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EC number: 424-660-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 April - 17 April, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
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:
- -
- EC Number:
- 424-660-8
- EC Name:
- -
- Cas Number:
- 224631-15-6
- Molecular formula:
- Hill formula: C18H26N4O5S CAS formula: C18H26N4O5S
- IUPAC Name:
- 2,5-dioxopyrrolidin-1-yl (2S)-3-methyl-2-{[methyl({[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl})carbamoyl]amino}butanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Eight female rabbits from HRP Inc, Kalamazoo, Michigan weighing 2- 2.5 kg (approx. 13 weeks) on arrival were allowed to acclimatise for 7 days before treatment. 6 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 63 - 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:
- 0.1ml
- Duration of treatment / exposure:
- 0.1gl test material was placed in the conjunctival 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 and 7 after treatments. - Number of animals or in vitro replicates:
- 6 female rabbits
- Details on study design:
- On the day prior to treatment the eyes were checked by a veterinarian.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Score:
- ca. 2
- Max. score:
- 3
- Remarks on result:
- other: max duration 7 h; max value at end of observation period: 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Score:
- ca. 2.5
- Max. score:
- 4
- Remarks on result:
- other: max duration 7 h; max value at end of observation period: 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Score:
- ca. 1
- Max. score:
- 3
- Remarks on result:
- other: max duration 7 h; max value at end of observation period: 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Score:
- ca. 0.5
- Max. score:
- 1
- Remarks on result:
- other: max duration 7 h; max value at end of observation period: 1
- Other effects:
- Local irritation observed in the treated eye of all 6 rabbits included: corneal opacity (grades 1,2 or 3) , conjunctivial redness (grades 2 or 3), conjunctival chemosis (grades 3 or 4) and conjuctival discharge (grades 1, 2 or 3).
Iritis (grade 1) was noted in the eye of 5 rabbits.
Little or no improvement in the corneal or conjuctival irritation was noted in the treated eye of rabbits through day 7 of the observation period.
Any other information on results incl. tables
No overt signs of toxicity were observed in rabbits following test material application to the anterior surface of the eye in this study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Severe local irritation
- Conclusions:
- Abbott-133816.0 produced severe local irritation in the eye of all rabbits following a single application to the anterior surface of the eye in this study.
- Executive summary:
Abbott-133816.0 produced severe local irritation in the eye of all rabbits following a single application to the anterior surface of the eye in this study.
Little or no improvement in the corneal or conjuctival irritation was noted in the treated eye of rabbits through day 7 of the observation period.
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