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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
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- Solubility in organic solvents / fat solubility
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- pH
- Dissociation constant
- Viscosity
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- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- 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
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- Terrestrial toxicity
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- Biotransformation and kinetics
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- 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:
- April - May 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye 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
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - odour: odourless
- color: colourless
- expiration date: 16 October 2020
Constituent 1
- Specific details on test material used for the study:
- - Storage conditions: Controlled room temperature (15-25°C, ≤70% relative humidity), protected from light and humidity (stored in a tightly closed container)
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: ROSS 308
- Details on test animals or tissues and environmental conditions:
- Source: TARAVIS KFT (Address: 9600 Sárvár, Rábasömjéni utca 129., Hungary)
Chicken heads were collected after slaughter in a commercial abattoir from chickens (approximately 7 weeks old) which are used for human consumption. Heads were collected by a slaughter house technician and heads transported to Charles River Laboratories Hungary Kft. at ambient temperature at the earliest convenience. After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then placed in a plastic box which was closed (4-5 heads per box). The heads were received at Charles River Laboratories Hungary Kft. and processed within 2 hours of collection.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg test item
- Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- Two experiments were conducted. In each experiment, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined.
- Details on study design:
- In each experiment after the zero reference measurements, the eye was held in horizontal position and 30 mg test item was applied onto the centre of the cornea in such a way that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with physiological saline. Positive control eyes were treated with 30 mg powdered Imidazole. The negative control eye was treated with 30 µL of physiological saline (0.9% (w/v) NaCl solution). In each experiment, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined. Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) were evaluated.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 1
- Value:
- 3.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: up to320 min; indication of slight irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 1.33
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: up to 240 min.; indication of slight irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1
- Value:
- 0.17
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: up to 240 min.; indication of slight irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 2
- Value:
- 2.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: up to 240 min; indication of slight irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 2
- Value:
- 1.33
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: up to 240 min.; indication of slight irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 2
- Value:
- 0.33
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: up to 240 min.; indication of slight irritation
- Other effects / acceptance of results:
- Experiment 1:
Minimal corneal swelling change (mean = 3.9%) was observed during the four-hour observation period on test item treated eyes. Slight cornea opacity change (mean = 1.33) was observed. Minimal fluorescein retention change (mean = 0.33) was noted. Minimal amount of test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse. No other morphological effect was observed.
Experiment 2:
Minimal corneal swelling change (mean = -1.1%) was observed during the four-hour observation period on test item treated eyes. Slight cornea opacity change (mean = 1.33) was observed. Minimal fluorescein retention change (mean = 0.33) was noted. Minimal amount of test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse. No other morphological effect was observed.
Minimal amount of test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse.
Any other information on results incl. tables
Experiment I |
||
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
3.3% |
I |
Mean maximum corneal swelling at up to 240 min |
3.9% |
I |
Mean maximum corneal opacity change |
1.33 |
II |
Mean fluorescein retention change |
0.17 |
I |
Other Observations |
Minimal amount of test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse. |
|
Overall ICE Class |
2xI 1xII |
Experiment II |
||
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
1.6% |
I |
Mean maximum corneal swelling at up to 240 min |
2.2% |
I |
Mean maximum corneal opacity change |
1.33 |
II |
Mean fluorescein retention change |
0.33 |
I |
Other Observations |
Minimal amount of test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse. |
|
Overall ICE Class |
2xI 1xII |
SUMMARY TABLE FOR UN GHS CLASSIFICATION
Criteria for “No category” (all true) |
|
3 endpoints classed as I or 2 endpoints classed as I and 1 endpoint classed as II or 1 endpoint classed as I and 2 endpoints classed as II: |
True |
No severe corneal morphological changes: |
True |
Test item was not stuck to the cornea at 240 minutes after the post-treatment rinse: |
False* |
Criteria for “Category 1” (one or more true) |
|
2 or more endpoints classed as IV: |
False |
Corneal opacity ≥ 3 at 30 min (in at least 2 eyes): |
False |
Corneal opacity = 4 at any time point (in at least 2 eyes): |
False |
Severe loosening of epithelium (in at least 1 eye): |
False |
Criteria for “No prediction can be made” (one or two true) |
|
Based on the endpoints not classifiable for No Category, or for Category 1: |
False |
Particles of test item were stuck to the cornea and could not be washed off during the study: |
False* |
* Minimal amount of test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse. The cornea surfaces were considered clear enough to make a valid visual assessment of any effects and this fact had no impact on classification of the test item
The test item showed no corneal effect in the first experiment. As the test item was solid, the negative results were confirmed by a second experiment according to the recommendations of the OECD No. 438 guideline. The second experiment confirmed the negative results. Therefore, based on thesein vitroeye irritation tests in isolated chicken eyes, the test item was non-irritant, UN GHS Classification: No Category.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these in vitroeye irritation tests in isolated chicken eyes, the test item was found to be non-irritant (UN GHS Classification: No Category).
- Executive summary:
An in-vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline. The test item showed no corneal effect in the first experiment. As the test item was solid, the negative results were confirmed by a second experiment according to the recommendations of the OECD No. 438 guideline. The second experiment confirmed the negative results. Minimal amount of test item (negligible) was observed on the corneal surfaces any eyes in experiments at 240 minutes after the post-treatment rinse. This fact had no impact classification of the test item. Therefore, based on these in vitroeye irritation tests in isolated chicken eyes, the test item was non-irritant, UN GHS Classification: No Category.
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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