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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
Endpoint summary
Administrative data
Description of key information
Trans-Tilidin-HCL-Hemidhydrat, a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate is considered to be irritating to the eye under the test conditions of a GLP-compliant eye irritation study (OECD guideline 405).
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No studies on the potential to cause eye damage of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. One OECD 405 guideline study, that evaluates the potential to cause eye damage, is available for the structural analogue Trans-Tilidin-HCL-Hemidhydrat.
The potential to cause damage to the conjunctiva, iris of cornea was assessed, in a GLP complaint OECD 405 guideline study in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL (approx. 49 mg) Trans-Tilidin-HCL-Hemidhydrat on day 0 (BASF 2002). About 24 hours after application the eye was rinsed with tap water. Slight to severe conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed during the course of the study. In addition moderate or severe iritis and slight corneal opacity was noted within the first week of the observation period. Moreover the animals exhibited injected scleral vessels in a circumscribed area as well as circular, small retraction in the eyelid, suppuration, contracted pupil, discharge of blood and white discolored parts of the nictitating membrane during the study period. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 1.0 and 1.0 for corneal opacity, 0.0, 1.3 and 0.7 for iris lesions, 2.0, 3.0 and 2.0 for redness of the conjunctiva and 1.3, 2.3 and 1.3 for chemosis, for animals 1, 2, and 3 respectively. Findings were reversible within 14 days after application. It was concluded that the substance was irritating to the eye.
Justification for selection of eye irritation endpoint:
There is one study available that evaluated the potential to cause eye damage for a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate. This study is performed according to OECD 405 and GLP. This study is sufficiently adequate for this endpoint.
Effects on eye irritation: irritating
Justification for classification or non-classification
In all 3 animals exposed to Trans-Tilidin-HCL-Hemidhydrat eye irritation was observed. Because Trans-Tilidin-HCL-Hemidhydrat is a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate, ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate is also suspected to be eye irritating. Based on this ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate is classified as Xi:R36: Irritating to eyes in accordance with Directive 67/548/EEC (DSD) and Eye Irrit 2:H319 Causes serious eye irritation in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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