboratory in glass ampoules, which were rinsed with test solution before they were filled. The transport to the Analytical Laboratory was done on the day of sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test concentrations were prepared separately for each test vessel. The test substance was weighed into a beaker. The defined volume of test water was filled into the test vessel. An aliquot from the test water in the test vessel was taken and mixed with the test substance in the beaker using an ultra turrax. The mixture was poured into the test vessel and the whole test batch was homogenized again with an ultra turrax. No solvents or dispersants were used tor the preparation of the test concentrations. All test batches were present as clear solutions over the exposure period according to visual inspection.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST SECIES
- Common name: Zebrafish
- Animal supplier: Zierfisch-Center Klöckner, Ludwigshafen, Germany
- Body weight (wet weight): 0.53 g (0.37 - 0.76 g)
- Body length (from the top of the snout to the end of the caudal fin): 3.9 cm (3.5 - 4.3 cm)
- Age of the animais: Approx. 4 months
- Hatching date: Jun. 24, 2002
- Arrival at the testing facility: Aug. 28, 2002
- All animals used for the study were derived from the same batch of fish.
- All test animals were observed for their health state during insertion into the test vessels. No signs for sickness, injuries or abnormalities were observed.
ACCLIMATION:
- Duration of acclimatization to testing conditions including test water and light regime: 14 days
- Photoperiod: 16 hours light, 8 hours dark
- Water quality: Non chlorinated charcoal filtered tap water (Frankenthal, Germany)
- Diet: Commercial fish diet "Tetramin", supplier Tetra-Werke, Melle, Germany, ad libitum, additionally generally on workdays live brine shrimp (artemia).
- Withdrawal of feed: During the last day before start of exposure
- Medical treatment: None during acclimatization
- Mortality during the last week before start of exposure: 0 %
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 250 mg/L (as CaCO3)
- Test temperature:
- 22-23 °C
- pH:
- 7.8-8.3
- Dissolved oxygen:
- 7.3-8.5 mg/L
- Nominal and measured concentrations:
- - Nominal concentrations: 0 (control), 5, 10, 22, 50 and 100 mg/L (based on range finding study).
- Measured concentrations: n.d., 4.3, 8.6, 18.7, 42.4 and 92.8 mg/L (mean value of analytical concentrations at t=oh and t=96h) - Details on test conditions:
- TEST CONDITIONS:
- Test vessels: Glass aquaria (30 cm long, 22 cm wide, 24 cm high)
- Volume of water: 10 L
- Animals/test vessel: 10
- Loading (g fish/L water): 0.5
- Test vessel/concentration: 1
- Photoperiod: 16 hours light, 8 hours darkness
- Aeration: Slight
- Feeding: None
INSERTION OF ANIMALS:
- The test organisms were introduced into the test vessels according to a randomization plan prepared by the testing laboratory using a program of the Iaboratory data evaluation group of the testing facility.
OBSERVATIONS:
- Symptoms and lethality: The fish were observed for survival and toxic signs (changes in appearance, swimming behaviour and behaviour in comparison to the control group) within 1 hour after start of exposure and 4, 24, 48, 72 and 96 hours after start of exposure. Fish were considered dead if there was no visible movement and no reaction after touching. Dead fish were removed from the test vessels.
- Water parameter: Temperature, oxygen content and pH-value were measured in each test vessel within 1 hour after start of exposure and after 24, 48, 72 and 96 hours. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 18.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- No symptoms were observed up to a concentration of 10 mg/L nominal. At higher concentrations apathy and swimming at the bottom were recorded.
- Reported statistics and error estimates:
- Finney, D.J., Probit Analysis; Cambr. Univ. Press, 3rd ed., 1971 (certain aspects of this method have been modified)
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Cumulative mortality
Measured concentration (mg/L)
No. of fish at start
No. of fish dead after 96h
Mortality (%)
0
10
0
0
4.31
10
0
0
8.56
10
0
0
18.73
10
5
50
42.40
10
10
100
92.80
10
10
100
Applicant's summary and conclusion
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.