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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Specific details on test material used for the study:
Identification: Irone Alpha
Description: pale yellow liquid
Batch Number 9000372727
Stability of test item: Stable under storage conditions, expiration date 17-Feb-2002

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Rationale: Recognized by the international guidelines as the recommended test system
Source: Elevage Scienfitique des Dombes, F-01400 Chatillon sur Charlaronne / France
Number of Animals: 1 male and 2 females
Age at start of treatment: 14 weeks (male), 12 and 13 weeks (females)
Body weights at start of treatment: 2.8 - 3.1 kg
Identification: By unique cage number and corresponding ear number
Acclimatization: Five to six days under laboratory conditions after health examination. Only anomals without any visual signs of illness were used for the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml / animal
Duration of treatment / exposure:
The treated eyes were not rinsed after instillation.
Observation period (in vivo):
1, 24, 48 and 72 hours as well as 7 days after application.
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
Treatment
The eyes of the animals were examined one day prior to test item administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, Irone Alpha was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.

Observations
Viability/Mortality: Daily from delivery of the animals to the termination of test
Clinical signs: Daily from delivery of the animals to the termination of test
Body weights: At the start of acclimatization, on the day of application and at termination of observation

Irritation Scores
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commision Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours as well as 7 days after application.

Necropsy
All rabbits were sacrificed by an intravenous injection of NARCOREN into the ear at a dose of at least 1 ml/kg bosy weight and discarded.
No necropsy was performed on the animals sacrificed at termination of observation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corneal and iridal effects were observed. Some blood vessels of the conjunctivae/nictitating membrane were definitely hyperemic in all animals at the 1-hour reading. The slight redness was still observeed in one animal at the 24 hours. Slight swelling of the conjunctivae/nictitating membrane was still observed in all animals at the 1-hour reading. A slight redness of the sclera was seen n all animals at the 1- and 24- hour reading. It persisted in one animal at the 48 and 72 hurs, A slight watery discharge was noted on one animal at the 1-hour reading. All eye reactions were clear within 7 days after treatment.
Other effects:
No staining of treated eyes was observed.
No corrosion of the cornea was observed at any of the reading times.
The body weights of all the rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the referred classification criteria (EEC Commision Directive 93/21/EEC of April 27, 1993), Irone Alpha is considered to be 'not irritating' to the rabbit eye.