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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented pre-guideline study without GLP. Observations can be re-assessed according to present day criteria based on available data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
A different method has been used to evaluate the study. The Draize score reading is available and therefore data can be translated in the OECD 405-type of evaluation.
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
FR 43, No., 163, Aug. 22, 1978
Principles of method if other than guideline:
The primary eye irritation index was determined by summing the mean reaction scores for cornea, iris and conjunctivae after 1, 2, 3 and 7 days and divided by 5.
After instillation of the substance into the conjunctival sac, the treated eye was flushed with physiological saline in three out of six animals.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Batch: 502834

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ivanovas, 7964 Kissleg/Allgau, germany and Madorin AG, 4114 Fullinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individual housing in metal cages
- Diet (e.g. ad libitum): Rabbit standard food, NAFAG No. 814 (Nafag, Gossau, Switzerland)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 14/10.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each animal was not treated and served as an untreated control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
In three out of six animals approximately 30 seconds after tretament the treated eye was flushed with 10 mL physiological saline.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
The test material in an amount of 0.1 mL was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. In 3 out of six animals approximately 30 seconds after tretament the treated eye was flushed with 10 mL physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: 246, 247 and 248 (rinsed eye)
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: 248
Time point:
other: 48 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Redening of the conjunctivae with vessels definitely above normal was noted in all three animals with rinsed eyes at the 24-hour reading and persisted in one animal at the 48-hour reading. No irritant effects were noted in the unrinsed treated eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the condition of the study the test material was found to cause minimal irritation when applied to rabbit eye and does not have to be classified with respect to eye irritation.
Executive summary:

The primary eye irritation potential of the test material was investigated according to US EPA, FR Vol. 43, No. 163, August 22, 1978. The test item was applied by instillation of 0.1 mL into the left eye of each of six adult New Zealand White rabbits. Approximately 30 seconds afer treatment the treated eye was flushed with physiological saline in three out of six animals. Scoring of irritation effects was performed approximately 24, 48 and 72 hours as well as 4 and 7 days after test item instillation.

The instillation of the test material into the eye resulted in mild, early-onset and transient ocular changes, such as conjunctival reddening. These effects were reversible and were no longer evident 48 hours or 72 hours after treatment. No abnormal findings were observed

in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye and does not have to be classified with respect to the eye irritation.