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EC number: 253-604-3 | CAS number: 37673-37-3
- 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:
- Bovine Corneal Opacity and Permeability(BCOP) test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 09, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- yes
- Remarks:
- but the study integrity was not adversely affected by the deviation
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-octyldodecyl 5-oxo-L-prolinate
- EC Number:
- 253-604-3
- EC Name:
- 2-octyldodecyl 5-oxo-L-prolinate
- Cas Number:
- 37673-37-3
- Molecular formula:
- C25H47NO3
- IUPAC Name:
- 2-octyldodecyl 5-oxo-L-prolinate
- Test material form:
- other: liquid
- Details on test material:
- - Test substance: 2-octyldodecyl 5-oxo-L-prolinate
- ZS Name: Pyroglutaminsaureoctyldodecylester
- ZS Number: 1856
- Batch number: 192955 01
- Appearance: liquid
Constituent 1
- Specific details on test material used for the study:
- Batch no.: CH 192955/01
Purity/composition: 99.98%
Appearance: clear yellow liquid
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- other: positive control: ethanol (purity: > or = to 99.9%).
- Amount / concentration applied:
- 750 µL of undiluted test substance
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours (followed by opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The Bovine Corneal Opacity and Permeability (BCOP) test is an organic model that provides short-term maintenance of normal physiological and biological function of the bovine cornea in an isolated system. In this test method, damage by the test substance is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitymeter and an ultraviolet/visible spectrophotometer, respectively.
1. Preparation of corneas
The isolated corneas were stored in a petri dish with cMEM containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum. The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 +/- 1°C. The corneas were incubated for the minimum of 1 hour at 32 +/- 1°C.
2. Opacity reading
After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer. The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded.
3. Treatment of corneas and opacity measurements
The medium from the anterior compartment was removed and 750 µl of the negative control and 20% (w/v) imidazole solution (positive control) were introduced onto the epithelium of the cornea. The test substance was weighed in a bottle and applied directly on the corneas in such a way that the cornea was completely covered. The holder was slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the solutions over the entire cornea. Corneas were incubated in a horizontal position for 240 +/- 10 minutes at 32 +/- 1°C. After the incubation the solutions and the test substance were removed and the epithelium was washed at least three times with MEM with phenol red. Possible pH effects of the test item on the corneas were recorded. Each cornea was inspected visually for dissimilar opacity patterns. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM and the opacity determinations were performed.
4. Opacity measurement
The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance (I = luminous flux per area, unit: lux) by a light meter. The opacity value (measured with the device OP-KIT) was calculated according to:
Opacity = (I0/I - 0.9894)/0.0251 (with I0 the empirically determined illuminance through a cornea holder but with windows and medium, and I the measured illuminance through a holder with cornea).
5. Application of sodium fluorescein and Permeability determinations
Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated. The medium of both compartments (anterior compartment first) was removed. The posterior compartment was refilled with fresh cMEM. The anterior compartment was filled with 1 ml of 5 mg Na-fluorescein/ml cMEM solution. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the sodium-fluorescein solution over the entire cornea. Corneas were incubated in a horizontal position for 90 +/- 5 minutes at 32 +/- 1°C. After the incubation period, the medium in the posterior compartment of each holder was removed and placed into a sampling tube labelled according to holder number. 360 µl of the medium from each sampling tube was transferred to a 96-well plate. The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- in vitro irritancy score (opacity and permeability)
- Value:
- 0.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - The individual in vitro irritancy scores for the negative controls ranged from 0.5 to 1.5. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.
- The individual positive control in vitro irritancy scores ranged from 53 to 72 for ethanol. The corneas treated with the positive control substance were translucent after the 10 minutes of treatment. The mean in vitro irritancy score of the positive control was 62 and was within two standard deviations of the current historical positive control mean.
Based on the results, it was therefore concluded that the test conditions were adequate and that the test system functioned properly.
- The corneas treated with the test substance showed opacity values ranging from 0.0 to 1.5 and permeability values ranging from -0.032 to -0.016. The corneas were clear after the 10 minutes of treatment with the test substance. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -0.2 to 1.0 after 10 minutes of treatment with the test substance. The test substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.4 after 10 minutes of treatment. Since the test substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Any other information on results incl. tables
Interpretation of the results:
- In vitro irritancy score
The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score: in vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Additionally the opacity and permeability values were evaluated independently to determine whether the test substance induced irritation through only one of the two endpoints. The IVIS cut-off values for identifying the test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given hereafter:
< or = 3: no category,
>3 and < or = to 55: no prediction can be made,
> 55: category 1.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance did not induce ocular irritation through both endpoints (cornea opacity and permeability) and was therefore considered non-irritant to cattle eye.
- Executive summary:
A study was conducted to determine the in vitro eye irritation potential of the test substance according to OECD guideline 437 (bovine corneal opacity and permeability (BCOP) test), in compliance with GLP. Bovine corneas were exposed to the undiluted test substance for a period of 10 minutes (followed by a post-incubation of 2h with fresh medium). Opacity and permeability were measured and an in vitro irritancy score was then established. Physiological saline and ethanol were used as negative and positive controls, respectively. The corneas treated with the test substance showed opacity values ranging from 0.0 to 1.5 and permeability values ranging from -0.032 to -0.016. The corneas were clear after the 10 minutes of treatment with the test substance. No pH effect of the test substance was observed on the rinsing medium. The in vitro irritancy scores ranged from -0.2 to 1.0 after 10 minutes of treatment. The individual in vitro irritancy scores ranged from 0.5 to 1.5 for the negative control and from 53 to 72 for the positive control. The corneas treated with the positive control were transluscent after the 10 minutes of treatment. The negative and positive control values were within the expected range; hence the experiment was considered valid. Under the study conditions, the test substance did not induce ocular irritation through both endpoints to cattle eye, resulting in a mean in vitro irritancy score of 0.4 after 10 minutes of treatment. Since the test substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage (Eurlings, 2016).
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