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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:
weight of evidence
Study period:
12th March to 9th April 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Similar to OECD guideline and conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material used in this study was an amber viscous liquid, coded B8959-20-1. Composition data is held by the sponsor. It was received from the sponsor on February 21, 1990 and stored at ambient temperature. In the opinion of the sponsor, the test material is stable under the recommended storage conditions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: R and R Rabbitry, Stanwood, Washington, U.S.A
- Age at study initiation: The animals were 12-20 weeks old when dosed.
- Housing: The animals were housed individually in stainless steel support bar-bottom cages in an air-conditioned room.
- Diet (e.g. ad libitum): The animals were fed a daily ration of Purina Certified High Fiber Rabbit Chow #5325
- Water (e.g. ad libitum): Free access to water
- Acclimation period: Conditioning period of 4-10 weeks and examined for ocular defects before dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 46 - 66%
- Photoperiod (hrs dark / hrs light): The photoperiod was a 12-hour light/dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
1, 24, 48 & 72 hours after treatment and at days 7 & 14.
Number of animals or in vitro replicates:
6 animals for unwashed eyes and 3 animals for washed eyes
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After a 30-second exposure, both eyes of three of the rabbits were additionally rinsed with distilled water for one minute at a rate of approximately 250 milliliters per minute.

SCORING SYSTEM:
Irritation was graded using the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0
Reversibility:
other: no effects seen
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0
Reversibility:
other: no effects seen
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
1.8
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
In treated-unrinsed eyes, no corneal opacity or iritis was observed. Conjunctival redness, chemosis and discharge were observed at one through 24 hours. Conjunctival discharge cleared by 24 hours in treated-rinsed eyes. The mean 24-hour Draize score for treated-unrinsed eyes was 5.0/110. Conjunctival redness continued to Day 4 in rinsed eyes and Day 7 in unrinsed eyes. All eyes were clear by Day 10. Alopecia and flaky skin were observed around the eye to Day 14. Lackluster cornea, white material in the conjunctival sac, and a thickening of the conjunctival sac were also observed. Rinsing did not significantly affect the severity or persistence of irritation.

Any other information on results incl. tables

In treated-unrinsed eyes, no corneal opacity or iritis was observed. Conjunctival redness, chemosis and discharge were observed at one through 24 hours. Conjunctival discharge cleared by 24 hours in treated-rinsed eyes. The mean 24-hour Draize score for treated-unrinsed eyes was 5.0/110. Conjunctival redness continued to Day 4 in rinsed eyes and Day 7 in unrinsed eyes. All eyes were clear by Day 10. Alopecia and flaky skin were observed around the eye to Day 14. Lackluster cornea, white material in the conjunctival sac, and a thickening of the conjunctival sac were also observed. Rinsing did not significantly affect the severity or persistence of irritation.

Untreated-Rinsed Eyes: No corneal opacity or iritis was observed. Conjunctival redness was observed at one hour. All eyes were clear at 24 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No corneal opacity or iritis was observed. Conjunctival irritation persisted to Day 7, with a mean 24-hour Draize score for treated-unrinsed eyes of 5.0/110. The severity and persistence of irritation was comparable between rinsed and unrinsed eyes. The test substance is not classified as irritating under EU classifications.
Executive summary:

One-tenth milliliter of the test material was placed in the conjunctival sac of one eye in each of nine rabbits. Three of the rabbits were further treated after a 30-second exposure by rinsing the eyes for one minute with distilled water at a rate of approximately 250 milliliters per minute.

No corneal opacity or iritis was observed. Conjunctival redness, chemosis and discharge were observed at 1 through 24 hours. The mean 24-hour Draize score for treated-unrinsed eyes was 5.0/110. Conjunctival redness continued to Day 7. All eyes were clear by Day 10. The severity and persistence of irritation was comparable between rinsed and unrinsed eyes. The test substance is not classified as irritating under EU classifications.

The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating according to the dangerous substances directive, 67/548/EEC.