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EC number: 427-430-5 | CAS number: 54301-26-7
- 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:
- 17 November 1997 to 07 December 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- UG
- IUPAC Name:
- UG
- Details on test material:
- • Identification, reference : UG - batch 97302300
• Appearance white solid (pieces)
• Quantity received, packaging: 100 g, plastic box
• Date ofreceipt : November 10, 1997
• Laboratory reference: 97-3691
• Analytical sheet flot supplied
• Homogeneity test flot required for less than 28 days studies
• Storage: at room temperature, away from the light and heat
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Species, strain, supplier : New-zealand albino rabbit, Charles RIVER (76110 Saint Aubin Les Elbeuf France).
Reason for species selection the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex 3 females
If strong eyes effects are foreseeable, the test is performed in one animal. From the results obtained, the test may be flot realized in the two others.
- Average weight: 2.4 kg
- Identification: auricular ring
- Acclimatization : at least 5 days
- Housing, diet : environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individual housing on floor grid). Complete pelleted rabbit maintenance diet ERG]LAP Anco, COFNA (37018 - TOURS, FRANCE).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye as control
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- after 1h, 24h, 48h and 72 hour,up to 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After checking that the rabbit has healthy, defect-free eyes, the test material is placed at a dose of 0.1 ml or 0.1 g if test substance is pasty or solid in the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball.
The lids are then gently held together for about one second in order to prevent loss of the material.
The other eye, which remains untreated, serves as a control.
Afler a one hour period of contention, the animal is returned to its individual cage.
In this study, the test substance is used as such at the dose of 0.1 mI/eye (after pounding it in a mortar).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the 67/548/EEC order classification, the substance UG batch 97302300 should be considered as irritant to eyes (with formation of important ocular iesions).
- Executive summary:
The instillation of the substance UG - batch 97302300 at the dose of 0.1 ml into the eye of three rabbits, produced one hour after instillation, in ail the animals, the outbreak of diffuse purple enanthemae with important lacrimations and chemosis. A congestion ofthe iris was also noted in the 3 animals and a slight and partial opacification of the cornea was found in two of them.
24 hours afier instillation, these reactions were maintained and severe cornea lesions werc evidenced in the three rabbits. A pannus noted on the cornea of two rabbits on D9 was maintained till D19 for one of them and D21 for the second one. The reversibility of the ocular reactions was flot complete at the end ofthe 21-day-observation period in two of the animals.
According to the 67/548/EEC order classification the substance UG batch 97302300 is classified among the substances irritating to eyes (with important ocular lesions).
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