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EC number: 800-940-9 | CAS number: 35836-72-7
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline 437 without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate
- EC Number:
- 800-940-9
- Cas Number:
- 35836-72-7
- Molecular formula:
- C13H20O2
- IUPAC Name:
- (1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No.: 117042
Purity: 99.3%
Name of test material (as cited in study report): NOPYL ACETATE
Physical state: colourless - slightly amber liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 10 April 2013
Constituent 1
impurity 1
Test animals / tissue source
- Species:
- other: bovine eye
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
Bovine eyes (from cattle less than 12 months old) collected at the slaughterhouses of La Talaudière - France (42350) and carried in a stable medium (Hanks medium buffered with sodium bicarbonate), at room temperature, and used within 4 h after killing the animals.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, 2 groups (positive and negative controls) containing 3 corneas each.
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 750 ± 8 µL
Concentrations:
- test material: undiluted
- negative control: 0.9 % (w/v) sodium chloride
- positive control: 10 % (w/v) sodium hydroxide - Duration of treatment / exposure:
- 10 ± 1 min
- Observation period (in vivo):
- Corneal opacity was measured after 2 h ± 10 min of incubation.
Corneal permeability was measured after 90 ± 5 min of incubation. - Number of animals or in vitro replicates:
- Total: 9 corneas (3 corneas/group)
- Details on study design:
- Details of test procedure: bovine eyes recovered from a slaughterhouse were inspected and undamaged corneas were dissected and mounted in specially constructed BCOP corneal holders. After 1 h incubation in media, the basal opacity of each cornea was recorded using an opacitometer. 750 ± 8 µL of the test item and of each control were applied directly on the cornea using a positive-displacement micropipette and incubated in a water-bath at 32 ± 1 °C, in a vertical position (screw upward) for 10 ± 1 min. Before reading the final opacity, the corneas were rinsed and incubated for 2 h ± 10 min in fresh media to equilibrate. Then the permeability of each cornea was determined with a fluorescein solution after an incubation of 90 ± 5 min. An aliquot (360 µL) of the media from the posterior compartment was read in a plate reader at 490 nm to determine the permeability of the cornea to the fluorescein solution. The opacity and permeability values were combined to obtain an in vitro irritancy score (IVIS).
Incubation temperature: 32 ± 1 °C
Calibration information for devices used for measuring opacity and permeability (e.g., opacitometer and spectrophotometer): opacitometer (OPKIT) was calibrated with specific calibrators before each measurement of the corneal opacity. Values of opacity after three calibrations were 73-77, 147-153 and 220-240, respectively.
Controls: 0.9 % (w/v) sodium chloride and 10 % (w/v) sodium hydroxide were used as negative and positive controls, respectively.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- ca. -1.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2
- Value:
- ca. -3.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- ca. -4.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 7.3.2/1: Opacity and optical density
Treatment |
Opacity |
Optical density |
IVIS |
||||
Before treatment (OPT0) |
After 2 h (OPT2) |
Difference (OPT2-OPT0) |
Corrected |
OD |
Corrected |
Score |
|
Negative control |
1 |
8 |
7 |
0.037 |
|||
0 |
3 |
3 |
0.018 |
||||
1 |
5 |
4 |
0.034 |
||||
Mean |
4.7 |
0.03 |
|||||
Standard deviation |
2.1 |
0.01 |
|||||
10 % (w/v) NaOH |
3 |
126 |
123 |
118.3 |
7.848 |
7.818 |
235.6 |
4 |
130 |
126 |
121.3 |
7.888 |
7.858 |
239.2 |
|
1 |
96 |
95 |
90.3 |
7.864 |
7.834 |
207.8 |
|
Mean |
110.0 |
7.837 |
227.6 |
||||
Standard deviation |
17.1 |
0.020 |
17.2 |
||||
Test item |
0 |
3 |
3 |
-1.7 |
0.034 |
0.004 |
-1.6 |
1 |
2 |
1 |
-3.7 |
0.038 |
0.008 |
-3.5 |
|
3 |
3 |
0 |
-4.7 |
0.051 |
0.021 |
-4.3 |
|
Mean |
-3.3 |
0.011 |
-3.2 |
||||
Standard deviation |
1.5 |
0.009 |
1.4 |
In vitro irritancy score (IVIS) = (OPT2-OPT0) + (15 x OD)
O.D. of the fluorescein solution (8 µg/mL): 1.490
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information (IVIS<55.1) Criteria used for interpretation of results: EU
- Conclusions:
- IVIS of nopyl acetate was 0.0. Therefore it is not classified as corrosive or severe irritant for the isolated bovine cornea, after a 10 min contact period.
- Executive summary:
In an in vitro eye irritation study performed according to OECD Guideline No 437 and in compliance with GLP, 750 ± 8 µL of nopyl acetate were applied directly to isolated bovine corneas (3 corneas/group), mounted in specially constructed BCOP corneal holders, and incubated in a water-bath at 32 ± 1°C for 10 ± 1 min. Before reading the final opacity, the corneas were rinsed and incubated for 2 h in fresh media to equilibrate. Then the permeability of each cornea was determined with a fluorescein solution after an incubation of 90 min. An aliquot (360 µL) of the media from posterior compartment was read in a plate reader at 490 nm to determine the permeability of the cornea to the fluorescein solution. The opacity and permeability values were combined to obtain an in vitro irritancy score (IVIS). 0.9% (w/v) sodium chloride and 10% (w/v) sodium hydroxide were used as negative and positive controls, respectively.
The IVIS of the test item and positive control were 0.0 and 227.6 ± 17.2 respectively. Optical density values for the negative control corneas (nutritive medium) and fluorescein solution (8 µg/mL) were within the desired range and thus confirmed the validity of the test.
IVIS of nopyl acetate is 0.0. Therefore it is not classified as corrosive or severe irritant for the isolated bovine cornea, after 10 min of contact.
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