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EC number: 414-810-0 | CAS number: - A-88820.605
- 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
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- Flash point
- Auto flammability
- Flammability
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- Endpoint summary
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- 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
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- Terrestrial toxicity
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- 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:
- 12 April - 03 May 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 92/69/EEC
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- EC Number:
- 414-810-0
- EC Name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- Cas Number:
- 144163-85-9
- Molecular formula:
- Empirical formula: C25H35N2O5
- IUPAC Name:
- butanedioic acid; propan-2-ol; bis(tert-butyl N-[(4R)-5-amino-4-hydroxy-1,6-diphenylhexan-2-yl]carbamate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Seven male rabbits from Charles River, Montreal, Canada weighing 2- 3 kg (approx. 10 to 15 weeks old) on arrival were allowed to acclimatise for 13 days before treatment. Six animals were assigned to the study.
The animals were housed in individual stainless steel ventilated hanging cages. 100 -130g Certified High Fibre Rabbit Chow was provided each day and water ad libitum. The temperature was maintained at 64 - 68°F. The animal room was on a 12 hour daily light cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other: right eye of each animal was untreated
- Amount / concentration applied:
- 40mg (which, when gently compacted, occupied a volume of approx.0.1ml)
- Duration of treatment / exposure:
- 40mg test material was instilled into the lower everted lid of the left eye. The material was placed in the conjuctival sac of the left eye after gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one or two second after treatment to prevent loose of material and then released. The right eye was left untreated to serve as the control.
- Observation period (in vivo):
- After the 24hr observation period the eyes of all rabbits were washed with lukewarm water.
All animals were observed daily for signs of ill health or toxicity.
Evaluations made at 1, 24, 48, 72 hrs and days 4, 7, 14 and 21 after treatments. - Number of animals or in vitro replicates:
- 6 male rabbits
- Details on study design:
- Prior to treatment the eyes were checked by a veterinarian.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 21 d
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 21 d
- Reversibility:
- other: minimal reversibility
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 21 d
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 21 d
- Reversibility:
- other: minimal reversibility
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 21 d
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 21 d
- Reversibility:
- other: minimal reversibility
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 21 d
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 21 d
- Reversibility:
- other: minimal reversibility
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 21 d
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 21 d
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 21 d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Severe corneal opacity , involving at least ¾ of the cornea was observed in all the rabbits in this study.
Opaque corneas were noted in four of the rabbits on day 14.
Severe chemosis and discharge were observed in all six rabbits during the observation period after treatment.
Severe conjunctival redness was noted in two rabbits with lesser degrees of redness noted in the remaining four rabbits.
Severity of chemosis, discharge and conjunctival redness decreased during the later observation periods and was minimal or not noted for each of the three irritation parameters at the final observation period.
Iritis scores were not determined during most observation periods due to the severity of the corneal opacity and the area of corneal involvement. However, in cases when it was possible to score for iritis, the iris appeared normal for this parameter.
Any other information on results incl. tables
Body weights were measured on the day of treatment.
Applicant's summary and conclusion
- Interpretation of results:
- other: Severe ocular damage
- Conclusions:
- Abbott-88820 succinate caused severe occular damage including severe ocular opacity, chemosis and discharge to the eye of rabbits in this study.
- Executive summary:
Abbott-88820 succinate caused severe occular damage including severe ocular opacity, chemosis and discharge to the eye of rabbits in this study.
Although the severity for chemosis, discharge and conjunctival redness decreased with time after treatment, opaque corneas were observed in four rabbits as late as day 14 of the observation period.
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