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Diss Factsheets

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: According to OECD 405 (1987).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

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

Test material

Constituent 1
Reference substance name:
SR 256, no further ID given
IUPAC Name:
SR 256, no further ID given
Test material form:
other: clear colorless liquid
Details on test material:
The test article was used as received.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zeland White rabbits were received from Ace Animals, Boyertown, PA and quarantined for at least 5 days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animals were examined according to the Draize technique for any evidence for irritation or abnormalities of the cornea, iris and /or conjuciva.
The animals weer hused 1/ cage in suspended cages. Bedding was palced beneath the cages and changed at least three times /week. Fresh purina Rabbit Chow was provided daily. Water was availabel ad libitum. The animal room, reserved exclusively for rabbits on acute test, was temperature controlled, had a 12 hour light/dark cycle and was kept clean and vermin free.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
-
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:

DOSING:
- One eyee of each rabbit was dosed. the contralateral eye served as a control. the test articel (0.1ml)was placed by syringe into the conjuctival sac, which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test substance.

TYPE and FREQUENCY of OBSERVATIONS:
Using a hand-held auxillary source of illumination, the treated eye on each rabbit was examined for irritation of the cornea, iri and conjuctiva at 1, 24, 48, 72 hours post dose and on day 7. Ocular reactions were graded accordingly to the numerical Draize technique.

ANALYSIS of DATA:
The primary eye irritation score of each rabbit was calculated from the weighted Draize scale. Mean total scores for each time period were also calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: hour 1
Score:
3.33
Max. score:
10
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: hour 24
Score:
20
Max. score:
30
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: hour 48
Score:
13.3
Max. score:
20
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: hour 72
Score:
3.33
Max. score:
10
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: hour 1
Score:
1.67
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
other: hour 24
Score:
5
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
other: hour 48
Score:
3.33
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
other: hour 72
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: hour 1
Score:
12
Max. score:
12
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: hour 24
Score:
13.3
Max. score:
14
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: hour 48
Score:
12
Max. score:
12
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: hour 72
Score:
4
Max. score:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
0
Irritant / corrosive response data:
Corneal opacity and conjuctival irritation, noted in 3/3 eyes, cleared by day 7. Iritis, noted in 3/3 eyes, cleared by day 3.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to scoring for eye irritation in this study the substance should according to the CLP-criteria be classified as Eye Irrit 2, H319
Executive summary:

An OECD 405 study was conducted in three New Zealand White female rabbits using conjunctival exposure to 0.1 ml of the substance SR 256 . Draize scoring was performed at 1, 24, 48, and 72 hours post dosing and the mean total scores were calculated. Corneal opacity and iritis occurred in all rabbits but cleared by day 7 and day 3, respectively.

According to scoring for eye irritation in this study the substance should according to the CLP-criteria be classified as Eye Irrit 2, H319