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EC number: 947-711-0 | CAS number: -
- 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 vitro / ex vivo
- Remarks:
- eye corrosion
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- from 2018-02-09 to 2018-05-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol
- EC Number:
- 947-711-0
- Molecular formula:
- C14H28O
- IUPAC Name:
- Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: Gallus gallus e.g. Ross 308 Broiler
- Details on test animals or tissues and environmental conditions:
- - Species: Spring chickens ( Gallus gallus e.g. Ross 308 Broiler)
- Number: Multiple chicken heads (three eyes for the test item, three eyes for the positive control item and two eyes for the negative control item)
- Sex: Male or female
- Age of chicken (at slaughter): Approximately 56 days old
- Weight of chicken (at slaughter): Approximately 3 kg
- Storage, temperature and transport conditions of ocular tissue: Heads were removed immediately after the chickens had been humanely killed at the source, for use on the same day. Following slaughter, the intact chicken heads were placed into individual plastic compartments within a plastic box in order to minimize any damage to the eyes. The base of each compartment was lined with a paper towel moistened with isotonic saline. The heads were transported to the test facility at ambient temperature.
- Time interval prior to initiating testing: The time interval between collection of chicken heads and placing the eyes in the superfusion chamber following enucleation was minimized.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.03 mL per eye of the test item
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- observations prior to treatment and at 30, 75, 120, 180 and 240 minutes after decontamination with isotonic saline
- Number of animals or in vitro replicates:
- 3 eyes for the test item
3 eyes for the positive control
2 eyes for the negative control - Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
Eyelids were carefully excised. The integrity of the cornea was measured with a drop of 2 % (w/v) sodium fluorescein to the surface of the cornea and then rinsed with isotonic saline after a few seconds. The treated eyes were examined for damage to the cornea. When the fluorescein retention and corneal opacity scores were ≤ 0.5, the eyes were selected for the test. Acceptable eyes were dissected from the skull and pulled from the orbit by holding the nictitating membrane firmly with surgical forceps. Enucleated eyes were transferred to an appropriate clamp keeping the cornea vertical. They were then transferred to chambers within the superfusion apparatus ensuring the corneas received sufficient isotonic saline from the saline drip. The temperature of the chambers was at 32.0 ± 1.5 °C.
EQUILIBRATION AND BASELINE RECORDINGS
Once all eyes were placed in the superfusion apparatus, the eyes were examined again to ensure the eyes had not been damaged by the dissection procedure. Corneal thickness measurements are taken with a depth measuring device at the center of each cornea. After the approval process the eyes were incubated for 45 minutes for equilibrium purposes. Time zero measurements for corneal thickness and opacity were taken to serve as a baseline. The baseline for the fluorescein measurements were taken at dissection.
NUMBER OF REPLICATES
3 eyes for the test item
3 eyes for the positive control
2 eyes for the negative control
NEGATIVE CONTROL USED
0.03 mL of the negative control item was applied ot the cornea of each negative control eye.
POSITIVE CONTROL USED
0.03 mL of the positive control item, Benzalkonium chloride (5% v/v), was applied and after 10 seconds was rinsed with 20 mL isotonic saline.
APPLICATION DOSE AND EXPOSURE TIME
0.03 mL of the test item were applied to the cornea. The tets item was used in its initial state. The test item remained in place for 10 seconds and was then rinsed from the eye using 20 mL of 0.9 % (w/v) sodium chloride solution.
OBSERVATION PERIOD
observations prior to treatment and at 30, 75, 120, 180 and 240 minutes after decontamination with isotonic saline
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: 20 mL of 0.9 % (w/v) sodium chloride solution after 10 seconds exposure
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: calculated with the most densely opacified areas for scoring
- Damage to epithelium based on fluorescein retention: calculated at the 30 minute time interval only
- Swelling: assessed from corneal thickness measurements
- Macroscopic morphological damage to the surface: observations for pitting, sloughing, roughening of the corneal surface, and adhering of test item were made
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 240 mins
- Value:
- 1.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class: III
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 30 mins
- Value:
- 1.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class: II
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 240 mins
- Value:
- 8.96
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class: III
Any other information on results incl. tables
Table 1. Summary of test items results for all endpoints
Mean Corneal Opacity |
Mean |
Mean Corneal Thickness% Compared to Time Zero (ICE class) |
Combination of the 3 Endpoints |
||||
30 mins |
75 mins |
120 mins |
180 mins |
240 mins |
|||
1.7 |
1.5 |
8.02 (II) |
13.21 (III) |
8.49 (II) |
8.02 (II) |
8.96 (II) |
|
(III) |
1 x II, 2 x III |
||||||
Classification: |
No Prediction Can Be Made |
Corneal Opacity Scores
Scattered or diffuse areas; details of the iris are clearly visible was noted in one test item treated eye and Easily discernible translucent area; details of the iris are slightly obscured were noted in two test item treated eyes.
Complete corneal opacity; iris invisible was noted in all positive control treated eyes.
Very faint opacity was noted in the negative control treated eyes.
No morphological effects were noted in the test item or negative control item treated eyes. Sloughing was noted in two of the positive control treated eyes.
Fluorescein Retention Scores
Very minor single cell staining was noted in one test item treated eye. Focal or confluent dense single cell staining was noted in two test item treated eyes. Confluent large areas of the cornea retaining fluorescein were noted in all positive control treated eyes. No fluorescein retention to very minor single cell staining was noted in the negative control treated eyes.
Positive control item
Maximal mean score for corneal opacity: 4.0 ICE Class IV
Mean score of Fluorescein Retention: 3.0 ICE Class IV
Maximal mean corneal swelling compared to time zero: 37.98% ICE Class IV
Negative Control Item
Maximal mean score for corneal opacity: 0.5 ICE Class I
Mean score of Fluorescein Retention: 0.3 ICE Class I
Maximal mean corneal swelling compared to time zero: 0.00% ICE Class I
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified in Category 1
- Conclusions:
- The substance is not to be classified as severely eye damaging (Cat. 1).
- Executive summary:
This ex vivo study was performed to assess the eye irritation potential of the test item by means of the Isolated Chicken Eye Test according to OECD 438 and GLP. The study was performed to evaluate the possible corrosivity or severe irritancy potential of the test item as measured by its ability to induce toxicity in an enucleated chicken eye. 0.03 mL of the test item were applied onto the cornea of each of three enucleated eyes. A further three enucleated eyes were treated with positive control item (Benzalkonium chloride). A further two enucleated eyes were treated with Sodium chloride for control purposes. Treatment with the test item showed inconclusive results with regard to eye irritation. In conclusion, the substance is not to be classified as severely eye damaging (Cat. 1).
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