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EC number: 915-371-2 | 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:
- 04 June 2018 - 07 November 2018
- 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)
- Version / remarks:
- 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile
- EC Number:
- 268-417-2
- EC Name:
- 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile
- Cas Number:
- 68084-04-8
- Molecular formula:
- C13H19N
- IUPAC Name:
- 3-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbonitrile
- Reference substance name:
- 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile
- EC Number:
- 244-530-2
- EC Name:
- 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile
- Cas Number:
- 21690-43-7
- Molecular formula:
- C13H19N
- IUPAC Name:
- 4-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbonitrile
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Name: Reaction mass of 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile and 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile
Public name: Azuril
EC number: 915-371-2
CAS number: n/a (pre-registration 21690-43-7)
Batch/Lot number: A170421E
Appearance: Clear, pale yellow liquid
Purity**: 99.35 %
Expiry date: 06 June 2019
Storage conditions: Room temperature (15-25 °C, ≤ 70 % relative humidity (RH)), under inert gas, protected from humidity (tightly closed container).
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: ROSS 308
- Details on test animals or tissues and environmental conditions:
- DETAILS ON SOURCE CHICKENS FOR HEADS/EYES
- Source: Slaughter house TARAVIS KFT. (Address: 9600 Sárvár, Rábasömjéni út. 129, Hungary)
- Age during the head collection: 7 weeks
- Weight during the head collection: about 2.65 kg
- Collection of heads: by a slaughter house technician
- Transportation of heads to laboratory: within 2 hours of collection (in plastic box wrapped with tissue paper moistened with saline)
- Acclimatization period and temperature: approximately 45 to 60 minutes at 32 ± 1.5°C
- Temperature during testing: 32 ± 1.5°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 μL of test item, positive and negative control
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- 240 minutes (evaluations after 30, 75, 120, 180 and 240 minutes post-teatment)
- Number of animals or in vitro replicates:
- 3 eyes for test item
3 eyes for positive control
1 eye for negative control - Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
Eyes 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 2% (w/v) fluorescein solution was applied onto the cornea surface for a few seconds and subsequently rinsed off with 20 mL physiological saline. Then the fluorescein-treated cornea was examined with a hand-held slit lamp 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 wet papers in a closed box so that the appropriate humidity was maintained.
EQUILIBRATION AND BASELINE RECORDINGS
Baseline assessments:At the end of the acclimatization period, a zero reference measurement was recorded for cornea thickness and opacity to serve as a baseline (t=0) for each individual eye. The cornea thickness of the eyes should not change by more than 5% within the -45 minute and the zero time. No changes in thickness (0.0%) were observed in the eyes in the experiment. Following the equilibration period, the fluorescein retention was measured. Baseline values were required to evaluate any potential test item related effect after treatment. All eyes were considered to be suitable for the assay.
NUMBER OF REPLICATES
3 eyes for test item, 3 eyes for positive control, 1 eye for negative control
NEGATIVE CONTROL USED
0.9% (w/v) NaCl
POSITIVE CONTROL USED
5% (w/v) Benzalkonium chloride solution
APPLICATION DOSE AND EXPOSURE TIME
30 μL of test item, positive and negative control. Exposure 10 seconds.
OBSERVATION PERIOD
240 minutes (evaluations after 30, 75, 120, 180 and 240 minutes post-teatment)
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: rinsed thoroughly with 20 mL physiological saline solution at ambient temperature
- Indicate any deviation from test procedure in the Guideline : no deviations
METHODS FOR MEASURED ENDPOINTS:
Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at baseline (t=0) and approximately 30 minutes after the post-treatment rinse. A Haag-Streit Bern 900 slit-lamp microscope, with depth-measuring device no. 1 and slit-width setting at 9½, was used for the measurements. No histopathology was performed.
SCORING SYSTEM:
- Mean corneal swelling (%)
- Mean maximum opacity score
- Mean fluorescein retention score at 30 minutes post-treatment
DECISION CRITERIA: According to the OECD 438 test guideline.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 75 min
- Run / experiment:
- 1
- Value:
- -1.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- ICE Class I
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 240 min
- Run / experiment:
- 1
- Value:
- -2.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- ICE Class I
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean maximum
- Run / experiment:
- 1
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- ICE Class I
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Run / experiment:
- 1
- Value:
- 0.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- ICE Class II
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this in vitro eye irritation in the isolated chicken eyes test with Azuril [Reaction mass of 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile and 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile], the test item is non-irritant, UN GHS Classification: No Category.
- Executive summary:
An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline (09 October 2017).
After the zero reference measurements, the eyes were held in a horizontal position and the test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered in all cases. After 10 seconds, the surface of the eyes was rinsed with physiological saline solution. Three eyes were treated with 30 μL of the undiluted test item. The three positive control eyes were treated in a similar way with 30 μL of 5% (w/v) Benzalkonium chloride solution. The negative control eye was treated with 30 μL of physiological saline (0.9% (w/v) NaCl solution). Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) were evaluated.
No significant corneal swelling (0 to -5%) was observed during the four-hour observation period on the test item treated eyes. No significant cornea opacity change (severity 0.5) was observed on three eyes. Slight fluorescein retention change (severity 0.5 on two eyes and severity 1 on one eye) was noted in all three eyes. No other corneal effect was observed.
The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in the experiment. Thus, the experiment was considered to be valid.
Based on this in vitro eye irritation in the isolated chicken eyes test with Azuril [Reaction mass of 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile and 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbonitrile], the test item is non-irritant, UN GHS Classification: No Category.
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