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Diss Factsheets
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EC number: 919-701-6 | CAS number: 503157-00-4
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Source: 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.
Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- No correction was made for the purity/composition of the test substance.
A 20% (w/w) solution of FAT 40866/A TE was prepared in physiological saline (Merck, Darmstadt, Germany). The stock solution was treated with ultrasonic waves until the test substance had completely dissolved. - Duration of treatment / exposure:
- The medium from the anterior compartment was removed and 750 µl of either the negative control, positive control (20% (w/v) Imidazole solution) or 20% (w/w) test substance was introduced onto the epithelium of the cornea. 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 ± 1ºC. After the incubation the solutions were removed and the epithelium was washed at least three times with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation). Possible pH effects of the test substance on the corneas were recorded. The anterior and the posterior compartment were refilled with fresh cMEM and an opacity determination was performed without any further incubation. After the completion of the incubation period each cornea were inspected visually for dissimilar opacity patterns and the opacity determination was performed. To verify the results a repeat experiment was performed (Experiment 2).
- Observation period (in vivo):
- None
- Number of animals or in vitro replicates:
- None
- Details on study design:
- Acceptability of the assay:
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within the laboratory historical mean value.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean In vitro Irritation Score
- Value:
- 3.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean In vitro Irritation Score
- Value:
- 0.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- None
- Other effects:
- None
Any other information on results incl. tables
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 mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 115 in experiment 1 and 128 in experiment 2 and within the historical positive control data range.
It was therefore concluded that the test conditions were adequate and that the test system functioned properly. FAT 40866/A TE showed in vitro irritancy scores of 0.6, 0.5 and 10.8 after 240 minutes of treatment. Since one out of three corneas showed an IVIS above 3, the test was repeated to confirm the results, resulting in IVIS scores of -0.2 to 1.0. Therefore the value of 10.8 observed in the first experiment can be considered an outlier.
Finally, it is concluded that this test is valid and that FAT 40866/A TE is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
Since FAT 40866/A TE induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- It is concluded that this test is valid and that FAT 40866/A TE is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
- Executive summary:
Screening for the eye irritancy potential of FAT 40866/A TE using the Bovine Corneal Opacity and Permeability test (BCOP test).
This report describes the ocular irritation properties of FAT 40866/A TE on an isolated bovine cornea.
The possible ocular irritancy of FAT 40866/A TE was tested through topical application for approximately 240 minutes.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch BOP 04-13 (Lot: BS-MIF 975) of FAT 40866/A TE was a red-brown powder. The test substance was applied as a 20% (w/w) solution (750 μl) directly on top of the corneas.
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 mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 115 (experiment 1) and 128 (experiment 2) and within the historical positive control data range in two independent experiments. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
FAT 40866/A TE showed in vitro irritancy scores of 0.6, 0.5 and 10.8 after 240 minutes of treatment. Since one out of three corneas showed an IVIS above 3, the test was repeated to confirm the results, resulting in IVIS scores of -0.2 to 1.0. Therefore the value of 10.8 observed in the first experiment can be considered an outlier.
Finally, it is concluded that this test is valid and that FAT 40866/A TE is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
Since FAT 40866/A TE induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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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