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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, test method comparable to guideline OPPTS 870.2400

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
no
Remarks:
(Pre-GLP)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
This is formulation of 49.2% of the test substance in water.
Specific details on test material used for the study:
- Name of test material (as cited in study report): Barquat MB-80
- Analytical purity: >93%
- Stability under test conditions: Test substance is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least five years under standard laboratory conditions.

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72h (no eye wash done)
Observation period (in vivo):
24, 48 and 72h
Number of animals or in vitro replicates:
6
Details on study design:
Removal of test substance:
- Washing (if done): Eyes were not washed throughout the study.
- Time after start of exposure: 72h
Scoring system: Ocular reactions were evaluated according to Draize scale for scoring ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24-72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(chemosis)
Basis:
mean
Time point:
other: 24-72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
The test substance produced severe and irreversible damage in rabbit eyes.

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the test substance produced severe and irreversible damage in rabbit eyes.
Executive summary:

A study was conducted to determine the eye irritation / corrosion potential of the test substance according to a method similar to OECD Guideline 405. The experiment was performed in rabbits. All six test rabbits received 0.1 mL of the undiluted test substance in one eye. The other eye remained untreated. Eyes were not washed throughout the study. After 24, 48 and 72 h, eyes were evaluated for ocular lesions according to the Draize scale. Under the conditions of the study, the test substance produced severe and irreversible damage in rabbit eyes (Wallace, 1975).