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EC number: 441-520-1 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 441-520-1
- EC Name:
- -
- Cas Number:
- 170577-61-4
- Molecular formula:
- C28H38O4S
- IUPAC Name:
- 2-{[2-tert-butyl-4-({5-tert-butyl-2-methyl-4-[(oxiran-2-yl)methoxy]phenyl}sulfanyl)-5-methylphenoxy]methyl}oxirane
- Test material form:
- solid
- Details on test material:
- - Storage: room temperature 15-25 °C, continuously protected from all light
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: ROSS 308
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Chicken heads were collected after slaughter in a commercial abattoir from chickens which are used for human consumption. Heads were collected by a slaughter house technician and heads transported to the testing laboratory at ambient temperature at the earliest convenience.
- After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then placed in a plastic box which was closed (4-5 heads per box). The heads were received at the testing laboratory and processed within approximately 2 hours of collection.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µg - Duration of treatment / exposure:
- 10 seconds
- Number of animals or in vitro replicates:
- 3 replicates for the test material and positive control treated eyes and a single negative control treated eye.
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
- Eye selection: After removing the head from the plastic box, it was put on soft paper. The eyelids were carefully cut away with scissors, avoiding damaging the cornea. One small drop of fluorescein solution 2 (w/v) % was applied onto the cornea surface for a few seconds and subsequently rinsed off with 20 mL isotonic saline. Then the fluorescein-treated cornea was examined with hand-held slit lamp or slit lamp microscope, with the eye in the head, to ensure that the cornea was not damaged. If the cornea was in good condition, the eyeball was carefully removed from the orbit.
- Preparation of eyes: The eye ball was carefully removed from the orbit by holding the nictitating membrane with a surgical forceps, while cutting the eye muscles with bent scissors. Care was taken to remove the eyeball from the orbit without cutting off the optical nerve too short. The procedure avoided pressure on the eye while removing the eyeball from the orbit, in order to prevent distortion of the cornea and subsequent corneal opacity. Once removed from the orbit, the eye was placed onto damp paper and the nictitating membrane was cut away with other connective tissue. The prepared eyes were kept on the wet papers in a closed box so that the appropriate humidity was maintained.
EQUILIBRATION AND BASELINE RECORDINGS
- The prepared eye was placed in a steel clamp with the cornea positioned vertically with the eye in the correct relative position (same position as in the chicken head). Again avoiding too much pressure on the eye by the clamp. Because of the relatively firm sclera of the chicken eyeball, only slight pressure was needed to fix the eye properly. The clamp with the eyeball was transferred to a chamber of the superfusion apparatus. The clamp holding the eye was positioned in such a way that the entire cornea was supplied with isotonic saline dripping from a stainless steel tube, at a rate of approximately 2 or 4 drops/minute. The door of the chamber was closed except for manipulations and examinations, to maintain temperature and humidity.
- The appropriate number of eyes was selected and after being placed in the superfusion apparatus, were examined again with the slit lamp microscope to ensure that they were in good condition. The focus was adjusted to see clearly the isotonic saline which was flowing on the cornea surface. Eyes with a high baseline fluorescein staining (i.e., > 0.5) or corneal opacity score (i.e., > 0.5) were rejected. The cornea thickness was measured, any eye with cornea thickness deviating more than 10% from the mean value for the eyes, or eyes that showed any other signs of damage, were rejected and replaced. If the selected eyes were appropriate for the test, acclimatisation started and was conducted for approximately 45 to 60 minutes. Temperature of the circulating water was verified to ensure that all chambers were in the range of 32 ± 1.5°C during the acclimatisation and treatment periods.
- The base line assessments: At the end of the acclimatisation period, a zero reference measurement was recorded for cornea thickness and opacity to serve as a base line (t = 0) for each individual eye. The cornea thickness of the eyes should not increase by more than 5 - 7% between the -45 and the zero time. Slight changes in thickness (+2 to -3%) were observed in the eyes, this is considered normal when maintaining enucleated eyes. Following the equilibration period, the fluorescein retention was measured. Base line values were required to evaluate any potential test material related effects after treatment; the location of any minor findings were marked on the record sheet as a drawing. All eyes were considered to be suitable for the assay.
NUMBER OF REPLICATES: 3 replicates for the test material and positive control treated eyes and a single negative control treated eye.
NEGATIVE CONTROL USED
- Sodium chloride (Salsol solution 0.9%)
POSITIVE CONTROL USED
- Imidazole
APPLICATION DOSE AND EXPOSURE TIME
- 30 µg of test material was uniformly applied by powdering the entire surface of the cornea, taking care not to damage or touch the cornea with the application equipment. The positive control eyes were treated in a similar way with 30 μg of imidazole. The negative control eye was treated with 30 μL of isotonic saline.
REMOVAL OF TEST MATERIAL
- The time of application was observed, then after an exposure period of 10 seconds the cornea surface was rinsed thoroughly with 20 mL isotonic saline at ambient temperature, taking care not to damage the cornea but attempting to remove all the residual test material if possible.
OBSERVATION PERIOD
- The control eye and test eyes were evaluated pre-treatment and at approximately 30, 60, 75, 120, 180 and 240 minutes after the post-treatment rinse. Minor variations within ± 5 minutes were considered acceptable.
- The cornea thickness and cornea opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t = 0) and 30 minutes after the post-treatment rinse.
TREATMENT OF DATA
- Cornea swelling was calculated according to the following formulae:
CS at time t = (CT at time t –CT at t=0 / CT at t=0) x 100
Mean CSmax at up to 75 min = [FECSmax(30min to 75min)+ SECSmax(30min to 75min) + TECSmax(30min to 75min)] / 3
Mean CSmax at up to 240 min = [FECSmax(30min to 240min)+ SECSmax(30min to 240min) + TECSmax(30min to 240min)] / 3
CS = cornea swelling
CT = cornea thickness
FECS = first eye cornea swelling
SECS = second eye cornea swelling
TECS = third eye cornea swelling
max(30min to 75min) = maximum swelling of the individual eye at 30 to 75 minutes max
(30min to 240min) = maximum swelling of the individual eye at 30 to 240 minutes
- Small negative numbers for swelling following application are counted as zero (larger negative numbers due to erosion invalidate the swelling evaluation, but indicate a severe effect)
- Cornea opacity was calculated according to the following formulae:
CO at time t = CO at time t – CO at t=0
Mean COmax = [FECOmax(30min to 240min)+ SECOmax(30min to 240min) + TECOmax(30min to 240min)] / 3
FECO = first eye cornea opacity
SECO = second eye cornea opacity
TECO= third eye cornea opacity max
(30min to 240min) = maximum opacity of the individual eye at 30 to 240 minutes
- Fluorescein retention was calculated according to the following formulae:
FR at time t = FR at time t – FR at t=0
Mean FR = [FEFR (30min) + SEFR(30min) + TEFR(30min)] / 3
FR = fluorescein retention
FEFR = first eye fluorescein retention
SEFR = second eye fluorescein retention
TEFR = third eye fluorescein retention
STORAGE OF CORNEAS
- At the end of the procedures, the corneas from the eyes were carefully removed from the eyes and placed individually into labelled containers of preservative fluid (10% neutral buffered formalin) for potential histopathology and stored.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean
- Value:
- 0.17
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Other effects / acceptance of results:
- - Results of this in vitro eye irritation study, in isolated chicken eyes, suggest that the test material was not irritating.
- The positive control, imidazole, was classed as severely irritating, GHS Classification: Category 1.
- The negative control, sodium chloride 0.9%, had no significant effects on the chicken eyes in this study.
Any other information on results incl. tables
Table 1: Study Results
Observation |
Test Material |
Positive Control |
Negative Control |
|||
Value |
ICE Class |
Value |
ICE Class |
Value |
ICE Class |
|
Mean maximum corneal swelling at up to 75 min |
1 % |
I |
11 % |
II |
1 % |
I |
Mean maximum corneal swelling at up to 240 min |
1 % |
I |
12 % |
II |
1 % |
I |
Mean maximum corneal opacity |
0.00 |
I |
4.00 |
IV |
0.00 |
I |
Mean fluorescein retention |
0.17 |
I |
2.83 |
IV |
0.00 |
I |
Other Observations |
Minimal test material was stuck on the cornea after the post-treatment rinse. The cornea surface was clear 240 min after the post-treatment rinse |
The positive control material was stuck on the cornea surface after the post-treatment rinse. The cornea surface was not cleared 240 min after the post-treatment rinse. |
None |
|||
Overall ICE Class |
3 x I |
1 x II, 2 x IV |
3 x I |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU Criteria.
- Conclusions:
- Under the conditions of this study, the test material was not irritating to eyes.
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the standardised guideline OECD 438, under GLP conditions.
An in vitro eye irritation study of the test material was performed in chicken’s eyes.
After the zero reference measurements, 30 μg of the test material was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated in a similar way with 30 μg imidazole. The negative control eye was treated with 30 μL of isotonic saline. The eyes were examined for a period of 4 hours following treatment.
The results suggested that the test material was not irritating. The positive control, imidazole, was classed as severely irritating, GHS Classification: Category 1. The negative control, sodium chloride 0.9%, had no significant effects on the chicken eye in this study.
Under the conditions of this study, the test material was not irritating to eyes.
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