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EC number: 812-491-6 | CAS number: 1312943-23-9
- 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
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
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- 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
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Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Nature of substance: Powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 66 mg (equivalent to 0.1 ml of bulk substance)
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Remarks:
- Mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Remarks:
- Mean score 1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Remarks:
- Mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 72 h
- Max. score:
- 2
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 1
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Max. score:
- 0
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 1
- Remarks on result:
- other: Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Following fluorescein application to the eyes of all three animals at 24 hours, 30% of the total cornea area in animal number 2 was stained indicating epithelial damage. A repeat of fluorescein treatment at 72 hours yielded negative findings. Immediately after fluorescein examination at 24 hours, both eyes of all three animals were rinsed with water. Residual test substance remained in the eye of animal no. 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The overall scores at 24, 48 and 72 hours for the three animals were 0, 1.7 and 0.3 for conjunctivae (redness), 0, 0.3 and 0 for chemosis, 0 for all animals for cornea and 0, 0.3 and 0 for iris. A maximum score of 2 was observed at 72 hours for conjunctivae (redness) and a maximum score of 1 was observed at 24 hours for chemosis and iris.
- Executive summary:
The test item was analysed for eye irritation effects on New Zealand White rabbits according to EU Annex V guidelines. Three rabbits were exposed to 66 mg of the test item in powder form (corresponding to 0.1 mL of bulk substance). The overall scores at 24, 48 and 72 hours for the three animals were 0, 1.7 and 0.3 for conjunctivae (redness), 0, 0.3 and 0 for chemosis, 0 for all animals for cornea and 0, 0.3 and 0 for iris. A maximum score of 2 was observed at 72 hours for conjunctivae (redness) and a maximum score of 1 was observed at 24 hours for chemosis and iris. Following fluorescein application to the eyes of all three animals at 24 hours, 30% of the total cornea area in animal number 2 was stained indicating epithelial damage. A repeat of fluorescein treatment at 72 hours yielded negative findings. Changes were fully reversible within 7 days. The test item is not classified for eye irritation.
The study is a GLP compliant, guideline experimental study and is acceptable for assessment with restrictions.
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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