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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study initiation date - 20 November 2020; Experiment start date - 21 November 2020; Experiment end date - 22 November 2020; Study completion date - 22 December 2020.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test Item name: FAT 75637/B TE
Batch no.: AT-0063765400
Manufactured date: 21 April 2020
Expiry date: 27 May 2025
Storage condition: Ambient (+15 to +25 °C)
Physical Appearance: Light yellow powder
Solubility: Insoluble in water
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- The bovine eyes were procured from local abattoir and transported in a jar containing Hank’s Balanced Salt Solution (HBSS) and penicillin-streptomycin (100 IU & 100 μg/mL) in an ice box.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The positive control (Chlorhexidine) & test item (FAT 75637/B TE) were applied to the corneas as neat (quantity sufficient to cover entire corneal surface area), whereas negative control (Distilled water) was applied 0.75 mL to the each cornea.
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 4 hours
- Number of animals or in vitro replicates:
- 3 corneas/group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- Procurement of corneas: The bovine eyes were procured from local abattoir and transported in a jar x containing Hank’s Balanced Salt Solution (HBSS) and penicillin-streptomycin (100 IU & 100 μg/mL) in an ice box. On day of experiment 25 numbers were found suitable for experiment.
- Dissection: On day of experiment, post pretest examination, eyes were dissected to isolate the corneas from surrounding tissue and then placed in a container of fresh HBSS (Hank Balanced Salt Solution).
- Mounting: The isolated corneas were mounted in the cornea holder, which separated holder into anterior and posterior chambers. During mounting, it was ensured that the epithelium of the cornea projected into the anterior chamber. The EMEM medium was added in to both the chambers and kept in an incubator (32 °C) for 1 hour.
- Opacity and Permeability: All the selected corneas for the study were tested for their opacity and permeability to calculate IVIS (In vitro irritancy score).
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Experiment 1
- Value:
- 1.765
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
The assay results are found to be accepted because the positive control i.e. Chlorhexidine used in this study has exhibited an IVIS score of 161.704 which fall between two standard deviations of the historical mean i.e 155-172.
Also, the negative control i.e. Distilled water response resulted in opacity and permeability values that are less than established upper limits for negative control opacity and permeability values.
Any other information on results incl. tables
Calculation of IVIS Score:
Treatment group | Mean Opacity value | Constant | Mean Permeability value | IVIS | Classification |
Negative control (Distilled water) | 0 | 15 | 0.0484 | 0.726 | No Category |
Chlorhexidine | 133 | 15 | 1.9136 | 161.704 | Category I |
FAT 75637/B | 2 | 15 | -0.0157 | 1.765 | No Category |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 75637/B referred as non eye irritant or as agent causing no serious eye damage, with the BCOP test method.
- Executive summary:
The evaluation of the ocular irritancy of FAT 75637/B was carried out using the Bovine Corneal Opacity and Permeability assay. This study was conducted according to OECD test guideline 437 in a GLP-certified laboratory. Sufficient quantity to cover entire corneal surface area of the test item (FAT 75637/B) and positive control (Chlorhexidine) was applied to each cornea by means of open chamber method. A volume of 0.75 mL of negative control (Distilled water) were applied on the corneal surface by means of open chamber method. The control and treated corneas were then subjected to the opacity and permeability measurements. In this study, the negative control (Distilled water) was classified as UN GHS No Category (IVIS score 0.726) and the positive control (Chlorhexidine) was classified under Category 1 (IVIS score 161.704). The test item FAT 75637/B exhibited an IVIS score of 1.765 and was classified under UN GHS “No Category”. From the results, it can be concluded as the test item FAT 75637/B referred as non eye irritatant or as agent causing no serious eye damage, with the BCOP test method.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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