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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
Study period:
May 19 -may 26 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according draft of U.S. guideline and before GLP was in place. Reliable observations and reliable report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Principles of method if other than guideline:
Based on the draft guideline 163.81-4, FR 43, 163 of August 22, 1978. No difference to the final guideline identified.
GLP compliance:
no
Remarks:
study performed before GLP was in place.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Substance type: organic
- Physical state: liquid
- Storage condition of test material: In refrigerator (2-8°C) in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd, Sisseln, Switzerland
- Sex: male
- Weight at study initiation: 2-3 kg
- Housing: Individual housing in metal cages, numbered by ear tags
- Diet (e.g. ad libitum): ad libitum access to standard rabbit food, NAFAG No. 814
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours light per day

IN-LIFE DATES: From: To: May 19, 1980 to May 26, 1980

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was treated, the right eye was untreated and used as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml inserted into the conjunctival sac of the left eye
- Concentration (if solution): 100%
Duration of treatment / exposure:
3 animals: unrinsed, 3 animals: eyes rinsed about 30 sec after instillation
Observation period (in vivo):
7 days, examinatinos on day 1, 2, 3, 4 and 7
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals the eye was washed with physiological saline, in 3 animals the eye was not washed
- Time after start of exposure: 30 sec

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results
Irritation parameter:
other: Please refer to the table below in "Any other information on results incl. tables" field.
Reversibility:
other: Please refer to the table below in "Any other information on results incl. tables" field.
Remarks on result:
other: Please refer to the table below in "Any other information on results incl. tables" field.
Irritant / corrosive response data:
slightly irritant, see table

Any other information on results incl. tables

days after exposure mean reaction score (3 animals)
unrinsed eyes rinsed eyes
cornea iris conjunctiva cornea iris conjunctiva
Redness Chemosis Discharge Redness Chemosis Discharge
1 0.33 0 1.66 1.33 0.66 0 0 1 0.33 0.33
2 0.33 0 1.33 1 1 0 0 0.66 0.33 0.33
3 0 0 0.66 0.66 0.66 0 0 0 0 0
4 0 0 0.66 0.66 0.33 0 0 0 0 0
7 0 0 0.66 0.66 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not an eye irritant according to Regulation (EC) No 1272/2008.
Executive summary:

The eye irritancy was investigated in rabbits. The effect on the left eye of each three rabbits was scored after instillation of 0.1 ml of test material, either rinsed after 30 seconds of exposure or unrinsed. The right eyes were left untreated and used as control. The observation period was 7 days. There were slight effects on the cornea and iris visible for 2 days or less. The conjunctiva of an unrinsed eye of one rabbit remained reddened until the end of the observation period, all other animals did not show an effect on day 3 and thereafter.