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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:
- 2016-10-28 to 2017-02-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- adopted 26 July 2013
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dated 23 October 2015
Test material
- Test material form:
- liquid: viscous
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 30 µL of the test item was applied, as supplied, to the cornea such that the entire surface of the cornea was evently covered with the test item. The test item was applied for 10 seconds and then rinsed from the eye with 20 mL of physiological saline at ambient temperature.
Concurrent negative control (physiological saline - Dutscher batch n° 3012316) and positive control (5% Benzalkonium chloride) were included in this experiment. The 5% Benzalkonium chloride was prepared as follows: 0.25 g of Benzalkonium chloride (Sigma, batch n° BCBQ4374V) was weighed in a flask qsp. 5 mL with physiological saline. The preparation was magnetically stirred during 10 minutes to obtain a colourless solution just before the administration. - Observation period (in vivo):
- All observations of the cornea and measurement of corneal thickness were performed using a Haag-Streit BP900 slit-lamp microscope with depth-measuring device n° I. For the measurement of corneal thickness, the slit-width was set at 9½ equalling 0.095 mm.
Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 0 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 75 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 1.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 120 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 2.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 180 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 2.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 240 min
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 0 min
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 75 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 10
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 120 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 12
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 180 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 240 min
In vivo
- Irritant / corrosive response data:
- Corneal opacity: maximal mean score = 2.3 at 240 min corresponding to ICE class IIII
Fluorescein retention: maximal mean score = 3.0 at 30 min corresponding to ICE class IV
Corneal swelling: maximal mean = + 13% at 240 min corresponding to ICE class II
Combination of the 3 endpoints: 1 x IV, 1 x III, 1 x II
The results obtained under these experimental conditions lead to the category 'No prediction can be made'.
Any other information on results incl. tables
The combination of the 3 endpoints for the positive control, Benzalkonium chloride, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.
The combination of the 3 endpoints for the negative control, physiological saline, was 2 x I, 1 x II. Therefore the negative control as 'No category' as expected.
Applicant's summary and conclusion
- Interpretation of results:
- other: No prediction can be made.
- Conclusions:
- In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions lead to the category 'No prediction can be made' as defined by the O.E.C.D. test guideline n° 438. Therefore, the test item is not predicted as causing sever eye damage (Caetegory) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing are required to establish a definitive classification.
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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