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EC number: 619-079-3 | CAS number: 949109-75-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a scientifically acceptable protocol, but not in compliance with GLP. There was limited information on the purity of the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See 'Principles of method other than guideline'
- Principles of method if other than guideline:
- The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with physiological saline 30 seconds after instillation of the test article. The treated eyes were examined with sodium fluorescein and an ultraviolet lamp at 24, 48 and 72 hours using the Draize scoring for ocular lesions.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Not applicable-UVCB
- EC Number:
- 619-079-3
- Cas Number:
- 949109-75-5
- Molecular formula:
- UVCB- Mixture of many formulae.
- IUPAC Name:
- Not applicable-UVCB
- Details on test material:
- Gernerol 122, Lot IKI6257
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- The treated eyes of six animals remained unwashed and three rabbits' eyes were irrigated with physiological saline 30 seconds after instillation of the test article.
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6 animals with no washout after test material instillation
3 animals with washout after test material instillation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- All scores in all animals were zero at all time points, except for one animal (out of the six animals the eyes of which were not washed out 30 seconds after instillation). Irritant effects were only present at the 24 hour reading (reported in the results table), which were fully reversible by the 72 hour reading.
Any other information on results incl. tables
Results: mean eye irritation scores (+/- S.D) at -
24 hours | 48 hours | 72 hours | |
6 eyes ( no wash out) | 4.7 (+/- 11.4) | 0 | 0 |
3 eyes washed 10 seconds after instillation | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the scoring and classification system employed by the study authors, the test substance is considered to be minimally (slightly) irritating to the eyes of rabbits without a washout, and non irritating with a washout 30 seconds after instillation. Only one animal had any irritant effects at 24 hours, which were fully reversible by 72 hours. In accordance with current guideline (EC 1272/2008), the results of the test are not considered irritating.
- Executive summary:
In a well conducted study to determine the ocular irritation potential of the test substance, 0.1 ml of test material (as 100%) was instilled in one eye of 9 white New Zealand rabbits.
The treated eyes were then examined with sodium fluorescein and a UV lamp at 24, 48 and 72 hours using the Draize scale for scoring ocular lesions. The treated eyes of the six animals remained unwashed and three rabbits' eyes were irrigated with physiological saline 30 seconds after instillation of the test article.Based on the scoring and classification system as shown above, Generol 122 is considered to be minimally (slightly) irritating to the rabbit eyes without a wash out and non irritating with a wash out 30 seconds after instillation.
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