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EC number: 274-660-5 | CAS number: 70528-90-4
- 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:
- Start of experiment: November 7, 1989; End of experiment: November 14, 1989; Study completion date: 14 November 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- .
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile
- EC Number:
- 274-660-5
- EC Name:
- 5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile
- Cas Number:
- 70528-90-4
- Molecular formula:
- C15H12ClN5O4
- IUPAC Name:
- 5-[(4-chloro-2-nitrophenyl)diazenyl]-1-ethyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 36019/F
Batch No.: EN 162190.96
Storage conditions: room temperature
Validity: October 1994
Safety precautions: gloves and face masks
Test material received: October 26, 1999
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The albino rabbit is the recommended species for Acute Eye Irritation/Corrosion studies.
- Animal strain: New Zealand white rabbits (Chbb:NZW)
- Breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Acclimatisation period: at least 5 days-
Group size and husbandry:
The test was performed on 3 female rabbits, checked for normal eye conditions, weighing between 2630 to 2860 g (approx. 9-13 weeks old) . The animals were housed individually in metal cages, identified by ear tattoo, kept at a constant room temperature of 20+3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day. The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml (42 mg)
- Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- 0.1 ml (42 mg) of FAT 36091/F was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 36091/F. A slit-lamp was used to facilitate the evaluation.
SCORING SYSTEM:
CORNEA
- Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
- Easily discernible translucent area, details of iris slightly obscured 2
- Nacrous area, no details of iris visible, size of pupil barely discernible 3
- Opaque cornea, iris not discernible through the opacity 4
IRIS
- Normal 0
- Markedly deepended rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
- No reaction to light, haemorrhage, gross destruction ( any or all of these ) 2
CONJUNCTIVAE
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal 0
- Some blood vessels definitely hyperaemic (injected) 1
- Diffuse, crimson colour, individual vessels not easily discernible 2
- Diffusy beefy red 3
CHEMOSIS
lids and/or nictating membranes
- No swelling 0
- Any swelling above normal (includes nictating membranes ) 1
- Obvious swelling with partial eversion of lids 2
- Swelling with lids about half closed 3
- Swelling with lids more than, half closed 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No abnormal increase in body weight was noted.
Any other information on results incl. tables
Individual eye scores
CORNEA | IRIS | CONJUNCTIVA | ||||
Animal number 310/F | Redness | Chemosis | ||||
ce | te | ce | te | ce/te | ce/te | |
After 1 hour | 0 | 0 | 0 | 0 | 0/2 | 0/1 |
After 24 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 48 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 72 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
Mean 24 -72 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 7 days | 0 | 0 | 0 | 0 | 0/0 | 0/0 |
CORNEA | IRIS | CONJUNCTIVA | ||||
Animal number 304/F | Redness | Chemosis | ||||
ce | te | ce | te | ce/te | ce/te | |
After 1 hour | 0 | 1 | 0 | 0 | 0/2 | 0/2 |
After 24 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 48 hours | 0 | 0 | 0 | 0 | 0/0 | 0/0 |
After 72 hours | 0 | 0 | 0 | 0 | 0/0 | 0/0 |
Mean 24 -72 hours | 0 | 0 | 0 | 0 | 0/0.33 | 0/0 |
After 7 days | 0 | 0 | 0 | 0 | 0/0 | 0/0 |
CORNEA | IRIS | CONJUNCTIVA | ||||
Animal number 318/F | Redness | Chemosis | ||||
ce | te | ce | te | ce/te | ce/te | |
After 1 hour | 0 | 0 | 0 | 0 | 0/2 | 0/2 |
After 24 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 48 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 72 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
Mean 24 -72 hours | 0 | 0 | 0 | 0 | 0/1 | 0/0 |
After 7 days | 0 | 0 | 0 | 0 | 0/0 | 0/0 |
ce=control eye
te= test eye
M=Male
F=Female
Body weights (q)
Animal N° | 310/F | 404/F | 318/F |
At start of test | 2860 | 2630 | 2670 |
After 3 days | 2870 | 2690 | 2840 |
After 7 days (end) | 2970 | 2760 | 2980 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed FAT 36091/F induced irritation of the cornea and conjunctiva when instilled into the conjunctival sac of albino rabbits.
- Executive summary:
The eye irritation in New Zaeland White after single application was performed to determined the irritant potency of the test item on the rabbit eyes. This test was based on the OECD Guideline No. 405, adopted May 12, 1981, by the OECD council, and on Annex V, part B of Council Directive 79/831/EEC (Commission Directive 84/449/EEC of April 25, 1984; Official Journal L251, September 19, 1984). 0.1 ml (42 mg) of FAT 36091/F was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. Because reactions were observed within 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. No effects were observed on corneal opacity, iris and chemosis. Mean 24/48/72h conjuctiva score was found to be 0.78. According to the EEC classification of the results obtained 24/48.72 hours after instillation FAT 36091/F can be classified as non-irritant to albino rabbit's eye. The eye reactions observed were reversible within 72 hours.
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