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EC number: 853-587-8 | CAS number: 199387-97-8
- 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
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- Flash point
- Auto flammability
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- Stability: thermal, sunlight, metals
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- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Specific investigations
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2022-04-04 to 2022-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
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)
- Version / remarks:
- 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(N-{2-[bis(carboxymethyl)amino]ethyl}nonanamido)acetic acid
- EC Number:
- 853-587-8
- Cas Number:
- 199387-97-8
- Molecular formula:
- C17 H30 N2 O7
- IUPAC Name:
- 2-(N-{2-[bis(carboxymethyl)amino]ethyl}nonanamido)acetic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Test material form: white to off-white crystalline powder
- Batch No.: LFND3B1003
- Storage conditions: 2 - 8 °C
- Expiry date: 01 August 2025
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: LFND3B1003
- Purity: 100% (HPLC)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test item was used as provided by the sponsor and moistened wit ha drop of physiological saline 0.9% NaCl.
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Abattoir Vion Beef B.V., Buchloe, Germany
On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in corneal holders (Duratec GmbH) with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI 1640 medium (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI 1640 medium). The posterior chamber was always filled first. The corneas were incubated for one hour at 32 ± 1 °C to allow equilibration.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): enough test item to completely cover the cornea (due to the low density of the test material less than 750 mg sufficed for completely covering the cornea which is conformity to OECD guideline 437)
- Concentration (if solution): The test item was moistened with a drop of physiological saline
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 0.9%
- Lot/batch no. (if required): 21412415 - Duration of treatment / exposure:
- 4 hours ± 5 minutes
- Duration of post- treatment incubation (in vitro):
- The optical density at 490 nm was measured upon 90 minutes of incubation with fluorescein after exposure to the test item by using a spectrophotometer.
- Number of animals or in vitro replicates:
- 3 corneas each for the test item, solvent control and positive control
- Details on study design:
- NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: physiological saline 0.9% NaCl
POSITIVE CONTROL USED: 20% imidazole
APPLICATION DOSE AND EXPOSURE TIME: enough test item to completely cover the cornea was applied; 4 hours ± 5 minutes incubation
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
After incubation the test substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI 1640 medium (without phenol red). The anterior chamber was refilled with complete RPMI 1640 medium (without phenol red) and an illuminance measurement was performed.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer (BASF-OP3.0, Duratec GmbH). Calibration was performed before the test and is documented in the raw data. The filter holder was placed into the opacitometer and the readout was adjusted to 1000 ± 10 lux using the “Calibrate”-turning knob. For calibration the glass filter F2 was introduced into the filter holder. The readout lay in the range between 540-560 lux.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
- Others: Following treatment and washing steps, each cornea was observed visually and pertinent observations were recorded.
SCORING SYSTEM:
In Vitro Irritancy Score (IVIS) = mean opacity value + (15x mean permeability OD490 value)
DECISION CRITERIA: As indicated in the OECD TG 437:
- IVIS ≤ 3: No Category
- 3- >55: Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of triplicates
- Value:
- 0.34
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not specified
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control (opacity 2.07; permeability 0.043).
- Acceptance criteria met for positive control: Due to the fact that the IVIS of the positive control did not fall within two standard deviations of the current historical mean in the first experiment, it was not considered to be valid. Therefore, the experiment was repeated. The results of both experiments are reported, noting that data from the first experiment is invalid and is not considered for experimental outcome in the present study. All data presented refers to the 2nd experiment. In the second experiment the in vitro irritation score obtained with the positive control fell within two standard deviations of the current historical mean and therefore this assay is considered to be valid (Range of historical mean IVIS Score of Positive Control: 83.91 - 155.02).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, based on the mean in vitro irritation score of 0.34 obtained in the bovine corneal opacity and permeability assay (BCOP, OECD 437), the test item can be considered to be non-irritant and no classification for eye irritation/serious eye damage is warranted.
- Executive summary:
The eye irritation potential of the test item was investigated in the bovine corneal opacity and permeability assay (BCOP, OECD 437). The test item N-[2-[bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)Glycine (purity: 99%) was directly applied on the cornea and moistened with a drop of 0.9% NaCl. A mean in vitro irritation score of 0.34 was determined. The positive and negative controls induced the appropriate responses, indicating the validity of the assay. Based on the results obtained, no classification for eye irritation/serious eye damage is warranted.
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