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Diss Factsheets
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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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP non-guideline, published in peer reviewed literature, limitation in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Zur Pharmakologie eines neuen stark wirksamen Analgeticums
- Author:
- Herrmann M.
- Year:
- 1 970
- Bibliographic source:
- Arzneimittelforschung. 1970 Aug;20(8):977-83.
Materials and methods
- Principles of method if other than guideline:
- Ten SIV 50 male rats per dose were exposed intravenously to the test substance. Animals were observed for 7 days, clinical signs and mortality were recorded.
- GLP compliance:
- no
- Limit test:
- no
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
- Reference substance name:
- 3-Cyclohexene-1-carboxylic acid, 2-(dimethylamino)-1-phenyl-, ethyl ester, hydrochloride, (1R,2S)-rel-
- IUPAC Name:
- 3-Cyclohexene-1-carboxylic acid, 2-(dimethylamino)-1-phenyl-, ethyl ester, hydrochloride, (1R,2S)-rel-
- Details on test material:
- - Name of test material (as cited in study report): Go 1261 C; Tilidine HCl
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: SIV 50
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100 - 130 g
- Fasting period before study: 24 hours
- Water: ad libitum
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- not specified
- Details on exposure:
- Injection volume: 1 mL/100 g
- No. of animals per sex per dose:
- 10
- Details on study design:
- - Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs - Statistics:
- The experimental results were statistically analyzed according to the method of Litchfield J.T. and Wilcoxon (1949).
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 74.1 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 61 - 90.2
- Mortality:
- Animals that died, died within 12 hours after administration.
- Clinical signs:
- - At doses corresponding to about ten times the analgesic dose, the typical Straub-like tail phenomenon (S-shaped tail completely bent over the back of the animal) was observed. Tonic-clonic convulsions were observed at higher doses.
- All clinical signs were disappeared within 24 h in animals that survived.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, the LD50 was determined to be 74.1 mg/kg bw.
- Executive summary:
Ten SIV 50 male rats per dose were exposed intravenously to the test substance. Animals were observed for 7 days, clinical signs and mortality were recorded. The typical Straub-like tail phenomenon was observed at doses ten times the analgesic dose. Tonic-clonic convulsions were observed at higher doses. The LD50 was determined to be 74.1 mg/kg bw.
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