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EC number: 412-280-5 | CAS number: 2511-00-4 POIRENATE
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 11 to 25 November 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to the Directive 84/449/EEC Part B, Method B.5 and it is GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 2-cyclohexylpropionate
- EC Number:
- 412-280-5
- EC Name:
- Ethyl 2-cyclohexylpropionate
- Cas Number:
- 2511-00-4
- Molecular formula:
- C11H20O2
- IUPAC Name:
- ethyl 2-cyclohexylpropanoate
- Details on test material:
- - Physical state: clear liquid
- Storage condition of test material: 4ºC in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (Uk) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 13-15 week
- Weight at study initiation: 3.1-3.6 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the cobtralateral eye remained untreated
- Amount / concentration applied:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed (pilot animal see Table 1).
0.1 mL amount of the test substance was placed into the lower everted lid of one eye of each animals. - Duration of treatment / exposure:
- Examination of the eyes was made after 1 hour 1,2,3 (equivalent to 24,48 and 72 hours after instillation), 4 and 7 after instillation
- Observation period (in vivo):
- Observation of the eyes was aided by the use of a handheld light.
- Number of animals or in vitro replicates:
- Three animals: Male (pilot animal), one male and one female.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: after 7 days
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: after 7 days
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: after 7 days
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: after 2 days
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.
OCULAR RESPONSES
The numerical values given to the ocular reactions elicited by the test substance are shown in Table 1.
No corneal damage or iridial inflammation was observed.
Temporary mild conjunctival reactions only were seen.
The eyes were normal 2 to 3 days after instillation.
Any other information on results incl. tables
TABLE 1 | ||||||||
Ocular reactions observed after instillation of the test substance | ||||||||
Rabbit number and sex | Region of eye | One hour | Day after instillation | |||||
1 | 2 | 3 | 4 | 7 | ||||
1873 Male * | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjunctiva | Redness | 2 | 2 | 1 | 0 | 0 | 0 | |
Chemosis | 2 | 2 | 0 | 0 | 0 | 0 | ||
1961 Male | Cornea | 0 | ||||||
Iris | 0 | |||||||
Conjunctiva | Redness | 2 | ||||||
Chemosis | 2 | |||||||
1962 Female | Cornea | 0 | ||||||
Iris | 0 | |||||||
Conjunctiva | Redness | 2 | ||||||
Chemosis | 2 | |||||||
*Pilot animal |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of the test substance into the rabbit eye elicited temporary mild conjunctival irritation only.
- Executive summary:
A study was performed to assess the eye irritation potential of the test substance to the rabbit. The method followed was that described in the EEC Methods for the determination of toxicity, Directive 84/449/EEC Part B, Method B.5. Acute toxicity (eye irritation).
Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for a maximum of 7 days after instillation. A single instillation of the test substance into the eye of the rabbit elicited temporary mild conjuntival irritation. All reactions had resolved 2 to 3 days after instillation.
The test substance does not require labelling with the risk phrase R36 "Irritating to eyes", in accordance with Council Directive 79/831/EEC, Annex VI, Part II (D) as described in Commission Directive 91/325/EEC.
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