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EC number: 218-080-2 | CAS number: 2050-08-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with EU Method B.5 with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Too short observation period, however, no effects seen at 48 and 72 hour observation time points
- GLP compliance:
- yes
Test material
- Reference substance name:
- 25485-88-5
- EC Number:
- 607-733-0
- IUPAC Name:
- 25485-88-5
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Salicylsäurecyclohexylester
- Physical state: Colourless, oily liquid
- Analytical purity: 98.5%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Lot/batch No.: S 010
- Expiration date of the lot/batch: not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.8 to 2.9 kg
- Housing: individually in rabbit cages
- Diet (e.g. ad libitum): Altromin rabbit food 2023 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: about one month
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21
- Humidity (%): 45 to 50
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 mL of neat test substance was instilled into the right eye of each rabbit - Duration of treatment / exposure:
- The test subtstance remained in the treated eye
- Observation period (in vivo):
- 96 hours
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- SCORING SYSTEM:
Opacity: degree of density (reading performed with the most dense area)
No ulceration or opacity = 0, Scattered or diffuse areas of opacity; details of iris clearly visible = 1, Easily discernible translucent area; details of iris slightly obscured = 2, Nacrous area; no details of iris visible; size of pupil barely discernible = 3; Opaque cornea; iris not discernible through the opacity = 4
Iris
Normal = 0, Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light = 1, Haemorrhage, gross destruction, or no reaction to light = 2
Conjunctivae
Redness: refers to palpebral and bulbar conjunctivae
Normal = 0, Some blood vessels hyperaemic (injected) = 1, Diffuse, crimson colour; individual vessels not easily discernible = 2, Diffuse beefy red = 3
Chemosis
Swelling: refer to lids and /or nictating membranes
Normal = 0, Some swelling above norma = 1, Obvious swelling, with partial eversion of lids = 2, Swelling, with lids about half closed = 3, Swelling, with lids more than half closed = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after instillation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after instillation
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after instillation
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after instillation
- Score:
- 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No findings were noted at ratings at observation time points at 48 and 72 hours after instillation. The test was terminated at 96 hours after instillation.
- Other effects:
- No other effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was not irritating to the rabbit eye.
- Executive summary:
The eye irritation potential of the substance Cyclohexyl salicylate was studied under GLP in accordance with EU Method B.5. A volume of 0.1 mL of the neat substance was instilled into the right eyes of six healthy, adult male rabbits of the New Zealand White strain. Ratings of eye reactions were done 1 hour and 24, 48 and 72 hours after instillation. The substance was not corrosive to the rabbit eye. Slight reddening and swelling of conjunctivae was seen 1 and 24 hours after instillation. No findings were made at the observation time points at 48 and 72 hours after instillation. The test was terminated 96 hours after instillation. It was concluded that the test substance was not irritating to the rabbit eye.
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