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EC number: 430-910-7 | CAS number: 13335-71-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 September - 21 October, 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
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:
- 430-910-7
- EC Name:
- -
- Cas Number:
- 13335-71-2
- Molecular formula:
- Hill formula: C10H12O3 CAS formula: C10H12O3
- IUPAC Name:
- 2-(2,6-dimethylphenoxy)acetic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six male rabbits from Covance Research Products Inc, Kalamazoo, Michigan weighing 2- 2.5 kg (approx. 14 weeks old) on arrival were allowed to acclimatise for 14 days before treatment. 5 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 67 - 70°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:
- 46mg (which, when gently compacted, occupied a volume of approx.0.1ml)
- Duration of treatment / exposure:
- 46mg 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:
- 5 male 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:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: not specified
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: not specified
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 21 d
- Reversibility:
- not specified
- Remarks on result:
- other: no score provided
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 21 d
- Reversibility:
- not specified
- Remarks on result:
- other: no score provided
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The maximum irritation grades observed in the treated eye of rabbits in this study were: corneal opacity (grades 2 or 3), involving at least ¾ of the cornea, iritis(grades 1 or 2), conjunctivial redness (grade 3), conjunctival chemosis (grades 3 or 4) and conjuctival discharge (grades 2 or 3).
Signs of irritation were completely reversible in one rabbit by day 7, by day 14 in a second rabbit and by day 21 in a third rabbit.
Corneal opacity was observed in the eye of the remaining 2 rabbits on day 21. In addition, grade 1 conjunctival chemosis and discharge were noted in one of the same two rabbits on day 21.
Any other information on results incl. tables
Body weights ranged from 2.4 to 2.6kg on the day of treatment. No apparent treatment-related body weight changes were observed during the observation period following treatment.
Applicant's summary and conclusion
- Interpretation of results:
- other: Severe irritation
- Conclusions:
- Abbott-172245.0 produced severe irritation in the treated eye of rabbits in this study.
- Executive summary:
Abbott-172245.0 produced severe local irritation in the eye of rabbits in this study.
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