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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:
Between June 1st, 1992 and June 18th, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A dose response was examined, well documented study. Restrictions due to it was not a GLP study, and there was no observations beyond 72 hours to assess reversibility.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSA 16CFR1500
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid at room temperature
- Analytical purity: not provided
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: Mineral oil
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
3 male and 3 female/group (2 groups)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
undiluted test substance
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Remarks:
undiluted test substance
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
undiluted test substance
Basis:
mean
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Remarks:
undiluted test substance
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
not specified
Other effects:
In groups treated with undiluted test substance:
Blistered appearance to the conjunctiva were observed in 6/6, 4/6, and 1/6 animals at 24, 48 and 72 h, respectively;
Blistered appearance to the nictitating membrane were observed in 2/6, 0/6, and 0/6 animals at 24, 48 and 72 h, respectively;

Any other information on results incl. tables

6/6 animals treated showed evidence of positive corneal, iritic, or conjunctival changes in response to undiluted (100%) test substance.                   

      Table 1: Mean Scores (24,48 and 72 hours) for 100% Test Substance

Corneal Opacity

Iris

Conjunctival Erythema

Conjuctival Edema

1.3

0.8

1.5

2.1

 

1/6 animals tested showed evidence of positive corneal, iritic, or conjuctival changes in response to 50% w/w test substance.

   Table 2: Mean Scores (24,48 and 72 hours) for 50% w/w Test Substance

Corneal Opacity

Iris

Conjunctival Erythema

Conjuctival Edema

0.0

0.0

0.3

0.2

No evidence of corrosion was noted in response to the test substance at 100% or 50%w/w concentrations.

No observations were made beyond 72 hours, therefore, the reversibility of the effects could not be assessed.

The mineral oil vehicle used as the dilute was determined to be a non-irritant in a separate study. 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The undiluted (100%) test substance is classified as an irritant, whereas the test substance at 50% w/w is classified as a nonirritant.
Executive summary:

An eye irritation study was performed using male New Zealand White rabbits according to the definition of the FHSA 16CFR1500. Two groups of 6 rabbits (3 male and 3 female) were administered with a single dose of 0.1 ml test material to one eye of each animal, and eyes were examined and graded for ocular reaction at approximately 24, 48 and 72 h following dose administration using the Draize method. Following the 24 h reading the eyes were rinsed with physiological saline. Based on these scores, the undiluted (100%) test substance is classified as an irritant, whereas the test substance at 50% w/w is classified as a nonirritant.