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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study according to internationally accepted guidelines and GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Test item: IMIDAZOLE ETHANOL (CAS No. 24155-42-8)
Batch No.: L36066N
Physical state: Light-yellow powder
Active ingredient content (titrimetry): 92.1%
Impurities (HPLC): 9.18%
Storage: 15-30°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species and strain: New Zealand white rabbit
Source: S & K-LAP Kft.
Hygienic level during the study: good conventional
Number of animal: 3 males
Age of animals: adult rabbits, 16 weeks old
Body weight range at the beginning of the study: 3630 - 4100 g
Body weight range at the end of the study: 3850 - 4221 g
Acclimatisation time: 40 days in first animal, 41 days in second animal and 42 days in third animal
Animal health: Only animals in acceptable health condition were used for the test

Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as control.
Amount / concentration applied:
0.1 g of the test item was used for the study in undiluted state, as a single dose.
Duration of treatment / exposure:
The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours then 1 and 2 weeks after the application.
Number of animals or in vitro replicates:
3 male
Details on study design:
In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. In the initial test slight and moderate to severe irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. Moderate to severe irritant effects were observed 24 hour after treatment. Following treatment of the second animal, the second confirmatory test was conducted using a third animal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
other: 24h; 48h; 72h
Score:
0.66 - 2
Max. score:
2
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h; 48h; 72h
Score:
0
Max. score:
0
Irritation parameter:
other: redness (conjunctival)
Basis:
mean
Time point:
other: 24h; 48h; 72h
Score:
1.66 - 2
Max. score:
2
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
chemosis score
Remarks:
(conjunctival)
Basis:
mean
Time point:
other: 24h; 48h; 72h
Score:
2 - 3
Max. score:
3
Reversibility:
fully reversible within: 2 weeks
Irritation parameter:
other: conjunctival discharge
Basis:
mean
Time point:
other: 24h; 48h; 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 2 weeks
Irritant / corrosive response data:
Treated and control eyes were examined at 1, 24, 48 and 72 hours then 1 and 2 weeks after the application.
1 hour after the single application of test item into the eye of the rabbits, slight redness of the conjunctivae, slight to moderate chemosis of the conjunctivae, moderate to severe discharge of the conjunctivae and slight cornea opacity occurred. The area of cornea involved was greater than half, but less than three quarters or was greater than one quarter, but less than half.
24 hour after the treatment the signs of eye irritation became stronger. Slight to moderate redness of the conjunctivae, moderate to severe chemosis of the conjunctivae, severe discharge of the conjunctivae and moderate cornea opacity were detected. The area of cornea involved was greater than three quarters, up to the whole area in one animal and the area of cornea involved was greater than one quarter, but less than half (score 2) in two animals.
1 week after the treatment one animal became free of symptoms. Slight redness of the conjunctivae, moderate to severe chemosis of the conjunctivae, severe discharge of the conjunctivae and moderate cornea opacity were observed. The area of cornea involved was greater than three quarters, up to the whole area.
2 weeks after treatment all animals were free of symptoms, so the study was finished.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
In conclusion, test item “IMIDAZOLE ETHANOL” (CAS No. 24155-42-8) applied to the rabbits' eye mucosa, caused slight to severe conjunctival and moderate corneal irritant effects, fully reversible within 2 weeks. No systemic toxicity was observed on the day of the treatment and during the 2-week observation period.
The test item has been classified into GHS Category 2A.